First Female Sexual Dysfunction Medication Approved
August 18, 2015 – The U.S. Food and Drug Administration (FDA) approved Addyi™ (flibanserin), the first medication to boost sexual desire in women. Addyi, manufactured by Sprout Pharmaceuticals, is indicated for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. HSDD involves low sexual desire that is unrelated to other identifiable causes, such as physical, mental illnesses, relationship issues or side-effects from other medications. HSDD is acquired in women who previously had no problems with sexual desire and is generalized when it occurs regardless of sexual activity, situation or partner. It is estimated that up to 16 million American women may be affected. Drinking alcohol or using certain other prescription medications (including some antibiotics, some antiepileptic drugs, some antifungal drugs, some antivirals and opioids) while taking Addyi can cause blood pressure decreases low enough to result in fainting. Due to the potentially serious alcohol interaction, FDA required a boxed warning and a Risk Evaluation and Mitigation Strategy (REMS) for Addyi and will only be available through certified pharmacies.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.