UK drug firms deny safety doubts

One of the drugs under discussion is used as a diet treatment

British drug firms have defended the safety of two products which were deemed unsafe by an American expert.

Dr David Graham listed five medicines which he said posed serious health risks during a US Senate hearing.

Among them were Crestor, a cholesterol-lowering drug from AstraZeneca, and GlaxoSmithKline's Serevent, used by asthma patients.

Both firms saw their share value fall on the stock market last Friday after Dr Graham's comments.

Dr Graham is a member of the American Food and Drug administration's Office of Drug Safety.

He made his comments during a hearing into anti-inflammatory drug Vioxx, which was withdrawn after safety trials.

Safety defended

The FDA was quick to back the safety of the five drugs, which are all available in Britain.

Each of the firms which manufacturer them staunchly defenced their safety.

AstraZeneca said it was baffled by the comments and added: "AstraZeneca is confident in both the safety and efficacy of Crestor."

GlaxoSmithKline said: "GlaxoSmithKline stands firmly behind Serevent which is safe and effective when used appropriately and in accordance with labelling and treatment guidelines."

Responding to the safety fears, the UK Department of Health said it keeps medicines under constant review.

All of the drugs were licenced after clinical trials.

' No need to worry'

Dr Richard Nicholson, editor of The Bulletin of Medical Ethics, said there was no "immediate worry" from the evidence heard in America.

But he said that all drugs may have side-effects not discovered during the initial licencing phase.

The other three drugs are diet drug Meridia, from US-based Abbott Laboratories; acne medicine Accutane, from the Swiss pharmaceutical firm Roche, and Bextra, from the US firm Pfizer, which is an anti-inflammatory drug

Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, said: "The five specific drugs that Dr Graham identified in his oral testimony are currently approved as safe and effective for use in the US.

We are virtually defenceless Dr David Graham

"The FDA evaluates the safety and effectiveness of all drugs independently, on a case-by-case basis, before they are approved to enter the marketplace.

"It also evaluates reported adverse events with all drugs already on the market to assess whether unforeseen safety concerns need to be addressed."

But in an interview with NBC television on Friday, Dr Galson conceded that "all the drugs that are on the market have risks".

Dr Graham told the US Senate hearing into Vioxx on Thursday that the FDA was "incapable of protecting America against another Vioxx".

"We are virtually defenceless," he added.

Pharmaceutical giant Merck withdrew Vioxx from the market on 30 September in the biggest drug recall in history, after a company-sponsored trial found that patients who took the medication for more than 18 months doubled their risk of heart attack or stroke.