Category: Drug Safety Alerts
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Novantrone: FDA MedWatch Alert Regarding Heart Damage Risks
April 2005 "Dear Doctor" Letter Also Addressed an Increased Risk of AML In late May 2005 the FDA warned patients of the risk of heart damage from Serono’s multiple sclerosis drug Novantrone. In a…
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Pfizer Maintains There is No NAION / Blindness Risk from Viagra
Bayer Has Not Decided Whether to Add NAION Warning for Levitra On June 27, 2005 Pfizer Inc. issued a press release asserting that there is no evidence of any increased risk of developing non-arteritic…
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European Drug Regulators Want Increased Warnings on All COX-2 Inhibitor Drugs
Bextra: Suspension of Marketing in European Union to Continue In a June 27, 2005 press release issued by the European Medicines Agency (EMEA), the Agency’s Committee for Medicinal Products for Human Use (CHMP) said…
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Black-box Warning for Celebrex and Other NSAIDs
FDA Requires Warning Label Changes for Painkillers In June 2005 the FDA advised Pfizer, the maker of Celebrex, and several other drug manufacturers that the package insert, or warning label, for their prescription NSAID…
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Antipsychotic Risperdal Associated with Benign Tumors in Pituitary Gland
Another Possible Side Effect for Atypical Antipsychotic Class of Drugs On June 17, 2005 The Wall Street Journal reported that Risperdal, one of the so-called atypical antipsychotic drugs, has been associated with benign tumors…
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Tysabri: Will this Multiple Sclerosis Drug Return to U.S. Market or Not?
Fourth Case of Tysabri-related PML is Reported to FDA by Manufacturer A fourth patient taking the multiple sclerosis drug Tysabri may have contracted a deadly brain disease called progressive multifocal leukoencephalopathy, or PML, calling…
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Natrecor Given Regularly to Outpatients is Focus of Current Safety Controversy
In May 2005 Scios Sent a Natrecor "Dear Doctor" Letter to Heart Doctors Natrecor is a prescription drug approved by the FDA as a therapy for hospitalized patients or those rushed to emergency rooms…
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Viagra, Other ED Drugs Possibly Linked With Vision Loss and Blindness
FDA To Consider Warning Label Changes for Viagra, Cialis, and Levitra The FDA is investigating numerous reports of a possible serious side effect from the use of Viagra and other impotence, or erectile dysfunction…
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Crestor Side Effects: Reports to FDA MedWatch Analyzed by Tufts Doctors
Crestor-Rhabdomyolysis Link: New Study May Support Allegations by Public Citizen Group Rhabdomyolysis, proteinuria, nephropathy, and kidney or renal failure are serious side effects which apparently occur more often with the use of Crestor (rosuvastatin)…
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SSRI Drugs Can Increase Risk of Gastrointestinal Bleeding
Increased Risk of Acute Gastrointestinal Bleeding When Taking Both SSRIs and NSAIDs Long-term use of selective serotonin re-uptake inhibitors, or SSRIs, increases the risk of gastrointestinal bleeding to a degree similar to that caused…