The U.S. Food and Drug Administration (FDA) has announced that Ascend Laboratories is recalling multiple lots of a direct oral anticoagulant, dabigatran etexilate. The recall is due to unacceptable levels of N-nitrosodimethylamine (NDMA).
Dabigatran etexilate is prescribed to patients to help lower their risk of stroke or blood clots. The dabigatran etexilate capsules included in this recall are a generic version of the DOAC marketed and sold by Boehringer Ingelheim under the brand name Pradaxa. The recall does not include any Pradaxa tablets.
A total of 10 lots of dabigatran etexilate are included in this recall. They were distributed to customers from June 2022 to October 2022. Six of the lots are 150-mg capsules, and the other four lots are 75-mg capsules. A full list is available on the advisory on the FDA website.
No adverse events have been reported as a result of this issue. Patients affected by this recall are advised to keep taking their medication until they can speak to a physician about a potential alternative.
“Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product,” according to the advisory.
Ascend Laboratories, based out of New Jersey, is a wholly owned subsidiary of Alkem Laboratories.
What is NDMA?
NDMA is a contaminant commonly found in trace amounts in water and various foods. Too much exposure to this impurity, however, is associated with a heightened cancer risk.
Multiple recalls have been announced in recent years due to unacceptable NDMA levels. Read about some of them here, here and here.
More information from the FDA about NDMA and other related impurities is available here.
“FDA, in collaboration with regulatory counterparts around the world, has set internationally-recognized acceptable daily intake limits for nitrosamines,” according to the agency. “Nitrosamines below this level are acceptable in drugs. If drugs contain levels of nitrosamines above the acceptable daily intake limit, FDA recommends these drugs be recalled by the manufacturer.”
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.