Pharmaceutical Lawsuit and Recall Information
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The U.S. Food and Drug Administration has ordered drug maker, Sanofi-Aventis, to update the label for its anti-arrhythmic medication, Multaq, in order to inform users of the increased risk for death or serious cardiovascular events when taken by patients with permanent atrial fibrillation. The FDA has approved Multaq (dronedarone) to treat atrial flutter and paroxysmal [...]
Novartis AG, manufacturer of the drug, Gilenya (fingolimod), confirmed this week that a 59 year old patient suffering from multiple sclerosis passed away after beginning treatment with the drug, the first of its kind to be approved by the FDA to treat the neurological disease. Novartis noted that this is the first reported death to [...]
The European Medicines Agency (EMU) last month asked for the recall of several products manufactured by Ben Venue Laboratories over particle contamination concerns. At the time, Gilead’s antiviral medication Vistide (cidofovir) was not included on the list of products recommended for recall, as the drug was undergoing sterilization in an effort to lower the risk [...]
Last week, an FDA advisory panel voted 19 to 5 that the Ortho Evra birth control patch should remain on the market, finding that its benefits outweigh its potential risk for blood clots. While the panel’s final vote ultimately backed the continued use of the patch, it also recommended that information regarding the increased risk [...]
The U.S. Food and Drug Administration announced this week that it will conduct a complete safety review of the drug, Pradaxa (dabigatran), following reports that it may cause excessive bleeding. Pradaxa is an oral direct thrombin inhibitor that is used to prevent stroke in patients suffering from nonvalvular atrial fibrillation. The FDA’s safety review announcement [...]
The U.S. Food and Drug Administration this week issued a warning to consumers regarding weight-loss products containing the hormone HCG. The sale of products containing this hormone is illegal and using them can potentially be very dangerous. The FDA is urging that consumers steer clear of HCG-containing oral drops, pellets and sprays that can be [...]
As one of the most convenient, affordable and widely-consumed foods, canned soup is often a go-to meal choice from many people on the go. However, alarming research out of the Harvard School of Public Health (HSPH) suggests that our favorite can of soup may actually contain far more than just the usual amount of beef [...]
An estimated 100,000 emergency room visits for seniors are caused by adverse drug events (ADEs) each year. According to a new study, two-thirds of these visits can be linked to the use of only a small number of drugs. The study, which can be found in the November 24th issue of the New England Journal [...]
The U.S. Justice Department announced this week that drug maker, Merck, will pay a staggering $950 million to resolve investigations into the illegal marketing practices of its popular painkiller, Vioxx. Specifically, Merck will pay $321.6 million in criminal fines and $628.4 million as part of the civil settlement. The company will also plead guilty to [...]
According to a press release issued by the U.S. Food and Drug Administration, Kimberly-Clark has announced a product recall of a limited number of its Kotex Natural Balance Unscented Tampons Regular Absorbency that were distributed to specific retail stores within the United States. The tampons included in the recall were manufactured with a raw material [...]
