NEW YORK — Statins are powerful drugs used to lower high levels of "bad" cholesterol, a condition that can lead to heart disease. The Food and Drug Administration is considering whether to allow Merck & Co.'s Mevacor, the oldest statin drug on the market, to be sold in drugstores without a prescription.
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While selling Mevacor over the counter may make it more easily available to those who need it and aren't under a physician's care, some researchers are concerned that not everyone will use the drug safely or will be able to manage their cholesterol levels appropriately without a doctor's supervision.
NBC News' Robert Bazell addresses these concerns and answers questions about the availability of Mevacor on drugstore shelves.
Q. What is the argument for making cholesterol drugs available without a prescription?
A. The drug companies that want to sell their older statins this way argue that it would make the statin drugs available to many more people without the expense and bother of a visit to the doctor. A committee set up by the government estimates at least three times as many Americans should be taking the drugs [than are now].
Q. If it’s sold right next to aspirin and athlete’s foot treatments, would there be restrictions on who could buy it?
A. There is no system in place now to regulate who buys how much medication over the counter.
Q. Will over-the-counter sales affect the cost of the drugs?
A. For people who have prescription drug plans, it would be much more expensive to buy the drugs over the counter. They will probably sell for about $1 a pill which is the same as the drugs will sell for when they come off patent if they remain as prescription generics.
Q. The FDA turned down drug companies' request to make these medications available without a prescription in 2000. What has happened since then?
A. What has happened is that increasing numbers of the older statins are coming off patent and the drug companies want to find a way to sell the older drugs as over-the-counter products and keep selling the newer ones as prescription drugs. The other thing is that the proven benefits of statins have grown, leading to calls for more people to be taking them
Q. Statins have been used for a long time and are generally considered safe. What are the FDA’s concerns about people taking them without a doctor’s supervision?
A. The drugs are safe for most people, but not all and that is the biggest problem. All statins can cause a destruction of muscle tissue in about 1 percent of patients. The problem can come on even after people have been taking the drug for months or years. It usually causes pain and weakness but it can in extreme cases lead to kidney failure.
Q. Critics are particularly worried that pregnant women may take the drugs. What are the risks to babies and how would the drug companies handle that risk?
A. The risks of statins to pregnant women and their unborn babies are unknown and that is a problem that would have to be handled by a strong label warning.
Q. If Mevacor gets approved for over-the-counter sales, will other statins eventually be sold without prescription?
A. Certainly others would go over the counter as they come off patent.
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