Recently in Dangerous Side Effects Category

The Risks of Painkillers for Pregnant Women

April 14, 2014

a-whole-galaxy-of-multi-colored-uppers-downers.jpgRecent reports show that physicians are prescribing opioid painkillers to expectant mothers in exceedingly high numbers, even though the risks and potential dangers to developing fetuses are presently unknown. Dangerous drug lawyers at Pintas & Mullins take a closer look into this report and the possible repercussions of this troubling trend.

The new research analyzed over one million pregnant women enrolled in Medicaid, which is a federal program that covers medical expenses for about 45% of U.S. births. Researchers concluded that nearly 23% of pregnant women on Medicaid filled a prescription for an opioid painkiller in 2007, which is a marked increase from 2000 and the largest percentage to date. This amounts to one in five women using opioids during pregnancy.

Other research shows that among women using private health insurance, the amount that is prescribed an opioid painkiller holds steady between 12 and 14%. These figures are disconcerting for many reasons - first, because of how many women are so uproariously concerned about the effects of minor food and drug products on their pregnancies. Doctors note that they see many, many women who are worried about the effects a cup of coffee or piece of sushi may have on their pregnancy - but then turn around and pop an oxycodone.

The top-prescribed painkillers were codeine, hydrocodone, and oxycodone, and women were typically prescribed for short periods, about a week or less. Prescription rates were highest in the mountain states (Utah, Idaho) and in the South, and lowest in the Northwest and Northeast. The difference between the regions was stark, and concerning to researchers.

It is hard to believe, one doctor noted, that the Southern pregnant women suffer from that much more pain than expectant mothers in the Northeast. Further reinforcing the concern, opioid prescribing rates varied widely not only between states and regions, but between counties as well. This suggests an overall lack of attention and diligence to potential abuses.

Learning From the Past

The risks pharmaceuticals pose to fetuses are never known until it is too late - less than 10% of all medications in the U.S. have been adequately studied for effects on fetuses. Take, for example, the recent litigation and devastating stories from women who took an SSRI antidepressant while pregnant.

Expectant mothers who took medications like Prozac, Zoloft, Paxil, Celexa and Lexapro were giving birth to children with heart defects, limb and muscle malformations, and other severe disorders. Study after study confirmed the increased risk for mothers on SSRIs, and lawsuits began to be filed in large numbers. Litigation against SSRI drug manufacturers is ongoing, and mothers concerned that their child's birth defect was caused by a prescription should consider contacting a birth injury lawyer immediately.

Doctors are now seeing an increase in neural tube defects in children born to mothers taking opioids during pregnancy, particularly in first trimester use. Researchers note that opioid use in very early pregnancy translates to about double the risk of infant neural tube defects. Prolonged use of these drugs can also result in addiction in infancies, which is clinically referred to as neonatal abstinence syndrome.

In response to these troubling reports, the CDC recently established a Treating for Two initiative (website here), which aims to help doctors and patients treat ailments during, before and after pregnancy. The initiative aims to improve the health of mothers and children and prevent birth defects overall.

Some experts note that rising obesity rates may result in an increase in chronic back pain for pregnant women, which may help explain rising prescriptions; the most common ailments pregnant women on opioids suffer from are back and abdominal pain. Doctors note that there are many other alternative therapies, such as physical therapy or acupuncture, which would better help these ailments.

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Actos Plaintiff Receives $9 Billion Jury Award

April 9, 2014

952313_gavel.jpgThe jury is out, and the manufacturers of Actos, the once-popular type 2 diabetes medication, are now ordered to pay $9 billion (yes, with a 'b') to a man who developed bladder cancer from the medication. The award is the seventh-largest in U.S. history, and there thousands more Actos cases still to be heard. Actos attorneys at Pintas & Mullins take a closer look at Actos' first U.S. trial and what it could mean for other Actos plaintiffs.

The defendants in this case, Eli Lilly and Takeda Pharmaceuticals, are accused of many things in this Actos litigation, ranging from designing a defective drug to intentionally covering up its true side effects. The jury decided on such a large amount in part because of the seriousness of the drugs' side effects, and in part due to the poor conduct of Lilly and Takeda during the trial.

The plaintiff in this case, Terrence Allen, like too many others, developed bladder cancer from taking Actos, which was prescribed to help him manage his type 2 diabetes. The drug was introduced in 1999 and quickly became one of the hottest medications on the market; sales peaked in 2011, at $4.5 billion.

Allen and other Actos plaintiffs argue that the drugmakers knew the medication could cause cancer and chose not to adequately warn doctors and patients in efforts to boost drug sales. Pharmaceutical executives are accused on intentionally downplaying the risk of bladder cancer and misled the FDA about its true safety.

The link between Actos and bladder cancer was scientifically proven in 2004, but the manufacturers refused to acknowledge the association until 2011, when it finally placed warning labels on the drug at the request of federal regulators.

Allen was prescribed the drug in 2006 - meaning after the medical and pharmaceutical community knew of the link between Actos and bladder cancer, but before Lilly and Takeda decided to properly warn patients on the drug. He developed bladder cancer five years after he started taking the drug.

Evidence and Documents Destroyed

One of the most egregious aspects of this case, apart from the seriousness of the injury itself, was how Takeda and Lilly handled its events. Going back to 2004, when the bladder cancer risk was associated, Takeda executives sent internal emails stating that Actos was vital to the company's financial survival and to drag out placing a cancer risk on warning labels as long as possible.

