Articles Posted in Dangerous Side Effects

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newbornOur team of Zoloft lawyers report that Pfizer is currently in talks with the FDA to update the drugs’ labels to include the risk of heart defects in infants born to mothers took the drug during pregnancy. Pfizer is facing hundreds of birth defect lawsuits filed by women who took Zoloft while pregnant, assuming the drug was safe.

Zoloft’s new labels would state that there is an increased risk of congenital cardiac defects – and specifically septal defects – in women who took the drug during their first trimesters. Meanwhile, Pfizer is arguing in court that there is not enough research to suggest that taking Zoloft during pregnancy can lead to birth defects.

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spilled_pillsThe FDA recently issued a safety warning that certain type 2 diabetes drugs – such as Januvia, Janumet and Onglyza – can cause disabling joint pain in patients.  These drugs are in a class called DPP-4 inhibitors, and are also linked to heart failure, pancreatitis and pancreatic cancer. Our team of diabetes drug lawyers details this warning and the types of diabetes drug cases we are accepting.

DPP-4 inhibitors, also known as gliptins, are used alongside lifestyle changes to lower blood sugar in patients with type 2 diabetes. The FDA noted that patients taking these drugs reported severe joint pain beginning from the first day of taking the drug to years after they started taking it. Joint symptoms ended after stopping the medication, typically in about one month.

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newbornThe Depakote lawyers at Pintas & Mullins are currently accepting cases involving spina bifida in children born to mothers who took the anti-seizure drug Depakote during pregnancy. Here, we report on a Depakote injury lawsuit filed by an Ohio woman and her daughter, who was born in 2004 with numerous birth defects.

The mother, Pamela Rheinfrank, filed suit against Depakote’s manufacturers, Abbott Laboratories and AbbVie Inc, under claims of: defective design, negligent misrepresentation, failure to warn, fraud, breach of warranty, and unjust enrichment. The federal judge assigned to her case, U.S. District Judge Susan Dlott, preserved only her warranty and failure to warn claims.

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3003880273_bfd6a655d2Eliquis is one of four new anticoagulant, or blood thinning, drugs on U.S. markets. These drugs (Xarelto, Pradaxa, and Savaysa) are marketed as replacements to warfarin. Warfarin has been the first line treatment for blood thinning since the 1960s. Our team of Pradaxa and Xarelto lawyers examines these new anticoagulants and the false claims their manufacturers are making.

Pradaxa (dabigatran), Eliquis (apixaban), Savaysa (edoxaban), and Xarelto (rivaroxaban) are medically referred to as novel oral anticoagulants (NOACs). Eliquis is the only one of these drugs that claims to reduce deaths in patients with an irregular heartbeat. However, experts at the FDA and elsewhere question the validity of this claim.

In the clinical trial to approve Eliquis, researchers concluded that patients receiving the drug were 11% less likely to die from any cause compared to those receiving warfarin. Very important data was missing from this trial, however, most notably data involving patient deaths.

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pillsThe FDA strengthened warnings on over-the-counter and prescriptions painkillers known as nonsteroidal anti-inflammatory drugs (NSAIDs). This class of painkillers can cause serious, life-threatening cardiovascular events and are available in hundreds of forms, from Advil to Daypro. Our team of dangerous drug lawyers report on this new warning below.

The cardiovascular risks of NSAIDs have been known for 15 years, however, it was believed heart disease and stroke could only occur in people who took extremely high doses. Now, the FDA has updated drug labels to warn:

  • Heart attack or stroke can occur as early as the first week of NSAID use.
  • NSAIDs can increase the risk of heart attack or stroke in people without heart disease or other cardiovascular risk factors.
  • Those with, or at risk of, heart disease are at a greater risk of heart attack or stroke.
  • It is not clear if the risk is the same for all NSAIDs.
  • NSAIDs also present an increased risk of heart failure.
  • The risks are higher at higher doses and with longer use.

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sad womanDespite litigation and safety concerns, Mirena and other IUDs are experiencing a rapid rise in popularity. This rise is most notable among young women, who are choosing IUDs because they believe them to be long-acting, reversible, and safe. Our team of Mirena lawyers details the side effects of Mirena and the lawsuits stemming from these complications.

