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Dec14
Statins Do Not Get OTC Approval by FDA

The FDA has voted against making Mevacor available over the counter. This drug, used to treat high cholesterol patients, is part of a class of medications called statins. Statins are HMG-COA reductase inhibtors and helps lower cholesterol in people who are at risk for cardiovascualr disease.

Cholesterol.jpgDisapproval of making this drug over the counter and worries that people will not be able to make informed decisions on whether they actually need the drug. the FDA said that more monitoring of the drug is necessary, including watching consumer decision making in order to see whether making the drug over the counter would be a safe decision. Many people with high cholesterol go untreated, and making the drug more readily available to the public could decrease the amount of untreated.

Statins are said to be “safe and effective” and the public should decide whether they want to use the drug to control their cholesterol. “Safe and effective” if used properly. People must judge correctly if they are good candidates for the drug. When studied, those willing to get the drug over the counter were those with cardiovascular diseases that need to be monitored by doctors anyways.

Making this drug over the counter could be used as a reason not to visit a doctor. It is difficult to tell whether you do indeed have high cholesterol. In order to be certain tests must be done. Important to note is that people do not tend to use over the counter medication consistently. Also, despite Mevacor being “safe and effective” there are serious side effects such as liver abnormalities. It is also unsafe for pregnant women. Making the drug OTC will be discounting the severity of the issue. People need to be monitored and tested not just given the opportunity to control a condition if they feel like they have it. OTC medications will be seen in the same light as headache medications. When you have a headache you take a pill and then you stop. Cholesterol pills need to be taken even when one feels like or even sees that their cholesterol has lowered. Finally, making the pill accessible to just anyone could decrease the people’s view of it being a very serious issue that should create a dietary change and not just a ‘take a pill and get better’ attitude.

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