InjuryBoard Philadelphia Archives

• Investigation Into Settlement of Drug Patent Lawsuit

  Jamie Sheller | July 28, 2006 2:08 PM | 0 Comments
  Category: FDA & Prescription Drugs

  Bristol-Myers Squibb and Sanofi-Aventis are being investigated by the Justice Department. The investigation stems from a deal the companies made with a Canadian generic drug maker, Apotex. In January, the FDA approved Apotex's generic version of the drug Plavix. Sanofi and Bristol-Myers, who co-market Plavix, filed a patent lawsuit against Apotex. In March, the companies settled the lawsuit....

• Risk of Congestive Heart Failure With Gleevec

  Jamie Sheller | July 25, 2006 1:54 PM | 0 Comments
  Category: FDA & Prescription Drugs

  The drug Gleevec is a successful treatment for chronic myelogenous leukemia. However, a study led by Dr. Thomas Force of Thomas Jefferson University in Philadelphia, indicates that the drug may be linked to damage to the heart muscle. According to the study, several patients with normal heart function when starting to take Gleevec, developed congestive heart failure between one and 14 months...

• Danger With Mixing Migraine Drugs with Antidepressants

  Jamie Sheller | July 21, 2006 3:14 PM | 0 Comments
  Category: FDA & Prescription Drugs

  Recently, the FDA warned that a dangerous condition called serotonin-syndrome can occur when patients mix migraine drugs with antidepressants. "Serotonin-syndrome is characterized by rapid heart beat, sudden changes in blood pressure, and increased body temperature. Other symptoms include restlessness, hallucinations, loss of coordination, overactive reflexes, nausea, vomiting and diarrhea." ...

• FDA Warns Against Using "Dietary Supplements" Marketed For Sexual Enhancement

  Jamie Sheller | July 18, 2006 10:21 AM | 0 Comments
  Category: FDA & Prescription Drugs

  The FDA is warning that people should not purchase or use products marketed and sold as "dietary supplements" for enhancing sexual performance and treating erectile dysfunction. The products include Zimaxx, Libidus, Neophase, Nasutra, Vigor-25, Actra-Rx and 4EVERON. The FDA classifies these products are illegal drugs. The products contain undeclared ingredients that may be harmful to...

• Stroke Risk Increased With Evista Which Reduces Breast Cancer Risk

  Jamie Sheller | July 14, 2006 4:26 PM | 0 Comments
  Category: FDA & Prescription Drugs

  According to a study reported in the July 13 issue of the New England Journal of Medicine, compared with a placebo, Evista provided a 44% reduction in the risk of invasive breast cancer. However, along with the reduced breast cancer risk, came a 49% increase in the relative risk of fatal stroke. The study included over 10,000 postmenopausal women. Evista is manufactured by Lilly. Though...

• Recall of Another External Defibrillator

  Jamie Sheller | July 11, 2006 8:11 AM | 0 Comments
  Category: Medical Malpractice

  The FDA has issued a Class 1 recall of Welch Allyn PIC 50 Automated External Defibrillators, manufactured between March 2002 and October 2004. The device may delay or fail to resuscitate the patient. This failure is caused by an eletrical contact problem. During this failure, the device may display various error messages including the "Defib Comm" message.

• FDA Issues Warning Letter to Vaccine Manufacturer

  Jamie Sheller | July 07, 2006 2:02 PM | 0 Comments
  Category: FDA & Prescription Drugs

  Following inspections of the Sanofi Pasteur facility in Swiftwater, Pennsylvania, the FDA issued a warning letter to the pharmaceutical company. The letter outlined several significant problems at the facility, which the FDA said deviated from good manufacturing practices. Some of the observed deviations include failures regarding controlling aseptic conditions, prevention of...

• Manufacturing Deficiencies With Baxter's Infusion Pump

  Jamie Sheller | July 05, 2006 8:40 AM | 0 Comments
  Category: Medical Malpractice

  Baxter Healthcare Corp. (Baxter) has stopped production and distribution of its Colleague Volumetric Infusion Pump and Syndeo Patient Controlled Analgesic Syringe Pump until manufacturing deficiencies are corrected. This action was announced by the FDA and was part of a consent decree signed by Baxter and its CEO and Corporate Vice President. Patients use infusion pumps to control delivery of...