FDA & Prescription Drugs

• Cephalon Pays $425 Million For Off-Label Marketing Dispute

  Scott Kappes | November 13, 2007 10:49 AM | 0 CommentsHouston, TX

  On Monday it was announced that Cephalon has agreed to pay some $425 million to the U.S. Justice Department resolve Medicaid claims alleging that they promoted the powerful painkillers Actiq and Fentora for off-label use. Off-label use pertains to when doctors prescribe medications for uses they are not approved by the FDA to treat. Physicians are allowed prescribe medications as they see fit,...

• Vioxx Suits Settled For $4.85 Billion

  Scott Kappes | November 09, 2007 2:40 PM | 0 CommentsHouston, TX

  Friday it was announced that a settlement has been reached for the majority of Vioxx litigation. Merck & Co. announced that they will pay just under $5 billion dollars to settle thousands of Vioxx injury cases. The settlement is not a class action settlement and each case will be reviewed before any payment is made. Merck will place the money into a fund, which will be petitioned for...

• Birth Control Pill Linked to Clogged Arteries

  Scott Kappes | November 07, 2007 12:45 PM | 0 CommentsHouston, TX

  A report from USA Today claims that a new study has suggested a link between birth control pills and increased risk of artery clogging plaque. The study of just over 1300 women suggest that the likelihood of finding plaques in key arteries is increased between 20 and 30 percent when taking birth control pills. This risk is thought to increase over time. The study also ties this risk to women who...

• Heart Surgery Drug Suspended From Market

  Scott Kappes | November 06, 2007 4:36 PM | 0 CommentsHouston, TX

  Yesterday the FDA and Bayer Pharmaceutical Corp. announced that Trasylol is being pulled from the U.S. market. This news comes after a Canadian study suggested that it might cause an increased risk of death. The controversial drug is used to treat patients who have an elevated risk of excessive bleeding during heart surgery. The study was discontinued when preliminary results suggested this...

• Marketing Suspended for Bayer's Trasylol

  Scott Kappes | November 05, 2007 2:23 PM | 0 CommentsHouston, TX

  Today the FDA announced that at their request Bayer Pharmaceuticals Corp. has agreed to immediately cease all marketing associated with Trasylol. This comes as a follow up to a report from October 26 that suggested that their may be an increased risk of death connected to the drug used to control bleeding during heart surgery. The preliminary results of a Canadians study on Trasylol suggest this...

• Background of Medtronic Lead Recalls

  Scott Kappes | November 01, 2007 2:44 PM | 0 CommentsHouston, TX

  The FDA has issued a Class I Recall of Medtronic Sprint Fidelis defibrillator leads due to fracture risk that can result in unwarranted shocks being applied to the implanted patient's heart. In the case of this recall, it seems that physicians at the Minnesota Heart Institute made the company aware of possible problem back in February, when for two days in a row they had patients claim that they...

• Did Medtronic Wait Too Long to Pull Leads?

  Scott Kappes | October 31, 2007 5:29 PM | 0 CommentsHouston, TX

  A story published in the Wall Street Journal claims that Medtronic may have had knowledge of problems with their Sprit Fidelis defibrillator leads as far back as February but did not act until October. Last week the FDA issued a Class I Recall on the leads in question after two reports surfaced of people experiencing unwarranted shocks from their defibrillators. One 65-year-old woman claims that...

• CellCept Tied to Birth Defects

  Scott Kappes | October 30, 2007 2:28 PM | 0 CommentsHouston, TX

  The FDA issue a warning to healthcare professionals on Monday about elevated risks of birth defects associated with the drug CellCept. The drug is used as anti-rejection aid for patients that have received transplants. The FDA warns of concerns of an increased likelihood of miscarriage in the first trimester of pregnancy and the risk of severe birth defects during fetal development. The FDA has...

• MRI Dye Danger Confirmed by New Study

  Scott Kappes | October 23, 2007 12:41 PM | 0 CommentsHouston, TX

  Scottish researchers have now confirmed the suspected link between gadolinium based contrast agents, used in MRI's, and a rare skin disease known as nephrogenic systemic fibrosis (NSF). This news comes by way of a report in the most recent issue of Radiology(online),and is based on a retrospective study of patients who underwent renal replacement therapy (RRT) between 2000 and 2006 at Glasgow...

• Hearing Loss Attributed to ED Drugs

  Scott Kappes | October 22, 2007 1:47 PM | 0 CommentsHouston, TX

  The FDA has issued a warning to healthcare professionals and consumers of sudden decreases in hearing and hearing loss associated with certain erectile dysfunction medications. Labeling changes for such blockbuster medications as Viagra, Levitra, and Cialis have already been initiated. The FDA says that the hearing loss can be accompanied by tinnitus, the ringing of the ears, and dizziness....