Still another lot of Fentanyl Pain Patches has now been recalled. On October 21, Actavis, Inc (famous for its manufacturing defect of Digitek) recalled (but only to the wholesale level and the retail level) eighteen (18) lots of its Fentanyl Transdermal System 25 mcg/hour C-11 patches. Corium International (in the U.S.) was the company that manufactured the patches for Actavis. At least one lot (Control/Lot # 30349) was admitted to have at least one patch which released its active ingredient faster than the approved specification. That lot made it to market. Actavis, however, recalled 18 lots.
The Avandia news continues. Just last month, there was a meeting of a joint advisory committee reporting to the Food and Drug Administration (FDA) concerning the potential health risks of the diabetes drug Avandia. This was the second meeting of this committee. It originally met in July of 2007 and reported that Avandia was associated with an increased risk of heart attacks. Three years have now passed, and the committee has met again, and this time, although 12 members of the committee voted to withdraw Avandia from the marketplace, 21 members voted that it remain available for sale and use. (more…)
The hits just keep coming for drug giant J&J who recently issued recalls for some its most popular and profitable products like Children’s Tylenol, and just last week, its Acuvue contact lenses had to be pulled from the Asian and European markets. Yesterday, J&J’s DePuy Orthopedic division recalled the ASR XL Acetabular System, a hip socket used in traditional hip replacement, and the ASR Hip Resurfacing System, a partial hip replacement that involves placing a metal cap on the ball of the femur, a method intended to preserve more bone. (more…)
The good news keeps coming for Glaxo, the pharma giant that makes the diabetes drug Avandia. Yesterday the FDA ordered Glaxo to stop patient enrollment in a study that compared Avandia to a competing drug Actos, and to warn all patients already enrolled that Avandia may increase the risk of heart attacks.
Dr. Steven Nissen, whose 2007 study sounded the alarm about Avandia, was quoted in the New York Times today as saying he believed that the Panel’s findings about Avandia would eventually lead to suspension and abandonment of the study altogether. Nissen noted: “There was really no other action they [FDA] could take. Now the challenge is, if that trial is unethical, how can Avandia stay on the market?”
Stay tuned.
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After 2 days of intensive hearings, the FDA Advisory Panel charged with oversight of the Glaxo-SmithKline diabetes drug Avandia (Rosiglitazone) recommend to FDA that the drug be either withdrawn or otherwise its use should be severely restricted. The ruling came as a result of analyses done of GSK studies and others which show that users of Avandia suffer a clearly increased risk of heart attack when using the drug. Some panel members also questioned the truthfulness of GSK in light of the questions raised by internal company documents that revealed Glaxo’s efforts to hide critical safety data. (more…)
The truth about the Toyota Sudden Unanticipated Acceleration (“SUA”) defect lies beneath the headlines. The issues include: the reason why Toyota did not solve the problem even though it was identified over two (2) years ago; why Toyota decided to distract the American public with claims that its loose mats moved; how Toyota’s use of “common parts” in its manufacturing facilities may end up identifying an internal electronic cause rather that the mechanical (“sticky pedal”) case which Toyota now claims is the culprit. (more…)
Senator Sheldon Whitehouse (D-R.I.) with co-sponsorship from Senator Jeff Sessions (R-Al) and Senator Richard Durbin (D.Il) introduced legislation in the United States Senate to reduce the substantial problems involved in obtaining service of process on foreign manufacturers and then obtaining jurisdiction over them in American state or federal courts. (more…)
On July 28, the FDA issued a health advisory urging consumers to stop using body building nutritional products that claim to be substitutes for steroids. These products are usually marketed as “legal” ways to increase muscle mass without anabolic steroids. The FDA has sent a “Warning Letter” to the maker of nutritional supplements that claim to contain steroid-like ingredients. The FDA claims that these ingredients are in fact synthetic steroids. (more…)
The U S Food and Drug Administration (“FDA”) is an agency that is part of the United States Department of Health and Human Services. It is responsible for the regulation and oversight of many products consumers use on a daily basis, such as foodstuffs, drugs (both prescription and over the counter, or OTC drugs), medical devices (for example pacemakers and artificial joints), vaccines, radiation emitting devices (x-rays), veterinary products and even cosmetics! In 2004 the FDA employed 14,000 persons in its various departments. In 2009, the FDA’s budget was nearly 2.5 billion dollars, with nearly 628 million of that coming from user (pharmaceutical company) fees. (more…)
On August 15, 2008, Mitchell S. Cohen of Locks Law firm, filed a coal tar pitch (CTP) claim on behalf of a union roofer who developed COPD and fibrosis, despite his being a life-long non-smoker.
The Complaint charges the 12 defendants manufactured or distributed such products, during the time the Plaintiff was a roofer. The Complaint charges negligence, intentional misconduct, strict liability and claims on behalf of the injured Plaintiff’s wife. (more…)
