these are just notes, sorry!
recall affects brand only, prescription only, zantac preparations (i.e. The four products affected are Zantac 150mg/10ml Syrup, Zantac 50mg/2ml Injection, Zantac 150mg Tablets and Zantac 300mg Tablets) and not the over the counter version of zantac or other generics of raniditine.
Issues with this contaminant since summer 2018 – issues with several blood pressure drugs – like valsatran, amlodipine
MHRA said not a problem with the drug per se but a contaminant, NDMA, introduced during the manufacturing process
however, NDMA nitroso dimethyl amine is a known environmental contaminant , found in water, dairy, meats, etc also
eg solvent used during manufacturer – as here
https://www.healthline.com/health-news/blood-pressure-meds-recalled-heres-what-to-know#5
FDA statement end August 2018
had made an estimate that 8000 people taking highest possible exposure to NDMA for 4 years -one extra case of cancer during their lifetimes – revised this subsequently and decided much lower risk since worst case scenario be very hard to achieve
they said: Due to their known potent carcinogenic effects, and because it is feasible to limit these impurities by taking reasonable steps to prevent or eliminate their presence, FDA has determined that there is no acceptable specification for nitrosamines in ARB API and DP. Therefore, FDA advises that nitrosamines should be absent
https://www.fda.gov/media/122643/download
In manufacturing processes, recovered solvents and catalysts – may not be removed adequately
One issue is that manufacture process may be known not to produce nitrosamines but receive raw material already contaminated with it – so not tested, thus FDA recommended
- more testing of each batch
- testing of already distributed batches
MHRA in UK – say the risk of discontinuing the medicine is higher than the potential risk presented by the contaminant. A treatment review is not necessary until the next routine appointment. The MHRA has issued an alert to healthcare professionals, as GlaxoSmithKline is recalling all unexpired stock of four types of Zantac, the medicine used to treat conditions such as heartburn and stomach ulcers.
The MHRA also say: “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.” I think this would be hard to know however
Note: some generic forms of ranitidine are available as prescription medicines from some chemists;
and the zantac or over the counter generic ranitidine in 75mg doses should still be available and can be prescribed /used.
also note
-Valisure has suggested that this may be an old problem only just recognised, and that ranitidine inherently can contain NDMA ranitidine-tablets-heartburn-sales-suspended-recall-638697 ; however the MHRA “ cannot confirm any reports that this is a historical issue, we are working with all potentially affected manufacturers to obtain more information.”
The MHRA also say they have had independent testing – via the Official Medicines Control Laboratory Network (part of MHRA), also testing by FDA and EMA, German and Swiss authorities – these are the only products that pharmacists are currently being told to recall – they say that their investigation is continuing and they are considering doing further testing themselves.
https://inews.co.uk/news/health/zantac-cancer-risk-ranitidine-tablets-heartburn-sales-suspended-recall-638697inside health
European medicines association – asked manufacturers to take specific steps to analyse and report on their projects
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