These emails were produced in court because both Takeda and Lilly were under court orders to preserve all documents regarding Actos as evidence. Despite this order, Takeda failed to preserve much of its internal Actos documents - whether this was done intentionally or not is a point of debate, but after lawsuits started being filed the company destroyed the files of over 45 former and current employees, including top executives and sales representatives, so you be the judge.

Regardless, the evidence about how much Takeda knew and when was largely lost, so the judge penalized Takeda by telling jurors that the files may have strengthened and supported Allen's arguments about the company's wrongful information withholding.

Many believe that this document destruction bolstered the jury's award decision, to punish a drug company acting with such malice and disregard for not only patient safety but legal proceedings as well. This was the first bellwether trial in the Actos multi-district litigation (MDL), which consolidates thousands of Actos cases before a single judge in Louisiana.

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The Link Between Diabetes Medicines and Cancer

April 7, 2014

3949274968_1569515128_m.jpgMillions of Americans - over 8% of the population - have diabetes, the majority of which is type 2 diabetes. This makes the drug market for this condition extremely attractive and profitable to pharmaceutical companies around the world. Unfortunately, in its haste to develop new and better diabetic medications, Big Pharma is not testing these drugs for long-term safety risks, leaving millions of patients vulnerable to unknown, unstudied side effects. Diabetes drug lawyers at Pintas & Mullins take a closer look at some of the most dangerous diabetic medications.

What makes the issue particularly frightening is that researchers do not yet know exactly why different drugs affect cancer risks in diabetic patients. In the case of pancreatic cancer, which is most recently linked to metformin (Fortamet, Glumetza, Riomet, Glucophage), the differences in medical history between those who develop cancer and those who do not is minimal. Meaning, medical experts do not really know why the drugs spur cancer development in some patients over others.

Pancreatic cancer is also significantly associated with Januvia, Janumet, Byetta and Victoza, which are diabetic drugs in a class known as incretin mimetics. They are typically injected, and there has been massive litigation surrounding these drugs after it became clear they were causing pancreatic injury.

Pancreatic cancer is one of the most fatal cancers because it spreads incredibly fast and is extremely difficult to diagnose in its early stages, when it is easiest to remove or treat. The issue at center of the recent litigation against incretin mimetic manufacturers is that they knew, or reasonably should have known, that these drugs could cause cancer, and failed to inform doctors and patients.

Merck, which developed Januvia, failed to conduct safety studies in patients with a history of pancreatitis, even though this was a known risk factor for the drug. This seems even more negligent when one considers the three major risk factors of developing pancreatic cancer: excess body weight, pancreatitis, and diabetes. Researchers are now trying to differentiate between cancer incidence because of taking certain drugs, and what may simply be the result of a poor diet and lack of physical activity in patients with diabetes.

For some patients, the link is inarguable. One woman was in her mid-70s when she passed away from pancreatic cancer. Other than her diabetes diagnosis, she was otherwise pretty healthy and active, and prescribed to Januvia in 2006 to help her maintain her blood sugar. Just over a year after starting the medication she was diagnosed with pancreatic cancer, and died within month. The woman's daughter has filed a claim against Merck on her mother's behalf, accusing the company of designing a defective drug, failing to warn about the pancreatic risks, and negligent misrepresentation.

Actos and Bladder Cancer

Another medication for type 2 diabetes, Actos, has been subject to a mass of litigation due to its association with bladder cancer. The defendants in these cases, Eli Lilly and Takeda Pharmaceuticals, are accused of similar counts of negligence and failure to warn as Merck. Government drug agencies in many countries, including Germany and France, have pulled Actos from their markets because of the cancer risks, however, the FDA has failed to take any such action and it remains on American market.

In recent trial proceedings Actos plaintiffs called the Eli Lilly executive in charge of global marketing to testify on the drug and its sales materials. In his testimony, the executive showed a stunning lack of knowledge about the drugs' marketing despite previous statements that he was readily familiar on the drug. This type of lack of compliance with federal and legal proceedings is, unfortunately, not uncommon for Big Pharma.

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Steroid Drugs May Cause Heart Attack after Surgery

April 2, 2014

3428173616_c8b18b49ba_b.jpgA study recently revealed that certain steroids may increase the risk of heart attack when administered after surgery. The drug, Medrol (methylprednisolone), is typically prescribed to treat asthma, allergic reactions, and inflammation. Dangerous drug lawyers at Pintas & Mullins examine the risks of taking this drug, and who may be most vulnerable.

The study was presented at an American College of Cardiology conference by researchers from Ontario, Canada. This finding is important because inflammation after cardiac surgeries such as cardiopulmonary bypasses is very common, and physicians typically prescribed a steroid like Medrol to relieve the inflammation.

Inflammation after cardiac surgery can cause a series of health complications, some more severe than others. Specifically, it can cause an abnormal or irregular heartbeat and respiratory problems, which were the primary reasons physicians prescribed steroids to these patients. Researchers noted that there needs to be more study on how to reduce the risk of irregular heartbeat in cardiac surgery patients without using steroids or other risky medication.

The study was conducted in 80 medical facilities from 18 countries, and included over 7,500 adult patients. The average patient studies was 67 years of age and about 60% were male, most of the cardiac surgeries were for valve problems and coronary artery bypass grafting (CABG).