First, a little background: IUDs first became popular in the 1970s but were quickly recalled amid safety concerns. The FDA did not oversee devices then like it does now, and a particular IUD called the Dalkon Shield caused severe problems in women. More than 400,000 lawsuits were filed against the Shield’s manufacturer (including 18 wrongful death claims) causing the company to go bankrupt and the IUD market to collapse. Ultimately, $3 billion was paid to Dalkon Shield victims.

Decades later, one company chose to reintroduce a hormonal IUD into the American market.  Mirena enjoyed massive success in European countries and in 2000 the FDA approved the device. There was one caveat: it was approved only for women who already had children, which was an important but sneaky marketing move. Submitting Mirena for FDA approval only for women who had children rendered any concerns about infertility irrelevant. In other words, Bayer never had to prove that Mirena was safe for young, childless women.

In 2006, Bayer bought out the company that developed Mirena and continued aggressively marketing the product. One year later, the American College of Obstetricians and Gynecologists urged physicians to consider IUDs as a first-choice contraceptive for teens. By 2010, Bayer generated $714 million in Mirena sales.

So here is a hormonal contraceptive device that is federally approved for a specific subset of women, but is recommended by doctors to all women, including teenagers. What could go wrong?

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syringes-and-vialIn American culture, facial injections and reconstructions are commonplace. The prevalence of these procedures offers the illusion that they are completely safe, or at least have minimal risks. Unfortunately, there are very serious side effects resulting from dermal fillers. Our team of dangerous drug lawyers warns the public of these risks.

Dermal fillers – also called wrinkle fillers, injectable facial implants, or wrinkle fillers – are approved to smooth and plump the lips or cheeks. Patients receive injections directly into the treatment area from dermatologists, dentists, cosmetic or plastic surgeons, and other medical providers with appropriate training. More than one injection may be needed to achieve the desired result.

The FDA recently warned that these fillers can cause severe side effects if accidentally injected into facial blood vessels. Accidental injection can block facial veins, restricting the blood supply and potentially causing the filler to travel to other parts of the body. Other side effects include:

  • Blindness or vision impairment
  • Death of the skin (necrosis) and facial structure
  • Stroke

Accidental injection into blood vessels is more likely to occur on the skin between the eyebrows and nose, in the nose, the forehead, and around the nose and eyes. This can cause severe, permanent damage to patients. Blindness is most likely to occur from autologous fat filler, and is almost always irreversible.

Signs and symptoms of blood vessel injection include: vision changes, white-appearing skin near the injection site, unusual pain, and signs of stroke (difficulty walking, severe headache, dumbness, confusion, face drooping, dizziness).

Dermal fillers are the second-most popular facial procedure (second only to Botox). In 2013, more than 2.2 million soft tissue filler procedures were done, according to the American Society of Plastic Surgeons (ASPC). This is an alarming 243% increase from the numbers in 2010, when just over 650,000 soft tissue procedures were conducted.

The ASPC’s data also reveals that significantly more people in the Mountain / Pacific West and New England / Mid-Atlantic receive dermal fillers than in other parts of the country; and most patients are over the age of 55, Caucasian females.

An estimated 1 out of every 10,000 patients will suffer severe dermal filler complications. That’s hundreds of patients every year. The surge in dermal filler popularity means more patients will suffer from accidental blood vessel injection. The FDA will continue to monitor reports of adverse side effects.   Continue reading →

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injectionRecent studies show a strong link between the Depo-Provera birth control shot and the chances of being infected with HIV. Now, medical experts are asking the FDA to add the risk of HIV as a warning to the birth control’s labels. Dangerous drug lawyers at Pintas & Mullins explain this risk and the recent studies confirming it.

There are currently nearly 30 studies published on the Depro-Provera birth control shot. Researchers at the School of Public Health at the University of California at Berkeley examined all Depo studies in a meta-analysis, publishing the results in the medical journal Lancet Infectious Diseases.

Researchers found that Depo-Provera increased the risk of HIV infection by about 40%. It is important to note that this study was based on past data of women using different types of birth controls and HIV rates. This was not a new study based on new patients.

The risk of HIV infection was strongest among women who engage in commercial sex, injectable drug users, and those with known HIV-positive partners.

Depo-Provera is a shot that provides protection against pregnancy for three months at a time using the hormone progestin. In many parts of the world, this type of birth control is critically important as the only long-acting and discreet options available to women.

Thus, medical experts are calling on the FDA to add the risk of HIV to Depo’s labels, so women are aware and take precautions. Women need to have informed conversations with their healthcare providers about the known and unknown risks of contraceptives and all the options available to them.

