The ongoing blood pressure medication recall has been expanded once again, the FDA announced this week. The expansion covers the hypertension drug losartan potassium, some batches of which were found to have unacceptably high levels of an impurity that may cause cancer in some patients. The latest expansion covers 32 batches of the tablets, but the FDA warns you shouldn’t stop taking them.
In late April, Teva Pharmaceuticals USA announced that a voluntary recall of 35 bulk lots of the blood pressure medication losartan potassium, something it expanded on June 12 to cover half a dozen additional bulk lots. The recall was due to the discovery of an impurity involving levels of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) that exceeded what is currently considered to be the upper safe threshold.
Under the FDA’s current interim acceptable exposure limit rule, NMBA levels must remain under 9.82 ppm. At higher levels, the impurity is a potential cancer risk for some individuals who take the medication over a long period of time.
Another recall over NMBA
On June 26, the FDA published a new advisory that revealed Macleods Pharmaceuticals Limited is voluntarily recalling 32 lots of the same drug, losartan potassium USP tablets. The recall covers two lots of the drug in 50mg strength, as well as 30 lots of losartan potassium/hydrochlorothiazide combo tablets in strengths ranging from 50mg/12.5mg to 100mg/25mg.
These tablets were sold to patients with high blood pressure and left ventricular hypertrophy, according to the FDA. Macleods Pharmaceuticals states that as of the time of the recall, it had not received any reports of ‘adverse events.’ As with the previous recalls, patients are advised to continue taking the recalled tablets due to the greater risk associated with uncontrolled high blood pressure. These consumers should contact their pharmacist or doctor to see about getting replacement tablets.
Second contaminant found
In addition to the NMBA impurity, a report from earlier this month revealed the hypertension drug valsartan also contains an impurity that may cause cancer in some patients.
News of the impurity was discovered in documentation published by the FDA, which revealed that online pharmacy Valisure had identified high levels of the probable carcinogen dimethylformamide (DMF) in some valsartan tablets. Under current regulations, DMF levels can reach up to 8,800,000 nanograms, but Valisure is seeking to have that limit lowered to under 1,000 nanograms.