FDA & Prescription Drugs

• Another Psychotic Episode Linked To Chantix?

  Scott Kappes | January 25, 2008 10:58 AM | 0 CommentsGalveston Bay, TX

  I came across another frightening claim of psychotic behavior that appears could be linked to Pfizer's stop smoking drug Chantix. The story comes out of the UK where the drug is marketed as Champix. A woman living in the UK claims that on Christmas Eve her boyfriend who had been taking Champix for several months went what she described as "berserk." The woman claims that her boyfriend had been...

• FDA Warns of Contaminated Syringes

  Chrissie Cole | January 25, 2008 12:38 AM | 0 CommentsNew York City, NY

  The U.S. Food and Drug Administration (FDA) announced a nationwide drug recall of all lots of heparin and saline pre-filled flush syringes manufactured by AM2 PAT, Inc. under the brand name(s) Sierra Pre-filled, Inc. and B. Braun. The recall was announced after samples tested positive for Serratia marcescens, a bacterium that can cause death and serious injury. Serratia marcescens has been...

• Birth Control Patch Warning Label to be Revised

  Sandy Grinnell | January 24, 2008 5:47 AM | 0 CommentsOrlando, FL

  The FDA has approved changes to the warning labels on the Ortho Evra Contraceptive Transdermal (Skin) Patch. The label will now include a warning that users of the birth control patch were at higher risk of developing serious blood clots, also known as venous thromboembolism (VTE), than women using birth control pills. VTE can lead to pulmonary embolism.The warning comes from a study completed...

• Drug Companies Pull Vytorin TV Ad

  Joe Saunders | January 23, 2008 2:20 PM | 0 CommentsPinellas, FL

  A week after a study showed that Vytorin is no more effective in reducing cholesterol than the company's generic equivalent, Merck and Schering-Plough withdrew their direct-to-consumer marketing ads. Vytorin, a combination of Zetia and Merck's Zocor, lost patent protection in 2006. The marketing campaign was a familiar one to television viewers and was dubbed "food and family" depicting in a...

• Immediate Heparin Recall by Baxter Healthcare

  Sandy Grinnell | January 23, 2008 10:35 AM | 0 CommentsOrlando, FL

  Baxter Healthcare is voluntarily recalling nine lots of Heparin because of the reports of serious adverse reactions to the injections. Reported adverse events include abdominal pain, decreased blood pressure, burning sensation, chest pain, diarrhea, dizziness, drug ineffectiveness, dyspepsia, dyspnea, erythema, flushing, headache, hyperhidrosis, hypoesthesia, hypotension, increased lacrimation,...

• 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...

• Antidepressants: The Untold Story

  Scott Kappes | January 22, 2008 4:33 PM | 0 CommentsGalveston Bay, TX

  Last week the New England Journal of Medicine published an article claiming that the positive effect of antidepressants have been skewed way out of proportion by the lack of published reports that detail negative findings. After reviewing studies submitted to the FDA for 12 different antidepressants a report concluded that 88 per cent of studies that showed negative results were never published...

• 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...

• Ortho Evra Gets Additional Warnings

  Scott Kappes | January 21, 2008 4:53 PM | 0 CommentsGalveston Bay, TX

  Last Friday the FDA approved additional changes to the label of the once blockbuster Ortho Evra birth control patch to include results from a new epidemiology study that suggests that users of the patch are at higher risk for developing serious blood clots than those taking birth control pills. These dangerous blood clots are known as venous thromboembolism (VTE), which can lead to pulmonary...

• 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....