Medrol is typically given in 500 mg doses intravenously during the operation, however, the steroids failed to improve patient outcomes after 30 days. This statement was not influenced by patient age, gender, surgery type or length, or diabetic status. In sum, the study found that prescribing Medrol did not improve patient outcome, though it did increase the risk of suffering a heart attack after surgery.

Researchers are not aware, however, why exactly the steroid was causing heart attacks in some patients. They did provide a few potential explanations: first, that Merdol was interfering with white blood cells' ability to migrate and repair heart injury; and second, that perhaps the steroid caused resistance to insulin in the bloodstream, which would prevent glucose from helping the heart recover from surgery.

Drug Safety Trials Need Improvement

This study was unique in that it examined data from patients in so many different countries, from so many different demographics. Problems have been raised by advocacy groups in the U.S. recently over the lack of diversity in our clinical trial system.

In response, the FDA Commissioner recently stated that the agency would be launching an action plan to promote greater diversity in trial patient populations, and confirmed that there is a troubling gap in our drug and medical device safety data. She further assured public advocacy groups that the FDA will create a real solution to recruit more women, Latinos, African Americans, and other demographics.

Most clinical trials in the U.S. include a significantly higher ratio of white male patients, which then influences how pharmaceutical and medical device companies report their data on safety and efficacy. There are several reports noting that racial minorities are underrepresented in clinical trials, and many are now urging the FDA to make such diversity a requirement for all future trials.

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Weight-loss Drug Alli Recalled over Defects

March 28, 2014

8675484534_f5b59b1f8d.jpgOne of the country's most popular weight-loss drugs, Alli, is being recalled because of wide-spread tampering. The drug's manufacturer, GlaxoSmithKline (GSK), confirms at least a dozen consumer complaints from seven states. Drug recall lawyers at Pintas & Mullins are here to help anyone who was injured by a dangerous or defective medication.

GSK recently released a statement on the recall, detailing reports by consumer who found a range of different types of tablets and capsules inside Alli bottles. Some bottles were also missing labels or had protective seals that were clearly not made by GSK.

Fortunately, the company stated that it had not yet received any reports of serious consumer illnesses. Authentic Alli pills should be turquoise blue capsules with dark blue bands, imprinted with "60 Orlistat," which is the active ingredient.

The seven states from which the defective reports came are: Alabama, Florida, Louisiana, Mississippi, New York, North Carolina, and Texas. The FDA has joined GSK in its investigation into the tampering. In 2010, the FDA issued a public warning regarding another case of Alli tampering. A fraudulent company had started manufacturing fake Alli pills and selling them online under the label.

Alli was introduced in 2007 to a highly-anticipatory consumer base. It is the first FDA-approved over-the-counter diet pill, meant for overweight adults who struggle to lose excess pounds. It is a reduced strength version (60 mg) of Xenical (120 mg), which is a prescription drug to treat obesity.

Links to Permanent Liver and Kidney Damage

Two years after its approval, the FDA launched an investigation over concerns that Alli was causing severe liver injury, however, the agency found no causative relationship. The labels to both Alli and Xenical were changed to alert consumers of the symptoms of liver problems, such as yellowing of the eyes or skin, brown urine, and itching.

Several studies released in past years have linked Alli to kidney, liver, and other organ damage. The University of Rhode Island conducted a study in 2012, funded by the National Institutes of Health, on Alli and its potential to cause major organ damage. Researchers also found that Alli interfered with many different types of medication, including cancer treatments and blood thinners. They found that Alli in fact accelerated cancer cell growth.

The drug works by slightly inhibiting the absorption of fat in the intestines, which therefore decreases the number of calories the body takes in. Specifically, the drug disables lipase, which is an enzyme that helps break down dietary fat. When this enzyme is inhibited, fat goes undigested and continues through the intestines, into the colon and is eventually eliminated through waste.

The drug does have some gross side effects, which is (thankfully) beyond the scope of this article, but those considering starting on the pill should definitely be aware of them. The Mayo Clinic's page on Alli can be found here. Patients who should not take Alli include: those with problems absorbing food, anyone who has had an organ transplant, and those taking cyclosporine (brand name Neoral, Sandimmune, etc).

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Experts Concerned About Human Growth Hormone Health Risks

March 25, 2014

399336089_5ffcdfbbe4.jpgTestosterone therapy lawyers at Pintas & Mullins warn aging adults about another similar product hitting markets hard - human growth hormones, or HGH. Analysts predict these drugs will rise significantly in sales in the next few years, introducing a slew of serious health problems to American patients.

HGH drugs are biochemical agents that stimulate cell growth and division in the body, helping improve the appearance of skin, muscle tone, and other 'anti-aging' benefits. The drugs were traditionally prescribed to teens and children with low natural supplies of HGH to help them grow and develop normally. In recent years, healthy older adults have taken to requesting the drugs for their purported superficial benefits.

The market for these types of drugs is so large, that by 2018, officials estimate that HGH drugs will reach $4.7 billion in sales. This is similar to the trajectory of similar products marketed to men, such as AndroGel, which are known as testosterone therapy drugs.

Like testosterone therapies, recent studies have linked synthetic hormone products to troubling and often serious health problems. One such study, published in the journal Aging Cell in February 2014, noted that replacing or supplementing hormones in aging adults may not be a positive development.

