GSK pulls the plug on Zantac—no more heartburn relief in the UK yet
On Tuesday, GlaxoSmithKline (GSK) announced a full recall of its Zantac products across the United Kingdom. The move comes just days after the U.S. Food and Drug Administration (FDA) flagged “unacceptable” levels of a cancer‑causing impurity in the drug.
What’s the fuss about?
NDMA: The chemical culprit
- NDMA, short for N‑nitrosodimethylamine, is a suspect chemical that has been popping up in various meds.
- In Zantac, the impurity levels were found to be alarmingly high when tested under higher‑temperature conditions.
- Similar concerns have surfaced in certain blood‑pressure medications (the ARBs), prompting wider regulatory scrutiny.
GSK’s recall details
- The company is pulling four prescription‑only Zantac variants:
- Syrup
- Injection
- Tablets (150 mg and 300 mg)
- Over‑the‑counter 75 mg Zantac sold by a different manufacturer is not affected.
- GSK has halted the release, distribution, and supply of all Zantac dosage forms.
“We are continuing with investigations into the potential source of the NDMA (chemical),” an official told Reuters. “We’re working closely with our suppliers and external labs to run tests on finished product batches.”
What the MHRA told healthcare professionals
- “Stop supplying the products immediately.”
- “Quarantine all remaining stock and return it to the supplier.”
- Patients are advised not to cease their medication abruptly. They should keep taking it until their next routine appointment, but consult a doctor if they have any concerns.
Global fallout
Across continents, regulators are tightening the reins on ranitidine (the generic name for Zantac). Here’s the international rundown:
- U.S. & Europe: First looking into the safety of ranitidine after Valisure highlighted impurities.
- FDA findings: A low‑heat test revealed much lower NDMA levels than the high‑temperature test used by Valisure.
- Swiss drugmaker Novartis: halted worldwide distribution of its ranitidine drugs last month.
- Retail giants: Walmart, CVS Health, Walgreens Boots Alliance, and Rite Aid suspended over‑the‑counter sales of ranitidine‑based heartburn meds.
- Canada: Health authorities have told manufacturers to halt distribution while awaiting more data.
- Hong Kong & Ireland: Hong Kong pulled four products; Ireland recalled 13 ranitidine products.
In plain English: the culprit likely slipped in during changes to the manufacturing process. Now, drugmakers, regulators, and retail chains worldwide are tightening controls and urging consumers to stay vigilant.
