FDA Is Expanding Its Recall Of Blood-pressure Drugs Linked To Cancer

FDA Is Expanding Its Recall Of Blood-pressure Drugs Linked To Cancer
Posted at 11:09 AM, Jun 28, 2019
and last updated 2020-07-27 16:38:40-04

If you take blood pressure medication, check your prescription. The Food and Drug Administration is expanding an existing recall of a prescription medication used to treat high blood pressure because of the drug’s link to certain cancers.

There have been multiple recalls for blood-pressure medication since July 2018, and now 32 lots of the drug losartan, sold by Macleods Pharmaceuticals, have been added to the recall list. The recall includes two lots of 50-milligram-strength potassium tablets and 30 lots of potassium/hydrochlorothiazide (HCTZ) combination tablets. The 30-lot recall includes 12 lots of 50mg/12.5mg-strength; three lots of 100mg/12.5mg-strength; and 15 lots of 100mg/25mg-strength tables.


Losartan is an angiotensin II receptor blocker, or ARB, that is used to treat hypertension and hypertensive patients with left-ventricular hypertrophy. According to the FDA, the recall is due to “unacceptable amounts of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) in the losartan active pharmaceutical ingredient (API).”


The agency says the amount of these containments, called nitrosamines, in the recalled lots are above the acceptable exposure limit of 9.82 ppm.

As the FDA described, “The impurity was found in 32 lots of active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited that is above the US Food & Drug Administration’s interim acceptable exposure limit of 9.82 ppm. Based on the available information, the risk of developing cancer in a few patients following long-term use of the product cannot be ruled out.”


The agency continues to work with manufacturers to reduce and remove the nitrosamines from ARBS.

If you are taking one of the recalled drugs, the FDA recommends continuing to take it until your doctor prescribes a different medication. It says the risk of harm to a patient’s health may be higher if the treatment is stopped without an alternative treatment in place.

Research Into Cancer Conducted At The Cancer Research UK Cambridge Institute
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So far, Macleods Pharmaceuticals Limited has not received any reports of adverse events related to the recall. To see if the medicine you take is included in the recall, visit the FDA’s website and compare the list with the product name, manufacturer details and batch or lot number on your bottle.


For updates and all the recalls involving blood pressure medication over the last year or so, visit the FDA’s website.


If you have questions or want to report an adverse event in connection with this latest recall, contact Macleods Pharmaceuticals Limited at 855-926-3384 from 8 a.m. to 5 p.m. Eastern.

Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.


Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

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