There is proof of this in the recent past. Several years ago, physicians started recommending estrogen replacement therapy for female patients aged 50 and older, to stave off the physical effects of menopause. After some time, reports of stroke and breast cancer in women prescribed to estrogen therapies started proliferating. Then, official reports began conclusively finding that these hormones were related to increased risk of cardiac events and even breast cancer development.

Similarly, testosterone therapies like AndroGel and Testim have been subject to massive litigation after otherwise healthy male patients started suffering strokes, heart attack and cardiac death. It is becoming quite clear that the body's supply of hormones naturally decreases. Testosterone levels subside in men, and estrogen levels decline in women. This causes a plethora of side effects, some worse than others, but it is completely natural.

As stated, the FDA originally approved synthetic growth hormones for children who had atypically low levels. Unfortunately, recent data suggests that those children who received HGH drugs during childhood actually had a 30% increased risk of early death compared to the general population.

In adults taking HGH drugs, there is now definitive proof that the increased muscle from the drugs does not translate into actual increased strength. In other words, the muscles are all form, no function - muscles only work optimally when the neural pathways in the brain are repaired, which is beyond the scope of HGH drugs. Read more about the true nature of HGH drugs here.

Another notable risk for older adults taking HGH includes the possibility of cancer development. Type of cancer is not specified, but one group of researchers found that older people with higher growth hormone levels showed a fourfold heightened risk of cancer and 75% increase in general fatality. Overall, they concluded, human data overwhelmingly states that adults are better off not taking an HGH drug.

In essence, it is critically important for older adults considering a hormone therapy regiment to really think about their goals. For a small subset of patients, with real hormone disorders like hypogonadism, these drugs are worth the risks. For most, they simply are not.

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Topamax Birth Injury Plaintiff Awarded $3 Million

March 11, 2014

108998111_cb8565130c.jpgTopamax lawyers at Pintas & Mullins announce that a jury in Pennsylvania recently awarded $3 million to the family of a child born with a cleft lip after doctors prescribed Topamax to her mother. This is the third such case to go to trial, all of which have concluded in favor of the plaitniff.

Topamax (topiramate) is an anti-epileptic drug intended to treat seizures and chronic migraines. The mother in this case, Kelly Anderson, was prescribed Topamax throughout her pregnancy to treat chronic migraines. After her daughter was born with a cleft lip in 2009, Anderson started reading up on the incidents of cleft lips and palates in children exposed to the drug in utero.

She found and ultimately revealed in court that Topamax's manufacturer, Johnson & Johnson subsidiary Janssen Pharmaceuticals, knew about the risk of craniofacial birth defects as early as 2000. Despite this knowledge, Janssen never requested that Topamax be listed as a Pregnancy Category D medication, which warns patients and physicians of the fetal risks.

As a direct result of this negligence, Anderson argues, she was unaware that she was taking a drug during her pregnancy that could cause cleft lip in her child. It was not until March 2011 that the FDA official recognized Topamax as a Pregnancy Category D medication. The Anderson family filed suit in December of that year.

Cleft lips and palates are not merely cosmetic birth defects; the more severe cases can lead to hearing loss, psychological challenges, and speaking and eating problems. Corrected a cleft lip or palate can often require numerous surgeries, which can be financially impossible for many families.

Hundreds of Children Affected

There are over 130 similar Topamax lawsuits pending against Janssen, which have been consolidated in Philadelphia as part of a multi-district litigation (MDL). A previous lawsuit ended October 2013, when a jury awarded the family of a child born with a cleft palate $4 million. The child in that case needed five surgeries to correct the birth defects caused by Topamax.

By far the highest-awarding trial for plaintiffs was in November 2013, when a Philadelphia jury awarded a family $11 million. The plaintiff in this case, a stay-at-home mother whose son suffered a cleft lip, successfully argued that Janssen long knew of the risks of birth defects in Topamax patients and intentionally hid or minimized them.

The child in this case will need at least five more surgeries before his 21st birthday to correct the facial deformities, which also caused nasal problems. The mother claimed that Janssen operated in a culture of secrecy and intentionally worded labels inadequate and inappropriate.

Another of the 134 Topamax birth defects lawsuits began in late February 2014. Beyond these cases, Janssen previously agreed to pay over $80 million to settle an investigation by the U.S. Department of Justice over the drug's marketing.

The DOJ was responding to reports that Janssen improperly marketed Topamax for psychiatric use, which was never approved by the FDA. The federal government got involved when physicians started billing Medicare and Medicaid for Topamax prescriptions to treat psychiatric disorders such as binge eating, bipolar, and bulimia nervosa disorders.

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New Cholesterol Drugs Linked to Brain Disorders

March 10, 2014

lipitor-bottle_l.jpgThe FDA recently announced that it was aware that patients taking new, experimental drugs to treat high cholesterol were suffering adverse cognitive events. The new drugs, developed by Sanofi and Regeneron, are known as PCSK9 inhibitors. Cholesterol drug lawyers at Pintas & Mullins explain the potential side effects among these and other cholesterol-lowering drugs.

Both Pfizer and Amgen are also currently developing PCSK9 inhibitor medications, which investors are watching very closely and with high expectations. An estimated one in six adults, or about 17% of the population, has high cholesterol according to the CDC. This condition is a major factor in the development of heart disease and diabetes, and many patients need medications to maintain normal cholesterol levels in addition to diet and lifestyle changes.

