USA TODAY US Edition

FDA permits tainted drugs

Medication is crucial to blood pressure patients

- Ken Alltucker

The Food and Drug Administra­tion will allow certain lots of the blood pressure drug losartan that contain trace amounts of a potential carcinogen to be shipped to pharmacies.

The temporary measure is designed to avert a shortage of the critical medication – the nation’s ninth-most commonly prescribed drug.

Permitting losartan with tiny amounts of a nitrosamin­e impurity will not increase a person’s cancer risk, the FDA said. If people discontinu­e or can’t get the drug for conditions such as hypertensi­on, heart failure or kidney disease, it could put them at risk or force them to switch to another medicine.

Drug companies have recalled hundreds of lots of the blood pressure and heart medication­s valsartan, losartan and irbesartan since July after testing revealed some versions had small amounts of suspected carcinogen­s. These medication­s are part of a large class called angiotensi­n II receptor blockers (ARBs), which lower blood pressure by widening or relaxing blood vessels.

The temporary measure is designed to avert a shortage of the critical medication – the nation’s ninth-most commonly prescribed drug.

FDA investigat­ors suspect the root cause of the contaminat­ion stemmed from a change in how the blood pressure drug ingredient­s were made.

Drug companies found some batches of losartan contained small amounts of a nitrosamin­e impurity, NNitroso-N-methyl-4-aminobutyr­ic acid, or NMBA. The FDA will allow some of those tainted drugs to be sent to pharmacies as long as the levels of the contaminan­t do not exceed 9.82 parts per million. The agency will decide on a case-by-case basis whether the drugs can be used.

The FDA said the stopgap measure ensures consumers will have access to the drug while manufactur­ers make batches of losartan that do not contain the impurity. The agency expects it will take six months to replenish the nation’s supply of impurity-free losartan.

Not all versions of losartan will be allowed on the market under the new measure.

In a notice shared last week by the FDA, Torrent Pharmaceut­icals said it would recall 104 lots of losartan potassium and losartan potassium/hydrochlor­othiazide combinatio­n tablets that contained unacceptab­le levels of NMBA.

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