Evista Legal Information

Evista (raloxifene) is used to prevent and treat osteoporosis in postmenopausal women. Evista works like estrogen to stop bone loss in women after menopause. Clinical trials have shown that Evista may also help reduce the risk of invasive breast cancer in postmenopausal women.

Eli Lilly and Company manufactures Evista. The U.S. Food and Drug Administration (FDA) approved the drug in 1999. While regulators never approved Evista for reducing the risk of invasive breast cancer in postmenopausal women, Eli Lilly and Company started marketing the drug for this off-label use.

For more than five years, patients took the drug without issue. However, in 2006, clinical trials confirmed that Evista also increased a patient’s risk of blood clots and stroke.

This section discusses the side effects and adverse interactions of Evista. It also provides a timeline of news and research events related to Evista. You’ll also learn what to do if you develop blood clots or another health issue after taking this medication.

Pharmaceutical companies have a legal responsibility to ensure their medications carry adequate warnings and are safe to use. If you’ve been harmed by Evista or another drug, you have legal rights. Contact a product liability attorney near you to share your story and learn your legal options.

Benefits and Adverse Reactions to Evista

Many patients have benefitted from taking Evista. However, others have experienced severe side effects after taking the drug.

A study published in the New England Journal of Medicine in 2006 revealed evidence that postmenopausal women who took Evista developed significantly fewer cases of breast cancer than women who took a placebo. The study also showed that they had substantially more fatal strokes and potentially dangerous blood clots.

Common Side Effects of Evista

Evista doesn’t stimulate the uterus or breast. You should tell your doctor if you experience vaginal bleeding, breast pain, or enlargement. These could be signs of more severe health issues.

You should tell your healthcare professional if any of the following symptoms are severe or persistent:

• Hot flashes
• Leg cramps
• Swelling of the hands, feet, ankles, or lower legs
• Flu-like symptoms
• Sudden chest pain or chest heaviness
• Shortness of breath
• Joint pain

These are the minor side effects. Researchers have also linked Evista to serious health problems. These may include the following:

• Heart disease
• Kidney disease
• Atrial fibrillation
• Increased risk of high blood pressure

This might seem like a lot. However, studies show that Evista has fewer side effects than Tamoxifen, another osteoporosis medication.

What Should I Tell My Prescribing Physician Before Taking Evista?​

It’s always essential that you tell your doctor about your medical history before they prescribe any drugs. Your doctor will check for adverse drug interactions. They’ll also review your history to identify any allergies to a particular medicine.

Some information your doctor needs when treating you for osteoporosis or any other conditions includes the following:

• Have you had any unusual allergic reactions to Evista? Are you allergic to other substances like foods, preservatives, or dyes?
• When was your last mammogram?
• Are you pregnant/planning to become pregnant? Are you breastfeeding?
• Are you planning to have any surgery or have a long period of inactivity, such as sitting or bed rest?
• Do you have a history of blood clot formation issues, including deep vein thrombosis, pulmonary embolism, and retinal embolism?
• Have you ever had cancer or tumors?
• Do you suffer from high cholesterol? High triglyceride count?
• Does your family have a history of breast cancer?
• Do you have congestive heart failure? Are you at high risk for cardiac issues?
• Do you have any other condition that increases your risk of blood clots?
• Do you have liver disease?

Tell your doctor about any other measures you have taken to prevent osteoporosis. For example, if you’ve undergone hormone replacement therapy, your doctor needs to know. Before they give you any medical advice, your doctor needs to know your medical background.

Interactions Between Evista and Other Drugs or Foods

Evista and certain other medicines can interact with each other. Tell your healthcare professional and pharmacist about all the medications you take, including prescriptions, over-the-counter drugs, and herbal supplements, especially cholestyramine, estrogens, and warfarin.

Timeline of Evista News and Research Updates

Follow along below for significant news, research, and legal updates regarding Evista.

May 10, 2005: Government Fines Eli Lilly and Company $36 Million for Misbranding

When the FDA first approved Evista, it limited the drug’s legal use to the prevention and subsequent treatment of osteoporosis. Eli Lilly & Company asked regulators to approve the drug as a breast cancer prevention drug, but the FDA refused to do that. It also prohibited the manufacturer from marketing the medication to prevent cardiovascular disease.

Sales of Evista for the first year were less than a quarter of what the manufacturer thought they would be. To increase sales, Eli Lilly and Company expanded its marketing to include preventing invasive breast cancer and cardiovascular disease.

Sales quadrupled. However, when regulators found out what happened, the government got involved. The federal government alleged that the drug manufacturer illegally violated FDA guidelines and fined the company $36 million.

July 13, 2006: Study Suggests Evista Raises Risk of Stroke and Blood Clot

Clinical trials have shown that the osteoporosis drug Evista may reduce the risk of invasive breast cancer in postmenopausal women. A recent study published by the New England Journal of Medicine suggests that postmenopausal women who took Evista developed significantly fewer cases of breast cancer than women who took a placebo. They also had substantially more fatal strokes and potentially dangerous blood clots.

Learn more in this abstract from PubMed, a U.S. National Library of Medicine service.

2007: FDA Approves Evista for Breast Cancer Risk Reduction

In 2007, after reviewing clinical trials of Evista, the FDA approved the drug for reducing the high risk of breast cancer. This was beneficial for those patients who had a history of breast cancer. It’s important to point out that the FDA did not approve the medication for the treatment of breast cancer, only prevention.

Evista is a selective estrogen receptor modulator (SERM). These medications help prevent the growth of invasive cancer cells in women at high risk of breast cancer. Women who already have breast cancer should not take this drug.

August 9, 2011: Eli Lilly Press Release and Safety Warnings

In 2011, Eli Lilly and Company posted a safety warning regarding Evista on its website. According to this press release, people taking Evista were at risk of developing deep vein thrombosis (DVT), which is blood clots in the leg. The risk was exceptionally high for those patients already at risk of blood clots.

The safety alert warned that Evista did not cause an increased risk of stroke or heart attack. However, Eli Lilly did admit that women who took Evista and subsequently had a heart attack or stroke were more likely to die as compared to those who never took the medication.

2014: FDA Approves Generic Versions of Evista

Eli Lilly’s patent on Evista expired in 2014. At that time, the FDA invited other drug manufacturers to submit their generic versions of the drug.

Generic medications still require FDA approval. This was true for any generic version that contained the same active ingredient, 60 mg of raloxifene. However, drug companies were welcome to introduce generic Evista forms with unique, non-active ingredients.

From a legal standpoint, if a generic drug version harms a patient, the consumer may have a legal claim against the manufacturer. They cannot sue Eli Lilly and Company if they weren’t the ones who manufactured the generic medication.

Patients who sued Eli Lilly and Company and other manufacturers of raloxifene did so for the following reasons:

• Labeling issues
• Problems with the specific drug formulation
• Manufacturing defects
• Contamination
• Undeclared allergies

The incidence of severe adverse events with Evista has been low. But that does not mean the drug doesn’t have severe side effects.

Injured by Evista? Get Legal Help

If you or a loved one has experienced dangerous symptoms after taking Evista, contact your doctor or other healthcare professional. You may also wish to meet with an experienced lawyer to discuss your options and to protect your legal rights. An attorney can navigate the claims process and deal with the insurance companies. This way, you can focus on your medical treatment and recovery.

FindLaw’s directory of product liability attorneys can get you started. Select your state or city to review contact and ratings information for local experts. Your search results will also link you to additional details about the attorneys’ experience with dangerous drug cases. Many law offices offer free case evaluations.