Thursday, December 06, 2012

GSK have Paxil problems in Canada

Pharma company says it acted 'appropriately' in response to Paxil class-action

VANCOUVER - Pharmaceutical giant GlaxoSmithKline says it conducted its clinical trial program for the anti-depressant drug Paxil appropriately in marketing the medicine for use by women of childbearing age.

The statement comes after a B.C. Supreme Court judge certified a class-action lawsuit launched by a British Columbia mother whose daughter was born with a hole in her heart.

Lawyers allege the drug caused birth defects when taken during pregnancy, and say the company didn't properly warn doctors about the risks.

In a statement, spokeswoman Michelle Smolenaars Hunter says the company acted appropriately in its clinical trials, marketing, safety monitoring and updated pregnancy information as new information became available.

Faith Gibson's daughter Meah Bartram was born just two weeks before the company warned doctors that taking the drug during pregnancy could increase the chance of cardiovascular defects.

One of her lawyers, David Klein, argues the company ought to have know the risks before then, and is pointing to small-scale studies and studies on similar products that were already available to the scientific community.

But Smolenaars Hunter says the company acted responsibly.

"The company properly shared documentation and submitted results from studies on Paxil to regulators," she said in an email on Thursday, "and communicated important safety information to regulatory agencies, the scientific community and health-care professionals."

The company says it is currently evaluating its options with regard to the class certification.

It applies to women who took the drug in Canada.

No allegations have been proven in court.

Klein said about a dozen women have come forward so far. A notice of the suit will soon be distributed across the country. A trial isn't expected for a couple years.

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