Namibia Recalls Tainted Heartburn Medicine

The Namibia Medicines Regulatory Council has recalled a certain heartburn medicine brand due to a cancer-causing substance recently found in the drug.

Zantac, a ranitidine-containing medicine brand, has been recalled from the Namibian market.

Ranitidine is an over-the-counter and prescription drug used to reduce the production of stomach acid in patients with conditions such as heartburn and stomach ulcers.

Zantac has been banned due to the presence of N-nitrosodimethylamine (NDMA), a probable human carcinogen in some ranitidine-containing medicines.

Carcinogen is any substance that could cause cancer.

A statement issued by the Namibia Medicines Regulatory Council (NMRC)'s registrar of medicines, Johannes Gaeseb, last Wednesday alerted Namibian health professionals about the discovery.

"It has come to the attention of the NMRC that an impurity, NDMA, has been detected in several ranitidine-containing medicines, leading to recalls of the medicines from various markets, including Namibia," he said.

NDMA is also found in water and food, including meat, dairy products and vegetables as environmental contaminants. The council has encouraged healthcare professionals to advise patients who are on ranitidine-containing medicines to take up alternative treatment.They also advised patients taking the prescription to contact health professionals about alternatives.

"If necessary to stop or substitute a ranitidine-containing medicine, the decision should be guided by healthcare professionals and alternative medicines approved for similar indications should be considered," said Gaeseb.

The president of the Pharmaceutical Society of Namibia, Benjamin Khumalo, however, told The Namibian yesterday that, while products containing ranitidine are still being sold in Namibia, Zantac had been pulled off the shelves.

"Zantac has been off our shelves for a while now. It was actually withdrawn a while back due to our requirement registrations because the company withdrew their products from Namibia but we do have other forms of ranitidine which are just as effective as Zantac," he said.

He explained that contamination of a drug happens when manufacturing plants have lax quality control.

A pharmacist in Windhoek, who declined to provide her name, yesterday confirmed that they received the notice from the NDMA last week about the recall.

The suspension of the drug in Namibia follows a recent international recall from the Food and Drug Administration in the United States, of certain heartburn drugs containing ranitidine due to the possible link to cancer.

The Food and Drug Administration (FDA) is a federal agency of the United States department of health and human services, responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs.

According to the FDA website, results from laboratory tests found NDMA in Zantac and other related generic drugs used to treat ulcers and reflux disease. The administration body said the root of the contamination remains unknown. South Africa, Canada and France are among the countries which have already announced Zantac recalls.

The South African government has advised their citizens to return any heartburn medicine containing the substance ranitidine. All marketing of the brand has been banned in that country.

During an interview with eNCA (a South African television news broadcaster), Mlungisi Wondo from the South African Health Product Regulatory Authority said pharmacies have been told not to release any ranitidine products they have.

"We take the contamination very seriously, hence, we are minimising the availability of the product from the product owners. Even the healthcare professionals will realise that it is not available," he said.

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