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PremPro LogoWarning: Risks and Side Effects of PremPro (Hormone Replacement Therapy)

PremPro, Wyeth's best selling drug for hormone replacement therapy (HRT), was marketed for years as a safer alternative to estrogen therapy for postmenopausal women. The drug has been prescribed to treat symptoms of menopause such as hot flashes and a reduction in bone density leading to fractures (particularly fractures of the hip).

FDA Black Box Warning

In January 2003 the FDA issued a black box warning for PremPro. Based on a study conducted by the Women's Health Initiative (WHI) and the National Institute of Health (NIH), the warning has ended years of widespread PremPro use. The black box warning is the FDA's highest level of warning for a drug that is permitted to remain on the market.

The FDA warning required a label change which includes information from the WHI study. The new information states some increased risks to be:

  • Heart Attack
  • Stroke
  • Invasive breast cancer
  • Pulmonary emboli
  • Deep vein thrombosis

The risks are based on patients taking the drug for 5 years. The new label also included the warning that PremPro should be prescribed at the lowest effective dose for the shortest duration consistent with treatment goals.

If you think you have been harmed by PremPro or other HRT drugs contact a Dangerous Drug Attorney at Charlip Law Group, LC and we will evaluate your information to determine if your case is compensable. Click here to complete our free, confidential medical case evaluation form. A representative will respond promptly.

At Charlip Law Group, LC our attorneys will represent your matters with the full consideration and respect you deserve. The lawyers at our firm bring many years of training and experience to the practice of law. Our multi-lingual staff will deal with your issues promptly. We are conveniently located in Broward County. Our South Florida location allows us to serve our clients in Miami-Dade, Broward and Palm Beach Counties; throughout Florida and the United States. Contact Charlip Law Group, LC at our Hollywood, Florida offices toll-free at 1-800-773-1955 or 954-921-2131. You can send us a confidential email at This e-mail address is being protected from spambots. You need JavaScript enabled to view it