FDA warns Pfizer’s drug Tygacil raises risk of death

Reuters (9/27, Clarke), the AP (9/27) and the Wall Street Journal (9/27) reported on Friday that the Food and Drug Administration issued a warning that tigecycline (Tygacil), Pfizer Inc’s antibacterial drug, can increase the risk of death when used as authorized by the FDA or for other non-approved conditions.  A boxed warning will be added to the drug’s label, and the FDA indicated …

Severe Quality Violations at Factory Manufactoring Popular Generic Drug, Metoprolol

As reported today in Bloomberg News (9/27, Gokhale) “Urine Spills Staining Image of Wockhardt’s Generic Drugs,” the U.S. Food and Drug Administration inspected the generic drugmaker Wockhardt Ltd.’s factory in India and found serious quality violations including “urine spilling over open drains, soiled uniforms and mold growing in a raw-material storage area.”  This factory makes metoprolol, a generic version of the popular …

FDA strengthens HBV warning of two cancer drugs

As reported by Reuters (9/26, Clarke), the U.S. Food and Drug Administration has announced that GlaxoSmithKline Plc’s chronic lymphocytic leukemia (CLL) drug, Arzerra, and Roche Holding AG and Biogen Idec Inc’s drug, Rituxan, will now contain black box warnings on “the risk that they may reactivate the hepatitis B virus in patients previously infected with the disease.” Hepatitis B is a …

Bard Settles Second Vaginal Mesh Case

Bloomberg News (9/14, Feeley) reports that C.R. Bard, Inc. has “agreed to settle a woman’s claims that one of its vaginal-mesh implants caused internal problems before a trial set for this month in New Jersey.”   Specifically, Bard  agreed to pay an undisclosed sum for serious urinary problems caused by Bard’s Avaulta Plus insert.  This is the second vaginal-mesh case Bard settled since …

Philadelphia Woman Files Lawsuit Over Alleged Lipitor Diabetes

A Philadelphia woman is suing the manufacturers of the cholesterol drug Lipitor after she allegedly developed diabetes as a result of taking the drug. According to the Pennsylvania Record, Doris Brown alleges that she developed Type 2 diabetes after she began cholesterol treatment with the drug Lipitor in 2009. Brown said that she was prescribed the drug to reduce her …

FDA Announces da Vinci Surgical System Robot Recall

According to Bloomberg News, Intuitive Surgical Inc. (ISRG), which makes da Vinci Surgical System robots, informed the U.S. Food and Drug Administration last month that 30 devices may not have been tested properly, leading to a recall. The FDA said that the class 2 recall affects Intuitive’s da Vinci Si Vision System Cart, Si Surgeon Side Cart, Instrument Control Box …