Prempro: News, Research, and Litigation

Prempro is a menopause drug that treats symptoms of menopause. It also treats osteoporosis and endometriosis. Doctors primarily prescribe this medication to women suffering from vasomotor symptoms. These symptoms include the following:

• Hot flashes
• Mood swings
• Other unpleasant side effects of menopause

The U.S. Food and Drug Administration (FDA) approved Prempro in 1995. It was the first hormone replacement therapy drug on the market. Pfizer and Wyeth manufacture Prempro and its sister drug, Premphase. It's still one of the most popular HRT drugs available.

Over the years, the FDA has ordered Pfizer and the manufacturers of other HRT drugs to add specific warnings to their product labels. This resulted from clinical trials showing Prempro carried severe side effects.

Here, we'll briefly explain what these adverse side effects are. We'll also discuss the significant health risks patients face when taking Prempro. Finally, we'll highlight Prempro lawsuits that have made recent news.

Prempro Side Effects and Health Risks

Most prescription drugs carry harmful side effects. This is also true of Prempro. Experts have found the drug to cause numerous adverse health consequences. This isn't surprising. Prempro has been on the market for nearly 30 years.

Common side effects of Prempro include the following:

• Headaches
• Irregular periods
• Breast pain and tenderness
• Vaginitis
• Endometrial hyperplasia
• Angioedema

These side effects are unpleasant but typically don't require extensive medical treatment. But there are other health risks Prempro patients face that can be life-threatening.

Prempro may cause the following health complications:

• Heart disease
• Heart attack
• Stroke
• Increased risk of breast cancer
• High blood pressure
• Uterine or ovarian cancer
• Blood clots
• Increased risk of seizures in epileptic patients

If you experience any of these side effects, seek immediate medical attention. Your doctor may advise you to stop taking Prempro. There are alternate HRTs available that don't pose these severe health risks.

2023 Study Finds Increased Risk of Dementia in HRT Patients

A 2023 study by the Women's Health Initiative (WHI) of the National Institutes of Health (NIH) found that older women receiving HRT were more likely to develop dementia. This is versus women not taking HRT medications. Other studies have also found that HRT medications may increase a person's risk of neurocognitive disease.

July 2022: HRT May Reduce Risk of Dementia

A July 2022 study suggests that HRT drugs may help reduce a woman's risk of developing dementia. A similar study in May 2021 indicated that these medications may also reduce a patient's risk of Alzheimer's. Researchers warned that prescribers and patients must still be careful.

February 10, 2011: Pfizer Settles Lawsuits for $330 Million

According to Bloomberg, Prempro manufacturer Pfizer settled more than 2,200 lawsuits inherited from Wyeth. Pfizer acquired Wyeth in 2009. Thousands of Prempro breast cancer lawsuits were pending when Pfizer acquired the drug company.

On February 10, 2011, the pharmaceutical behemoth settled the cases for $330 million. Pfizer's executives said it wanted to resolve all outstanding Prempro claims quickly.

February 2007: Prempro Plaintiff Awarded $3 Million

A Philadelphia jury found sufficient evidence that an Ohio woman's breast cancer was the result of taking Prempro. The Pennsylvania judge ordered Wyeth to pay the plaintiff $3 million in damages. The jury also found that Wyeth failed to provide adequate warnings of Prempro's risks.

August 2006: Opening Statements in Prempro Trial

The first trial in a Prempro lawsuit against Wyeth began on August 23, 2006. The plaintiff filed suit in a federal court in Little Rock, Arkansas. The plaintiff developed breast cancer after taking Prempro for eight years.

The plaintiff, Helene Rush, blamed Wyeth's estrogen-progestin therapy drugs for her breast cancer. Her attorney alleged that Prempro manufacturer Wyeth repeatedly ignored evidence that its drug might cause cancer.

After deliberating for four days, the jury cleared hormone replacement drug maker Wyeth of any liability for the 67-year-old woman's breast cancer. The jury found that Wyeth adequately warned patients of the risks of Premarin and Prempro.

February 20, 2004: Wyeth Announces 'Lowest Effective Dose' of Prempro

Wyeth Pharmaceuticals and Pfizer, the manufacturers of Prempro, announced the availability of the "lowest effective dose" version of the drug. In a press release, Wyeth reiterated the FDA's opinion that women should use the lowest effective dose of the hormone therapy for the shortest duration of time needed.

What To Do if You Become Sick After Taking Prempro

If you become sick after taking Prempro or any other HRT drug, seek immediate medical attention. You should also contact an experienced product liability attorney. They can review your case and let you know if you have a valid claim.

Visit FindLaw.com's attorney directory to find a product liability lawyer near you.