Recently in Dangerous Side Effects Category

How Big Data is Helping the FDA Track Drug Complications

July 22, 2014

rosy-glasses-crimson-pills.jpgThe FDA is tasked with the immense responsibility of tracking adverse events, both major and minor, from over-the-counter and prescription medications. Recognizing the seeming impossibility of spotting serious side effects before they become a national problem, the agency is now looking toward big data for help. Dangerous drug attorneys at Pintas & Mullins detail this new effort, and how it could involve your own personal medical records.

This new government project, called Mini-Sentinel, costs around $116 million, and will mine national databases of medical records for adverse events from medications (this does not include supplements, as they are not regulated by the FDA). The current system used by the FDA to track adverse events is notoriously sub-par - it relies on voluntary reports from patients, doctors and pharmacists. The information received in this outlet, then, is random and cannot reflect true patient outcomes.

The director of the FDA's Center for Drug Evaluation and Research stated that the agency desperately needs a faster way to monitor drug safety. In its effort to do so, the FDA contracted with Mini-Sentinel, which manages the health records of nearly 180 million Americans. Almost all data used by the FDA is from billing records, meaning the agency is not looking at the actual doctor charts and notes, just codes from tests and procedures done for patients.

It took five years to build the pilot program and the team notes that it is impossible to mine the data based on individual doctors or patients, so privacy is kept intact. Mini-Sentinel is now a routine part of the FDA's safety monitoring, conducting hundreds of queries per year.

Real Problems, Real Solutions

If the FDA notices a trend of side effects from a certain drug, they call on Mini-Sentinel to conduct a data search into it. For example, a high blood pressure medication sold as Benicar was recently linked to serious intestinal problems in patients. Although initial reports denied a link between the two, a second investigation by Mini-Sentinel found a definitive link - but only in patients who had been taking Benicar for longer periods of time.

As a result of this comprehensive search, the FDA released label updates for Benicar warning patients of the risk of serious intestinal side effects. Officials state that such a quick and definitive answer would have otherwise been unavailable.

The ability to sift through huge mines of patient data seems like the most obvious opportunity for the FDA to track, monitor, and release information on drug safety information. What is at issue now, is how to properly do the sifting. Some experts believe that billing data was not meant to be used in this way, and are concerned that patients may get a false sense of security about the safety of medications.

The FDA's contract with Mini-Sentinel is up in September 2014; however, the agency is still trying to discern the best way to conduct its data searches. The agency is acutely aware that how you phrase questions about a drug's safety will greatly impact what the answer is.

For its part, Congress recently established a foundation called the Reagan-Udall Foundation for the FDA, which is researching how to use large databases to study drug safety. Needless to say, there is a lot of work that needs to be done to get a handle on this new science and to create set guidelines and methodology. One of the problems with the Reagan-Udall Foundation, however, is that nearly all of its funds come from Big Pharma: Johnson & Johnson, GlaxoSmithKline, Merck, Pfizer, etc.

Continue reading "How Big Data is Helping the FDA Track Drug Complications" »

Januvia Linked To Heart Failure and ER Visits

July 7, 2014

3447520846_68739029a0_b.jpgJanuvia, a popular type 2 diabetes drug, has been linked to many controversial and dangerous side effects in recent years. In the latest newsbreak, experts are taking a closer look into the risk of heart failure in patients taking Januvia. Our team of Januvia lawyers report on recent studies and reports linking the drug to life-threatening heart conditions.

An observational study on Januvia was recently published in the journal JACC Heart Failure. Medical researchers involved in the study analyzed insurance claims from more than 7,600 patients who suffered from both diabetes and heart failure. Researchers found that patients taking Januvia were much more likely to be hospitalized for heart failure than those not on the drug.

Fortunately, the study did not find that Januvia patients were more likely than non-users to pass away from cardiac events. This study adds to the growing body of evidence that Januvia and other drugs in its class (and perhaps even type 2 diabetes drugs overall) increase the risk of heart failure.

