Top Story, Pharma

Some doctors are speaking out about concerns with the FDA’s approval of Addyi

The approval of Addyi, or “female Viagra,” has received a lot of hype, but is it worth it from a doctor’s perspective?

As many are now aware, Addyi, or the “female Viagra,” has now been approved by the Food and Drug Administration. The drug, manufactured by Sprout Pharmaceuticals, has been interpreted by some as a demonstration of providing equal sexual enhancement opportunities for women when many medications have been been available to men for years.

In a recent MedCity News interview, Dr. Irwin Goldstein, president of the San Diego-based Institute for Sexual Medicine praised the drug’s approval and said, “A nuclear bomb has exploded in women’s sexual health.”

But not everyone feels that way. Not only is the drug significantly different in the way it works in the body compared to a drug like Viagra, the number of side effects are disconcerting.

Last night on PBS News Hour, Judy Woodruff discussed Addyi with Dr. Adriane Fugh-Berman, associate professor of pharmacology and physiology at Georgetown University Medical Center, and Dr. Mary Jane Minkin, a practicing obstetrician-gynecologist at the Yale Medical Group and clinical professor at the Yale University School of Medicine.

Both doctors shared their thoughts on the drug. Minkin said she would prescribe it, but Fugh-Berman had much bigger concerns. For one, she said she believed the side effect risk of losing consciousness should be considered very serious, and she believes the fact that women aren’t supposed to drink alcohol at all is unreasonable and will most likely be a problem.

She also made a point to say that the hype around this drug has been manufactured by the company, almost to say the hype doesn’t match up with what the drug really does and neglects the issues involved.

“This is a drug that’s really been approved by a public relations campaign,” Fugh-Berman said. “It’s definitely a mistake that the FDA approved it.”

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Here’s the PBS News Hour clip:

Photo: PBS News Hour