Healthy Skepticism Library item: 895

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Appleby J.
FDA rejects Crestor petition
USA Today 2005 Mar 15

Full text:

The anti-cholesterol drug Crestor does not pose a greater risk of muscle damage than other drugs like it, the FDA said Monday, rejecting an advocacy group’s petition to withdraw the drug.
The Food and Drug Administration also said there is no convincing evidence to support the group’s contention that Crestor could cause serious kidney damage.
The decision is a boost for AstraZeneca (AZN), maker of the drug, which has been dogged by controversy since it hit the U.S. market in 2003.

But it is a blow to advocacy group Public Citizen, which submitted its petition a year ago and last week supplemented it with data it says show Crestor linked to six times as many reports of muscle damage per million prescriptions than the combined total of all other cholesterol-lowering drugs called statins.

The FDA rejected those arguments based on its own review of those adverse-event reports and ongoing clinical trials and safety data gathered since the drug hit the market. All cholesterol drugs in the statin class carry some risk of muscle pain and damage, including a serious condition called rhabdomyolysis, in which muscle cells die and release toxins into the body.

“The available evidence … indicates Crestor does not pose a greater risk …,” the FDA said in a letter to Public Citizen.

The decision was immediately hailed by AstraZeneca. Crestor sales topped
$908 million worldwide last year. AstraZeneca shares closed at $41.90 Monday, down 22 cents.
“Patient safety is our top priority, and the FDA’s rejection of Public Citizen’s petition should reassure the millions of people who have been unnecessarily alarmed by the allegations,” David Brennan, CEO of AstraZeneca, said in a statement.

Crestor has not only been criticized by Public Citizen but also attacked in editorials in the British medical journal The Lancet, which criticized AstraZeneca’s marketing efforts. In November, an FDA scientist told Congress it was one of five drugs that warranted further safety study, although the FDA later said the scientist’s views did not reflect those of the agency.

AstraZeneca has also received two warning letters from the FDA saying its ads about Crestor were misleading. In addition, Crestor was the first new statin drug to hit the market after the cholesterol drug called Baycol was pulled in 2001 because it caused severe muscle damage.

Those factors helped raise awareness of the drug and its possible side effects, which may have led more doctors and patients to report adverse events in connection with Crestor, the FDA said.

Public Citizen, in its own statement, criticized the FDA for the decision and said any “post-Baycol” effect on awareness and side-effect reports would have affected all so-called statin drugs equally.

The group said the FDA failed to act quickly on other drugs that were eventually withdrawn, such as Baycol.
“Once again, when faced with concerns about the safety of a drug, the FDA has sided with the drug company instead of the public,” wrote Sidney Wolfe, a medical doctor and director of Public Citizen’s Health Research Group.