Addyi, the pill for women with low libido, was approved by the Food and Drug Administration last month even though at least three FDA reviewers recommended rejecting it.
They warned about possible side effects and expressed concern that “the marginal clinical benefits do not outweigh the serious risks,” according to a memo posted online that summarised the analysis within the US regulatory agency. More than a dozen offices reviewed the drug, though the memo doesn’t make clear how many people raised concerns.
One reviewer particularly wanted more study of the interaction between Addyi and alcohol because the tests were conducted almost exclusively with men.
While such disagreement isn’t typical, “it does happen,” said Ira Loss, a pharmaceutical analyst with Washington Analysis, a research company that evaluates the impact of public-policy change on financial markets.
The FDA had rejected the drug, chemically known as flibanserin, in 2010 and 2013 before approving it in August, so the dissenters were “not alone in their view. FDA gives them the right to say what they feel, and higher-ups make the decision.”
Internal dissent
Two years ago, there was internal dissent when the FDA approved Bristol-Myers Squibb and Pfizer’s blood thinner Eliquis. A decade ago, there also was division over the safety of Merck’s Vioxx painkiller, which has since been taken off the market, and Sanofi’s antibiotic Ketek.
"The FDA encourages robust scientific discussions among our staff," Andrea Fischer, an FDA spokeswoman, said in an e-mail.
“In most cases, alignment on a decision is achieved through discussion as reviews proceed,” but the official administrative file will reflect “differences of opinion if they exist”.
Tension inside the high-stakes discussion about Addyi, which will be available as soon as October 17th, echoes public debate that pitted even women's advocates against each other. Some encouraged approval because no other drugs are available for women with low libido. But Addyi, made by Sprout Pharmaceuticals, offers meaningful help for only about 10 per cent more patients than a placebo, according to the memo.
It also can cause high blood pressure and fainting, especially if patients drink alcohol while taking it.
While Addyi has become known as the “female Viagra,” it’s different from Pfizer’s best-selling erectile dysfunction drug because it targets the brain to increase desire, while the male pill simply helps men who already want to have sex.
