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Addyi Manufacturer Announces Changes

Addyi Manufacturer Announces ChangesThe manufacturer of Addyi (flibanserin), an oral drug used to treat general, acquired hypoactive sexual desire disorder (HSDD) in premenopausal women, has announced some changes for prescribers.

Affecting about 1 in 10 women, HSDD refers to a loss of sex drive accompanied by distress that can’t be easily explained by specific causes, like a health condition or drug side effect. HSDD is acquired if it happens after a period of healthy sex drive. It is considered general if it happens all the time, not just in certain sexual situations or with specific partners.

Addyi is a pill that balances the levels of three brain neurotransmitters: serotonin, dopamine, and norepinephrine. It is typically taken at bedtime.

The drug was approved by the FDA in the spring of 2015.

Alcohol Use

One of the labeling changes concerns alcohol use with Addyi.

When the drug was first approved, the FDA required Sprout Pharmaceuticals, the company that produces Addyi, to include a boxed warning (the strictest required by the FDA) that instructed women to avoid drinking any alcohol while taking Addyi.

At that time, “the FDA reviewed data that included several concerning cases of severe hypotension (low blood pressure) and syncope (passing out) when Addyi and alcohol were taken together,” the agency reported in an April 2019 press release.

Since the approval, subsequent post-marketing studies have shown that while there are still concerns about drinking alcohol and using Addyi, women can do so if they are careful and as long as the timing isn’t too close. The FDA still requires a boxed warning, but the language has been updated.

The current instructions are as follows, according to the Addyi website:

If a woman has had one or two alcoholic drinks, she should wait at least two hours before taking Addyi at bedtime.

If she has had three or more alcoholic drinks in one evening, she should skip her bedtime dose of Addyi.

If she has taken her regular dose of Addyi, she should not drink any alcohol until the next day.

Sprout Pharmaceuticals defines “1 standard alcoholic drink” as one 12-ounce regular beer, 5 ounces of wine, or 1.5 ounces of distilled spirits or shot.

Taking Addyi and drinking alcohol too close together could lead to severe low blood pressure and fainting.

REMS Certification

Before October 2019, clinicians who prescribed Addyi were required to have Risk Evaluation and Mitigation Strategy (REMS) certification through the FDA. REMS is a drug safety program for medications with safety concerns. Now, prescribers are no longer required to have REMS certification for Addyi.

More Information

Some of the more common side effects of Addyi are dizziness, drowsiness, nausea, fatigue, insomnia, and dry mouth.

A woman’s doctor can best advise on whether Addyi is an appropriate choice for her.

Resources

Addyi.com

“Important Safety Information”

https://addyi.com/faq/

International Society for Sexual Medicine

“FDA Modifies Boxed Warning for Addyi”

(April 22, 2019)

https://www.issm.info/news/sex-health-headlines/fda-modifies-boxed-warning-for-addyi/

Sprout Pharmaceuticals

Correspondence dated October 16, 2019 concerning changes for Addyi.

U.S. Food and Drug Administration (FDA)

“FDA orders important safety labeling changes for Addyi”

(Press release. April 11, 2019)

https://www.fda.gov/news-events/press-announcements/fda-orders-important-safety-labeling-changes-addyi

“Risk Evaluation and Mitigation Strategies | REMS”

(Content current as of August 8, 2019)

https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems