The recall of stomach acid blockers of the active substance ranitidine by the manufacturer Saraca Laboratories Limited, unsettled consumers. Because in Germany alone, preparations were prescribed with the drug 748.000 Time medically. Other drug manufacturers are now concerned, therefore, the recall was expanded.
Ranitidine-containing medicines are used in the case of heartburn, for the treatment of a so-called reflux disease, and for prophylaxis of gastric ulcers. Return all batches of medicinal products included by the manufacturer, Saraca Laboratories Limited manufactured active ingredient of ranitidine have been established.
According to information of the Federal Institute for drugs and medical devices (BfArM) would be available but circumstantial evidence that the active ingredient in the case of other manufacturers could be affected by the contamination. Now the recall has been extended to a further manufacturer (Stand: 25. September).
It is a matter of contamination with so-called N-nitroso dimethyl amine (NDMA), better known as Nitrosamines. "In the case of a recording of very small quantities have no harmful effect is erwarten" to;, the Federal Institute wrote. However, the active substance by the International Agency for research on cancer of the WHO and the EU as a " will;.probably krebserregend" classified.
Nitrosamines are also present in food, tobacco and cosmetics
According to the Bavarian state office for health and food safety, nitrosamines are formed in acidic medium by the action of nitro-ionizing substances, such as nitrite or nitrogen oxides. Nitrosamines occur in food, tobacco and cosmetics, but also, for example, through certain foods in the human body.
In animal studies, nitrosamines, led by damage to the DNA, to the formation of tumors. In humans, a causal relationship between cancer and nitrosamines, is to prove, according to the Bavarian state office for health and food safety difficult.
This ranitidine products are not affected (Stand: 25. September 2019):
- Ranitidin-ratiopharm® 150 mg and 300 mg, 20, 50 and 100 film-coated Tablets of all batches with the expiration date to 06/2021
- Ranitidin-ratiopharm® 50 mg/5 ml, 5×5 ml, solution for injection, all batches with the expiration date to 06/2021
- Ranitidine 150 mg and 300 mg, 50 and 100 film-coated Tablets AbZ, all batches with the expiration date to 06/2021
- Ranitidine 75 – 1 A Pharma, 10, and 14 film-coated Tablets of all batches
- Ranitidine 150 and 300 – 1 A Pharma, 20, 50 and 100 film-coated Tablets of all batches
- Ranitic® 75 mg acute in the case of heartburn, 14 film-coated Tablets of all batches
- Ranitic® 150 mg and 300 mg, 20, 50 and 100 film-coated Tablets of all batches
- Ranibeta 300, 50, and 100 film-coated Tablets, batch C700074, C700076, C700078
- Ranitidin Basics 150 mg, 20, 50 and 100 film-coated Tablets, Ranitidin Basics 300 mg, 10, 20, 50 and 100 film-coated Tablets
Millions of people in Germany take ranitidine-containing medicines
So far-containing medicinal products are not available for all of ranitidine concrete insights into whether, and in what concentrations they contained an impurity. The recall of successes, therefore, for reasons of preventive health protection.
The possible hazard potential is currently being assessed at European level, scientifically, informed the BfArM.
More than 748.000 Time in Germany prescribed
In Germany, millions of people stomach acid blockers called proton pump inhibitors. You are either subject to prescription or to be bought by patients without a prescription to the pharmacy.
According to the Scientific Institute of the AOK (WIdO) medicines were prescribed with the drug ranitidine in the past year 748.000 Time. The number refers to medicines that have been prescribed by Physicians on an outpatient basis and delivered through the public pharmacies, the expense of the statutory health insurance.
The BfArM recommends: "Patients who have questions about your current treatment, contact your Doctor or your doctor or your pharmacist or your pharmacist." There are various medicines that can be used in the same indication area as ranitidine would be, as the Alternatives available.
Nitrosamines in medication in the last year, it was Valsartan
Just last year, contaminated blood-pressure-lowering made for eddy. NDMA and similar Compounds as nitrosamines, were found in a number of the blood pressure. Here, too, the blood-pressure-lowering drug with the active ingredient Valsartan, were called back. As a consequence, other medicines worldwide are examined as a precautionary measure by health authorities to nitrosamines, including now also the ranitidine-containing medicines.
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