The most popular class of cholesterol-lowering drugs is known as statins, and includes drugs like Crestor, Lipitor, and Zocor (UPDATE: generic Lipitor was recently recalled, read more here). These medications block the liver's ability to produce LDL, or "bad" cholesterol and are prescribed to about 20 million Americans.

Similarly, PCSK9 drugs block the protein that maintains the presence of LDL cholesterol in the blood. In the most recent clinical trials, the FDA observed adverse neurocognitive side effects, such as memory loss and confusion, in patients. As a result, the agency has requested that Sanofi and Regeneron consider including neurocognitive tests in at least one group of patients.

Statins are also linked to adverse neurological side effects, including Lou Gehrig's disease, though for statin patients memory loss may be the least of their worries. Statins, particularly in high doses, are associated with extensive liver damage, muscle damage (rhabdomyolysis) and type 2 diabetes.

The FDA recently required all statin drugs to include the risk of increased blood sugar and type 2 diabetes, specifically among women. The side effects associated with cholesterol drugs have become increasingly serious, with patients losing their jobs due to memory loss and confusion, and being diagnosed with diabetes despite lifestyle changes.

It is important for patients to realize that once you decide to begin a medication to help lower your cholesterol, you will likely have to stay on it indefinitely. The only exception is in patients taking significant measures to change their diet and lifestyle. Factors that contribute to high cholesterol and can be changed through will alone include:

• Smoking
• A diet high in fat, salt and of course, LDL cholesterol
• Lack of exercising (about 30 minutes per day)
• Heavy alcohol use
• Stress and anger management
• Being overweight or obese

The FDA has been criticized in the past for failing to warn patients and physicians early enough about the risks of drugs. It seems that they are increasing the effort to be as transparent as possible and make the public aware of possible side effects. The warnings regarding PCSK9 drugs are part of the FDA's oversight of new drug development.

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FDA Approves Testosterone Injection Despite Heart Attack Concerns

March 7, 2014

doctor-greating-patient_l.jpgTestosterone therapy lawyers at Pintas & Mullins confirm that the FDA recently gave the nod to a new injectable T-Therapy drug by Endo Pharmaceuticals. The federal agency approved this new drug in the midst of medical concern about the actual safety and efficacy of T-Therapy. Several recently published studies have linked these drugs to significantly increased risks of heart attack, stroke, and cardiac death.

This is the third attempt at approve for Endo's new drug, Aveed. According to reports, the agency and Endo finally agreed on a risk evaluation strategy that will try to prevent extreme post-injection reactions. Apparently there is significant risk of patients suffering a pulmonary oil microembolism (POME) and a specific type of life-threatening allergic reaction known as anaphylaxis.

Anaphylaxis is the same allergic reactions suffered by those severely allergic to bee stings or peanuts. The body goes into shock, airways narrow, and normal breathing become impossible, even causing death in some cases. Similarly, POME can cause serious respiratory distress in some patients, and is often seen in body builders injecting oil-based steroids. It can also cause unconsciousness, circulatory collapse, and loss of bowel function.

Endo first filed for Aveed's approval in 2007. It was previously denied so many times because FDA experts were concerned that there was no way to tell who was at risk of suffering severe reactions. To address this, Endo agreed to include a black box warning on Aveed's labels, a training program for physicians who will prescribe and administer the drug, and other actions that would limit inappropriate use.

Aveel is the first long-acting T-Therapy drug, which will only be able to be administered in clinical offices, with a 30 minute waiting time post-injection. Patients with hypogonadism will receive one initial injection, another four weeks later, and a third injection after ten weeks.

Other risks associated with this injection include prostate enlargement, sleep apnea, liver toxicity, and venous thrombosis, or blood clots in the vein which can ultimately lead to fatal pulmonary embolisms. More minor complications include insomnia, acne, irritability, and fatigue.

Studies Link Testosterone Treatments Linked to Serious Cardiac Risks

Very quickly after the FDA approval was announced patient advocacy groups started asking for its reversal. Highly esteemed medical journals have published studies linking T-Therapy products to high rates of heart attack, stroke, and cardiac death, even among otherwise healthy men.

In response, the FDA announced in January 2014 that it would launch an investigation into these findings. One physician, Dr. Sidney Wolfe, sent a letter to the FDA Commissioner regarding the agency's reckless treatment of these products. He urged the agency to include black box warnings on all T-Therapy products warning patients about the very real risks of suffering cardiac event while on the medication. He also called the FDA's approval of Aveed "unsafe and unreasonable."

Black box warnings are the most serious alert the federal agency can required drugs to include on their labels, and are typically reserved for drugs associated with a heightened risk of death. What makes this issue so egregious is that the benefits of T-Therapy drugs are, at best, limited.

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Paxil Manufacturer Responsible for Attorney Suicide

March 5, 2014

Thumbnail image for 2169000524_ca20ccf787.jpgA judge in Illinois recently ruled that GlaxoSmithKline, the manufacturer of popular antidepressant Paxil, can be held liable for an attorney's suicide even though he was prescribed a generic version of the drug. Paxil attorneys at Pintas & Mullins take a closer look at this ruling and why it is so significant.

