Public Citizen today called on the U.S. Food and Drug Administration to investigate Europe’s second-largest drug company AstraZeneca for “illegally delaying the submission of reports of serious adverse reactions to the anti-cholesterol drug Crestor,” the group said in a statement.

“The company delayed the submission to the FDA of 23 such reports, with some delays being as long as 97 days beyond the 15-day reporting limit,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, in a letter to FDA’s Acting Commissioner Lester Crawford. “The delay hampered the FDA’s ability to assess the safety of what is a “uniquely dangerous drug,” Wolfe wrote.

Public Citizen in March filed a petition with the FDA to remove Crestor from the market.

“The latest allegation from Public Citizen is one more false, misleading, and inaccurate report from Mr. Wolfe and his organization,” AstraZeneca said in a statement. “Once again Mr. Wolfe and this organization are behaving irresponsibly in misrepresenting the facts about CRESTOR.”

Since Crestor went on the market in September 2003, some patients taking the drug have suffered severe muscle deterioration, kidney failure or kidney insufficiency, Public Citizen said.

“In 20 of the 23 cases that AstraZeneca delayed reporting, patients taking the drug were hospitalized. (Nineteen of the 23 cases involved muscle deterioration and four involved renal failure.),” Public Citizen said.

The Food, Drug and Cosmetic Act requires drug companies to report these kinds of adverse reactions “as soon as possible” but not later than 15 calendar days after the initial receipt of the information.

AstraZeneca, according to Public Citizen, reported these 23 cases to the FDA only in quarterly reports filed on March 5 and July 2. However, Public Citizen claims, quarterly reports are supposed to be used for adverse reactions that don’t fall into the 15-day category, which covers adverse reactions that are both serious and unexpected.

“We continue to urge the prompt removal of this uniquely dangerous drug from the market and believe that your investigation is likely to uncover further reasons to do so,” Wolfe wrote.

Over 2.8 million patients worldwide have been treated with CRESTOR and more than 8 million prescriptions have been dispensed since launch, according to AstraZeneca.

“The Company has operated diligently in accordance with the strict reporting procedures of the FDA,” AstraZeneca said.

(via Public Citizen)