Litigation continues over the allegation that Pfizer Inc.’s Wyeth unit downplayed the risks that its Prempro menopause drug could cause breast cancer. Pfizer/Wyeth has lost the vast majority of Prempro® lawsuits it has faced since trials began in 2006 and has settled out of court on approximately 60% of the 10,000 claims filed.
At this time hormone replacement therapy manufactured from pregnant mare’s urine was the only FDA-approved single-agent therapy for the treatment of menopausal hot flashes.
In mid 2012 two New Drug Applications (NDAs) were submitted to the U.S. FDA as potential replacements or alternatives for the Premarin family of drugs derived from CEEs (conjugated equine estrogens) – Sereda manufactured by Depomed Inc. and Noven Therapeutic’s LDMP (low-does mesylate salt of paroxetine).
Unfortunately on March 4, 2013, the US FDA Reproductive Health Drugs Advisory Committee voted that the overall risk/benefit profiles of both Serada and LDMP were not acceptable to support approval.
According to a new study conducted by the French National Institute for Health, taking estrogen pills increases a menopausal woman's risk of needing gallbladder surgery to treat complications of gallstones. Researchers analyzed data gathered from more than 70,000 women in France between 1992 and 2008.
A press release from Dr. Timothy Bilash of Solana Beach CA, who specializes in women’s health issues, highlighted a 2012 study claiming that there is a reduced incidence of breast cancer while taking estrogen. This study featured online in the Lancet Oncology journal was fraught with poor sampling methods and inadequate data collection techniques. As a result its validity is questionable.
In late June, the FDA approved the first non-hormonal treatment for hot flashes associated with menopause. Brisdell contains the selective serotonin reuptake inhibitor paroxetine mesylate and is manufactured by Noven Therapeutics. This was formerly labeled as Sereda – the drug that the US FDA Reproductive Health Drugs Advisory Committee deemed unsuitable for approval in March of 2013.
A study performed by the Group Health Research Institute revealed that women patients who were prescribed a generic version of estradiol – a bioequivalent estrogen – experienced fewer adverse vascular events than did those prescribed conjugated equine estrogens, the drug marketed as Premarin.
In particular, estradiol was associated with less risk of developing blood clots in leg veins (deep vein thrombosis) and clots in the lungs (pulmonary emboli) than was use of conjugated equine estrogens (Premarin).
Amid speculation regarding its safety profile and Pfizer/Wyeth’s lengthy struggle to gain approval, on October 3, 2013 – during the federal economic shutdown – the FDA approved the dual-acting drug DUAVEE, formerly known as Aprela. Aprela now called Duavee is prescribed for the treatment of menopausal symptoms and prevention of postmenopausal osteoporosis in women who have not undergone a hysterectomy.
What is disconcerting about the approval is that neither of the drugs that make up the combination has acceptable safety profiles. Bazedoxifene has yet to gain approval in the US due to increased risk of stroke in addition to higher incidences of deep vein thrombosis and retinal thrombosis while Premarin (CEEs) have a long history of increased cancer risks and is classified as a carcinogen.
A BONTV video report: “Horse urine a profitable industry in China” confirms the March 2012 report by the Int'l Fund for Horses the sad reality of the relocation of the majority of the PMU farms from North America to China.
As 2013 came to a close, 95% of the Prempro/Premarin lawsuits had been settled with expectations that Pfizer will have recompensed an estimated $1.6 billion to resolve these claims when all is said and done.
Yet Pfizer continues to market and sell these deadly drugs to millions of vulnerable women.
The lawsuits have consistently and repeatedly shown that Wyeth (now a division of Pfizer) failed to adequately warn consumers about the risks of these drugs and purposely hid the risk of breast cancer and other diseases.