Category: Drug Safety Alerts
-
Safety Warning Issued For Ortho Evra Birth Control Skin Patch
FDA: Possible Increased Risk of Blood Clots For Ortho Evra Users In November 2005 the FDA announced that it had approved an updated label, or package insert, for the Ortho Evra contraceptive patch. The…
-
Danish Study Suggests Celebrex And Vioxx To Be Avoided After Heart Attack
Increased Risk Of Death For Post-Heart Attack Patients Taking COX-2 Drugs In mid-November 2005 it was reported that Merck’s Vioxx and Pfizer’s Celebrex, as well as some similar painkillers, increase the risk of death…
-
Hormone Replacement Therapy With Alcohol Use Increases Breast Cancer Risk
November 2005 HRT-Alcohol Study Attempts To Find Out More About Mechanism Women who use postmenopausal hormone replacement therapy drugs and, at the same time, use alcohol are apparently at an increased risk of developing…
-
New Study Suggests Tysabri Not Likely Come Back On Market
FDA Will Determine Whether Risks Outweigh Any Potential Benefit Serious side effects associated with Tysabri may outweigh any potential benefit, according to a study published in early November 2005, such that the once-promising drug…
-
Biogen and FDA Warn of Severe Skin Reactions To Lymphoma Drug Zevalin
Toxic Epidermal Necrolysis (TEN), Stevens-Johnson Syndrome (SJS), and Erythema Multiforme (EM) In late October 2005 Biogen Idec Inc. and the FDA warned doctors about severe and sometimes fatal skin reactions that have been reported…
-
“Off-label” Prescribing of Psychosis Drugs For Alzheimer’s Has Risks
Careful Consideration Needed When Prescribing Zyprexa or Risperdal for Alzheimer’s-related Dementia Elderly patients with Alzheimer’s disease who are prescribed antipsychotic drugs such as Zyprexa and Risperdal have a higher risk of dying than patients…
-
Public Citizen Petitions FDA To Add Black-Box Warning On Impotence Drugs
Erectile Dysfunction Drugs Viagra, Cialis, and Levitra Linked to NAION Vision Loss In mid-October 2005 the consumer-advocacy group Public Citizen petitioned the FDA to add a "black-box" warning to the labels of Pfizer Inc.’s…
-
Eli Lilly Sends “Dear Doctor” Letter Regarding Cymbalta and Liver Injury
FDA Warning: Cymbalta May Cause Liver Damage For Patients With Chronic Liver Disease On October 17, 2005 the FDA and Eli Lilly & Co. said in a MedWatch drug alert that the antidepressant Cymbalta…
-
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…
-
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…