US Food and Drug Administration (FDA) has recently reported Zantac, a commonly used drug for heartburn by GlaxoSmithKline (GSK), to be contaminated with unacceptable levels of an impurity that may be linked with causing cancer.
Unacceptable Levels Of NDMA Found In Zantac
Following the report, GSK has announced a global recall of the medicine. Generically called Ranitidine, the recall affects four of the prescription-only variants of Zantac including 150 and 300 mg tablets, an injection, and a syrup. It was further highlighted that the production for 75 mg dosage is under another company which is why the 75 mg drug will not be recalled. The other four dosages are being further investigated for an impurity called N-nitrosodimethylamine (NDMA) that supposedly has the potential to cause cancer.
According to the GSK officials, the incidence might have happened due to a change that was recently introduced to the manufacturing process. The company has pledged to perform an in-depth investigation while Medicines and Healthcare Products Regulatory Agency (MHRA) has notified the healthcare professionals across the world to immediately stop recommending or supplying the drug and quarantine whatever is left of it in the stock. The leftover stock is to be returned to the suppliers as soon as possible.
NDMA Impurity Was Reported By Valisure
While the patients have not been recommended to halt the drug consumption by MHRA, they are advised to consult with their doctors in case of any concern or query. The impurities were first pointed out by Valisure, a Connecticut based online pharmacy, after which the healthcare regulating bodies from Europe and the United States of America have been working diligently to evaluate Ranitidine safety.
Valisure utilized a higher-temperature method for testing the drug that reported NDMA impurity at an unacceptably high level, as per the FDA report. NDMA impurities were recently found in ARBs (angiotensin II receptor blockers) as well. ARB is a class of drugs that are commonly used for hypertension.
FDA has directed GSK to be meticulous in performing assessment tests to quantify the levels of impurity in its products. GSK has further been advised to send the samples to the FDA for further investigation to proceed.
The list of prominent pharmacy chains that have complied with halting ranitidine distribution includes Novartis, CVS Health Corp, Rite Aid Corp, Walmart, and Walgreens Boots Alliance Inc. Countries like Hong Kong, Ireland, and Canada have also directed the manufacturers to cease distribution until further information is collected regarding the incidence.
The share prices for GSK have, however, not responded to the news so far. The GSK stock opened at 1,703.60 on Wednesday, October 9th, 2019, and is currently trading at 1,726.20 level.