GSK (GlaxoSmithKline) is recalling Zantac, the famous heartburn medicine from all markets. The withdrawal action arrives a few days after the US FDA has discovered improper levels of a carcinogen in the medication. Zantac, commonly available at stores as ranitidine, is a medicine to relieve and prevent heartburn linked with sour stomach and acidity. From 2018, regulators have had recalled some drugs of heart failure and blood pressure. Zantac is the new medicine in which the Food and Drug Administration has discovered impurities, which may lead to cancer.
According to the reports of a UK’s medicine watchdog, the recall includes four Zantac prescription-only medicines, i.e., an injection, a syrup, and pills of dosages 300mg and 150mg. Reportedly, GSK has recalled all those products citing probable contamination of NDMA (N-nitrosodimethylamine), a carcinogenic element. Notably, Zantac’s 75 mg dosage products available over the counter come from a different manufacturer; thus are safe to use.
According to a GSK representative, the company has notified the Medicines and Healthcare Products Regulatory Agency (MHRA) about its decision to halt the delivery, supply, and disposal of all doses from Zantac products. The executive noted GSK is seeking for the probable origin of the NDMA. The spokesperson also said the contamination was thought to be a result of changes in the production process. Whereas, MHRA said it had ordered healthcare professionals to cease supplying the products urgently. Besides, the agency has asked them to remove all the leftover medicines and return it to their supplier.
The healthcare agency has also issued an alert. On the other hand, it has suggested patients to continue taking the medicines until their doctor recommends. Dr. Andrew Gray, an MHRA official, said though it is a precautionary measure, patient safety is a serious concern for them. He noted, currently, there is no proof revealing the existence of nitrosamines that have harmed patients. Still, MHRA is closely supervising the situation and functioning with other federal agencies across the globe.