Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

“Take comfort in your protection with PROMETRIUM,” reads the tag line on the Web site for a treatment to prevent endometrial hyperplasia in postmenopausal women who still have a uterus and are taking estrogen. But there’s little comfort in the new labeling of the drug, which includes a black box warning of cardiovascular disorders, breast cancer and “probable dementia.”

PROMETRIUM is a bio-identical type of hormone therapy, meaning it is structurally identical to the naturally occurring progesterone in the body as opposed to synthetic progestins. Hormone therapy made headlines in 2002 after the Women’s Health Initiative study found that the use of HRT put menopausal and postmenopausal women at a much greater risk of developing serious health problems such as breast cancer, ovarian cancer, stroke and cardiovascular disorders.

The Food and Drug Administration’s drug labeling changes update shows that PROMETRIUM is not much safer. The new labeling states that PROMETRIUM carries the same risk as the synthetic HRTs. Solvay Pharmaceuticals, makers of PROMETRIUM, countered on their Web site with the statement, “While products marketed by Solvay Pharmaceuticals, Inc. were not studied in the WHI, in the absence of conclusive data, a conservative view would assume the risks to be similar.”

But PROMETRIUM’s boxed warning has an added concern – the probability of dementia. “The Women’s Health Initiative Memory Study (WHIMS), an ancillary study of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE 0.625 mg combined with medroxyprogesterone acetate (MPA 2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women,” according to the new labeling.

The labeling changes for PROMETRIUM and 30 other medications, were approved last month by the FDA Center for Drug Evaluation and Research.

This entry was posted on Wednesday, July 15th, 2009 at 9:37 am and is filed under product liability. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.