FDA finds impurities in antibiotics, says it won't seek recalls

The FDA said this week that it's aware of some impurities in samples of the antibiotics rifampin and rifapentine, but won't ask drugmakers to recall them because it doesn't want to cause a shortage of the lifesaving drugs. 

Rifampin and rifapentine are antibiotics used to treat tuberculosis. Rifampin is also used for other serious infections. 

The FDA said Aug. 26 that it's aware samples of the drugs contain nitrosamine impurities. Some nitrosamines are potential carcinogens. 

But despite the impurities, the FDA said it isn't asking for any recalls because it's concerned shortages would prevent patient access to the lifesaving medications. Patients taking the antibiotics should continue taking them and consult with a healthcare professional about any concerns, the agency said. The FDA said the risk of not taking the antibiotics to treat tuberculosis outweighs any potential risk from nitrosamine contamination. 

Drugmakers that find  nitrosamines in their rifampin or rifapentine products above  acceptable intake levels should contact the Center for Drug Evaluation and Research’s drug shortages staff, and the FDA will decide on a case-by-case basis if they should be distributed, the FDA said. 

Read the full news release here.

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