FDA halts distribution of Paxil
GlaxoSmithKline stopped distributing its Paxil CR antidepressant and Avandamet diabetes tablets after regulators seized the drugs Friday, saying manufacturing practices failed U.S. standards.
U.S. marshals seized lots of the two medications at manufacturing and distribution sites in Puerto Rico and Knoxville, Tennessee, the U.S. Food and Drug Administration said.
Paxil CR tablets could split apart and patients could receive a portion of the tablet that lacks active ingredients.
Neither of the products made by Glaxo, the biggest European drug maker, are medically necessary and alternatives are available, the agency said.