The U.S. Food and Drug Administration has alerted patients and health care professionals about a voluntary recall of 14 lots of Ranitidine capsules supplied by Sandoz Inc. Ranitidine capsules are in use for decreasing the amount of acid made by the stomach cells. And the presence of nitrosamine in these 14 lots of medicine was the reason for this recall.
Presence of nitrosamine in Ranitidine capsules
N-nitrosodimethylamine (NDMA), found in ranitidine capsules, is a substance that has the potential to cause cancer. So, categorized as a possible human carcinogen. Acting FDA Commissioner Ned Sharpless, M.D. said that the FDA has committed to ensuring the provision of safe and effective medicines to Americans.
So, they started testing ranitidine capsules soon after they learned of the possible impurity. FDA identifies lapses in the drug quality that can place patients at risk. And makes all possible efforts to understand the problem. Besides these, the FDA also gives the best recommendations to the people as quickly and precisely as possible.
The acting FDA commissioner has also said that they will continue to inspect and work to make sure that such types of impurities do not surpass acceptable limits. So that the patients may continue using the needed medicines without any concern.
Ranitidine is an OTC (over-the-counter) drug. It is a histamine-2 blocker that can lower the amount of acid made by the stomach. OTC ranitidine is an approved prescription drug. That prevents and relieves heartburn related to sour stomach and acid ingestion.
Ranitidine capsule has got approval for prescription in case of multiple indications. That may include the prevention and treatment of ulcers in the stomach and intestines and the treatment of GERD – gastroesophageal reflux disease.
Appropriate measures being taken by the FDA
FDA has provided the following guidelines for the health care professionals and patients on the recall of Sandoz Ranitidine capsules:
- If a patient is using one of the recalled drugs, he should follow the recall instructions given by the company. This information is accessible from the FDA’s website.
- While the FDA is examining the route cause and risk, patients and consumers can continue taking ranitidine that isn’t recalled.
- Patients who are using prescribed ranitidine and wish to discontinue its use should talk to their health care providers about any alternative treatment option.
- The consumers using OTC ranitidine can consider taking other OTC products according to their condition.
Moreover, Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research has also given a statement regarding this issue. He said that the FDA will continue its investigation and keep the public informed of any potential risks related to ranitidine products.
The agency is examining ranitidine products from multiple manufacturers. And analyzing their potential effect on patients taking this medicine. As part of its investigation, the FDA has posted a testing procedure, that can help industry and regulators to detect NDMA impurities in ranitidine.
The agency has also asked companies to start examining the NDMA levels in ranitidine in their own laboratories and to send ranitidine samples to the FDA for further testing by agency scientists. While the appropriate measures will be taken by the FDA and manufacturers based on the investigation results.
The FDA has also encouraged health care professionals and patients to report any adverse effects to the agency’s MedWatch program. This agency protects public health by ensuring the safety, and effectiveness of drugs, vaccines, and biological products for human use.