FDA & Prescription Drugs

• Researcher Leaked Avandia Report to Glaxo Before Publication

  Scott Kappes | January 31, 2008 11:34 AM | 0 CommentsHouston, TX

  A Texas researcher has admitted that he leaked a copy of the now infamous New England Journal of Medicine article that tied Avandia to an elevated heart risks. Steven Haffner of the University of Texas Health Science Center at San Antonio conceded that he faxed a pre-publication copy of the report to GlaxoSmithKline (GSK), the makers of Avandia, 17 days before the article was published. Haffner...

• Stop Smoking Aid Receives Approval in Japan

  Scott Kappes | January 29, 2008 10:03 AM | 0 CommentsHouston, TX

  Yesterday Pfizer announced that it had received approval from Japan's Ministry of Health, Labor, and Welfare to manufacture and market the popular stop smoking aid known as Chantix in the US. The drug will be marketed as Champix in Japan, as it is in the UK and EU. This will be the first oral smoking cessation aid availible in Japan and Pfizer expects it to be very popular among Japanese smokers...

• Chantix-Suicide Link Grows Stronger

  Scott Kappes | January 25, 2008 3:46 PM | 0 CommentsHouston, TX

  Today I came across yet another story that appears to link Pfizer's blockbuster stop smoking aid Chantix, marketed as Champix in the UK, to an increased risk of suicidal thought and behavior. The horrifying story of a 38-year-old UK woman taking Chantix who tried to take her own life with no recollection of the event is one of the most disturbing accounts that I have come across. Karen McGhee...

• Another Suicide Linked to Stop Smoking Drug

  Scott Kappes | January 22, 2008 5:19 PM | 0 CommentsHouston, TX

  This week Pfizer announced a label change for the popular smoking cessation medication Chantix in the U.S. due to increased concern of a possible link between the drug and suicidal thought and behavior. Just as this news hits the U.S. the United Kingdom is rattled by the news of yet another suicide being linked to Champix, the marketing name for Chantix in the UK. A 36-year-old welder and father...

• Improper Marketing Of Enbrel Prompts Investigation

  Scott Kappes | January 22, 2008 10:52 AM | 0 CommentsHouston, TX

  The New Jersey attorney general has subpoenaed drug maker, Amgen, following allegations of patient privacy law and marketing violations concerning the rheumatoid arthritis drug Enbrel. Former sales reps have made claims that they were pushed make attempts at accessing patient medical information and to market directly to patients. Amgen says that the claims have no merit and that their reps have...

• Suicide Warning Added to Chantix Label

  Scott Kappes | January 21, 2008 11:48 AM | 0 CommentsHouston, TX

  On Friday Pfizer announced that a labeling change for the popular stop smoking drug Chantix. The FDA is conducting an ongoing investigation of the drug and its possible link to suicidal thoughts and other psychological effects. The label has been altered to reflect the fact that some patients may experience "serious nueropsychiatric symptoms" including but not limited to suicidal behavior....

• FDA Issues Warning For Cold Remedies

  Scott Kappes | January 17, 2008 1:07 PM | 0 CommentsHouston, TX

  Today the FDA issued a warning that parents should not give toddlers over the counter cold and cough medicines. The agency says that these drugs are too dangerous for children less than two years of age. The agency has yet to decide whether OTC cold medications are appropriate for older children, but a decision can be expected in this matter sometime this spring. The warning was prompted by the...

• Supreme Court Refuses To Hear Unapproved Drugs Case

  Scott Kappes | January 16, 2008 2:20 PM | 0 CommentsHouston, TX

  On Monday the United States Supreme Court refused to hear an appeals case involving terminally ill patients' constitutional rights to experimental dugs that have not been approved by the FDA The case was originally filed 2003 when the Washington Legal Foundation and the Abigail Alliance for Better Access to Developmental Drugs initiated a claim that the FDA's policy of restricting terminally ill...

• Doctors' Group Encourages Vegan Diet Over Avandia

  Scott Kappes | January 15, 2008 5:02 PM | 0 CommentsHouston, TX

  A group of professional doctors has petitioned the FDA to add additional information to the label of the controversial type-2 diabetes drug Avandia. The request may surprise you as it did me. They are not petitioning to place another warning about heart failure or the increased risk of heart attack that has been so widely publicized in recent months, but rather to encourage diabetics to adopt a...

• US Ranks Last In Preventable Deaths

  Scott Kappes | January 10, 2008 5:18 PM | 0 CommentsHouston, TX

  A study of 19 industrialized nations ranked the United States worst in preventable death statistics. The report is published in this months issue Health Affairs and compares trends from 1997-8 and 2002-3 of people under 75 years of age whose deaths were classified as "amenable to health care," or preventable with appropriate health care. The study shows the United states falling well behind the...