Sprout Pharmaceuticals has revoked its Sept. 4 news release claiming the FDA eased restrictions on its controversial female libido pill, according to STAT.
In the news release, Sprout claimed the FDA removed a ban on the use of alcohol with Addyi, the first medicine approved in the U.S. to enhance a woman's sexual drive. The drugmaker also suggested the FDA eliminated the requirement that physicians and pharmacists must be certified to prescribe and dispense Addyi.
Sprout removed the news release from its website Sept. 7, and three days later the FDA began telling media outlets it had not made the changes Sprout indicated in its news release, according to STAT.
Sprout published an updated press release Sept. 11, acknowledging that the FDA did not agree with its initial release and asked the company to take it down.
Before approving the drug four years ago, the FDA raised concerns over the safety of mixing Addyi with alcohol after a study of 25 people indicated the combination led to low blood pressure and fainting. Concerns over the effectiveness of the drug were also raised because 23 of the 25 participants were male.
The latest incident between Sprout and the FDA comes as a competing drug hits the U.S. market. AMAG Pharmaceuticals last month began marketing the recently approved Vyleesi injection, designed to treat generalized hypoactive sexual desire disorder in premenopausal women.
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