WASHINGTON, Jan. 11 (UPI) -- The U.S. Food and Drug Administration urged drug companies to re-evaluate studies of more than 1,100 drugs because the results may be faulty.
The FDA identified more than 1,100 generic and brand name drugs either approved or awaiting approval that could be affected, HealthDay News said. Officials said the action was precautionary and stressed that there was no evidence of problems with the affected drugs.
The agency's recommendation comes after inspections of two MDS Pharma facilities raised questions about the validity and accuracy of results from studies MDS Pharma conducted from 2000-04, the FDA said in a news release.
MDS Pharma is a company contracted to perform pharmacokinetic testing services for a number of drug companies. A pharmacokinetic study, which measures the level of drug in a patient's blood, can be part the FDA drug approval process.
Besides working with MDS Pharma, agency officials said they would work with drug companies to ensure that they validate their pharmacokinetic data through audits, new analyses or by repeating tests within a reasonable time period.
