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FDA Table of Potential Drug Risks – from Adverse Event Reporting System (AERS)

Mike Havrilla (September 6th, 2008) Writes:
The FDA has published a table with the names of products and potential signals of serious risks and/or new safety information identified for these products during 1Q08 in the AERS database. The FDA notes that patients should not stop taking these medications and should consult their prescriber with any questions as the agency will investigate each of the claims further before taking action or issuing more definitive statements on the reported concerns. Some highlights from this table of products that are sold by public-traded pharma and biotech companies are listed below in the following format: active ingredient (brand name) - company(ies) - new safety information reported. Duloxetine (Cymbalta) - Eli Lilly (LLY) - Urinary retention Heparin - Baxter (BAX) & APP Pharma (APPX) - Anaphylactic-type reactions Lapatinib (Tykerb) - GlaxoSmithKline (GSK) – Liver toxicity Lenalidomide (Revlimid) - Celgene (CELG) – ...

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