Recalled ranitidine drugs had excessive amounts of NDMA carcinogen

KUALA LUMPUR: Ten recalled drugs containing the active ingredient ranitidine that treats stomach ulcers have been confirmed to contain the impurity N-Nitrosodimethylamine (NDMA) above the permitted level, said the Health Ministry.

Health director-general Datuk Dr Noor Hisham Abdullah said that the recall was based on evaluations and laboratory tests carried out by the ministry and companies holding the drug registrations, as well as information from international regulatory bodies.

He said that medications containing ranitidine are used to treat patients with heartburn and stomach ulcers by reducing acid production in the stomach and is usually used on a short-term basis, from a few days to a few weeks

Dr Noor Hisham added that NDMA is an impurity from the nitrosamine group and usually found at a low level in certain food and drinks, polluted air and from manufacturing processes.

According to the International Agency for Research on Cancer (IARC), NDMA can increase the risk of cancer in users in the long term.

"Although the risk of getting cancer over the short term is very low, the Health Ministry views the issue seriously," said Dr Noor Hisham in a statement on Wednesday (Oct 30).

However, he reminded individuals taking ranitidine that the benefit of continuing the treatment was more than the risk potential of containing small amounts of NDMA.

"As such, the user should continue and if necessary patients could get advice from health professionals to change to another medication," he said.

Dr Noor Hisham said the ministry will continue to assess products to ensure quality, safety and effectiveness with the collaboration of the relevant companies.

"Regulatory action will be taken accordingly on products following evaluation results and announcements will be made known from time to time," he added.

Recalled products containing ranitidine are:

1. Zantac Injection 50mg/2ml (MAL19950591ARZ)

2. Zantac Syrup 150mg/10ml (MAL19910829ACRZ)

3. Zantac Tablet 150mg (not marketed in Malaysia) (MAL19871471ARZ)

4. Hyzan Tablet 150mg (MAL19984063AZ)

5. Vesyca Film Coated Tablet 150mg (MAL19991131AZ)

6. Apo-Ranitidine 300mg Tablet (MAL19988448AZ)

7. Apo-Ranitidine 150mg Tablet (MAL19986966AZ)

8. Ranitic Tablet 150mg (MAL19988460AZ)

9. Pharmaniaga Ranitidine Tablet 150mg (MAL19987368AZ)

10. Pharmaniaga Ranitidine Tablet 300mg (MAL19987370AZ)