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Australia : Recall - Blooms the Chemist Metformin XR 1000 metformin hydrochloride 1000 mg modified release tablet blister pack; low levels of contamination with N-nitrosodimethylamine (NDMA) (English only)

The Therapeutic Goods Administration (TGA) announces that its laboratories have recently completed testing a selection of immediate- and extended-release metformin medicines for the presence of N-nitrosodimethylamine (NDMA). TGA found that approximately 30% of batches contained levels of NDMA that modestly exceed the acceptable limit (less than twice the limit). One batch of Blooms the Chemist Metformin XR 1000 metformin hydrochloride 1000 mg modified release tablet blister pack (Batch: M1819076Z; Expiry 30/04/2022) by Apotex Pty Ltd was found to have higher levels (4.4 times the limit). Only limited stock of this batch has been supplied, and it has now been recalled from wholesalers. For this recalled product, only a single batch (M1819076Z) is affected; no other stock is affected by this recall.

Metformin is an important treatment for diabetes. The risks from not treating diabetes are far greater than the risks posed by the levels of NDMA seen to date.

The TGA has carefully considered the risk for patients from batches that modestly exceed the limit. This included an analysis of the commonly prescribed doses of metformin using data from the general practice program MedicineInsight. Overall, the risk is considered to be very low for patients on both immediate- and extended-release products. The TGA investigation indicates that the majority of patients would not be exposed to levels of NDMA that exceed the acceptable intake limit.

The limits set by the TGA for NDMA are very conservative. They are calculated to ensure that an individuals' excess cancer risk would not exceed 1:100,000 if that individual was on the maximum daily dose of the medicine for 70 years. As most individuals do not take the maximum daily dose, and are not using metformin for this long, the risks are very low.

The TGA is continuing to work with the sponsors of metformin medicines to ensure that this critical medicine remains available, and that consumers are not exposed to unacceptable levels of NDMA. The TGA is also working with medicine manufacturers to oversee the implementation of improved manufacturing and testing processes that will ensure that metformin medicines supplied in Australia meet the high standards for quality.

Consumers are strongly advised to continue to take their metformin medicines as prescribed.

Please refer to the following websites in TGA for details:
http://apps.tga.gov.au/../arn-detail.aspx?k=RC-2020-RN-01153-1
http://www.tga.gov.au/alert/metformin-0

In Hong Kong, the above recalled product is not a registered pharmaceutical product.

Currently in Hong Kong, there are 125 registered pharmaceutical products containing metformin. All products are prescription-only medicines.

Related news on the detection of N-nitrosodimethylamine (NDMA) in metformin products was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 5 Dec 2019, with the latest update posted on 4 Nov 2020. Letters to inform local healthcare professionals were issued by the Department of Health (DH) on 6 Dec 2019. The DH has contacted the certificate holders of all registered metformin products for follow up on the local impact of the issue, and collected samples of metformin-containing products in the local market for analysis. When there are any health risks identified and posed to the public, a press statement will be issued as soon as possible. The following is the main content of the press statement issued previously:
- On 11 Mar 2020, the DH endorsed a licensed wholesale dealer, the International Medical Company Ltd, to recall 3 batches of Metformin-Teva 500mg Tablets (HK-60334) (batch number: 16532717, 16532817 and 16532917) from the market due to the potential presence of NDMA in the product.
- On 22 Jul 2020, the DH endorsed licensed wholesaler dealers Suntol Medical Ltd and Hovid Limited to recall Glucofit Extended-Release Tablets 500mg (HK-64640) and Diabetmin XR Extended-Release Tablets 500mg (HK-63333) respectively.
- On 24 Aug 2020, the DH endorsed licensed wholesaler dealer Suntol Medical Ltd to recall Glucofit Film Coated Tablets 500mg (HK-64639).
- On 9 Oct 2020, the DH endorsed licensed wholesale dealer Star Medical Supplies Ltd to recall one batch of Metformin Denk 850 Tablets 850mg (HK-49776) (batch number: 21334).

So far, the DH has received 17 cases of adverse drug reaction related to metformin. None of them is concluded to be related to the presence of NDMA. The DH will remain vigilant on the development of the issue and any safety update of the drug issued by overseas drug regulatory authorities for consideration of any action deemed necessary.

Patients who are taking metformin-containing products should not stop taking the medicines, but should seek advice from their healthcare professionals for proper arrangement.

Ends/ Wednesday, November 18, 2020
Issued at HKT 15:45

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