A drug dubbed the “female Viagra” – even though it works differently – has been approved by US regulators the Food and Drug Administration (FDA) despite fears over side effects.
Marketed as “Addyi”, it is the first drug to treat low sexual desire in women.
It will only be available through certified and specially trained health care professionals and pharmacies due to its safety issues.
“Today’s approval provides women distressed by their low sexual desire with an approved treatment option…" Details: http://t.co/ilY06vUOrv— Media Affairs (@FDAMedia) August 18, 2015
The US National Consumers League described the move as the biggest breakthrough in women’s sexual health since the advent of the Pill for contraception.
Also celebrating, the North Carolina company that makes the drug, Sprout Pharmaceuticals, welcomed the decision in a statement.
“All drugs have risks and we want to appropriately inform consumers of risks. So we do have a black box warning. It’s related to low blood pressure and/or fainting with alcohol use,” said Sprout CEO Cindy Whitehead.
Addyi, whose chemical name is flibanserin, works by boosting certain brain chemicals. It is designed for premenopausal women whose lack of sexual desire causes distress. The condition is formally known as hypoactive sexual desire disorder (HSDD).
What 8 medical experts think about "female Viagra" http://t.co/0L1XYcojex— TIME Health (@TIMEHealth) August 18, 2015
The FDA had twice rejected the drug, citing a lack of effectiveness and side effects like nausea and dizziness.
The turnaround comes after an advisory panel recommended approval under strict conditions to ensure patients are fully aware of the risks.
A consumer watchdog that testified against it said “unfortunately we haven’t heard the last of this drug”.
Public Citizen predicted that what it called “serious dangers” to women would lead to the drug’s removal from the market.
FierceBiotech, which monitors the drug development industry, accused the FDA of a “regulatory failure of the worst kind”.