A major issue facing pharmaceutical courts is whether or not Big Pharma can or should be responsible for injuries suffered by patients who took generic versions of their drugs. In this case, a corporate and securities attorney was prescribed the antidepressant Paxil, and, sadly, six days after starting the drug, committed suicide.

The man's wife consequently filed a lawsuit against GlaxoSmithKline (GSK), along with the Mylan Inc., the company that manufactured the generic version. She claimed that the drug companies failed to provide adequate warnings on the antidepressants, specifically that adult patients were at a heightened risk of suicidal thoughts and behavior (referred to as " suicidal ideation").

The judge overseeing the case threw out Mylan as a defendant because, under federal law, generic manufacturers are required to include the exact same labels and warnings and brand names (Mutual Pharmaceutical v. Bartlett). The judge stated that, although GSK cannot be held strictly liable for his suicide, it can be found negligent for failing to properly warn patients.

He further agreed that his suicide was directly connected to his antidepressant prescription. He came to this conclusion by consideration of four factors:

• GSK owes a duty to their patients

• Suicidal thoughts and behavior were foreseeable side effects from the medication

• This injury was likely to occur in adult patients

• GSK knew that generic companies would have to include the same exact labels as Paxil

The risk of suicide is a known side effect of antidepressants like Paxil and GSK has known about this since at least the early 2000s. The fact that drugs prescribed to treat depression often do not work, and actually cause or worsen it, is another issue for another blog post.

Only a specific class of antidepressants, SSRIs, carries this risk, however. Among them include Paxil, Prozac, Celexa, Lexapro, Zoloft, Effexor, Wellbutrin and Cymbalta. In May 2006 the FDA acknowledged that Paxil in particular demonstrated high rates of suicide in depressed adults, citing several scientific trials. The agency noted that depressed adults were 6.4 times more likely to have suicidal ideation while on an antidepressant than while taking a placebo pill.

Experts have been warning about this since the early 1990s, basing their assertions on suppressed or hidden data from companies like GSK. To this point, the most recent ruling against GSK is very important. In the judge's words, "that GSK did not manufacture the pill," that caused the attorney's suicide is irrelevant. Warnings of suicidal ideation should have been included on Paxil's labels from the beginning, as GSK was more than aware of it. Had the warnings been on Paxil's labels, they would have also been on the generics. This, he said, is precisely the point.

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Zometa Patient Awarded Over $1 Million

February 25, 2014

3446796287_53bba9189b.jpgPatients who took Zometa, a medication prescribed to treat a type of cancer, are now reporting serious side effects from the drug and filing lawsuits against its manufacturer, Novartis. This drug, a bisphosphonate like Fosamax, is causing jawbone death in patients throughout the country. Fosamax lawyers at Pintas & Mullins detail the similarity between these two drugs and their devastating side effects.

Zometa is prescribed to treat hypercalcemia along with complications from multiple myeloma and other cancers. The most recent plaintiff, Nancy Guenther, was part of the multi-district litigation (MDL-1760), which is located in the Middle District of Tennessee and also involves the bisphosphonate Aredia.

Guenther was fighting cancer when she was prescribed Zometa and claims she was never informed of the risk of bone death. Indeed, at the time she was prescribed, there was no indication on Zometa's labels of this risk despite knowledge by Novartis that the drug could cause the jaw bone to die and deteriorate.

The judge in her case asserted that Novartis knew or reasonably should have known about the association between Zometa and jawbone death. Zometa was approved in 2001, and around 2004 reports started flooding in to the FDA concerning serious side effects from the drug.

More Bisphosphonates More Problems

Bisphosphonates - which include Zometa, Fosamax, Reclast, Boniva, and more - are commonly used to treat and prevent osteoporosis and other bone density issues. In an ironic twist of fate, these drugs that are supposed to make bones stronger are actually causing extreme, often life-changing bone fractures in many patients, most notably in those who take them for longer than one year. The drugs are also associated with an increased risk of atrial fibrillation, esophageal cancer, and kidney impairment.

The FDA first started warning of these issues back in 2010 (the initial Safety Communication can be found here). Even before that, as early as 2007, the agency was aware of and investigating the risk of atrial fibrillation in bisphosphonate patients.

The atypical bone fractures that result from bisphosphonate use occur in the femur bone just below the hip joint. The femur is the largest, strongest bone in the body, which is what makes these injuries so severe and disconcerting. Atypical femur fractures account for less than 1% of all hip and femur fractures in the general population, however, an inordinate amount of patients taking bisphosphonates suffer the injury. You do the math. Notably, the FDA specifically asserted in its 2010 Safety Communication that the femur fracture warning did not apply to Zometa.

This is not to say that Zometa is without its own risks, evidenced by several multi-million dollar payouts to patients injured by the drug. Bloomberg recently reported on a $10.45 million verdict in favor of a Zometa patient, who suffered bone jaw death from the drug. This was the second-largest among similar cases concerning the drug; the first was for $12.8 million, awarded to a woman in North Carolina in 2010.

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FDA Overhauls Medication Ads

February 24, 2014

4216206720_5e080c0365.jpgBig Pharma knows the value of a great television commercial and how important advertisements can be in enticing the public to buy their latest drugs. In its efforts to heighten oversight and regulation, the FDA recently asked for more research to be done into how these ads could be improved, to in turn improve patient outcomes. Dangerous drug attorneys at Pintas & Mullins hope this call for research will actually reduce the prevalence of serious and unnecessary side effects.

