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Is Propecia an FDA approved drug? How important is an FDA certification for drugs like Propecia?

Propecia, generically known as finasteride is a drug that is used among males in order to reduce baldness and its effects. The drug potentially stops the conversion of testosterone to dihydrotestosterone which is the major cause of men’s balding. Unlike an OTC drug, usage of Propecia has lot of side effects like dwindled libido, premature ejaculation or ejaculation difficulties, orgasm disorders etc. In a simple sense, Propecia takes away the prime need of men for which they are fixing their bald head. Food and Drug Administration (FDA) has revised the commercial advertising terms in which the company must display regarding the libido disorder on the top of the packing in order to well alert the user. It’s more like displaying 'Cigarette smoking is injurious to health'.

FDA approved the drug Propecia in the year 1997, though there was a similar drug approved years before. FDA reviewed the side effects of the finasteride by studying 421 test males, where they evaluated their cause for poor libido, difficulty in ejaculation, failed orgasm etc. In a clinical study they found that around 4% men suffered from sexual dysfunction on taking Propecia other than compare to 2% while taking a placebo.

Why should FDA certify the sales of Propecia and similar drugs?

FDA is the authority who take care of things that are being consumed by their citizens. No matter it’s a food stuff or drug, they are concerned with the effects of consumed on the consumer. In order to rule out serious health effects, it is very mandatory for a drug like Propecia or a food to get FDA certification before commercially released to the market. Thus a consumer feels more confident and safe when using FDA approved propecia. It is done in Center for Drug Evaluation and research (CDER). CDER team consists of best in class physicians, statisticians, chemists, biotechnologists, pharmacologists and other scientist’s inorder to make sure that the drug about to be released into market is really safe.

It’s the sole responsibility of the government to ensure that the hair-loss medication Propecia is safe for their citizen. They always keep a close watch on the drug formulation for Propecia and always keep a market watch to ensure the risk is always under control. FDA periodically subject the drugs to certain test especially on releasing a new formulation or new batch in order to reduce any possible risk to a minimum. Thus FDA keep their laurels in high status such that a user purchasing Propecia would have an inner satisfaction that the drug is safe to use since it is certified by a government agency.