FDA Approves Flibanserin
ED Drugs Unlikely to Cause Melanoma, Study Says
Flibanserin has become the first medication approved by the FDA to treat hypoactive sexual desire disorder (HSDD).
The drug, which will be marketed with the name Addyi, was approved on August 18th after being rejected twice over concerns on safety and effectiveness.
After considering new study results, an FDA advisory panel recommended approval in June, which led to the FDA's decision this week.
Addyi is intended for premenopausal women who have acquired (not lifelong), generalized (occurring in all situations) HSDD.
There are still some safety concerns to consider. Women who take Addyi are at higher risk for syncope and hypotension, especially if they drink alcohol while taking the drug.
Sprout Pharmaceuticals expects Addyi to be available by October 17th.
The FDA's approval includes a strict risk evaluation and mitigation strategy (REMS). Clinicians and pharmacies must be trained and certified to prescribe and dispense Addyi.
For more information on Addyi, FDA approval, and the REMS, please click here. You may also read the ISSM's statement on Addyi's approval here.
Melanoma, a form of skin cancer, is likely not caused by drugs for erectile dysfunction (ED), according to a team of European and American scientists.
They collected data from over 20,000 men in Sweden, focusing on the number of prescriptions filled for three common ED drugs: sildenafil (Viagra), vardenafil (Levitra), and tadalafil (Cialis).
They also looked at rates of melanoma, basal cell carcinoma (another form of skin cancer), and disease stages.
Melanoma was found in 4,065 men. Eleven percent of them filled prescriptions.
In contrast, 8% of 20,325 men without melanoma filled prescriptions.
While melanoma rates were higher in men who took ED drugs, the researchers discovered that risk was higher in men who filled only one prescription, not several. Also, ED drugs were associated with lower stages of melanoma, not advanced ones.
They also found no connection between ED drugs and basal cell carcinoma, which acts differently from melanoma.
Thus, the team concluded that ED drugs probably don't cause melanoma.
They added that the men who took ED drugs generally had more education and higher incomes, giving them more opportunities for vacations in the sun and higher exposure to melanoma risk.
The study was published in June in the Journal of the American Medical Association (JAMA). More details are available here.