May 12, 2006
GlaxoSmithKline issues Paxil warning
GlaxoSmithKline has sent letters to doctors warning its antidepressant Paxil appeared to increase the risk of suicide attempts in young adults participating in clinical trials.
The company also said it would change the labeling on Paxil to reflect the findings of the study, which found that reported suicide attempts were rare but significantly more common in adults who took the drug for depression than those who received placebo pills.
Analysis of the study found that 11 of 3,455 people who were taking Paxil for depression reported an attempted suicide, compared with 1 in 1,978 taking placebo in the trials. Most were among adults ages 18 to 30, the company said.
Glaxo sent out the warnings voluntarily, and its data still show that the drug’s benefits outweigh the risks for people with depression, a company spokeswoman told The New York Times.
“We are now advising doctors to monitor all patients to make sure their symptoms don’t worsen” in the full course of treatment, the spokeswoman said.
In 2005, total global Paxil sales fell 42% to $1.1 billion, according to numbers from Glaxo. The decrease was attributed to generic competition and an interruption in supply to Paxil CR during the year due to manufacturing concerns.