Prempro Overview

Prempro, approved by the Food and Drug Administration (FDA) in 1995, is a drug that treats symptoms of menopause and osteoporosis.

Prempro is also known as conjugated estrogen/medroxyprogesterone acetate. It's a combination of two hormones — estrogen and progestin. Prempro was the first estrogen/progestin combination drug available for hormone replacement therapy (HRT). It's still one of the most common HRTs doctors prescribe today.

We'll explain how the medication works. We'll also discuss its side effects. Finally, this article will describe what to do if you become ill after taking Prempro.

What Is Prempro?

Prempro contains two hormones — estrogen and progestin. Healthcare professionals prescribe it to postmenopausal women who have not had a hysterectomy. They also prescribe this FDA-approved medication to women who have endometriosis.

About Prempro for osteoporosis, remember that no medication can replace calcium. Your doctor will tell you whether this drug is a good treatment. They will discuss whether it is contraindicated in your situation.

Prempro helps with the following:

• Reducing hot flashes
• Treating vaginal dryness
• Alleviating itching and burning
• Decreasing vasomotor symptoms
• Reducing chances of getting osteoporosis

According to clinical trials, progestin also reduces the risk of endometrial cancer in women.

Should Postmenopausal Women Take Estrogen Alone or Estrogen Plus Progestin?

Pfizer, the manufacturer of Prempro and Premphase, suggests that these medications are for postmenopausal women suffering from vasomotor symptoms. Check with your doctor if you're taking some form of estrogen, either alone or in combination with progestin.

There are different doses and types of Prempro. For example, Prempro 0.3 contains calcium, magnesium, and other chemicals. You may not want to overload your body with too many hormones. Your doctor can help determine the best plan for you.

Prempro Side Effects

Like most other drugs, there are several side effects of Prempro. Some of these are minor. Others may be a sign of a more significant problem like blood clots. If you experience any of these adverse side effects or experience an allergic reaction, see your doctor immediately.

Common side effects of Prempro include:

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

Before you start Prempro, you must tell your doctor about any supplements and medications you're taking.

It's also essential that you ask about taking this drug if you're pregnant or breastfeeding. There's a chance that these medications can affect your breast milk. You should also avoid certain things while taking Prempro, such as grapefruit. If you experience a missed dose of Prempro, consult your doctor. You don't want to take too much of any medication without your physician's advice.

Health Concerns About Prempro

In 1991, the National Heart, Lung, and Blood Institute (NHLBI) began a long-term study of ways to prevent heart disease, breast and colorectal cancer, and osteoporosis in women. This Women's Health Initiative (WHI) consists of clinical and observational studies involving more than 161,000 healthy, postmenopausal women.

One of the studies involved 16,608 women. Some took Prempro, while others took a placebo. This study aimed to see if Prempro helps prevent heart disease and hip fractures. Researchers cut the Prempro part of that study short three years early because researchers determined the risks of Prempro outweighed its benefits.

These risks included but were not limited to the following:

• Breast cancer
• Stroke
• Heart disease
• High blood pressure
• Cancer of the uterus or ovaries
• Blood clots
• Shortness of breath

A separate study also confirmed that taking Prempro increased the risk of seizures in postmenopausal women with epilepsy. Experts also warn women with a thyroid disorder to avoid taking Prempro.

Early FDA Action

In 2003, the FDA announced that it had approved new labels for Prempro. This new label included a new boxed warning to emphasize Pempro patients' increased risk of several disorders, including:

• Heart disease
• Heart attacks
• Strokes
• Breast cancer

Besides incorporating the WHI findings, the updated labels would state that Prempro isn't for preventing coronary heart disease. The labels would also say to take Prempro no longer than necessary. Doctors should periodically reevaluate your prescription.

These new warnings also advised that women should only take Prempro to prevent osteoporosis or to treat vaginal dryness and irritation. There are alternative, non-hormonal treatments that carry less risk.

The FDA also indicated that all manufacturers of estrogen and estrogen-progestin products should add similar warnings to labels and patient information leaflets.

Can You Sue the Manufacturers of Prempro?

Talking to a personal injury lawyer is the best way to determine if you have a valid claim against Pfizer. A qualified attorney can analyze the details of your case.

To date, Pfizer has paid more than $1 billion to settle legal claims. They have also litigated more than 10,000 lawsuits. In 2011 alone, the company settled claims for more than $300 million.

This doesn't mean you have a legitimate claim for damages. It depends on several factors, including how long you took the drug and the extent of your injuries.

Meet with a products liability attorney to determine your best course of action.

Get Help from a Personal Injury Lawyer

Almost all medications have some anticipated side effects. Drug manufacturers must adequately inform physicians about any known risks with their drugs. If a manufacturer fails to do so, it may be liable for patients' injuries.

If you or a loved one has taken Prempro and experienced any unusual side effects or suffered injury, contact a physician for medical attention. Then, contact a products liability attorney, who can assess your legal rights and help you get compensation for any injuries.