Pink pill arouses doubts

The first drug to treat low sexual desire in women won approval from US health regulators but concern over its side effects will delay any chance of it being available in Bahrain.

The ‘pink pill’ comes with a warning about potentially dangerous low blood pressure and fainting episodes.

The US Food and Drug Administration said the drug, to be sold under the brand name Addyi and made by Sprout Pharmaceuticals, will only be available through certified and specially-trained health care professionals and pharmacies in the US due to its safety issues.

Addyi, whose chemical name is flibanserin, is designed for premenopausal women whose lack of sexual desire causes distress. The condition is formally known as hypoactive sexual desire disorder, or HSDD. The drug needs to be taken daily.

Dr Bahaa Fateha, chief executive officer of the National Health Regulatory Authority in the kingdom, said: “The NHRA cannot allow any medicine to be marked and distributed in Bahrain unless it is fully registered in our database.

“The company/agent must first apply for registration of the medicine, with full documentation that includes safety issues.

“We must stress that there are safety issues related to this medication and we will study the complete file before approving or disallowing the medication in Bahrain.”

Addyi has been nicknamed the ‘female Viagra’ even though it does not work like Pfizer’s blockbuster Viagra pill for men launched in 1998.

“This is the biggest breakthrough in women’s sexual health since the advent of ‘the Pill’ for contraception,” The National Consumers League said in a statement. “It validates and legitimises female sexuality as an important component of health.”

But Public Citizen, a consumer watchdog group that testified against the drug earlier this year, predicted that Addyi will be pulled from the market within a few years because of ‘serious dangers to women, with little benefit’ to them.

The FDA in the US had twice rejected the firm’s drug. But the latest decision comes after an advisory panel concluded in June it should be approved with strict measures in place to ensure patients are fully aware of the risks.

Palatin’s experimental treatment called bremelanotide is now in late-stage trials and works differently from Addyi. It attempts to activate certain brain pathways. Palatin in a statement said its drug, if approved, would only be taken as needed, not on a daily basis like Addyi, thereby providing women ‘greater control and flexibility in their treatment’.

Unlike Viagra, which affects blood flow to the genitals, Addyi is meant to activate sexual impulses in the brain. It is similar to a class of other drugs known as selective serotonin reuptake inhibitors, or SSRI’s, that include antidepressants such as Prozac.

Women who took Addyi in a clinical study had an increase of about one sexually satisfying event per month compared with those taking a placebo. Advocates claim that increase is meaningful. Critics say the small benefit is outweighed by the drug’s risks.