Beginning in 2000, the FDA approved four drugs to treat premenstrual dysphoric disorder, a more severe form of PMS.
The hitch: The condition didn’t yet exist.
The FDA approvals started less than 2 years after a private meeting of six FDA officials with four executives from Eli Lilly. The drug company’s patent on the antidepressant Prozac (fluoxetine) was about to expire and officials had a new market in mind. […]
At the time, there was strong disagreement about the condition, which had been listed as being in need of further study by the American Psychiatric Association in the Diagnostic and Statistical Manual of Mental Disorders (DSM).
On their own, they determined PMDD was a distinct clinical disorder and declared that selective serotonin reuptake inhibitors (SSRIs) such as Prozac were effective at treating it.
Eight months later, a paper summing up the findings and describing the process that led to them, was published in a medical journal. […]
Treating PMDD with birth control pills, such as Yaz, that include the drug drospirenone is especially concerning, said Diana Zuckerman, PhD, president of of the National Center for Health Research, a nonprofit think tank that analyzes health research.
The drug’s label warns that women over 35 who smoke should not use Yaz, because of the risk of clots and the increased likelihood of a serious cardiovascular event.
“Safer drugs are available to effectively treat PMDD,” Zuckerman said. “How bad is your PMDD that you are willing to put your life at risk?”
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