A class of drugs, called bisphosphonates, has been linked to a serious, painful and possibly disfiguring condition called osteonecrosis (ONJ or "dead jaw"). This condition involves decay and death of the jawbone. Oral bisphosphonates, including Fosamax, which is manufactured by Merck, are often prescribed to treat osteoperosis in post-menopausal women. Injectable bisphosphonates, including...
The Heart Rhythm Society, a group of electrophysiologists, has drafted some guidelines regarding pacemakers and implantable defibrillators. The guidelines were drafted after the society, FDA representatives and industry representatives participated in a two-day meeting last September. Included in the guidelines are recommendations for independent watchdog committees to monitor manufacturing...
Shire PLC recently announced that the FDA had approved a new drug product, the first skin patch to treat attention deficit hyperactivity disorder. The patch is called Daytrana, and will be available in June or July. Daytrana is recommended to be worn for nine hours. One claimed advantage of the drug patch is that doctors can more easily manage dosage and possible side effects, by having...
Boca Medical Products voluntarily recalled some of its insulin syringes because of possible bacterial contamination. A contaminated syringe poses a risk of local infection and also introduction of bacteria into a sterile vial of insulin. The specific syringe is Ultilet Insulin Syringe 30g 1/2cc (Lot # 5GEXI, NDC# - 08326-3002-50). The syringes were distributed in the following states: AL, AR,...
An Atlantic City jury awarded a total of $13.5 million in damages to a plaintiff who alleged that his heart attack was caused by Vioxx. This verdict dealt a big blow to Merck because the trial happened in Merck's own backyard, less than 100 miles from the company's headquarters in Whitehouse Station, NJ. John McDarby took Vioxx for 4 years and had a heart attack in 2004. The jury found that...
Bausch & Lomb has recently voluntarily suspended shipment of its contact lens solution in the U.S. This action came after the company's ReNu with MoistureLoc contact solution, as well as its generic solution, have been linked to a significant number of fungal eye infections that are being investigated by the Centers for Disease Control. In February of this year Baush & Lomb stopped its sale of...
Manufacturers of ADHD drugs are probably feeling good right now. Things don't look as bleak for them as they did several weeks ago. In February of this year, the Drug Safety and Risk Management advisory committee of the FDA, recommended that Ritalin and other ADHD drugs should carry "black box" warnings about the risks of those drugs. However, recently the FDA's pediatric advisory committee...
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