Another safety communication could be ahead for proton pump inhibitors in the US following a UK warning that the active ingredients in the drugs available Rx and OTC are associated with rare cases of a non-scarring dermatosis that can develop on skin exposed to the sun.
UK Notes PPI Dermatosis Risk: Will FDA Make Similar Communication?
The UK drug regulator announces “a very low risk” of sub-acute cutaneous lupus erythematosus from use of PPIs, which are available there with the same ingredients approved for use in the US in products available OTC and RX – esomeprazole, lansoprazole and omeprazole – and Rx only, pantoprazole and rabeprazole.
More from United Kingdom
Non-Submissions To UK HTA Body Could Increase Unless Commercial Environment Improves, Warns Industry
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Finding ways to lower the rebates paid by the pharmaceutical industry to the UK government and fostering partnerships to make the UK a more attractive launch market could help reduce the number of terminated technology appraisals conducted by NICE, the health technology appraisal institute, says the UK pharmaceutical industry.
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Blood cancer therapies were most proportionately impacted by the failure of pharmaceutical companies to submit evidence on their cancer therapies to England’s health technology appraisal body, shows analysis by the Pink Sheet.
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The policy expectation that the model clinical trial agreements are used without modification is in line requests from industry and the NHS/HSC.
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Efforts by the medicines regulator, the MHRA, to clear all backlogs relating to its statutory functions and maintaining predictable review timeframes have put pressure on its staff.
More from Europe
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Blood cancer therapies were most proportionately impacted by the failure of pharmaceutical companies to submit evidence on their cancer therapies to England’s health technology appraisal body, shows analysis by the Pink Sheet.
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The policy expectation that the model clinical trial agreements are used without modification is in line requests from industry and the NHS/HSC.
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Plozasiran, Arrowhead Pharmaceuticals' treatment for familial chylomicronemia syndrome, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.