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FDA To Hold Two-Day Direct-To-Consumer Advertising Meeting In November 2005
Public Meeting to Review Rules Concerning Prescription Drug DTC Advertisements The FDA is considering revising rules about, first, how much side-effect risk information prescription drug commercials must include and, second, whether all direct-to-consumer ("DTC")…
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1500 New Vioxx Lawsuits Filed Against Merck Since Late August
3,481 NJ Vioxx Cases, 2625 MDL Cases, 450 "Others": October 2005 AP Report Reporter Linda A. Johnson, through the Associated Press ("AP"), informed us on October 13, 2005 that Merck now faces more than…
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Trileptal May Cause Toxic Epidermal Necrolysis and Stevens Johnson Syndrome
Trileptal-induced TEN, SJS, and Hypersensitivity Reactions Reported to FDA In April 2005 the FDA and Novartis Pharmaceuticals Corp. issued a MedWatch safety alert about the risk of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis…
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The Safety of Prescription Drugs During Pregnancy
FDA Uses Five Pregnancy Risk Categories At Present The FDA uses five risk categories to rank the safety of prescription drugs during pregnancy. In recent years, the FDA pregnancy risk categories have gone from…
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Health Canada Put Adderall Back on the Market Based on “Inconclusive Evidence”
Safety of Adderall Cannot be Adequately Evaluated Says Expert Committee Chairman In the October 11, 2005 edition of the Canadian Medical Association Journal ("CMAJ"), an article by Wayne Kondro reveals that Health Canada reintroduced…
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“Buyer Beware”, Especially If That New Drug Prescribed To You Was Just Approved By The FDA
FDA Approval Does Not Mean A New Drug Won’t Have Any Serious Side Effects In early October 2005, Jonathan D. Rockoff, of The Baltimore Sun, wrote a good article about an important issue for…
