Glaxo may have shipped faulty antidepressants


by Bloomberg News, 5 Oct 2006

GlaxoSmithKline PLC, the world's second-biggest drugmaker, recalled Paxil CR antidepressants last month because the pills may have lacked an active ingredient, and didn't warn patients.

Glaxo doesn't know how many of the 7.5 million recalled pills were missing paroxetine hydrochloride, or how many patients took the pills, spokesman Michael Fleming said yesterday . The company didn't tell patients because testing on a later lot suggested as few as one of the pills lacked the key ingredient, he said.

Doctors said the lack of a warning could mean that patients could face a sudden withdrawal that can spur suicidal thoughts, shooting pain, and flulike symptoms .

“If it is true that patients might have gotten dummy pills without knowing it, it is outrageous," said Stephen Ellen of the University of Massachusetts Medical School in Worcester .

About 280,000 Americans take Paxil CR , Fleming said .

Peter Lurie of Public Citizen, a Washington, D.C.-based advocacy group, said drugmakers can limit the number of returned products in a recall by not advising patients.

“This way the company gets to say they did a recall, they dump the responsibility on intermediaries, and the patient most likely hears nothing," he said.