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FDA Expanding Blood Pressure Drug Callback from Losartan



If you take blood pressure medicines, check your prescription. The Food and Drug Administration is expanding an existing recall of prescription drugs for the treatment of high blood pressure, as the drug is associated with certain cancers.

Since July 2018, blood pressure medicines have been repeatedly recalled, and now there are 32 lots of the drug marketed by Macleods Pharmaceuticals Losartan has been added to the recall list. The recall includes two batches of 50 mg strength potassium tablets and 30 batches of potassium / hydrochlorothiazide (HCTZ) combination tablets. The recall for 30 batches includes 12 batches of 50 mg / 12.5 mg. three batches with a strength of 100 mg / 12.5 mg; and 1

5 batches of 100 mg / 25 mg starch. [194559002]

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Losartan is an angiotensin II receptor blocker, or ARB, which is used to treat Treatment of hypertension and hypertensive patients with left ventricular hypertrophy is applied. According to the FDA, the recall is due to "unacceptable levels of N-nitroso-N-methyl-4-aminobutyric acid (NMBA) in the active ingredient losartan (API)." The amount of these ingredients is referred to as nitrosamines in the recalled batches above the permissible exposure limit of 9.82 ppm.

For this reason, the FDA says, "The risk of developing cancer in some patients after long-term use of the product can not be ruled out." They continue to work with manufacturers to reduce and eliminate nitrosamines in ARBS. If you are taking any of the recalled medications, the FDA recommends that you take it until your doctor prescribes another medicine. They say that the risk of harm to a patient's health may be higher if the treatment is discontinued without alternative treatment.

 Cancer Research conducted at the British Cambridge Institute
Getty Images | Dan Kitwood

To date, Macleods Pharmaceuticals Limited has not received any reports of adverse events related to the recall. To determine if the medicine you're taking is included in the recall, visit the FDA website and compare the list of product names, manufacturer information, and batch or batch numbers on your bottle.

For updates and any recalls that affect blood pressure medication over the past year or so, visit the FDA website. If you have any questions or would like to report an adverse event in connection with this last recall, please contact Macleods Pharmaceuticals Limited at 8:00 am to 5:00 pm at 855-926-3384. Eastern.

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