Monday 17 December, 2007

USFDA refused OTC status to statins

The USFDA 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.
Disapproval 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.
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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Disclaimer: "IP Pharma Doc" blog is published for information purpose only. "IP Pharma Doc" blog contains no legal advice. I assume no legal responsibility for the views/information expressed here. “IP Pharma Doc” blog is my personal website and not edited by my employer, accordingly, no part of my blog should be attributed to my employer. All information on the present blog should be double checked for its accuracy and applicability. © Dr. Sarwal (2007)
 
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