-Published: Wednesday, October 9, 2019-

By the A.M. Costa Rica staff

National Children's Hospital continues to use a medication that has come under scrutiny due to adulteration, the Ministry of Health said Tuesday, adding that hospital staffers use the stomach medicine in syrup and not in the pill form that is the subject of an alert.

Marjorie Arias Jiménez, a physician with the ministry said that no other health agency uses the drug, which contains ranitidine as an active ingredient. The ministry has issued a recall because testing has shown a substance called N-Nitrosodimethylamine has been found in some samples of the pills.

"On the detection of N-Nitrosodimethylamine in the analyzes carried out in the medicines that contain the active substance ranitidine and specifically in the presentations in tablets, we make a public statement that none of these products is in the inventory of the pharmacies of the institution," said the physician.

According to Social Security, the drug with ranitidine linked to the recall alert is in the form of 150- and 300-milligram tablets. The substance found in the pills is being investigated for the carcinogenic risk represented by the nitrosamines that are produced during the production of the drug, said the ministry.

As a response of the international alert, countries, such as the U.S. and Panamá have already withdrawn ranitidine in pill form from the market," Social Security said in its statement.

A.M. Costa Rica reported Tuesday the ministry acted on information published by different international regulatory authorities announced the detection of the adulterating substance.

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 ulcers, 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.

The ministry reported that nitrosamines are considered an impurity in some batches of the medication, and these substances 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, citing 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 from 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 alert.

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.

The A.M. Costa Rica staff request readers to share this alert with them contacts.



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Should Children's Hospital authorities avoid use of medicines containing ranitidine?  We would like to know your thoughts on this story. Send your comments to: news@amcostarica.com

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