December 10, 2005 by TP Admin
Posted in
On December 8, 2005, GlaxoSmithKline issued a press release advising of revisions to Paxil labeling. Paxil (paroxetine hydrochloride) and Paxil CR (paroxetine hydrochloride controlled release) labeling is changed from Pregnancy Category C to Pregnancy Category D (indicative of positive evidence of human fetal risk).
The label change is based on further analysis of a previous study "...together with new data from another study utilizing a large medical birth registry..."
For complete information, please see GlaxoSmithKline's Press Release - Paroxetine and FDA News - FDA Advising of Risk of Birth Defects with Paxil.
Paxil is a commonly prescribed antidepressant, and many generics are marketed in the US. For pill identification of Paxil and several generic paroxetine imprints, see Pharmer.org's Imprints of Antidepressants.
