FDA warns against recalled anti-depression drugs
May 27, 2014 8:06pm
Philippine health authorities on Tuesday advised the public against buying three batches of anti-depression drugs that had been recalled by their manufacturer.
The Food and Drug Administration said GlaxoSmithKline USA recalled batches of its Paroxetine 20mg tablet (Seroxat) that were made in Romania.
"A Warning Letter was issued by the US FDA to GlaxoSmithKline (GSK), USA because the active Pharmaceutical Ingredients (API) manufacturer, SmithKline Beecham (Cork) Ltd. at Currabinny Carriagaline Cork, Ireland had critical deviations which caused the Paroxetine API to be adulterated," FDA head Kenneth Hartigan-Go said in FDA Advisory 2014-038.
While the advisory was dated May 12, it was posted on the FDA website only on Tuesday.
Covered by the voluntary recall are batches 601, 602M, and 603.
Hartigan-Go said proxetine is used for treatment of depression, obsessive-compulsive disorder and panic disorder with or without agoraphobia or the fear of public places.
The FDA advised consumers to buy their medicines from legitimate pharmacies and drug outlets and ask for official receipts.
"If you happen to buy batches of Seroxat that are subject of product recall, the consumer may report to FDA via report@fda.gov.ph or to GalxoSmithKline Philippines Inc at tel. nos.: +6328648516 and +6328920762 ext. 8643 or mobile nos.: +639178882315 and+639178594598," it said.
Suspected adverse reactions should be reported immediately to FDA by visiting www.fda.gov.ph. —Joel Locsin/NB, GMA News