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Addyi: 'Female Viagra' approved for US use in world first

Tuesday, August 18, 2015

Female Viagra

The world's first prescription drug designed to boost sexual desire in women has been approved by regulators in the United States.

The move by the Food and Drug Administration has been hailed as a milestone long sought by a pharmaceutical industry eager to replicate the blockbuster success of impotence drugs for men.

However, despite Addyi being dubbed the 'female Viagra' in some quarters, it is unlikely to achieve anything like the sales figures of its little blue counterpart, thanks to stringent safety measures.
The drug's label will bear a boxed warning - the most serious type - alerting doctors and patients to the risks of dangerously low blood pressure and fainting, especially when the pill is combined with alcohol.

The same problems can occur when taking the drug with other commonly prescribed medications, including antifungals used to treat yeast infections.

"Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment," said Dr Janet Woodcock, director of the FDA's drug centre.

Under an FDA-imposed safety plan, doctors will only be able to prescribe Addyi after completing an online certification process that requires counselling patients about Addyi's risks.

Pharmacists will also need certification and will be required to remind patients not to drink alcohol while taking the drug.

Opponents of the drug say it is not worth the side effects, which also include nausea, drowsiness and dizziness. They point out that the FDA rejected the drug twice, in 2010 and 2013, because of these these risks.
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