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FDA’s Adverse Event Reporting System (AERS) Needs Improvement
Reports of Potential Drug Side Effects by Physicians, Pharmacists, Patients, and Manufacturers The Adverse Event Reporting System, or AERS, is the FDA’s system to monitor potential side effects of a prescription drug after it…
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Drug-induced Liver Injury Most Frequent Reason for Drug Recall
Adverse Drug Reactions are Primary Cause of Acute Liver Failure in U.S. Drug-induced liver injury is the most frequent reason cited for the withdrawal from the U.S. market of an FDA-approved prescription drug. Relatedly,…
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Crestor Label Changes from March 2005 Not Posted on FDA MedWatch Site Until May 2005
Crestor Package Insert Label Changes Include Rhabdomyolysis Risk In March 2005 the FDA and AstraZeneca reached agreement about making certain changes to the package insert label for the pharmaceutical company’s cholesterol-lowering drug Crestor (rosuvastatin). …
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Sudden Cardiac Death Caused by Some Commonly Prescribed Drugs
Increased Risk of Sudden Death Linked to Use of Some Widely Used Medications A study which analyzed 775 cases of sudden cardiac deaths in the Netherlands has found some commonly prescribed drugs may interfere…
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Medicare to Aid FDA by Creation of Drug-safey Database
Serious Side Effects and Other Safety Issues Would be Discovered Sooner In an effort to reduce delay in the issuance of FDA safety recalls of drugs, Medicare wants to create a massive electronic database…
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Recalled Drug Bextra Might Return to U.S. Market
FDA Had Pfizer Pull Bextra Because of Serious Skin Reaction Side Effects Pfizer Inc. wants its arthritis drug Bextra returned to the U.S. market and plans to discuss with the FDA how it might…
