Drug Injury Lawyers Blog

In one Massachusetts drug defect lawsuit, Kimberley A. Yout is suing Elan Pharmaceuticals and Biogen Idec Inc. for over $1 million in damages. Yout, 45, contends that taking Tysabri to regulate her multiple sclerosis caused her to develop progressive multifocal leukoencephalopath (PML), which is a rare brain infection. Yout, is not the only one claiming that the two companies did not warn patients about the risks involved with prolonged use of the medication. She took Tysabri for six years. Now, Yout says she can’t balance her checkbook, see out of an eye, use an ATM, or live independently.

Approved by the FDA in 2004, Elan and Biogen Idec took it off the market after there were reports of several cases of PML resulting in two fatalities. Despite the possible risks, Tysabri was brought back out again in 2006 with regulator approval and a “risk management” program supposed to train doctors on how to prescribe Tysabri and properly monitor patients.

Tysabri is a huge-selling drug. Last year, the medication was used by about 118,000 patients and brought in $1.6 billion of revenue. That said, Tysabri continues to be linked to incidents of PML. Per Biogen Idec data, there have been about 395 cases of PML linked to the medication, including 92 fatalities in the US.

Johnson & Johnson says that it is adding red warning alerts to the caps of its Extra Strength Tylenol and the majority of other Tylenol bottles. The warning will make it clear that the over-the-counter medication contains acetaminophen, which is designed to relieve pain but also has become the number one cause of sudden liver failure. The packaging change comes in the wake of government pressure and at least 85 dangerous drug lawsuits.

Million of people take Tylenol every day. The red lettered-caution on the cap is for people who don’t read the warning found in fine print on the drug’s label.

Plaintiffs with Tylenol injury lawsuits contend that the medication is the cause of wrongful death and liver injuries. Many of them believe that the drug maker knew that the drug came with a risk of acute liver failure from overdose and toxicity (even when used properly) but failed to properly warn the public.

What is Lipitor?
Lipitor (atorvastatin calcium) is a popular prescription statin drug used to treat high cholesterol. More than 29 million people across the United States alone have been prescribed to Lipitor. In conjunction with a healthy diet and regular exercise, Lipitor works to block the cholesterol-making enzyme found in the liver. It is clinically shown to lower LDL (“bad”) cholesterol, and raise HDL (“good”) cholesterol, by removing fatty cholesterol deposits that build up on artery walls that may cause blockages of blood flow to the heart, brain, and other organs. Lipitor is proven to lower the risk for heart disease, heart attack, stroke, certain types of heart surgery, and chest pain in patients who have heart disease.

What are the risks?
While Lipitor has demonstrated itself as a proactive solution to treating high cholesterol, it is also a medication that may cause serious and even debilitating health issues. Most patients are not adversely affected by Lipitor, and physicians prescribe drugs like Lipitor based on calculated risk-the benefits of the drug outweigh the risk for potential side effects. The most common issues reported by patients while taking Lipitor include fatigue, nearsightedness, upset stomach and diarrhea, memory loss, and confusion. Though the side effects generally associated with Lipitor tend to be mild, they may become more severe with prolonged use of the drug. In some cases, patients have reported serious symptoms including:

• Muscle pain or weakness • Chronic stomach pain • Dark colored urine • Difficulty breathing or swallowing • Yellowing or jaundice of the eyes and skin • Hives and rash on the skin
Although rare, Lipitor has been linked to the development of Type-2 diabetes in patients. An estimated 1 out of every 100 statin drug users develops Type-2 diabetes. In February of 2012, the U.S. Food and Drug Administration (FDA) ordered Lipitor manufacturers, as well as other statin drug manufacturers, to post a warning label on the outside of the bottle, warning both healthcare professionals and patients of the risk of Type 2 diabetes. Because there is sufficient evidence between statin drugs use and diabetes, patients who were diagnosed with diabetes after beginning cholesterol treatment with Lipitor, may have grounds to file a lawsuit against Lipitor’s manufacturer Pfizer.
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Data published by the United States Food and Drug Administration suggests that the taking the drug Topamax (topiramate) while pregnant, increases the risk for birth defects, including oral cleft defects and organ malformations. Topamax is a product of Janssen Pharmaceuticals, a subsidiary pharmaceutical company of Johnson & Johnson.

Topiramate is primarily used as an anticonvulsant drug; used to prevent and treat episodic seizures caused by epilepsy, and to prevent migraine headaches. Topiramate is also occasionally used on an off-label basis to treat psychological conditions such as obesity, bipolar disorder, and alcoholism.

In 2011, the FDA released findings of the drug and its association with birth defects. The FDA found that pregnant women who took topiramate while pregnant were more likely to birth a child with a defect than those who took an alternative epilepsy medication or took no medication at all during their pregnancy.

According to the FDA, 1.4% of infants who were exposed to topiramate during their mother’s first trimester of pregnancy, developed cleft lip or cleft palate, compared to 0.38-0.55% of infants who were exposed to other epilepsy medications. Infants who did not have any exposure to topiramate or epilepsy drugs were at a much lower risk for developing an oral birth defect (0.07%). Oral clefts are birth defects that occur when parts of an infant’s lips and palate do not completely fuse together during early stages of pregnancy. The defect can be a small notch in the lip to a groove that runs to the roof of the mouth and nose. These defects can ultimately cause a multitude of issues for children such as problems eating or talking, as well as frequent ear infections.

In addition to oral defects, infants exposed to the drug were more likely to develop bodily malformations such as malformations of the lungs, heart, and limbs. Topiramate exposure has also been linked to incidences of neural tube defects, such as spina bifida; a condition that occurs when the embryonic neural tube does not completely close. Based on the information, the FDA now designates topiramate as having a Pregnancy Category D rating. That is, there is significant evidence linking topiramate exposure to fetal birth defects.
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