Pharmaceutical Lawsuit and Recall Information
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The U.S. Food and Drug Administration recently convened two advisory panels in order to conduct a broad safety review of bone-building drugs, which are currently being used by approximately five million women in the United States alone. The two groups ultimately concluded that stronger cautionary language should be added to these bone-building drugs, which include [...]
The makers of surgical mesh may soon have to submit additional safety data to regulators in order to keep their products on the market. New reports have shown that the use of transvaginal surgical mesh has failed to yield better results than non-mesh procedures. The surgical mesh can also pose a higher risk to patients. [...]
New research recently reported in MedPage Today suggests that only a limited number of advertisements for prescription drugs are actually in compliance with FDA regulations on marketing to doctors. The research, which was conducted by Dr. Deborah Korenstein of Mount Sinai School of Medicine in New York, revealed that during a one month period, almost [...]
Each quarter, the U.S. Food and Drug Administration releases an updated list of drugs to watch for potential signs of serious side effects or safety issues. For the fifth consecutive time, Sanofi-Aventis’ Multaq (dronedarone) is included. The FDA’s most recent watch list covers the first three months of 2011. During this span of time, the [...]
According to a new study published in the Canadian Medical Association Journal on Tuesday, the anti-smoking drug, Chantix, could substantially increase a patient’s risk of being hospitalized for a heart attack. The new information is based on the review and analysis 14 previously completed studies, including more than 8,200 healthy individuals taking Chantix or a [...]
The FDA’s Arthritis Advisory Committee firmly voted against recommending the Novartis drug, Ilaris, as a treatment for gout. The 11 to 1 vote against backing the drug stemmed from safety concerns over the risk for patients to develop serious infections and other problems. While the panel noted that the data did demonstrate the drug is [...]
The U.S. Food and Drug Administration issued a warning to generic drug maker, Impax Laboratories, Inc., regarding manufacturing practices in its Hayward, California pant. During a review conducted between Dec 13 and Jan 21, FDA inspectors identified problems with Impax’s sampling and testing procedures, as well as the process by which the company determines which [...]
