Evista News

Evista is a drug doctors prescribe to treat osteoporosis. The FDA approved the drug in 1997 for osteoporosis prevention. Two years later, the FDA approved the medication for the treatment of osteoporosis.

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 article will provide a timeline of news events related to Evista. This article also explains what to do if you develop blood clots or another health issue after taking this medication.

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.

Click here for the abstract in 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

Thankfully, the incidence of severe adverse events with Evista has been low. Of course, that does not mean the drug doesn't have severe side effects.

Side Effects of Evista

Since Eli Lilly first released Evista, patients have complained of serious side effects. This is the case with most prescription medications. Sometimes, patients suffer a severe allergy. In these cases, the drug manufacturer can often point the finger at the plaintiff's healthcare provider. Other times, the patient has several risk factors that make it more likely that they'll experience an adverse event.

Some of the common side effects of Evista include, but are not limited to, the following:

• Hot flashes
• Leg cramps
• Swollen legs, hands, and feet

Some of the more severe side effects include:

• Atrial fibrillation
• Pulmonary embolism
• Venous thromboembolism
• Fracture risk
• Stroke
• Heart attack

You must immediately visit the doctor or emergency room if you suffer any of these. Then, you need to contact an experienced product liability attorney.

What To Do if You Suffer a Stroke or Heart Attack After Taking Evista

The odds of anyone having a stroke or heart attack after taking Evista are low. However, there are reports of this happening to patients. You may have a legal claim if you suspect you've developed any severe side effects described above.

You should contact an experienced lawyer near you right away. You should be able to schedule your free case evaluation over the phone. Your attorney will protect your legal rights and deal with the insurance companies. This way, you can focus on getting the medical attention you need.