The Food and Drug Administration has issued an update on a second expanded voluntary recall of additional lots of potassium salt tablets from Torrent Pharmaceuticals due to unacceptable amounts of an impurity considered probably carcinogenic to humans by national and international organizations.
According to the Jan. 23 update, Torrent Pharmaceuticals is expanding its voluntary recall of Dec. 20 and Jan. 3 of losartan potassium tablets to include six lots of losartan potassium and hydrochlorothiazide combination tablets that treat high blood pressure for a total of 16 lots of losartan-containing medicines.
This recall, similar to the first two, is attributed to unacceptable amounts of N-Nitrosodiethylamine (NDEA) in the losartan active pharmaceutical ingredient manufactured by India-based Hetero Labs Limited.
A number of medications in the class of drugs known as angiotensin II receptor blockers have been under voluntary recall since July because of the detection of unacceptable levels of NDEA and/or N-nitrosodimethylamine (NDMA) in their active pharmaceutical ingredient such as losartan, valsartan or irbesartan.
The drugs under voluntary recall block receptors in the body that contribute to conditions like high blood pressure and the FDA is now investigating and testing all ARBs for the presence of NDEA and NDMA.
Its investigation has included setting interim acceptable intake levels for NDEA and NDMA and updating testing methods to detect NDMA and NDEA impurities.
The FDA said Jan. 2 that it "is taking swift action when it identifies these impurities that are above interim acceptable daily intake levels."
NDMA and NDEA are chemical compounds in the nitrosamines class and the two are considered to be a probable cancer-causing risk in humans at certain exposure levels.
In its early updates in July related to contaminated products with the active pharmaceutical ingredient valsartan manufactured by China-based Zhejiang Huahai Pharmaceuticals, the FDA said the "presence of the potentially cancer-causing NDMA was unexpected, and the agency believes the NDMA is related to changes in the way the active substance was manufactured."
The FDA said it "had determined the recalled valsartan products pose an unnecessary risk to patients.
It added, "Some levels of the impurity may have been in the valsartan-containing products for as long as four years."
In early December, the FDA said that it was "working with industry and international regulators to ensure products entering the market do not contain these impurities, but we are tolerating the impurities below the level established in the table for a short period of time to avoid a possible shortage of ARBs."
The FDA alerted health care professionals and patients Jan. 18 to a voluntary recall of one lot of irbesartan and seven lots of irbesartan and hydrochlorothiazide combination tablets distributed by Solco Healthcare LLC, a Prinston Pharmaceutical Inc. subsidiary, due to unacceptable amounts of NDEA in the active pharmaceutical ingredient manufactured by Zhejiang Huahai.
The most recent update notes Torrent is only recalling lots of losartan-containing medication containing NDEA above the interim acceptable intake limits of 0.27 parts per million as set by the FDA.
The announcement by the company posted Jan. 22 on the FDA website says it has not received any reports of adverse events related to this recall.
The announcement advises patients to contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.
Patients are also advised to continue taking their medication, until their pharmacist provides a replacement, or their doctor prescribes a different medication that treats the same condition as the risk of harm to a patient's health may be higher if the treatment is stopped immediately without any alternative treatment.
Losartan is used to treat hypertension, hypertensive patients with left ventricular hypertrophy and for the treatment of nephropathy in type 2 diabetic patients.
The FDA has updated its list of losartan medications under recall as well as irbesartan products under recall as well as valsartan products.