Januvia is part of a class of diabetes drugs known as DPP-4 inhibitors. Among the other drugs in this class include:

• Janumet
• Victoza
• Byetta
• Onglyza
• Juvisync
• Bydureon

Among many others (a full list of DPP-4 inhibitors can be found on our website, here). Onglyza was also recently investigated for heart failure risks. In February 2014, the FDA announced that it was requesting clinical trial data from Onglyza's manufacturer. This investigation was launched in response to a study that found Onglyza patients had substantially high rates of hospitalization from heart failure.

Pancreatic Cancer Risks

Januvia, Onglyza and the like initially received national attention after the risk of pancreatic cancer became evident. Pancreatic cancer is one of the deadliest forms of cancer, as it spreads incredibly rapidly and is extremely difficult to diagnose in its early stages.

Patients who suffered pancreatic cancer after taking these drugs are now filing lawsuits against drug manufacturers by the thousands. The issue at the center of this litigation is whether the drug makers knew about the risk of pancreatic injury and deaths before the drugs were put on market.

It has been reported and confirmed that Januvia's manufacturer, Merck, failed to conduct safety studies in patients with a history of pancreatic issues, even though it was a known risk factor. Merck's failure to conduct safety studies for something as serious and fatal as pancreatic cancer is inexcusable, and why so many patients are choosing to file suit against the drugmaker.

One plaintiff was in her mid-70s when she died from pancreatic cancer. Although she had diabetes, she lived an otherwise healthy lifestyle for someone her age, and was prescribed Januvia in 2006 to help her manage her illness. Just over one year after starting on the drug, she was diagnosed with pancreatic cancer. She died within a month of diagnosis. Her daughter recently filed a lawsuit against Merck, claiming the company designed and misrepresented a defective drug, which directly caused her mother's death.

Continue reading "Januvia Linked To Heart Failure and ER Visits " »

Actos Manufacturer Guilty of Destroying Evidence

June 23, 2014

364748005_c10f9bbd46_b.jpgActos attorneys at Pintas & Mullins recently reported that the jury in the first bellwether lawsuit decided to award plaintiffs injured by the diabetes drug Actos $9 billion. In addition to this immense award, the judge in the case also found that Takeda Pharmaceuticals (which marketed Actos along with Eli Lilly) was guilty of intentionally destroying evidence.

Throughout the trial, which was filed by a man named Terrence Allen who developed bladder cancer from taking Actos, it became clear that Takeda had knowingly destroyed millions of documents relating to the drug. This, despite being under court orders to preserve such documents since 2002.

The Louisiana federal judge presiding over this case, Judge Doherty, informed the jury that Takeda destroyed much of its internal communications regarding the drug, including emails from more than 45 current and former employees. The judge then allowed the jury to infer, if it wanted to, that the missing documents could have proved that Takeda executives knew about the causal link between Actos and bladder cancer.

Surprisingly, Actos is still legally prescribed and sold in the United States and has not been recalled by the FDA. The agency did, however, issue a Safety Announcement regarding Actos in September 2010, in which it stated that it was reviewing data from a decade-long study to determine whether there was a strong link between bladder cancer and Actos use.

Causation and Liability

The reason this document destruction is such a big deal is because it could, if more information were available, prove liability. Pharmaceutical companies are typically not held legally responsible for significant side effects of their prescription drugs unless they were aware of these effects and failed to warn doctors about them. If it becomes clear the company willingly chose to fail to warn patients and physicians of the dangers, lawsuits may be filed.

In this Louisiana case, the judge stated that the destroyed documents were in fact relevant to the case, intentionally erased, and that their erasure negatively affected the plaintiff's case. The plaintiffs, Terrence Allen and his wife Susan, alleged that Takeda knew of the bladder cancer risk even before it applied for Actos approval in 1999.

What is a Bellwether?

Thousands of lawsuits have been filed on behalf of those diagnosed with cancer after taking Actos, with more than 6,000 currently pending in the Louisiana MDL. As stated, this $9 billion jury award was the first bellwhether case in this MDL. Bellwether trials are used as tools to help resolve mass tort.