The FDA study is entitled "Disclosure Regarding Additional Risks in Direct-to-Consumer (DTC) Prescription Drug Televisions Advertisements," which refers to the long-winded list of possible side effects present at the end of every medication commercials. You know the commercials I'm talking about - let's take a more recent example, for testosterone therapy in men of certain age.

The ads usually play during sports games or other male-oriented programs, and depict a man in his 40s or 50s, with his wife, talking about his symptoms of low testosterone. Testosterone decreases in men as they age, just as estrogen decreases in women. Symptoms of this natural occurrence are different for everyone, but can include low energy, decreased libido, irritability, and changes in fat distribution.

The man in the commercial discussed his issues with his doctor, who diagnosed him with "low T." This is where AndroGel comes in to save this man, his wife and his Ford Mustang, from the completely natural phenomenon of low T (even though AndroGel was only approved for treatment of low T in conjunction with another medical disorder). The narrator then spends about 40 seconds detailing the possible side effects of AndroGel, which are vast and extremely severe. This list, often delivered with Busta Rhymes-like rapidity, is known as the major statement.

Too Little To Late?

This is what the FDA is now attempting to fix. There have been many Saturday Night Live sketches satirizing these commercials and their laundry lists of extreme, often fatal side effects. Many believe the FDA hopes to shorten the major statement in favor of listing only the "serious and actionable" risks. It is also important to note that the agency is actively seeking our public comment on how to improve major statements. A link to comment can be found here.

The argument is that consumers become desensitized to drugs' real dangers (such as death or heart attack) when they are cataloged between a list of a dozen more trivial side effects (such as nausea or skin irritation). According to an NPR article, the agency has been considering this type of change for years along with academics, medical experts, and Big Pharma.

Many believe that cutting back on the catalogue of information and instead referring patients to physicians for more information is the correct change. In turn, drug makers will have to make drug labels easier to read and understand. There are numerous studies that examine how people remember and track information given to them. Among their findings, researchers concluded that the order or information really does affect whether it is remembered and slower speech improved understanding.

Conversely, data by the Pharmaceutical Research and Manufacturers of America show that direct to consumer marketing does not actually work that well in conveying true risks of drugs. The group asserts that advertisements are good at one thing and one thing only: increasing drug sales. This causes not only misunderstandings about possible side effects, but also leads to overtreatment.

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Paxil's Link to Breast Cancer

February 21, 2014

2169000524_ca20ccf787.jpgPaxil attorneys at Pintas & Mullins report on a new study that suggests a link between popular antidepressant Paxil and breast cancer development. Researchers conducted a survey of nearly 450 drugs and found that Paxil stood out as having a particularly unique chemistry that could promote the development of breast tumors.

Paxil (paroxetine) was recently re-branded as Brisdelle to treat hot flashes and other symptoms of menopause. This is worrisome for several reasons, not least of all because of this new association with breast cancer. Paxil is prescribed most commonly to treat symptoms of depression, and women are 70% more likely than men to experience depression in their lifetime, according to the National Institute of Health.

Additionally, both breast cancer and menopause are known to cause or worsen depressive symptoms, which could in turn lead doctors to prescribe Paxil. As many as 25% of women currently undergoing treatment for breast cancer are also battling depression, making these new findings even more pertinent.

First Birth Defects, Now Breast Cancer, What's Next?

Paxil was approved by the FDA in 1992 as part of a class of antidepressant drugs labelled selective serotonin reuptake inhibitors (SSRIs). Other well-known drugs part of this class includes Celexa, Effexor, Lexapro, Zoloft and Prozac. More than a decade after Paxil was introduced, several studies emerged proving that these drugs cause serious, life-changing birth defects in infants born to mother who took an SSRI while pregnant.

In 2005, a team of Danish researchers analyzed their country's medical database and confirmed that women who took an SSRI like Paxil during pregnancy were 60% more likely to birth a child with a severe congenital heart defect. Other birth defects linked to SSRIs include lung conditions like PPHN, limb malformations, such as cleft lip or palate, and neural tube defects.

These findings spurred mass litigation against Paxil manufacturer, GlaxoSmithKline, among other SSRI manufacturers. By 2010, Glaxo had paid over $2 billion to resolve Paxil birth injury lawsuits.

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Over 2,000 Pradaxa Lawsuits Filed

February 14, 2014

7866565462_241dea3e9e.jpgMore than 2,000 plaintiffs are now part of the Pradaxa multidistrict litigation (MDL) that formed just over a year ago. Plaintiffs in this MDL claim that Pradaxa's manufacturer, Boehringer Inhelheim International, misled patients about the true risks of severe bleeding and other injuries related to the drug. Our team of Pradaxa attorneys will continue to update readers as the MDL moves forward.

Pradaxa is a popular blood thinner originally touted as a replacement to warfarin, which has been the most commonly prescribed blood thinner used for about six decades. The drug was approved in 2010 and was an instant blockbuster, earning Boehringer over $1 billion in sales. Just a few months after its approval, however, more than 300 patients reported serious bleeding complications after taking the drug, many of which resulted in wrongful death.

