Female libido drug Addyi from Sprout stirred up its fair share of controversy last week with its FDA green light, which came despite serious potential side effects such as severe drowsiness, nausea and dizziness. But if it can succeed despite those side effect worries, it certainly wouldn't be the first drug to do so.
Take Advair, GlaxoSmithKline's ($GSK) long-reigning asthma king, Bloomberg points out. One of the two ingredients in the med--salmeterol--can actually increase the risk of asthma-related death, with one large study turning up 13 deaths of patients who received salmeterol and just three who took placebo.
Then there are antidepressants, which have long been linked to upticks in suicidal thoughts and behavior for some patients. The FDA long ago tasked drugmakers with adding warnings about risks for children and adolescents, later expanding those warnings for those up to age 24.
And the list goes on. Bisphosphonates like Merck's ($MRK) Fosamax, meant to strengthen bones and help prevent fractures in those with osteoporosis, has raised red flags about the death of bone cells in the jaw, and the FDA has said it's "not clear" whether the treatments cause atypical femoral fractures. Anemia drugs such as Amgen's ($AMGN) Epogen, frequently used in those undergoing chemo, can spur tumors to grow faster. And cases of the rare brain infection progressive multifocal leukoencephalopathy (PML) have been recorded in patients taking hot new multiple sclerosis pills Gilenya from Novartis ($NVS) and Tecfidera from Biogen ($BIIB), the news service points out.
With Addyi, the challenge will be getting doctors and patients to take those potential side effects in stride despite what the FDA termed only "modest" efficacy. In the largest trial of the drug, it improved sexual desire in 9% more women than placebo did, with severe drowsiness increasing 13% over the control group, nausea increasing 6%, and dizziness increasing 9%, Bloomberg notes. It posted smaller increases in more worrisome side effects, too, including dangerously low blood pressure and fainting.
Going forward, though, those obstacles will be Valeant's ($VRX) to worry about. The Canadian drugmaker agreed to fork over $1 billion to buy Sprout just one day after Addyi won FDA approval, with plans to launch the drug in October.
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