FDA Rejects Bid to Ban AstraZeneca's Crestor
The Food and Drug Administration on Monday rejected a petition from a consumer group that sought the ban of the cholesterol-fighting drug Crestor manufactured by
AstraZeneca
(AZN) - Get Report
.
The agency turned down the request from Public Citizen, a longtime critic of the drug that has alleged that Crestor causes more dangerous side effects -- including kidney damage and a rare muscle-wasting disease -- than similar drugs.
"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 organization's allegations," said David Brennan, President and CEO of AstraZeneca's U.S. operations.
The FDA's 36-page response essentially reprised comments that the agency made earlier this month when it announced the
toughening of certain restrictions listed on the Crestor label. The agency also said Crestor's side effects were similar to those of other cholesterol-fighting drugs known as statins.
After reviewing all of the evidence, the FDA said in its letter to Public Citizen released Monday that Crestor "does not pose a risk of muscle toxicity greater than that of other approved statins."
These drugs include Lipitor from
Pfizer
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, Zocor from
Merck
(MRK) - Get Report
and Pravachol from
Bristol-Myers Squibb
(BMY) - Get Report
.
In addition, the FDA said "there is no convincing evidence that Crestor poses a risk of serious
kidney injury."
Public Citizen attacked the FDA's decision as having "a familiar ring in its similarity to the agency's initial response to the dangers of many other drugs that were eventually banned." The FDA's action "should give no comfort to either physicians or patients who are using or considering using Crestor," said Dr. Sidney M. Wolfe, director of Public Citizen's Health Research Group.
AstraZeneca's stock lost 22 cents to close at $41.90.