FDA & Prescription Drugs

• Attorneys Challenge Vioxx Settlement Provision

  Scott Kappes | January 07, 2008 9:32 AM | 0 CommentsHouston, TX

  Lawyers for thousands of people injured by Merck's recalled painkiller Vioxx are challenging a specific provision of the $4.85 billion settlement proposed in November. The provision in dispute requires lawyers representing injured parties to advise either all of their clients to accept the settlement or none of their clients to accept the deal. This is a quite perplexing ethical situation for...

• Popular New Year's Resolution Could Be Dangerous

  Scott Kappes | January 02, 2008 11:02 AM | 0 CommentsHouston, TX

  Many people will have made their New Year's resolution to quit smoking, but some could be getting more than they bargained for. People who want to quit smoking will try every remedy available from gum and lozenges to prescription medications like Zyban and Chantix. Most people have seen better results from prescriptions than other methods, but even these are not free from risk. Recent reports...

• Chantix Featured on CBS Evening News

  Scott Kappes | December 27, 2007 3:18 PM | 0 CommentsHouston, TX

  Last night the CBS Evening News featured an interesting story on Pfizer's prescription stop smoking drug Chantix. The story featured an interview with 33 year-old Amy Garza, a 17 year smoker who tried Chantix to help her quit smoking. Garza was initially very pleased with the results she got from the drug and thought she was well on her way to living a smoke-free life, that is until she tried to...

• Pain Patches Get Another FDA Warning

  Scott Kappes | December 21, 2007 4:48 PM | 0 CommentsHouston, TX

  Today the FDA issued a public safety warning regarding Johnson and Johnson's Duragesic pain patch and its generic equivalents. This is the second such warning for these devices. Recent reports to the FDA confirm that improper use of the patches is still causing severe adverse reactions and death. In July of 2005 a similar warning was issued for the patch after 120 patients died while taking the...

• Over 40 Patients Infected By Syringes Contaminated With Bacteria

  Scott Kappes | December 20, 2007 2:59 PM | 0 CommentsHouston, TX

  The Serratia marcescens bacteria infected hospital patients in both Texas and Illinois when contaminated syringes were used to administer medication to them. In all 41 patients have been treated for the infection from the contaminated syringes. Over 20 patents were infected a Rush Medical Center in Chicago and another 20 caught the infection at a Dallas area oncology clinic. Seirra Pre-Filled...

• FDA Warns Wyeth About Effexor Ad

  Scott Kappes | December 18, 2007 12:29 PM | 0 CommentsHouston, TX

  Last Friday the FDA issued a warning letter to Wyeth Pharmaceuticals Inc. over an advertisement for Effexor XR published in a professional journal. The FDA states that the letter overstates the efficacy of Effexor XR and makes unsubstantiated claims of the drug's superiority to other treatments. The letter also claims that the ad understates the risks associated with the use of Effexor XR. These...

• Champix Will Carry Suicide Warning in Europe

  Scott Kappes | December 17, 2007 10:01 AM | 0 CommentsHouston, TX

  The European Medicines Agency has decided that Pfizer's smoking cessation drug Champix, marketed as Chantix in the States, needs to include a an updated warning to inform physicians and consumers of the possibility of depression, suicidal thought and even suicide attempts associated with the drug. There have been reports of several suicides and numerous claims of suicidal ideation attributed to...

• New Study Adds More Fuel to the Fire Around GSK's Avandia

  Scott Kappes | December 12, 2007 10:21 AM | 0 CommentsHouston, TX

  Yesterday the findings of a new study on Avandia out of Canada were published in the Journal of the American Medical Association. The study reaffirms another study published in May of this year demonstrating a link between Avandia and an increased risk of heart attack. The new study was conducted by a non-profit organization looking at over 159,000 older patients with diabetes. All patients...

• Judge Overturns Prempro Verdict

  Scott Kappes | December 10, 2007 11:59 PM | 0 CommentsHouston, TX

  Late last week a Pennsylvania state court judge Richard C. Jackson overturned a $3 million award to a woman claiming that the hormone-replacement drug Prempro caused her breast cancer. The judge declared that she did not show sufficient evidence of negligence on behalf of Wyeth, the maker of the drug. The woman, Jennie Nelson, is appealing the ruling. Nelson was diagnosed in 2001 after taking...

• Avandia Withdrawal Disparity Between U.S. and E.U.

  Scott Kappes | December 10, 2007 3:35 PM | 0 CommentsHouston, TX

  According to new research from TNS Healthcare's DiabetesDynamics American doctors have made much more significant changes in the way they prescribe Avandia when compared to doctors of Europe. Since the May article linking Avandia to a possible 42 percent increased risk of heart attack 70 percent of prescribing changes have been attributed to withdrawal, or basically doctors switching to another...