Boehringer Behaving Badly

When the MDL was approved, there were just over 20 injury lawsuits pending against Pradaxa's manufacturer. Today, as stated, there are over 2,000. In December 2012, just four months after MDL approval, the judge slapped Boehringer with a $1 million penalty for failing to produce thousands of documents related to the trial. According to the complaint, Boehringer acted in bad faith in destroying the relevant documents, which could have had immense impact on plaintiffs' arguments.

One week after the penalty was issued the judge ruled that Boehinger may be even more severely punished for its bad faith throughout trial. Meaning, should the issue arise in court the jury will be informed of Boehringer's misconduct. The company may also be subject to additional fines, or may be banned from making specific arguments during trial.

Specifically, Boehringer destroyed or otherwise failed to preserve documents related to its former executive Thorstein Lehr, including smartphone and computer relevant to court proceedings. Lehr was a top-level scientist for Boehringer who specifically worked on Pradaxa research products.

In addition to Lehr's data, Boehringer also destroyed evidence from a number of its sales representatives, medical liaisons, and clinical science consultants. Much of this information was contained on Boehringer's shared network, "G Drive," which the company claimed was plagued by production issues.

The Trouble with Pradaxa

Overall, bleeding events associated with Pradaxa use are not any more prevalent than those associated with warfarin. The problem lies in the complete lack of remedy for Pradaxa patients. Those prescribed to warfarin who suffer any incident of bleeding can be easily treated with Vitamin K, or a number of other easily-accessible remedies. In Pradaxa patients, however, there is no known treatment to stop bleeding.

In other words, if a patient with atrial fibrillation is prescribed Pradaxa to thin the blood, and that patient suffers even a minor accident -such as a fall or cut - that patients could bleed to death on hospital tables while doctors watch, helplessly. This exact incident has occurred more times than we know. Doctors throughout the country report scenes of minor injuries leading to catastrophic death because the patient was unable to stop bleeding from Pradaxa.

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Diabetes Drug Onglyza Investigated for Heart Failure Risk

February 12, 2014

2340891984_4150ba0447.jpgThe FDA recently announced its plans to investigate the type 2 diabetes drug Onglyza (saxagliptin) and its association with heart failure. The federal agency requested clinical trial data to analyze from the drug's manufacturer, AstraZeneca. Our team of Onglyza lawyers hopes that this investigation will lead to more restrictions on this dangerous drug.

Onglyza is an oral tablet used along with diet and exercise to control high blood sugar levels in patients with type 2 diabetes. It is often prescribed in combination with another drug, Kombiglyze XR, to increase the amount of insulin the body produces after meals.

This investigation is in reaction to a study recently published in the New England Journal of Medicine, which found a substantially increased rate of hospitalization for heart failure in Onglyza patients. Surprisingly, despite the increased risk of heart failure, the study did not note any increased rates of death, heart attack or stroke in the same patients.

Diabetes Drugs Subject to Heightened FDA Scrutiny

AstraZeneca has until March 2014 to submit its clinical trial data to the FDA. According to its website, this Onglyza investigation is part of a broader evaluation of all medications that treat type 2 diabetes. With the epidemic of diabetes in the United States, the list of medications to treat this ailment is long, complex and confusing to many patients. As more and more Americans are diagnosed with this disorder, the amount of prescriptions written and filled is also rising in extreme rates.

There are risks and side effects that come with any type of medication, whether it is for diabetes or osteoporosis. The main concern with type 2 diabetes medications is the heightened risk of cardiovascular side effects, and, in one particular class, the risk of pancreatic cancer (this refers to recent litigation over Byetta, Victoza, Januvia and Janumet. More information can be found here).

The clinical trial at issue over Onglyza is called SAVOR-TIMI 53 (SAVOR), and was published in September 2013. SAVOR enrolled nearly 16,500 patients and placed half on the medication and half on a placebo. Ultimately, about 3.5% of Onglyza-prescribed patients had to be hospitalized for heart failure - which happens when the heart does not pump blood well enough -compared to just over 2% of placebo patients.

Increased Risks without Any Clear Benefits

Since the FDA is merely taking a closer look into the SAVOR trial and not conducting a new, larger Onglyza study, it is quite unlikely that this investigation will provide any clear-cut or definitive answers. The drug was approved in 2009, and is among AstraZeneca's best-selling medications, with sales expected to top $1 billion in 2015.

As stated, diabetes medications are booming in the U.S. despite lack of substantial evidence that they can do more for patients than diet and exercise alone. According to the Mayo Clinic, healthy lifestyle choices (weight control, daily physical activity, diet and portion control), provide the foundation for managing type 2 diabetes. Yes, in severe cases some patients may require medication to achieve optimum blood sugar levels, however, for most patients this is not the case.

Drug companies want you to depend on their medications, or more ideally, depend on a combination of their medications (Onglyza + Kombiglyze). Diabetes drugs are among AstraZeneca's five priority growth areas, so it has a large incentive to keep these drugs on market and in the cabinets of diabetics. The actual benefits of medications like Onglyza and AstraZeneca's other top-selling drug, Crestor, compared to their risks is ominous at best.

Crestor, for example, is now the subject of major litigation throughout the country. The drug is a statin intended to treat high cholesterol (which, coincidentally, can also be managed best through healthy lifestyle changes alone) and is associated with serious heart-related conditions. Among them include congestive heart failure, irregular heartbeat, strokes and heart attack, to name only a few.

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