Personal Injury Law

FDA Panel Recommends Crestor For Healthy People

By Jane Akre

Giving Drugs To The Healthy?

In seems incongruous - giving a medication to people who are healthy and not considered 'at risk' for any disease.

A panel of the Food and Drug Administration (FDA) has voted to recommend that the cholesterol-lowering drug, Crestor, be approved for people who have inflammation.

This includes patients with no history of heart disease, but who may have an inflammatory biomarker C-reactive protein.

The panel voted 12-4 after a study showed that rosuvastatin, a potent statin known commercially as Crestor, showed promising results in lowering stroke, heart attack, hospitalization, and death over a placebo.

But there was a statistically significant increase, 27 percent, higher rate of developing diabetes among the group taking Crestor.

Also the study showed that 13 patients died from gastrointestinal disorders among the Crestor group. 18 patients reported confusion out of the same group.

The FDA has issued warnings in the past about Crestor and muscle damage.

The panel recommends that users of Crestor be monitored for diabetes but that the benefit outweighs the risk. Drug maker,AstraZeneca, should also 'carefully define the target population in marketing materials,' the panel said.

Controversial Decision

Not everyone in the medical community is onboard with the recommendation.

Dr. Steven Nissen, chair of cardiovascular medicine at the Cleveland Clinic tells ABC News, 'If the FDA accepts this recommendation, it will expand the number of Americans eligible for statin therapy by millions,'

But others believe the recommendation should be followed, especially if patients are 50 or older for men, 60 or older for women and have LDL cholesterol less than 130 mg/dL, triglycerides of less than 500 mg/L, or if the patient has high blood levels of the inflammation marker, C-reactive protein (CRP).

Cardiologist, Dr. Christopher Cannon of Brigham and Women's Hospital in Boston, tells ABC News this is 'outstanding news for people who are at risk but who would not previously known it. The treatment can reduce almost in half their risk of a first heart attack or other cardiac event," he said.

ABC also talked to family care doctors who agree that this is bad patient care, among them, Dr. Michael Good of ProHealth Physicians in Middletown, Conn.

"We know that giving statins to any population will lower their heart attack risk, and there are some in the cardiology community who feel that 'we should put it in the water.' However, unlike fluoride, which we do put in the water, statins have considerable side effects and risks. About one in 10 patients experience muscle pain and weakness, some have liver function changes and the statins as a group have many, many drug interactions."

AstraZeneca Study Basis of Recommendation

While the FDA is not required to follow the recommendation of an expert panel, it often does. This would mark the first time a prescription drug, normally used to lower dangerously high levels of bad cholesterol (LDL) among those 'at risk' for suffering a heart attack or stroke, be approved for the prevention of heart attack in healthy people.

The JUPITER study of almost 18,000 men and women, which the panel looked at to make its recommendation, was sponsored by Astra Zeneca (AZ), the company that makes Crestor.

The drug was the third-best selling product for AZ last year with sales of $3.6 billion and has been taking shares away from competitor, Lipitor, reports AP. #

Full post as published by InjuryBoard on December 17, 2009 (boomark / email).