U.S. regulators have told European drugmaker AstraZeneca Plc to stop circulating promotions that claim its antibiotic, Merrem, is effective against drug-resistant infections.
THE FOOD and Drug Administration, in a letter to the company posted on the agency’s Web site Monday, objected to physician-directed sales materials with the claim “Attacking the Tide of Resistance” and other suggestions that Merrem could fight bacteria that did not succumb to other treatments.
“FDA is not aware of substantial evidence or substantial clinical experience to support this claim of clinical efficacy against resistant pathogens,” the agency said in the letter, which was dated Oct. 3.
In some cases, AstraZeneca cited data showing Merrem worked against resistant bacteria in laboratory tests. That type of data is “not an adequate basis on which to accurately predict the clinical effectiveness of an antimicrobial agent,” the FDA said.
AstraZeneca, Europe’s No. 2 drug maker, is evaluating the letter, company spokeswoman Cindy Callaghan said.
“We will work cooperatively with the FDA to resolve the matter,” she said.
The emergence of drug-resistant bacteria is a major public health concern as more pathogens become difficult to treat. Inappropriate prescribing is considered a contributing factor.
“To suggest that Merrem I.V. is effective for the treatment of drug-resistant pathogens may promote inappropriate prescribing,” the FDA letter said.
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