Yesterday, the FDA warned that the drug Diflucan (fluconazole) can result in rare and distinctive birth defects if taken during the first trimester of pregnancy. The FDA Safety Information and Adverse Event Reporting Program issued this safety alert to obstetricians, gynecologists, pharmacists, and infectious disease physicians, as well as the […]
Category: Product Defect
Two very popular and enormously successful diabetes drugs have come under intense regulatory scrutiny over the past year. Avandia and Actos were developed and prescribed to treat type 2 diabetes. In people with type 2 diabetes the body does not make enough insulin, and the insulin that the body produces […]
Johnson & Johnson claims that its numerous product recalls last year can be attributed to poor management, staffing cuts, and integrating the consumer unit it purchased from Pfizer Inc., the company said in court papers. The report makes clear, however, that top executives are not to blame. This poses an […]
Perhaps the abysmal performance of the Toyota executives in their delay in recalling vehicles with sudden acceleration and braking problems has led to an increase in vehicle manufacturer vigilance in monitoring their own vehicles for possible safety problems. On the National Highway Traffic Safety Administration site is found the July […]
Tragically, it is too late for 2-year old Harrison Kothari. Harrison died as a result of using a anit-bacterial wipe that was contaminated with life-threatening bacteria. Wipes manufactured by Triad and H&P have been linked to very serious illnesses in the cases of four patients with multiple sclerosis. A […]
A product that should have carried a very clear and detailed warning of its dangers is causing severe injuries. The product is called “Napafire”, distributed through Bed, Bath & Beyond (and other national distributors); and is packaged and distributed by Napa Home & Garden, Inc. The NAPA product is manufactured […]
Are you taking the cholesterol lowering drugs: Zocor, Vytorin or Simcor? The Food & Drug Administration published a release recommending new safety criteria for high does simvastatin; which is a key ingredient in all these drugs: “The FDA has revised the drug labels for simvastatin and Vytorin to include the […]
Johnson & Johnson has been ordered by a South Carolina court to pay $327 million for minimizing the links between its antipsychotic drug, Risperdal, and diabetes. The case centers on allegations that Johnson & Johnson marketed Risperdal in a way that was misleading in product labels, “Dear Doctor letters” and […]
Is it possible that four studies have demonstrated that certain birth control medications, like Yaz, Yasmin, and Ocella, are dangerous and the manufacturer, Bayer, knew nothing about the dangers? It is reasonable to conclude that if the manufacturer did not actually know, through reasonable and prudent drug evaluation; those dangerous […]
Now that summer is upon us, many South Floridians will cool off by jumping into the pool. But be careful before you dive in. On May 26, 2011, the U.S. Consumer Product Safety Commission announced that eight manufacturers have voluntarily recalled one million pool and in-ground spa drain covers due […]