The United States Food and Drug Adminstration (FDA) announces that Macleods Pharmaceuticals Limited has initiated a voluntary nationwide recall, to the patient level, of 32 lots of Losartan Potassium USP Tablets (2 lots of 50mg strength) and Losartan Potassium/Hydrochlorothiazide combination Tablets (12 lots of 50mg/12.5mg strength, 3 lots of 100mg/12.5mg strength and 15 100mg/25mg strength) due to the detection of trace amounts of an unexpected impurity, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). The impurity was found in 32 lots of active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited that is above the FDA's interim acceptable exposure limit of 9.82 ppm. Based on the available information, the risk of developing cancer in a few patients following long-term use of the product cannot be ruled out.
Losartan Potassium Tablets and Losartan Potassium/Hydrochlorothiazide combination Tablets are indicated to treat hypertension and hypertensive patients with Left Ventricular Hypertrophy. Patients who are on Losartan Potassium Tablets and Losartan Potassium/Hydrochlorothiazide combination Tablets, USP should continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment, as the risk of harm to the patient's health may be higher if the treatment is stopped immediately without any alternative treatment.
To date, Macleods Pharmaceuticals Limited has not received any reports of adverse events related to this recall.
The products subject to recall are listed below:
- Losartan Potassium Tablets 50 mg (lot numbers: BLl711A, BLl710A)
- Losartan Potassium and Hydrochlorothiazide Tablets 50 mg/ 12.5 mg (lot numbers: BLK719A, BLK720A, BLK721A, BLK722A, BLK723A, BLK724A, BLK725A, BLK726A, BLK804A, BLK806A, BLK825A, BLK826A)
- Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 12.5 mg (lot numbers: BLL801A, BLL802A, BLL803A)
- Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 25 mg (lot numbers: BLM716A, BLM717A, BLM719A, BLM720A, BLM721A, BLM722A, BLM723A, BLM724A, BLM725A, BLM726A, BLM802A, BLM803A, BLM825A, BLM826A, BLM827A)
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/macleods-pharmaceutical-limited-issues-voluntary-nationwide-consumer-level-recall-losartan-potassium
In Hong Kong, the above products are not registered pharmaceutical products.
Currently in Hong Kong, there are 243 registered pharmaceutical products containing valsartan (82 products), candesartan (19 products), irbesartan (62 products), losartan (63 products) and olmesartan (17 products). All products are prescription-only medicines.
Regarding impurities in sartan-containing products, a public announcement was first issued on 6 Jul 2018, and letters to inform local healthcare professionals were issued by the Department of Health (DH) on 6 Jul 2018, 9 Jul 2018, 25 Jul 2018 and 3 Aug 2018. Related news was also previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 6 Jul 2018, with the latest update posted on 12 June 2019.
Regarding the announcements issued by various overseas drug regulatory authorities on the detection of N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) in sartan-containing products, the following 5 valsartan products and 1 irbesartan product were affected and recalled from the Hong Kong market on 6 Jul 2018 and 20 Dec 2018 respectively: HK-61786, HK-61787, HK-61784, HK-61785, HK-60794 and HK-63378. The DH noted that these recalls were completed.
The DH had collected samples of sartan-containing products in the local market for analysis. No NDMA and NDEA were detected.
Regarding the announcements issued by various overseas drug regulatory authorities on the detection of NMBA in losartan, the DH endorsed the recall of 4 losartan products (HK-61932, HK-61933, HK-62634 and HK-62635) from the local market as a precautionary measure due to the potential for NMBA in the products on 11 Mar 2019. The DH noted that the recall was completed.
So far, the DH has received 18 cases of adverse drug reaction related to valsartan, candesartan, irbesartan, losartan and olmesartan. None of them is concluded to be related to the presence of impurities such as NDMA, NDEA and/or NMBA. The DH will keep vigilant on any safety updates on detection of impurities in sartan-containing products issued by overseas regulatory authorities.
Patients who are taking sartan-containing products should not stop taking the medicines, but should seek advice from their healthcare professionals as soon as possible for proper arrangement.
Ends/ Thursday, June 27, 2019
Issued at HKT 15:30
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