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Health Law

: Health Law Prof Blog

Behind the FDA's "Black Box" Warnings

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The Los Angeles Times discusses why Cipro and similar antibiotics are given the FDA's strictest label, while epilepsy drugs Lyrica, Depakote and Topamax may have escaped. Karen Ravn writes, Two groups of drugs were under the Food and Drug Administration...

Full post as published by Health Law Prof Blog on August 16, 2008 (boomark / email).

Lawsuits and Settlements

Cipro
The FDA is seeking to add black box warnings of the risk of tendon rupture associated with Cipro and Levaquin. The ruptures can involve Achilles tendon, shoulder, hand, bicep or thumb tendons, and is especially increased in patients older than 60, or people who have received kidney, heart or lung transplants, as well as people on steroid therapy...

Acetaminophen
FDA Wants New Safety Warnings

CellCept
Roche Issues Changes to Warnings and Adverse Events

Darvon
Other Propoxyphene-Containing Meds to Require Stronger Warnings

Homelite, Husky and Black Max Generators Recalled
Homelite, Husky and Black Max Generators Recalled

Black & Decker Coffeemakers Recalled Due to Burn Hazard
Black & Decker Coffeemakers Recalled Due to Burn Hazard

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