Mass mailing warns of Accutane's psychiatric risks

Article Abstract:

Hoffmann-La Roche begun mailing medication guides and patient consent forms for its Accutane anti-acne product, which has been linked to depression and suicide. The guide and consent form were sent to dermatologists, family physicians, psychiatrists and pharmacists all over the US. The medication guide also details well-documented risk of birth defects in babies of mothers who took Accutane while pregnant. It serves as a precaution to patients, many of whom do not read package inserts accompanying their medications.

Antiacne & Antiseborrheic Preparations, Antiacne agents, Hoffmann-La Roche Inc.

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Abbott Labs fined $100M

Article Abstract:

Abbott Laboratories was issued a fine of $100 million and a directive to cease distribution of over one-third of its tests, after the FDA found company violating the Federal Food, Drug and Cosmetic Act. The company said that its consent agreement with the FDA is not an admission of wrongdoing, although this would result in losses of around $250 million. The FDA asserted that the violation of manufacturing practice regulations does not imply that Abbott's products are harmful to patients.

Legal issues & crime, Surgical and Medical Instrument Manufacturing, Diagnostic Test Kits & Reagents, Medical testing products, Abbott Laboratories (Abbott Park, Illinois)

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Diabetes drug taken off shelf

Article Abstract:

Warner Lambert/Parke Davis has recalled its controversial diabetes drug Rezulin at the urging of the Food and Drug Administration. The FDA said a review of safety data indicated that the drug poses an unacceptable risk to patients. The drug, which is used to treat Type 2 diabetes, was found to be more toxic to the liver than similar treatments. The FDA has received reports of 60 deaths linked to Rezulin, according to Public Citizen, a Washington, DC-based advocacy group.

Antidiabetic Preparations, Hypoglycemic agents, Parke Davis Group

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