Decades of Research

In 2012 the CDC acknowledged that several studies suggested the link between progestin-only birth control shots and increased HIV risk. These studies are not meant to guide individuals, but to help women make the best practical decisions for their health and wellbeing. Frankly, this information is most relevant for women where Depo is one of very few contraceptive options and where HIV rates are high – namely, East and South Africa.

American women using Depo should know that there is data suggesting this shot increases HIV acquisition risk. Women who do not know their partners’ health status, have many partners, or have an HIV-positive partner should consider switching their contraceptive method, preferably to condoms. There are many contraceptive options in the U.S. that do not have the increased risk of HIV; Depo-Provera should be the last-resort choice for at-risk populations.

The link between Depo and HIV has been a topic of research for over 20 years by agencies like the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO). Some animal studies have shown that progestin can cause vaginal inflation and the suppression of T-Cell activation, which protect the body’s immune system. T-Cells are also the same cells that are infected and attacked by HIV.

Nearly two dozen American doctors and scientists have petitioned the FDA to add language to Depo’s labelling that warns of the risk of HIV. Depo’s labels currently say that the shot does not prevent HIV, without any further warning. The petitioners highlighted one particular study which found that women using a different form of birth control shots, Noristerat, did not have similar HIV infection increases. This rules out the possibility that women who receive contraceptive shots were less likely to take measures to prevent HIV.

Our team of dangerous drug attorneys is currently investigating cases of serious illness from contraceptives like Depo-Provera and Mirena. We provide free legal consultations to concerned individuals and their families nationwide. We have been fighting against drug companies for 30 years and have won millions for our injured clients.

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file00053336815-thumb-250x187-94324The FDA recently announced that six diabetes drugs are causing serious blood problems in patients. The drugs, including Farxiga and Invokana, can cause a disorder known as diabetic ketoacidosis. Our team of diabetes drug lawyers warns the public that medications to treat Type 2 diabetes can cause severe, life-threatening side effects.

Diabetic ketoacidosis occurs when the body produces high levels of ketones, which are types of blood acids. This complication is normally seen in patients with Type 1 diabetes, which makes these recent reports all the more disturbing. All patients suffering this side effect had to be hospitalized or go to the ER, and some continue to experience complications.

Signs and symptoms of diabetic ketoacidosis develop quite quickly, and can include:

• Nausea and vomiting
• Fruity-scented breath
• High blood sugar levels
• Excessive thirst and frequent urination
• Abdominal pain
• Confusion
• Unusual fatigue

Normally, when sugar enters the body it is used as energy for muscles and other tissue with the help of insulin. If there is not enough insulin in the body, cells cannot convert sugar to energy, prompting the release of hormones that break down fat as an alternate energy source. This process then produces toxic acids – ketones – and any excess acids spill over into the urine.

Diabetic ketoacidosis is usually triggered by an infection or illness, such as pneumonia or a UTI. Missed insulin treatments or improper insulin therapy can also trigger the condition, along with alcohol or drug abuse, physical or emotional trauma, or high fever.
If left untreated, diabetic ketoacidosis can be fatal. Those at highest risk of fatal complications are patients younger than 19 and patients who frequently miss insulin doses.

Six Drugs Named in FDA Reports

The six drugs causing this condition make up the class of Type 2 diabetes drugs called sodium-glucose contransporter-2 inhibitors, or SGLT2 inhibitors. These include Farxiga, Xigduo XR, Invokana, Invokamet, Jardiance, and Glyxambi.

At least one of the manufacturers (Janssen, which makes Invokana and Invokamet) did report that there were cases of diabetic ketoacidosis during clinical trials.

Diabetes Drugs Marketed as Weight-Loss Aids

We recently wrote a post involving three of these drugs (Farxiga, Jardiance, and Invokana) and how they are marketed. The FDA has been asked to penalize makers of these drugs for advertising them as weight-loss products. A public advocacy group stated these direct-to-consumer ads are misleading, overstating the benefits of these drugs while undermining the very real and severe risks. The FDA has never reviewed the validity of weight loss from diabetes drugs, and the recent diabetic ketoacidosis developments are further proof that these drugs are causing much more harm than good.

Farxiga has also been linked to bladder cancer and Invokana has been linked to cardiovascular and bone risks. Despite these known serious risks, millions of prescriptions continue to be written and filled.

