Safety Alerts & Recalls

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Latest Alerts

Recall on Several Heartburn Products
In the December 2009 Drug Safety Update, the MHRA announced the following batches of medicine are being recalled from the market because of low levels of contamination by bacteria: Gaviscon Advance Peppermint Flavour - Batch numbers 924471 and 925071 Boots Heartburn Relief Peppermint Flavour - Batch number 41808 Peptac Peppermint Liquid - Batch numbers 41808 and 41957 Peptac Liquid Aniseed Flavour - Batch number 41757 For more information, please visit: http://www.mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dDocName=CON065445&RevisionSelectionMethod=LatestReleased
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Serious infections Reported with Use of MabThera in Patients with Rheumatoid Arthritis
In the December 2009 Drug Safety Update, the MHRA reported about a third case of progressive multifocal leukoencephalopathy (PML) in a patient with rheumatoid arthritis treated with rituximab (MabThera). PML is a rare but life threatening disease of the brain and nervous system. This is the first case of PML in a patient with rheumatoid arthritis treated with rituximab who has not previously received treatment with a Tumor Necrosis Factor (TNF) antagonist, a class of medications used to treat rheumatoid arthritis. Cases of PML have also been reported in patients with other autoimmune diseases treated with rituximab. The MHRA is reminding health care professionals that rituximab is not indicated for first-line treatment of rheumatoid arthritis. Rituximab is marketed under the brand name MabThera. Rituximab in combination with methotrexate is indicated for the treatment of adults with severe active rheumatoid arthritis who have failed to respond to other therapies. Rituximab is also indicated for treatment of non-Hodgkin's lymphoma and chronic lymphocytic leukaemia in combination with chemotherapy. For more information, please visit: http://www.mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dDocName=CON065445&RevisionSelectionMethod=LatestReleased
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