GlaxoSmithKline is recalling all of its Zantac heartburn medication globally. This recall comes only days after the FDA announced that it had detected unacceptable levels of cancer-causing impurities in Zantac. This recall also affects the generic version of Zantac, ranitidine.
Not All Versions Are Affected
Zantac isn’t just being recalled in the US; GlaxoSmithKline’s recall applies globally. Zantac from every country is being recalled over concerns due to the carcinogen concentration in the drug.
Notably, the over-the-counter 75mg dosage of Zantac isn’t covered by this recall. This is because the OTC version of Zantac is produced by a different company, meaning the N-nitrosodimethylamine (NDMA) that regulators are concerned about isn’t present in it.
Meanwhile, four prescription versions of Zantac are affected by this recall. They includes an injectable version, a syrup version, and two tablets: one in a 150mg dose and another in a 300mg dose. On Monday, doctors were told to immediately stop prescribing the medication over fears that the NDMA impurities were carcinogens.
How did NDMA Get into the Medication?
GlaxoSmithKline is investigating the source of the NDMA impurities in their medications. The suspected carcinogen may have been introduced into the medication due to a change in the manufacturing process.
This same carcinogen was the reason for recent recalls of blood pressure medications. Ranitidine, the generic form of a blood pressure medication covered by a similar recall, is also being investigated.
At present, while patients are urged to not discontinue use of their medicine, they are urged to speak with their doctors about what they should do if they need a refill of their existing prescriptions.
The Official Word on the Recall
A spokesperson for GlaxoSmithKline confirmed the news in an interview with Reuters: “GSK informed the MHRA [Medicines and Healthcare products Regulatory Agency] of our decision to suspend the release, distribution and supply of all dose forms of Zantac products.”
The MHRA warned, “We are advising that patients should not stop taking their medication, and do not need to see their doctor until their next routine appointment but should seek their doctor’s advice if they have any concerns.”