GlaxoSmithKline issues Paxil warning

Share this article:
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.
Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in Business Briefs

Email Newsletters

MM&M Future Leaders


Register now

Early bird $1,950 before 31 October 2014

*Group discounts available on request 

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Business Briefs

Monday Moves: September 15

Hires and promotions for manufacturers, regulatory and agencies

Kantar acquires Evidências, expands Brazilian presence

The company's acquisition signals the growing importance of understanding the Brazilian healthcare market and evidence-based healthcare management services.

Study says statins not enough for diabetic hearts

Researchers using an experimental test have discovered that the 50% of surveyed diabetics may also have undetected heart muscle damage.