To back up a little, mass tort litigation involves many lawsuits filed by plaintiffs who suffered similar injuries from the same drug, product or device. The Actos lawsuits are considered a mass tort because most plaintiffs are all suing the drug manufacturer for causing a similar injury - bladder cancer, and withholding the information it had about this injury.

So, one of the tools federal courts have in mass torts is known as a bellwether trial, which judges decide to use. During bellwether trials, the plaintiffs, defendants and judge all decide on 5-10 specific cases that will represent the larger class as samples. These cases are then prepared and tried to a jury, to give all interested parties a good idea of what will likely occur in the future trials. For example, if more Actos plaintiffs win their bellwether trials, Takeda will become more and more willing to settle for a large amount.

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Pradaxa Lawsuits Settle for $650 Million

May 29, 2014

Thumbnail image for 7866565462_241dea3e9e_c.jpgOur team of dangerous drug lawyers confirm that patients seriously injured by the blood-thinning drug Pradaxa recently got a dose of good news: Pradaxa manufacturer Boehringer Ingelheim just agreed to end most of the injury cases in a $650 million settlement. The popular blood thinner is associated with at least 500 patient deaths.

Boehringer was scheduled to defend itself in the first Pradaxa injury case in September 2014 - the first of over 4,000. The majority of these lawsuits were filed on behalf of family members who died from bleed-outs caused by the drug, which has no antidote.

Pradaxa is a blockbuster drug initially touted as a replacement for warfarin, which was close to the only option for blood thinners for about 60 years. Warfarin, unlike Pradaxa, requires close medical monitoring, however, which gave Pradaxa a leg-up on its competition.

As mentioned, there is no antidote for Pradaxa. This means that if a patient taking the drug starts to bleed - even from a minor contusion like falling on a sidewalk or a cut to the hand - they could suffer fatal bleed-outs. Many doctors have come forward saying they were forced to helplessly watch Pradaxa patients bleed to death on their tables. Patients are now claiming that Boehringer marketed Pradaxa as superior to warfarin without sufficient evidence, and without fully disclosing its devastating lack of reversing agent.

The average payout per plaintiff is estimated at around $163,000 - many contend that Boehringer wanted to settle these lawsuits en masse because the problems with Pradaxa are clear and tragic. Patients argue that the company knew about Pradaxa's fatal risks even before it was released onto market in 2010.

By 2011, over 540 deaths had been reported in associated with the drug, along with nearly 4,000 serious side effects. As patients started filing lawsuits, it became clear that Boehringer hid key data about Pradaxa from federal regulators, including dozens of reports of fatal bleeding. The company failed to disclose this data in order to win approval.

Then, earlier this year, a judge ordered Boehringer to pay nearly $1 billion in fines for failing to preserve evidence - internal documents, files, emails, etc - concerning the maketing and development of Pradaxa. More on that scandal can be found here.

Similarly, the manufacturers of Actos were recently charged for destroying documents in the Actos bladder cancer litigation, and leading to a $9 billion punitive award for the plaintiffs.

Continue reading "Pradaxa Lawsuits Settle for $650 Million" »

Urgent Recall for Patients on Blood Thinners

May 13, 2014

7866565462_241dea3e9e_c.jpgOur team of product recall lawyers announce that a Class I recall was recently initiated for Alere PT/INR Professional Test Strips, which are used to monitor anticoagulant drugs status at home. Patients taking oral anticoagulant drugs like warfarim, Coumadin, Pradaxa or heparin, should check their brand of PT/INR test strips immediately. Three patients have died due to the defective strips.

The specific product being recalled is the Alere INRatio 2 PT/INR Professional Test Strips (PN 99008G2). Patients using these strips are experiencing false reads on them, meaning that patients with dangerously high INR readings are seeing inaccurate results on their strips. These defective products are telling patients that their INR readings are normal when they are in reality dangerously, even fatally high.

