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The FDA Has Real Concerns About the Safety of ADDYI

If you were watching the news this week, you may have heard that ADDYI (Flibanserin), the new medication for low female sex drive (Hypoactive Sexual Desire Disorder), was released this week and is available by prescription. This is a big deal because this is the first drug to gain FDA approval for the treatment of female sexual dysfunction.

If you read my previous blog post, you may recall that there are 26 different FDA approved medications for the treatment of male sexual dysfunction, and, until this week, absolutely none for women. Now, I personally think this is the beginning of a cultural shift that is worth celebrating but ADDYI has some real issues that will probably limit its use and effectiveness to a relatively small group of women.

Despite approving this medication, the FDA has some real concerns about the safety of ADDYI. The company has agreed to forego any “direct to consumer” advertising for 18 months so you won’t be seeing commercials for ADDYI on the evening news and you won’t be seeing ads in magazines. Practitioners that prescribe ADDYI and pharmacists that dispense ADDYI have to be certified.

I’ve gone through the certification so I want to pass on some information and some of my concerns about ADDYI.

  • ADDYI is not the female Viagra. Viagra affects blood flow in the penis and treats erectile dysfunction, not sex drive. ADDYI is not hormonal. It is not a form of testosterone. ADDYI increases the level of the neurotransmitters dopamine and norepinephrine in the brain. It most resembles an anti-depressant in its mechanism of action.
  • Unlike Viagra, which is taken only with sexual activity, ADDYI needs to be taken once nightly, every night. Its effects on sexual desire were not seen until 3-4 weeks of use and often did not peak until 8 weeks of use.
  • You can’t drink alcohol when on ADDYI—and I mean none. When studied, a significant number of subjects (17%) had serious decreases in blood pressure and/or loss of consciousness with as little as two glasses of wine. You will be required to sign a consent form stating that you understand that you must not drink while taking this medication.
  • ADDYI is metabolized by the liver. You cannot take ADDYI if you have liver problems.
  • ADDYI should not be used if you are on certain drugs. These drugs have an effect on how ADDYI is broken down in the body, and their use with ADDYI could lead to abnormally high levels of ADDYI in the body and potentially severe side effects. Examples of these drugs (Cyp3A4 inhibitors) are Verapamil, Diltiazem, Diflucan, Valerian and Erythromycin. Grapefruit juice can also increase levels of ADDYI in the blood.
  • ADDYI was studied in pre-menopausal women. Effectiveness and safety has not been studied in post-menopausal women.
  • ADDYI did show a statistically significant improvement in the number of satisfying sexual events and reduced distress related to sexual desire, though the benefits were modest.
  • ADDYI is not going to be cheap. I’ve heard $400/month if not covered by insurance. Male erectile dysfunction medications are not covered by insurance so I think it is unlikely that ADDYI will be covered. The company, Sprout Pharmaceuticals, will be offering the first 2-3 months at $20/month so that you can see if it works for you but after that you’ll probably be on the hook for $400/month.

So what are my recommendations?

  1. First, sexual desire in women is complex and there is no “one size fits all solution” and the first thing I recommend is to find a doctor who specializes in female sexuality and determine where you have disconnected from your sexual self. This can be any number of things including physical health, partner issues, excessive stress, hormone imbalance, and neurochemical imbalance. This is an important first step and I strongly advise doing this before getting a prescription for ADDYI.
  2. Decide if you are willing to be “alcohol-free” in order to be on this medication.
  3. Make the lifestyle changes like eating right, regular exercise, and stress reduction which are so important for normal sex drive.
  4. Schedule an appointment with me to discuss the pros and cons of ADDYI for you, specifically.

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