New Campaign Warns Women of Harm from Drug FDA Approved in August

Feminist Health Advocates Cite Unsafe Sex Drug for Women in Call for Next FDA Commissioner to Resist Political Pressure

WASHINGTON, D.C. – As Dr. Robert Califf testifies before the Senate on his nomination for commissioner of the Food and Drug Administration, the National Women’s Health Networks called for any future FDA chief to staunchly resist political pressure and lobbying by the pharmaceutical industry. If confirmed, Dr. Califf will impact the health and safety of millions of American women as the main line of defense between consumers and a drug industry pushing unsafe products not properly tested or ready for market.

“As Dr. Califf testifies, the National Women’s Health Network is launching an emergency medical alert and awareness campaign about the dangerous sex drug Addyi, which the FDA approved earlier this year,” said Cindy Pearson, Executive Director of the National Women’s Health Network. “The FDA caved in to political pressure and approved Addyi, ‘the pink pill’, to treat low libido in premenopausal women. Clinical trials showed Addyi doesn’t work for 9 out of 10 women and barely works, if at all, for the ten percent. Serious side effects include severe low blood pressure and sudden prolonged unconsciousness, which increase with alcohol. Addyi should never have been approved and is not safe.”

The FDA was so concerned about safety that it ordered Valeant Pharmaceuticals, which paid $1 billion for Addyi, to specially train and certify every clinician and pharmacist that prescribes and dispenses the pills. Women must sign a pledge to abstain from drinking and only take the pink pill at bedtime in case they faint. FDA approved the drug despite knowing that the single trial with alcohol included only 2 women and 23 men. As the drug is being prescribed for American women, clinical trials of women combining alcohol and Addyi are ongoing.

“FDA’s approval of Addyi was a disgrace and a dereliction of duty by those charged with protecting women’s health,” said Pearson. “The next commissioner must learn from this mistake. Women should wake up to the fact that ‘FDA-approved’ does not assure that medication is safe and well-studied. To make sure women know the truth about Addyi, we are launching a national campaign urging women to ‘Pass on the Pink Pill – Or Pass Out!’”

For more information about the National Women’s Health Network and the dangers of Addyi check out our campaign page HERE and #PassOnThePinkPill.

The National Women’s Health Network is a nonprofit advocacy organization that works to improve the health of all women. We bring the voices of women consumers to policy and regulatory decision-making bodies. We are supported by our members and do not take financial contributions from drug companies, medical device manufacturers, insurance companies, or any other entity with a financial stake in women’s health decision-making.

Cindy Pearson was the NWHN’s Executive Director from 1996 to 2021. One of the nation's leading advocates for women's health, Cindy often testified before Congress,  NIH and the FDA and was frequently featured in the news as a consumer expert on women’s health issues. When she retired, Cindy received a Congressional Resolution in honor of her outstanding contributions to the health of women and girls.

Read more from Cindy Pearson.