October 26

FDA Rejects Crestor Petition–Sacrificing Patient safety

FDA Rejects Crestor Petition–Sacrificing Patient safety

Tue, 15 Mar 2005

The FDA’s safety standard for allowing a drug to be marketed has been turned on its head. The law requires that a manufacturer provide scientific proof that a drug is safe and effective before it can be licensed for marketing.

The FDA has shifted the burden of proof from manufacturers by insisting that analysts who detect a lethal drug effect must provide evidence from controlled clinical trials to prove it.

Public Citizen submitted several petitions requesting that the statin, Crestor, be recalled because of its lethal effects, stating that “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.”

In its October 2004, petition, which was based on adverse reaction reports through August 26, 2004, there have been 117 cases of rhabdomyolysis reported in the U.S. since the drug was first marketed in September 2003, and 41 cases of kidney failure–both higher than seen with the other currently marketed statins.

The FDA is well aware that the rate of rhabdomyolysis in patients prescribed Crestor is higher than that of the other statins, the FDA covers up that fact by saying the rate is "similar".

FDA Statement: "Data available to date from controlled trials, as well as post-marketing safety information, indicate that the risk of serious muscle damage is similar with Crestor compared to other marketed statins."

Public Citizen Response: Crestor was the only statin that caused rhabdomyolysis at any dose in clinical trials prior to approval. (The cases occurred at 80 mg, a dosage not approved, but most of the post-marketing cases are occurring at 10 or 20 mg.)

Safety concerns withheld approval of Crestor in several countries, including Germany, Norway and Spain.

The FDA argued disingenuously that it is difficult to differentiate between the lethal and the less severe forms of muscle damage. While acknowledging that the effect can be catastrophic, resulting in death…FDA’s official, but unsigned 36 page response suggested: “even full-blown rhabdomyolysis is often reversible.”

FDA response: http://www.fda.gov/cder/drug/infopage/rosuvastatin/crestor_CP.pdf

The letter of rejection also noted but dismissed the significance of “sporadically” observed cases of urine abnormalities–including blood in the urine–and 2 cases of renal failure and cases of renal insufficiency which were confirmed by challenge -rechallenge tests (withdrawal of Crestor resulted in symptom abatement, reintroduction of Crestor produced renal insufficiency again).

It is difficult to justify maintaining an agency at public expense when that agency’s decisions undermine public safety.

“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 Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group.

Contact: Vera Hassner Sharav


Updated 3/15/2005 2:05 AM
FDA rejects Crestor petition
By Julie Appleby, USA TODAY

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.

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