Warning on statins: FDA more open about risks

By Robert BazellChief science and health correspondent NBC News

Not long ago, statins were jokingly promoted by some doctorswith a put them in the drinking water argument.Physicians and drug company expertssuggested that the ubiquitous cholesterol-lowering drugs --including Lipitor, Mevacor, Crestor and Zocor -- should be sold over the counter like cold medications, or offered to everyone above a certain age. The medications appeared so beneficial to health and seemed so free of side effects.

But on Tuesday, the Food and Drug Administrationissued a new health alert requiring the drugs carrylabels warning about confusion and memory loss, elevated blood sugar leading to Type 2 diabetes, and muscle weakness.

These warnings should put an end to the all the silliness about giving the drugs to everyone, says Dr. Garret FitzGerald, chairman of pharmacology at the University of Pennsylvania.

Warnings for diabetes, memory loss added to statins

There is no question that statins -- the most profitable and among the most prescribed drugs ever -- have saved or prolonged millions of lives and will continue to do so.Most people at elevated risk for heart disease should be taking statins.The big issue now will center on determining whose risk is low to moderate and may not need medication.

The not-so-well-kept secret is that a daily dose of statin allows millions to eat whatever fatty food they like without worrying how it affects their cholesterol levels.Thats a tempting proposition. At the same time, drug companies find nothing more appealing than a pill that healthy people take daily for the rest of their lives.These two motivations combine to get million on statins who may not need them-- not much of a problem if there are no risks.But now we have evidence there is.

The FDA approved the first statin, Mercks lovastatin, in 1987.Other companies produced their own versions over the last two decades as evidence of the drugs effectiveness continued to accumulate, adding to their popularity. But, early on, plenty of side effects warnings popped up.

Every time NBC News reported on statinsI would receive many communications from viewers who had suffered the muscle-weakening condition, known as rhabdomyolysis,after taking the medication.When they stopped the drug, their muscles usually returned to normal.Doctors who frequently prescribe statins report that a certain percentage-- the best guess is about to 1 percent-- suffer the muscle problems.Thats a rare occurrence as side effects go, but when many millions are taking the drugs, the numbers add up.

As for elevated blood sugar and memory problems, both conditions have been reported for years, but it is harder to guess how widespread the complications are.In fact, last month, a survey of 150,000 participants in the Womens Health Initiative -- the governments gigantic study that ended most hormone replacement -- found that older women taking statins were 48 percent more likely to develop diabetes.(The researchers tried to control for obesity and other risk factors.)

Read the original:
Warning on statins: FDA more open about risks