Another voluntary recall of medications used in the treatment of high blood pressure has been issued due to the detection in the active pharmaceutical ingredient of an impurity considered probably carcinogenic to humans by the U.S. Environmental Protection Agency.
The recalls – the third such one in a month’s time – stretch back to summer and now involve the Food and Drug Administration issuing warning letters to at least one Chinese manufacturer of the active ingredients and updating detection and screening for such impurities.
The most recent FDA alert to patients and health care professionals is for 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.
Irbesartan and irbesartan HCTZ are used to control high blood pressure and for the treatment of heart failure. Irbesartan in combination with amlodipine plus the diuretic hydrochlorothiazide is used to control high blood pressure.
The recall is due to unacceptable amounts of N-Nitrosodiethylamine (NDEA) in the irbesartan active pharmaceutical ingredient manufactured by Zhejiang Huahai Pharmaceuticals.
Some of Solco Healthcare’s valsartan and valsartan/HCTZ products were among those recalled in July after the detection of N-nitrosodimethylamine (NDMA) in the active pharmaceutical ingredient manufactured by Zhejiang Huahai which has since been warned by the FDA about its manufacturing processes and to update its screening for such impurities.
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.
The detection of traces amounts of the NDEA as well as NDMA in the active pharmaceutical ingredient of several medications used to treat cardiovascular conditions, has resulted in a number of voluntary recalls during the last six months, and a number of actions by the FDA.
These have included setting interim acceptable intake levels for NDEA and NDMA and updating testing methods to detect NDMA and NDEA impurities.
The drugs involved block receptors in the body that contribute to conditions like high blood pressure and the FDA is now investigating and testing all angiotensin II receptor blockers (ARBs) for the presence of NDEA and NDMA.
The contamination, which has been associated with manufacturing facilities in India and China, is sometimes an unintended byproduct resulting from a change in manufacturing procedures.
The FDA announcement notes that Solco is only recalling lots of irbesartan-containing medication where NDEA has been detected above the interim limit of 0.088 parts per million.
In its Jan. 18 voluntary recall announcement on the FDA website, parent Prinston Pharmaceutical Inc. said it has not received any reports of adverse events related to this recall.
The announcement advised patients to contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.
Patients who are on irbesartan are 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.
The FDA says on its website that it is working with manufacturers to reduce and remove nitrosamines from ARBs.
The FDA also updated the list of irbesartan products under recall.
Earlier this month Torrent Pharmaceuticals Limited expanded its voluntary recall from two lots of losartan potassium tablets to a total of 10 lots due to trace amounts of NDEA in the losartan active pharmaceutical ingredient manufactured by India-based Hetero Labs Limited.
Aurobindo Pharma USA announced Dec. 31 a voluntary recall of 80 lots of amlodipine valsartan tablets, valsartan tablets with the diuretic hydrochlorothiazide, and valsartan tablets due to the detection of trace amounts of NDEA above “interim acceptable daily intake level of 0.083 parts per million.”