Category: Drug Safety Alerts
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Psoriasis Drug Raptiva Increases the Risk of Serious Infections
July 2005 "Dear Doctor" Letter Warns About Some Blood Disorders, Also Genentech Inc. and the FDA announced recently that the drug company had added a new warning for the psoriasis drug Raptiva about an…
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All NSAIDs May Be Linked to Increased Risk of Heart Attack (or Not)
June 2005 BMJ Article Calls Into Doubt Cardiovascular Safety of All NSAIDs There is new evidence that all selective and nonselective nonsteroidal anti-inflammatory drugs (NSAIDs) are associated with an increased risk of having a…
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Case Report: Adderall-induced Heart Attack in Young Boy
Reports of Sudden Unexplained Death (SUD) Involving Children Being Studied by FDA After Adderall Withdrawn in Canada An article entitled "Myocardial infarction in an adolescent taking Adderall", by Pritesh J. Gandhi, et.al., was published…
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Duragesic Pain Patch: Johnson & Johnson Adds Warning to Label and Sends “Dear Doctor” Letter
FDA Follows With Public Health Advisory on Duragesic and Other Fentanyl Patches On July 8, 2005 Johnson & Johnson Inc. added warnings about possible misuse and abuse to its Duragesic pain patch package insert…
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Scios Sends Second “Dear Doctor” Letter On Heart Drug Natrecor
Cardiologist Eric Topol Calls For Limited Use of Johnson & Johnson Drug Natrecor On July 13, 2005 the Scios division of Johnson & Johnson sent a second "Dear Doctor" letter about Natrecor, a heart-failure…
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Health Canada Advisory About Statins and Rhabdomyolysis Side Effect
July 2005 Statin Advisory Provides Patients With Important Safety Information On July 12, 2005 Health Canada issued an advisory about rhabdomyolysis being a serious side effect of all cholesterol-lowering drugs known as statins. Specifically,…
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Recent Study Shows How Vioxx, Bextra, and Celebrex Can Damage Heart
A Theory of Why COX-2 Inhibitors Affect the Heart and Raise Heart Attack Risk In May 2005 it was reported that medical researchers affiliated with the University of Pennsylvania School of Medicine have…
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FDA Mandates NAION Warning on Several Impotence and ED Drugs
Labels on Viagra, Cialis and Levitra are Changed to Address Blindness Issue On July 8, 2005 the FDA ordered warnings be put on the package insert labels of Viagra, Cialis, and Levitra to the…
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Health Canada Advisory Panel Supports Return of Painkiller Vioxx to Market
Canadian Panel Votes Against Bextra Due to Increased Risk of Serious Skin Reactions On July 7, 2005, a panel of medical experts advised Health Canada officials that, in its opinion, the arthritis drug and…
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FDA Knew of Possible Viagra-Blindness Link as Early as January 2004
Senator Grassley's June 2005 Letter Criticizes FDA's Delay in Alerting Doctors and Patients In January 2004 an FDA safety officer told her FDA supervisors that doctors and patients should be warned of a possible…