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Key things to know about so-called 'female Viagra'

You can't get a controlled drug without a prescription. That does not mean drug companies don't do all they can to boost sales by marketing directly to you. Whatever your aches or pains, big pharma is ready to put its wares in front of you with the follow-up message - "talk to your doctor about …."

If the drug has made it into the marketplace it typically means it has won approval from the U.S. Food and Drug Administration. But as we noted in a post earlier this month, the FDA's seal of approval is not a guarantee of efficacy. And it doesn't mean manufacturers or even drug retailers are clear of liability if a drug winds up causing harm to users.

Too often, unfortunately, defective drug products don't reveal themselves until they reach consumers and by then it is too late. Someone has suffered significant dangerous side effects or been killed.

It's in that light that we feel it's a good idea to share with Houston readers some of the cautions that experts are issuing in connection with the new drug flibanserin. The drug only earned preliminary FDA OK earlier this month and it's already been dubbed the "female Viagra." And that's where the cautions begin.

The experts say that the Viagra tag suggests that it somehow compares with the little blue pill for erectile dysfunction in men. But it isn't at all the same.

Viagra affects physical sexual functioning. Flibanserin meanwhile affects the brain. It works more like an antidepressant, addressing the distress that some women might feel at having a low sex drive.

Another way flibanserin differs from Viagra is time to effectiveness. Viagra works within 45 minutes. Experts say flibanserin has to be taken daily and may take days to deliver noticeable results.

Flibanserin's maker estimates one in three women experience low sex drive, but it acknowledges not all of those women are distressed about it, so it's estimated the product might only help about one in 10 women. And even among those, it might not be all that effective.

The final caution is perhaps the most important. Experts say there are safety concerns over possible fainting, nausea and low blood pressure. They say those shouldn't simply be labeled as possible side effects. The drug should carry clear warnings about the issues.

Meanwhile, final FDA approval is pending.

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