FDA & Prescription Drugs

• FDA Deadlines May Affect Drug Safety

  Scott Kappes | March 28, 2008 2:55 PM | 0 CommentsHouston, TX

  According to a study published in the New England Journal of Medicine deadlines for response to new drug applications may be causing the agency to make hasty decisions. The study suggests that drugs approved closer to the deadline end up having more safety issues once on the market than drugs that are approved earlier in the process. The study shows that of the 97 drugs that were approved within...

• FDA To Investigate Singulair-Suicide Link

  Scott Kappes | March 27, 2008 1:50 PM | 0 CommentsHouston, TX

  Today the FDA announced that they would be launching a probe to investigate a possible link between Merck's asthma medication Singulair and suicidal ideation and action. The agency is reviewing the issue due to reports of mood and behavioral changes, including suicidal thoughts and action, associated with the drug. Singulair is most commonly used to treat asthma but is also often used to treat...

• Gadolinium Based Contrast Agent Prompts Lawsuit

  Scott Kappes | March 17, 2008 3:55 PM | 0 CommentsHouston, TX

  A San Francisco couple has filed a lawsuit against Bayer and other drug manufacturers alleging that gadolinium based contrasted agents manufactured and distributed by the Defendants can cause patients to develop a severely painful and debilitating disease. William Paschal claims that he contracted Nephrogenic Systemic Fibrosis (NSF) from an intravenous injection of a gadolinium based contrast...

• Flu Meds Tied to Neuropsychiatric Events

  Scott Kappes | March 04, 2008 5:23 PM | 0 CommentsHouston, TX

  Millions of people the world over catch the flu each year. Many experience extremely debilitating symptoms from the influenza virus. Drugs like Tamiflu and Relenza have been developed to treat these symptoms and offer those infected some relief from the relentless illness. Recent news however has linked these treatments to neuropsychiatric events in some instances. Post-marketing reports, mostly...

• Trasylol Linked to Over 20,000 Deaths

  Scott Kappes | February 26, 2008 2:03 PM | 0 CommentsHouston, TX

  A recent study found that patients that received Bayer's Trasylol during heart surgery were significantly more likely to die within the next decade. Another study of 78,000 patients, originally withheld by Bayer, found a 78 percent increased risk of death within a week following the surgery. In November Bayer suspended sales of Trasylol after a Canadian trial linked the drug to higher death...

• Heparin Investigation Uncovers Chinese Link

  Scott Kappes | February 15, 2008 12:50 PM | 0 CommentsHouston, TX

  A probe into the cause behind 350 bad reactions to the blood-thinner Heparin discovered that most of the active ingredient used in Heparin is produced at a Chinese facility. This information casts new doubt on the safety of the growing percentage of Chinese-based pharmaceutical plants. About 40 percent of the bad reactions were classified as serious, including four possible deaths. The cause of...

• Chantix: FDA Issues Public Health Advisory

  Scott Kappes | February 01, 2008 4:20 PM | 0 CommentsHouston, TX

  Today the FDA issued a Public Health Advisory for Pfizer's stop smoking drug Chantix to inform health care providers and consumers about concerns surrounding the drug. Last November the agency issued an Early Communication on Chantix in response to an abundance of adverse events reported to the agency following the tragic shooting death of Dallas musician Carter Albrecht. Reports of behavioral...

• 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...

• 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....