Alere has received several reports of patient injury, including three deaths from false INR readings. The company reports that the strips can read anywhere between 3.1 and 12.2 units lower than the actual INR. This can cause patients to suffer spontaneous bleeding episodes, which can ultimately result in fatal bleed-outs. All three deaths were associated with uncontrollable bleeding.

The manufacturer has not yet stated how or why the products are defective, and stated that all patients using these strips should have received a letter around April 16, 2014 informing them of the problems. Anticoagulant and blood-thinning therapy is prescribed to patients who have recently undergone heart valve surgery, have a history of heart attacks, or suffer from an irregular heartbeat (atrial fibrillation). Drugs like warfarin, heparin, Coumadin, and Pradaxa help prevent blood clots that could cause strokes and heart attacks in these vulnerable patients.

Pradaxa Patients Suffer Similar Fate

This month, the Journal of Neurosurgery reported that the side effects of popular blood thinner Pradaxa are just as fatal and irreversible as from defective testing products. The authors of that report focused on one Pradaxa patient, an elderly man, who had been on the drug for just one month. The man suffered a seemingly minor fall at his home, and despite immediate medical care, doctors were unable to stop his intracranial bleeding, taking his life.

Pradaxa is commonly prescribed to elderly patients, and far too many fatal bleeding episodes are triggered by falls at home or in nursing homes. Patients over the age of 75 with pre-existing kidney conditions should be extremely cautious when considering taking a blood thinner, particularly Pradaxa.

This is because, unlike warfarin, Coumadin and heparin, Pradaxa has no antidote. Meaning, if a patient on a warfarin blood thinner starts to bleed uncontrollably, the effects can be reversed with a high dose of Vitamin K. This therapy does not exist for Pradaxa, so patients who start to bleed, even minimally, may suffer fatal bleed-outs while doctors watch on, helpless.

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The Deadly Risks of Epidurals

April 24, 2014

The FDA recently issued a warning regarding injectable steroid epidurals. New warning labels on these steroid drugs will now indicate that they may cause rare but fatal complications in some patients, sometimes within just minutes. Medical malpractice attorneys at Pintas & Mullins highlight this newly-recognized risk and who may be most likely to suffer fatal complications.

labor-shortly-after-epidural.jpg Spinal injections of steroids are used for many reasons in the medical community despite lack of federal approval. It may be surprising to hear (it certainly surprised us) that corticosteroid injections into the epidural are not approved by the FDA, since the drugs have been used in this way for many decades throughout the U.S. The FDA asserts that it has not approved steroid injections in the epidural because it has not yet been proved the practice is safe and effective.

The potential side effects are largely neurological, and include:

• Blindness
• Stroke
• Paralysis
• Death

Steroids are often injected to treat neck or back pain that radiates to the arms and legs, and to reduce swelling or inflammation. The FDA launched an investigation into this practice after a large number of medical professionals started voicing concerns about the neurological side effects.

After it became clear there was a significant safety issue, the FDA started an official review of the agency's Adverse Event Reporting System database and other medical literature. After this review, the agency decided to update all the warning labels of steroid injections on the life-threatening risks of injecting patients for pain.

To further raise awareness of this issue, the FDA's Safe Use Initiative called together a panel of medical experts - including pain management experts - to help define the proper techniques for using steroid injections. This panel's recommendations on reducing harm to patients will be released once they are finalized.

Later this year, the FDA also plans to convene an Advisory Committee meeting of even more experts, who will discuss the benefits and risks of epidural steroid injections. This committee will decide whether or not the agency needs to take even further action to prevent serious harm.

The following steroid drugs are commonly injected into the epidural (bottom area of the spine) to relieve pain:

• Betamethasone
• Dexamethasone
• Hydrocortizone
• Methylpredisolone
• Triamcinolone

Continue reading "The Deadly Risks of Epidurals " »

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).

Continue reading "Weight-loss Drug Alli Recalled over Defects" »

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.

Continue reading "Experts Concerned About Human Growth Hormone Health Risks " »

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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