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Medications for heartburn are recalled because of the carcinogenic substance
A few days ago it became known that certain gastric acid blockers in the EU were recalled because they showed traces of a substance that is classified as likely to cause cancer in humans. The callback has now been expanded.
The Federal Institute for Drugs and Medical Devices (BfArM) recently announced that there is a recall in the European Union of medicinal products containing the active substance ranitidine manufactured by the active substance manufacturer Saraca Laboratories Limited. Small amounts / traces of the nitrosamine N-nitrosodimethylamine (NDMA) have been detected in these drugs. "This substance is classified by the international cancer research agency of the WHO and the EU as likely to be carcinogenic in humans," write the experts. The callback has now been expanded.
Medicines to control stomach acid production in heartburn
Ranitidine medicines are used to control gastric acid production in heartburn, to treat reflux disease and to prevent gastric ulcers. These drugs are available both over-the-counter and prescription-only.
When the BfArM informed about the recall last week, it pointed out that concrete information is not yet available for all ranitidine-containing medicinal products as to whether and in what concentrations the contamination is contained. Therefore, all batches with active ingredient from the manufacturer Saraca Laboratories Limited are recalled for reasons of preventive health protection until the matter is clarified.
But the experts also said: "There is evidence that the active ingredient of other active ingredient manufacturers could also be affected by the contamination." And in fact, another company, Basics GmbH, is now calling back ranitidine preparations.
No acute patient risk
On the website of the ABDA - Federal Association of German Pharmacist Associations e. V., the Pharmaceutical Commission of the German Pharmacists (AMK) summarizes the published batch recalls and recalls for ranitine-containing medicinal products, which were published due to contamination with N-nitrosodimethylamine (NDMA):
- September 17, 2019
Ranibeta 300, 50 and 100 film-coated tablets
- Ranitic® 75 mg acute for heartburn, 14 film-coated tablets, Ranitic® 150 mg and 300 mg, 20, 50 and 100 film-coated tablets
- Ranitidine 75 - 1 A Pharma, 10 and 14 film-coated tablets, Ranitidine 150 and 300 - 1 A Pharma, 20, 50 and 100 film-coated tablets
- Ranitidine AbZ 150 mg and 300 mg, 50 and 100 film-coated tablets
- Ranitidine-ratiopharm® 150 mg and 300 mg, 20, 50 and 100 film-coated tablets, ranitidine-ratiopharm® 50 mg / 5 ml, 5 × 5 ml solution for injection
- Ranidura® T 150 mg and 300 mg, 20, 50 and 100 film-coated tablets
September 25, 2019
Ranitidine Basics 150 mg, 20, 50 and 100 film-coated tablets, Ranitidine Basics 300 mg, 10, 20, 50 and 100 film-coated tablets
According to the company Basics GmbH, "there is currently no acute patient risk due to the contamination found". The BfArM also points out that there is no acute patient risk. “Patients who have questions about their current treatment can contact their doctor or pharmacist. There are various medicinal products available as alternatives that can be used in the same indication area as ranitidine, ”writes the Federal Institute. (ad)
Author and source information
This text corresponds to the requirements of the medical literature, medical guidelines and current studies and has been checked by medical doctors.