Cholesterol drug to be sold without prescription in Britain

Wednesday, May 12th 2004, 9:28 am

By: News On 6

LONDON (AP) _ In a bid to prevent heart attacks and strokes, Britain will be the first country to permit nonprescription sales of a cholesterol-lowering drug, the government said Wednesday.

The British Heart Foundation welcomed the decision, but other experts said people taking such drugs needed supervision and an assessments of risks.

Health officials said a low-dose version of simvastatin, marketed as Zocor by Merck and Co. of Mount Laurel, N.J., will be available without a prescription at pharmacies across the country starting later this year. No date was announced.

Simvastatin belongs to a class of drugs called statins, considered a powerful weapon against the buildup of fat deposits that clogs arteries, leading to heart attacks and strokes.

``This new move will allow more people to protect themselves from the risk of coronary heart disease and heart attacks,'' said Health Secretary John Reid. ``By extending access to this drug we are giving people more choice about how they protect their health. We are committed to extending choice whenever advised it is safe to do so.''

Pharmacists will ask people a series of questions and, if needed, will offer a range of optional health tests to ensure it is safe to take the drug, Reid added.

The Royal College of General Practitioners and the British Medical Association raised concerns. The drugs remain available only by prescription in the United States.

``We are concerned that there won't have been a sufficiently thorough risk assessment before the drug is purchased,'' said Dr. John Chisholm, chairman of the British Medical Association's general practitioner committee. Patients on statins should be regularly monitored to assess the effectiveness of the treatment, he added.

``For those patients who do need to take statins,'' he said, ``the low dosage available over the counter may not be enough to reduce cholesterol to safe levels.''

Also, pharmacists will come under pressure to assess heart disease risk in people without having access to their medical records, other experts worried.

The drug may be sold to people who do not need it, said Dr. Jim Kennedy of the Royal College of General Practitioners.

``The risk of the drug may then outweigh the benefits,'' he said.

Side effects are usually mild and temporary, and mostly involving muscle aches and headache.

The British Heart Foundation, which funded one of the key studies establishing the benefits of statins, welcomed the move.

``The evidence is that, in people at risk of heart attack and stroke, taking 10 milligrams of simvastatin each night can reduce their risk by about 27 percent,'' said Sir Charles George, medical director of the foundation.

Under current guidelines, doctors can prescribe statins for those patients who have a 30 percent chance of having a heart attack in the next 10 years.

Johnson & Johnson.MSD, a British joint venture of Johnson & Johnson and Merck's U.K. subsidiary Merck, Sharpe and Dohme Ltd., will produce the over-the-counter version of simvastatin.