Prempro
Rather than improving long-term health for serious diseases, risks of Prempro apparently outweigh the benefits.
In 2000, Premarin was the second most prescribed drug in the United States with over $1 billion in sales
and 46 million prescriptions; Prempro accounted for 22.3 million prescriptions. Large scale Class Action
Lawsuits and Personal Injury Litigation are anticipated.
Prempro Hormone Replacement Therapy ( HRT; Wyeth / American Home Products ) is linked to strokes,
coronary heart disease (leading to heart attacks), and venous thrombotic embolisms ( blood clots in veins ),
the combined risk offsetting the benefits of decrease in colon-rectal cancers and hip fractures (from osteoporosis).
Description:
estrogen 0.625 mg + medroxyprogesterone acetate (2.5 mg)
Usage:
Hysterectomy or menopause replacement
Prempro Adverse Effects:
Increase in stroke, coronary heart disease, blood clot formation, breast cancer
Company:
Wyeth (American Home Products)
Patient presentation:
Stroke, heart attack, many possible sequelae of venous thromboembolism
Further Prempro Lawsuit info:
www.drugintel.com
Despite the low absolute risk (2.5%) of prempro, "the balance of risks significantly outweighs the benefits"
(Denise E. Bonds, Wake Forest University).
These Hormone Replacement Therapy studies were obtained in post-menopausal women without hysterectomy.
Estrogen / medroxyprogesterone (progestin) replacement after menopause in asymptomatic women (i.e., not
for treating hot flashes, vaginal dryness, and cognitive effects) is thus a hotly debated women's gynecological
health issue in view of these dangers. Prempro and other HRTs progesterone side effects are also controversial,
raising the possibility of an FDA recall and drug lawsuits over personal injury.
A mare's nest of legal, medical, and scientific issues. No stranger to controversy in the courts over drug
safety, Wyeth is not in as vulnerable a position as might be supposed at first glance. The reported increase
in breast cancer noted in the Women's Health Initiative randomized controlled trial* broke the predetermined
safety limit for unacceptable incidence in breast cancer without satisfying some tests for statistical significance.
Further clinical trials to definitively demonstrate an association may be prevented due to ethical considerations.
Absent other data, plaintiffs alleging Prempro-induced breast cancer (estimated to number around 80,000) face
some challenges in documenting causation. Allusion to some of the risks now documented were made in the
physicians' label for Prempro, but received less attention than, for instance, the touted ability of
lifelong Prempro use to prevent Alzheimer disease.
Prempro Litigation is expected to be controversial and complex.
Other comparable medications include: Activella - Pharmacia (Pfizer) - plant derived estrogen/progestin
femhrt - Pfizer - norethindrone acetate (1 milligram ) and ethinyl estradiol (5 microgram)
Ortho-Prefest - Ortho (Johnson & Johnson) 17(beta)-estradiol with the progestin norgestimate
Premphase - Wyeth - medications customized for the cycle including Premarin only (estrogen) for
the first two weeks followed by Premarin plus progestin for the balance of the cycle.
All of these drugs are in principal the same as Prempro but minor differences in
composition, formulation, and delivery raise obstacles to direct extrapolation from
Prempro. Will similar Litigation follow for these?
The very difficult question for sponsor Wyeth to answer is how their scientists
could detect the beneficial ability of Prempro to retard colorectal cancer and hip
fractures in clinical trials, and yet fail to note the more robust detrimental effects
of Prempro on breast cancer, stroke, venous thromboembolism, and coronary heart disease.
Alternatively, since the label mentions some of these sequelae, inadequate emphasis was
conceivably given to these risk issues compared to the more modest beneficial effects.
Indeed, alleging that Prempro is a defective product unsafe to be used in any manner
might be a tenable position in a Class Action Lawsuit.
Lawyers, attorneys, and expert witnesses debate Prempro Pharmaceutical Litigation during a
national Pharmaceutical Webcast, Oct. 13, 2002.
Although intended for leading lawyers and attorneys, interested groups and individuals can
obtain the list of participants free of charge to identify the prestigious plaintiff and
defense attorneys and expert witnesses in this field.