By the A.M. Costa Rica staff

The Ministry of Health in a follow-up to alerts and informative notes published by different international regulatory authorities, announced the detection of the substance nitrosodimethylamine in the analyzes carried out in several batches of the medicines containing the active substance known as ranitidine.

Ranitidine, sold under the trade name Zantac among others, is a medication that decreases stomach acid production. It is commonly used in the treatment of peptic ulcer disease, gastroesophageal reflux disease, and Zollinger–Ellison syndrome. There is also tentative evidence of benefit for hives. It can be taken by mouth or by injection into a muscle or into a vein.

"Ranitidine is a medication used to reduce the production of acid in the stomach in situations such as a gastric ulcer or gastroesophageal reflux," said the ministry in its statement.

With respect to nitrosamines, the ministry reports these substances, considered an impurity in some batches of the medication, are classified as a probable carcinogen based on animal studies, which means that long-term exposure above certain levels may increase the risk of cancer.

The substance is present in some foods and in some water sources, but it is not expected to cause any harm when ingested in very small quantities, the ministry said in its statement.

According to the ministry, with the available data there is no evidence that the presence of this substance has been able to cause damage to patients who have consumed the drug. However, the potential risk derived from the cumulative effect, makes it necessary for regulatory authorities to health take different precautionary measures to avoid their presence in medications, it said.

Given this information, the ministry decided, as a preventive measure, to recall of the market all registered medications containing oral ranitidine.

Once the analyzes concerning the presence of impurities are carried out, the authorities will determine whether or not to remove this measure.

The representatives of the laboratories manufacturers of products that contain that substance will be carrying out the removal of the lots distributed in the national territory, therefore, pharmacies should keep the product in quarantine and coordinate with the distributors their respective return, said the ministry.

The authorities make the following recommendations to the public:

- Do not start treatments with medicine containing ranitidine.

- Pharmacies are prohibited from selling these medicines.

- Anyone using any of the medications that contain ranitidine should contact a doctor for another suitable medication.

- It is not recommended to stop treatment without consulting a doctor.

- Any suspicion that medications with that substance are sold should be reported to the ministry by phone, (506) 2223-0333

According to the ministry, the review of the drugs containing ranitidine is still ongoing, therefore, it will keep on constant search and review of new findings that allow updating information on this substance.




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