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Pharmacies pull heartburn meds over contamination concerns

European and US authorities are investigating potential issues with ranitidine.

Farmaseutti pitelee Zantac-lääkepakkausta.
Zantac, among other medicines, is being withdrawn from pharmacies. Image: AOP

The Finnish Medicines Agency (Fimea) said on Wednesday that drugs containing ranitidine will be withdrawn from pharmacies. Ranitidine is a medication used to treat and prevent symptoms of acidity such as heartburn and stomach ulcers. European and US authorities are currently investigating problems with the drug.

Fimea said that there are no acute risks to patients who are taking ranitidine and urged them to continue using it. Those who want to switch to a different medicine may do so after consulting their doctor.

In Finland, the banned substance is found in brand-name medicines such as Inside, Inside Brus, Ranisan, Ranitidin Mylan, Ranixal and Zantac.

Authorities are investigating the presence of an impurity, N-nitrosodimethylamine (NDMA), which has been found to increase the risk of cancer in animals. NDMA is also found in certain food and water. According to Fimea, very small concentrations of the contaminant are probably not harmful to humans. However, the impurity limit guidelines for medicines are very strict.

The European Commission, the European Medicines Agency (EMA) and national medical authorities are currently investigating the levels of NDMA in medicines and its potential effects on patients. Fimea said that it will continue collaborating with other European medical authorities to look into the issue.

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