Nearly 26 million Americans have diabetes, and the vast majority suffers from Type 2. Unfortunately, drugs have become the first line of treatment to help lower blood sugar levels, even though study after study shows drugs increase the risk of death, heart attack, cancer, and other complications. The problem with these drugs is that they do not treat the underlying cause of diabetes and do not prevent the long-term damage caused by Type 2 diabetes. They merely mask the symptoms short-term, so patients believe they have a handle on a disease that is ravaging their body.

The hard truth: Type 2 diabetes is directly caused by lifestyle, and the only way to successfully treat and eventually reverse it is by implementing lifestyle changes. It is best to speak with your doctor, but some of the lifestyle changes with the most far-reaching and irrefutable effects are also the most obvious: cutting out added sugar and processed foods, exercising, following a nutrition plan, and addressing any underlying emotional issues.
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file1201295296054.jpgThousands of men have filed lawsuits against makers of testosterone treatments for injuries ranging from stroke to heart attack. Our team of t-therapy lawyers is constantly working to provide our clients the latest updates on these claims.

Seven manufacturers have been named in t-therapy litigation, which was recently centralized in the Northern District of Illinois. The first case is expected to begin in the fall of 2016. Some legal experts believe these claims will set a precedent in pharmaceutical litigation because t-therapy drugs were heavily marketed to men suffering from so-called “Low T,” which is not an FDA-approved use for these drugs, nor is it a valid medical condition.

Low T is not a recognized disease in any sense of the word – men’s testosterone levels naturally decrease with age, just as women’s estrogen levels naturally decrease. It is simply a part of getting older. Despite this, drug companies spend millions of dollars on direct-to-consumer ads every year that tell men they should consult their doctor about the possibility of Low T. “Borderline Low T,” was a term invented by Big Pharma to profit off the insecurities of aging men.

Over the past decade, t-therapy prescriptions have increased 10-fold in the United States. It is worth noting that the U.S. is one of only three countries in the world (along with Canada and New Zealand) that allows direct-to-consumer advertising for prescription drugs.

In response to this disease mongering, the FDA issued several warnings to t-therapy manufacturers demanding labels be revised so patients and doctors know that these drugs are approved only to treat serious medical conditions such as hypogonadism. The labels, updated in March 2015, also must warn that these drugs carry extreme, life-threatening cardiovascular risks.

Gels, Patches and Shots, Oh My!

The most well-known product at the center of these claims is AndroGel, however, recent studies have shown that short-acting injections carry the greatest risks. One study examined data from half-million new users of t-therapy. Of these, 7% used patches, 37% received injections, and 55% used gels.

The men who received injections had the greatest risk of cardiovascular side effects (stroke and heart attack), hospitalization, and death. There was no marked difference between patches and gels. This study did not include long-acting forms of t-therapy, which was just recently approved in the U.S.

The shorter-acting forms of injectable t-therapy, which were studied, caused testosterone levels to spike more severely. Researchers suggested that it may be wise for patients to take lower doses of the injections at more frequent office visits. Injections are typically much less expensive than gels or patches, making these findings all the more worrisome.

As mentioned, these drugs should only be prescribed to patients with hypogonadism or other medical conditions that cause dangerously low hormone levels. These drugs are not safe or at all necessary for men experiencing normal testosterone decline.

It’s this kind of sensationalism that has endangered healthy men and led to thousands of life-threatening injuries. The major complaint in the t-therapy litigation regards how heavily Big Pharma marketed these drugs to men who did not suffer from an FDA-approved medical condition. By doing this, drug companies purposefully put men’s lives in danger in order to reap larger profits.

Reports from the manufacturer of AndroGel illuminates how far Big Pharma was willing to go in its marketing to healthy men. Before AndroGel was approved, the company estimated hypogonadism (again, the only condition approved for t-therapy) affected about one million men. After the gel was approved, the company announced the market grew to about four million. Three years later, in 2003, the company estimated approximately 20 million men were eligible to receive AndroGel.

Hypogonadism is listed as a rare disease by the Office of Rare Diseases, which is part of the National Institutes of Health. To be classified as such, it would have to affect less than 200,000 Americans. This condition is either caused by dysfunction of the gonads or of the brain’s ability to message the gonads. Patients are either born with hypogonadism or develop it from injury or infection. In other words, there is a pronounced difference between naturally declining testosterone and hypogonadism.
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