A federal judge has opened a window for plaintiffs to make a claim for strict liability against prescription drugmakers on a manufacturing defect theory. Despite developing case law in the opposite direction, U.S. District Judge Malachy Mannion of the Middle District of Pennsylvania ruled that Ryan Bergstresser could bring a manufacturing-defect claim against Bristol-Myers Squibb over its antipsychotic drug, Abilify. Bergstresser alleges he suffered from dystonia, which is characterized by involuntary muscle contractions, after his psychiatrist increased his dosage of the drug.

On April 30, 2013, the Food and Drug Administration (FDA) issued their second alert to patients and health care providers concerning the drug tolvaptan (SAMSCA). The warning had two main points: Tolvaptan use should be limited to no more than 30 days, and it should not be used at all in patients who have liver disease.
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On March 14, 2013, Fresenius Medical Care North America (FMCNA), announced that it has received yet another reprimand from the FDA, indicating that the agency found that the company failed to properly study artificial kidneys being used in its dialysis machines. The letter is not a formal recall, but it comes in the wake of the mid-2012 GranuFlo and NaturaLyte dialysis product recalls. These products were recalled when it was revealed that there is a serious and high risk of sudden cardiac arrest or death due to elevated bicarbonate levels in these dialysis additives

The FDA issued a warning for the popular antibiotic (azithromycin) commonly known as a Z-Pack and sold under the brand names Zithromax and Zmax. This common antibiotic is widely used to treat sinus infections and bronchitis. In 2011 alone, there were over 50 million prescriptions for the Z-pack with sales in excess of 464 million dollars.
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On March 5, 2013, Pogust Braslow & Millrood, LLC filed its first personal injury suit against Eli Lily and Company over Cymbalta withdrawal symptoms. The case, Carnes v. Eli Lilly and Co., was filed in the United States District Court for the District of South Carolina. Cymbalta withdrawal symptoms can be severe, long-lasting, and debilitating. The complaint details that Mr. Carnes suffered from severe brain zaps and aggression, and alleges that the company should have known about the likelihood, extent, and severity of experiencing withdrawal symptoms and yet failed to adequately warn doctors and patients about the risk.
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A 2010 study, published in the American Heart Association’s journal Circulation, found that the risk for heart attacks was the same for Actos as it was for Avandia. According to the study, patients taking Actos or Avandia were 4 percent more likely to experience heart attacks. The study included over 36,000 patients with an average age of 54. This study was conducted over 33 months, including 14 months of treatment on either medication. Among the patients, 602 Avandia users and 599 Actos users suffered a heart attack, heart failure, or died. Even more concerning, there were 217 deaths in each group. Despite these alarming numbers, some found the results of this study to be inconclusive.
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Benzodiazepines, such as Valium, Ativan, Librium and Xanax (and their generic versions), have been around for a long time. They are the most popular drugs the world, selling an estimated $880 billion in 2011 alone. They are commonly prescribed for generalized anxiety and to help with insomnia. They also come with many dangerous known side effects, including the potential to cause drug-induced addiction.
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Last month, the Institute for Safe Medication Practices (ISMP), an independent, non-profit FDA watchdog agency, issued its quarterly report, detailing the 90% increase in adverse events (AEs) reported to the FDA since 2008. Included in the report are findings from a specific investigation aimed at Cymbalta and withdrawal symptoms.
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