Drug Company Rapped Over Teen Deaths
March 7th 2008
A drug company has been spared prosecution after failing to declare disturbing findings about the effect of an anti-depressant drug on teenagers. Glaxosmithkline submitted information about the drug Seroxat to British regulators in May 2003 - and regulators say they are still "concerned" that it could have submitted the information earlier.
The information showed the drug was ineffective in young people under the age of 18 - and that there was also an increased risk of suicidal behaviour.
Investigators studied more than a million pages of evidence before concluding that a prosecution would not be successful - because there were not strong enough laws in force at the time.
Professor Kent Woods, chief executive of the Medicines and Healthcare Products Regulatory Agency, said: "I remain concerned that GSK could and should have reported this information earlier than they did.
"All companies have a responsibility to patients, and should report any adverse data signals to us as soon as they discover them.
"This investigation has revealed important weaknesses in the drug safety legislation in force at the time.
"Subsequent legislation has partially addressed the problem, but we will take immediate steps to ensure the law is strengthened further, so that there can be no doubt as to companies’ obligations to report safety issues."
Dr Alastair Benbow, medical director for GSK Europe said: "We firmly believe we acted properly and responsibly in first carrying out this important clinical trials programme and then informing the regulatory agencies when we identified a potential increased risk of suicidal thinking and behaviour in patients under 18."
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