Things have quickly gone from bad to worse for GlaxoSmithKline and its popular heartburn medication Zantac. And it all began thanks to the care and caution of an online pharmacy; not a government regulator.
The pharmacy, Valisure, tests all the medications it makes available to its customers itself. And it was that testing; not that of the FDA or any other government entity tasked with keeping its citizens safe, that detected the contamination with the dangerous carcinogen. In fact, when initially asked about the contamination, the FDA refused to comment and only indicated that they were taking a ‘wait-and-see’ approach. “Our testing of ranitidine (Zantac’s pharmaceutical name) is ongoing,” the agency said, “and we will take appropriate measures based on the results of the investigation.”
Those measures wouldn’t arrive until weeks later when the agency reported that it had found “unacceptable levels” of a compound known as NDMA, or N-nitrosodimethylamine, in both the name brand and generic compounds used in the drug’s manufacture.
This isn’t the first time NDMA contamination has been discovered in the global pharmaceutical supply. Shipments of several types of valsartan-based heart medications had to be recalled last year after NDMA and other contaminants were discovered in the compounds used to make the drugs. Those compounds originated in China and were manufactured by Zhejiang Huahai Pharmaceuticals. The discovery and subsequent recall led to a torrent of lawsuits and calls for consolidation into a multidistrict litigation.
The contamination affecting Zantac shipments appears to have originated out of two pharmaceutical suppliers in India. Dr. Reddy’s Laboratories and Saraca Laboratories Ltd. have been named by GSK as the source of the most recent contamination.
For a recall that is global in scale, the impact to GSK and Zantac’s generic manufacturers has been minimal at best, with stock prices falling less than a percentage point in most European markets once news of the recall hit.
