Effient Earns FDA Approval to Fight Heart Attacks in Angioplasty Patients

Effient, a blood-thinning pill used to reduce the risk of blood clots in heart patients after undergoing angioplasty, has been approved by the Food and Drug Administration.

A clinical trial of the Eli Lilly drug, known generically as prasugrel, found that some patients given Effient had lower rates of non-fatal heart attacks, death, and stroke. However, the drug was associated with increased significant bleeding and an increase in the rate of subsequent strokes in patients who had suffered earlier strokes.

Angioplasty involves the use of a tiny, inflatable balloon which is inserted into a narrowed section of artery to open up the vessel. In many cases, a small wire mesh tube called a stent is then inserted to prop open the widened section of artery and improve circulation.

After angioplasty, blood platelets may begin to clump around the surgical site, causing blood clots to form. When these blood clots break free and flow through the blood to reach the lungs, brain, or heart, they can lead to deadly heart attack and stroke.

Concerns About Excessive Bleeding

Effient was approved despite concerns about its safety recently aired by a prominent medical researcher. Johns Hopkins University physician Victor Serebruany said the proposed dose for Effient could result in life-threatening internal bleeding, but that a lower dose of the drug might result in a lower risk of internal bleeding.

Effient’s labeling will include a boxed warning alerting physicians about the risks of significant, even fatal, bleeding, the FDA said. Also, the drug will not be recommended for use in patients with active pathological bleeding, a history of mini-strokes (transient ischemic attacks) or stroke, or urgent need for surgery, including coronary artery bypass graft surgery.

Study Finds Benefits, Risks

In a study of 13,608 patients at risk of heart attack who were about to have angioplasty, Effient was compared to another leading blood thinner, Plavix. The number of patients who had non-fatal heart attacks was reduced 7.0 percent for patients given Effient and 9.1 percent for patients who got Plavix.

The new drug gives doctors another option in treating heart patients who have undergone angioplasty and need to reduce the risk of blood clots, the FDA said.

“Effient offers physicians an alternative treatment for preventing dangerous blood clots from forming and causing a heart attack or stroke during or after an angioplasty procedure,” said John Jenkins, M.D., director of the Office of New Drugs, in the FDA’s Center for Drug Evaluation and Research. “Physicians must carefully weigh the potential benefits and risks of Effient as they decide which patients should receive the drug.”

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