Pharmacovigilance

On 15 October, the Committee of the European Directorate for quality of medical products (EDQM) decided to suspend the certificate of suitability R1-CEP 2009-267-Rev 01 for the pharmaceutical substance "Erythromycin" and the certificate of suitability R0-CEP 2013-342-Rev 02 for the pharmaceutical substance "Bisoprolol fumarate" produced by "Meta Eypiay HTP".Ltd.", India ("Mehta API Pvt.Ltd."; Gut No.546,571,519 & 520, Kumbhavali Village Tarapur, District Palghar India-Boisar 401 506, Maharashtra). The decision was made on the basis of the results of the inspection of the specified production site.

On the basis of this information, Roszdravnadzor asks manufacturers that produce drugs using the above pharmaceutical substances, and organizations-importers of drugs produced with their use, to provide information on the decisions taken with respect to these substances and drugs produced from them by 29.11.2019.

The recall of prescription drugs ranitidine from the market continues. GSK's zantac (ranitidine) drug ("GlaxoSmithKline"), used for heartburn and stomach ulcers, was withdrawn from the US market in October this year after the FDA found it to contain an "unacceptable" carcinogen due to possible contamination with N-nitrosodimethylamine (NDMA). NDMA is classified as a "probable human carcinogen" by laboratory tests. The recall also affected ranitidine, an oral solution, 30 mg / ml, produced by Creo Pharma Limited, and ranitidine, a tablet, 150 mg, produced by Tillomed Laboratories.

The FDA demanded the immediate termination of the supply of these drugs, placing the remaining stocks in quarantine and their immediate return to the supplier. However, patients were advised to continue taking the prescribed drugs ranitidine until the next scheduled visit to the doctor without changing the treatment regimen.

The MHRA has required risk assessments from relevant companies, including testing of potentially contaminated batches of drugs.

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