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Drug maker cited for not reporting serious side effects

U.S. health regulators have warned Sanofi-Aventis SA's U.S. unit for failing to submit reports of possible serious side effects in a timely manner.
/ Source: Reuters

U.S. health regulators have warned Sanofi-Aventis SA's U.S. unit for failing to submit reports of possible serious side effects in a timely manner.

In a January 28 letter made public on Tuesday, the Food and Drug Administration said an early response from the drugmaker and its "promised corrective actions are inadequate to address the deficiencies."

"We remain concerned that your .... adverse drug experience reporting system has not been fully validated, and may have resulted in inaccurate assessment and untimely submission of 15-day alerts," FDA said.

The agency uses reports of possible side effects from companies, on top of other reports sent directly to the agency, to weigh whether "real world" use of a drug shows new or greater complications that could merit label changes, warnings or even a drug withdrawal.

Sanofi spokesman Jack Cox in an e-mailed statement said the company acknowledged the FDA's observations and is working with the agency to comply.

The FDA's letter stems from agency inspections of Sanofi's Bridgewater, New Jersey, facility in April and May 2010. The agency found the drugmaker had inadequate procedures in place to monitor adverse events and also failed to submit serious and unexpected adverse drug experiences by the FDA's deadline.

It also did not include information on postmarketing studies for several drugs -- including its diabetes drug Apidra, colon cancer drug Eloxatin and antibiotic Ketek -- in its annual report to the agency, according to the letter, posted on the FDA's website.

Information on completed, unpublished clinical trials on drugs such as Apidra, Eloxatin and sleep aid Ambien were also not submitted as required.

Sanofi later responded to the agency in June, July and October 2010 with plans to correct the problem, but FDA on Tuesday told the drugmaker its response was lacking.

The agency called on the company to take prompt action to correct the problem and respond to the agency within 15 days. FDA also said it could do another inspection.

While most warning letters are resolved without incident, the agency can seek penalties such as fines and injuctions.

Separately, FDA also released a warning letter to Sanofi's German unit regarding manufacturing violations that led to contamination issues.

In that letter, dated February 9, the agency cited the drugmaker for not having proper written or manufacturing procedures in place to prevent microbiological contamination such as the one found in June 2010 with Sanofi's Apidra.

Its staff also was not properly trained to help prevent contamination, FDA added.

Sanofi's Cox said the drugmaker had moved quickly to address the problems and that it takes the matter seriously.

"The company began addressing the FDA's recommendations immediately, even before the inspection was completed and has developed a thorough action plan with a monthly regular update of the FDA," he said, adding that Sanofi "is convinced that these issues will not disrupt its ability to supply products."

That letter is posted on the FDA website.