Regulatory

Lilly's Strattera may be associated with liver problems - UK agency

Last Updated: 2005-02-03 15:33:57 -0400 (Reuters Health)

By Richard Woodman

LONDON (Agence de Presse Medicale for Reuters Health) - Eli Lilly's hyperactivity drug Strattera (atomoxetine) may "very rarely be associated with liver reactions", Britain's Medicines and Healthcare Products Regulatory Agency said on Thursday.

The agency said in a statement it was alerting patients to the possible risk and advising doctors to stop treatment if they suspect that liver problems are occurring.

Strattera, a non-stimulant drug for the treatment of attention deficit hyperactivity disorder, has been prescribed to around two million patients in the US and around 10,000 patients in the UK.

It is being rolled out in other EU countries under the mutual recognition process.

The agency said the UK committee on safety of medicines had reviewed new evidence on the drug at the end of January that suggested an association with liver problems -- though the frequency of serious reactions was less than 1 in 50,000 patients.

"Parents should not be dissuaded from having their children treated with this medicine but it is right that they should be aware of possible, but rare, side effects," said committee chairman, Professor Gordon Duff.

"That is why we have today issued new advice to doctors, and a question and answer sheet for parents and patients. These documents raise awareness of this new evidence so that prescribers, patients and their families can be alert to any signs suggestive of liver problems."

Duff said any concerned parents should discuss the subject with their doctor but should not stop treatment with the drug before doing so. "We have advised doctors that if they suspect that liver problems are occurring, treatment should be stopped and an alternative treatment initiated."

The committee has recommended more work to find out what may be causing these side effects in a small minority of patients, as this will help to identify which patients are more likely to be affected.

A company spokesman told APM that there had been two reports of serious but reversible liver problems out of 2 million patients who had been prescribed the drug globally. "It could be that they are drug-related but we are not sure."

The company sent out a "Dear Doctor" letter in the United States in December advising patients with jaundice or liver injury to stop taking Strattera.