(Article changed on November 13, 2012 at 17:02)
It was supposed to replace the millions Wyeth lost when its hormone drugs Prempro and Premarin tanked in 2002 thanks to links to breast cancer, heart disease, blood clots and strokes. So many women quit the Wyeth menopause drugs when the risks surfaced, the company announced it would close its Rouses Point, NY plant where it manufactured them and eliminate 1,200 jobs. No wonder Pristiq, a serotonin/norepinephrine reuptake inhibitor (SNRI) looked like the way to retain the lucrative menopause market. It wasn't a hormone.
But the FDA had other plans. Though it approved Pristiq in 2008 for the treatment of adults with major depressive disorder, it gave no such green light to Pristiq for hot flashes associated with menopause. There were too many safety signals.
Why did two women in the study group taking Pristiq have heart attacks and three need procedures to repair clogged arteries compared with none taking placebo, asked the FDA? Why did trials disclose serious liver complications? How could Wyeth assure the long term safety of Pristiq when 604 of the 2,158 test subjects took it for only six months? Seventeen suicides were also reported in Pristiq's post-marketing data.
This week Pfizer, who acquired Wyeth in 2009, agreed to settle a class-action lawsuit by former Wyeth shareholders claiming they were misled about Pristiq's risks, for $67.5 million. Pristiq has already cost the company severely, losing it $7.6 billion in market value when the FDA refused the menopause indication, reports Reuters.
Even before this week's settlement, Pristiq had few friends in the Pharma community. "Pristiq is not a good drug by any standard," wrote an anonymous poster on the industry chatroom cafepharma when the FDA declined the menopause indication.
"We tried to get 100 mg approved as the standard dose. But our patients got so sick that they care less about the efﬁcacy," wrote another poster. "They just couldn't tolerate the drug long enough to see any improvement."
Smelling blood in the water at Wyeth's setback other posters piled on. "No study exists showing any antidepressant including Pristiq works any better than a placebo for reducing hot ﬂashes, which are subjective anyway and only last a few minutes long at worst," wrote another industry insider. "That is a heavy price to pay to take a heavy duty drug 24/7 for a few minutes of daily relief that a sugar pill also provides. FDA is crazy (or bought) if they allow this unproven drug travesty on the market."
Would women want to trade "hot flashes for decreased libido, nausea, increased blood pressure and incredible withdrawal issues" found with Pristiq asked another poster? "Women and their physicians are not as gullible as they were back in the Premarin days."