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(Alliance News) - The UK's Medicines & Healthcare Products Regulatory Agency issued an alert to healthcare professionals on Tuesday as GlaxoSmithKline PLC recalled all unexpired stock for four types Zantac.
Zantac is used to treat heartburn and stomach ulcers. The four recalled products are "Zantac 150mg/10ml Syrup, Zantac 50mg/2ml Injection, Zantac 150mg Tablets and Zantac 300mg Tablets." All of these are prescription-only.
The over-the-counter Zantac products, Zantac 75 Relief and Zantac 75 Tablets are not affected by the recall because they are made by a different company.
The recall was described by the agency as "a precautionary measure" resulting from "possible contamination" of Zantac's active substance, ranitidine, with NDMA. NDMA or N-nitrosodimethylamine "has been identified as a risk factor in the development of certain cancers".
The MHRA did not advise patients to stop taking their medication or to see a doctor before their next routine appointment, though they "should seek their doctor's advice if they have any concerns".
Healthcare professionals, however, are to stop supplying the recalled products immediately and quarantine any remaining stock before returning it to the supplier.
The MHRA is looking into other medicines containing ranitidine which might also be contaminates. Further updates on the investigation will be published by the agency. The MHRA has requested that manufacturers quarantine all ranitidine products that might "contain the active pharmaceutical ingredient that is potentially affected by this issue".
Andrew Gray, MHRA deputy director of Inspections, Enforcement & Standards, said: "We have asked companies to quarantine batches of potentially affected medicines whilst we investigate and we will take action as necessary, including product recalls where appropriate.
"We have also requested risk assessments from the relevant companies which will include the testing of potentially affected batches.
"Currently, there is no evidence that medicines containing nitrosamines have caused any harm to patients, but the agency is closely monitoring the situation, and working with other regulatory agencies around world."
Shares in Glaxo were broadly flat at 1,716.10 pence in London on Tuesday afternoon shortly before market close.
Also on Tuesday, the drug maker announced the launch of a five-year collaboration with San-Francisco-based biotech firm Lyell Immunopharma. The goal of the collaboration will be "to develop new technologies to improve cell therapies for cancer patients".
Lyell's technologies will be used to strengthen the Glaxo cell therapy pipeline including drug candidate GSK3377794, which targets an antigen expressed by "multiple cancer types".
Thus far, two cell therapies have obtained approval for blood-borne cancers but engineering immune cells called T cells as a treatment has so far failed to produce "strong clinical activity in common solid tumours".
Lyell is currently working on "several approaches" to improve T cell function and fitness with the goal of delaying T cell exhaustion to make these therapies more effective. This is a focus of the Glaxo-Lyell collaboration.
Hal Barron, chief scientific officer & president of Research & Development at Glaxo, said: "We are witnessing significant scientific innovation in cell and gene therapies, transforming the treatment of some blood-borne cancers, but patients with solid tumours are in need of equally effective treatments. Applying Lyell's novel approach to counter T cell exhaustion and working with world class scientists, such as Rick Klausner and his impressive team, increases our probability of delivering the next generation of cancer cell therapies for patients with solid tumours."
By Anna Farley; annafarley@alliancenews.com
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