Safety Alerts & Recalls

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Early communication of ongoing safety review
The US FDA has issued an early communication about the ongoing review of new safety data for bisphosphanate medicines such as { drug_name }. The communication was issued by the FDA after it received reports of abnormal heart rhythms that may have been associated with bisphosphanate use. Upon initial review, it is unclear how this data should be interpreted. Therefore, FDA does not believe that healthcare providers or patients should change either their prescribing practices or their use of bisphosphonates at this time. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm070303.htm
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Ciclosporin Must Be Prescribed and Dispensed By Brand Name
In the December 2009 Drug Safety Update, the MHRA advises that Ciclosporin must be prescribed and dispensed by brand name. Ciclosporin is indicated for the prevention and treatment of transplant rejection, psoriasis, atopic dermatitis, rheumatoid arthritis, and nephrotic syndrome. Ciclosporin is a critical-dose drug where dosing is very specific for an individual patient and is based on monitoring blood levels and side effects. The established ciclosporine brands are Neoral and Sandimmun. Recently, a number of new versions of ciclosporin-containing products have been granted marketing licenses in the UK, including the brand Deximune. However, because of the critical-dose nature of the drug, even small differences in how the medicine dissolves, absorbs, and releases in the blood stream could affect ciclosporin blood levels in patients stabilised on a specific brand or formulation. This difference could potentially lead to organ rejection or side effects. Therefore, all prescribing and dispensing of ciclosporin should be by brand name to avoid accidental switching. For more information, please visit: http://www.mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dDocName=CON065445&RevisionSelectionMethod=LatestReleased and http://www.mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dDocName=CON068167&RevisionSelectionMethod=Latest
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Date Published Title Medicine Source
2007-10-01 Early communication of ongoing safety review Pamidronic Acid FDA
2009-12-09 Ciclosporin Must Be Prescribed and Dispensed By Brand Name Ciclosporin MHRA
2009-12-09 Reports of Male Breast Cancer With Finasteride (Proscar/Propecia) Finasteride MediGuard CRT
2009-12-09 Warning About Serious Skin Reactions with Use of Intelence Etravirine MHRA
2009-12-09 Serious infections Reported with Use of MabThera in Patients with Rheumatoid Arthritis Rituximab MHRA
2009-12-11 Recall on Several Heartburn Products Gaviscon Advance MHRA
2009-12-11 Recall on Several Heartburn Products Peptac MHRA
2009-12-11 Recall on Several Heartburn Products Cimetidine MHRA
2009-12-16 Recall of Several Batches of Dentinox Cetylpyridium and Lidocaine MHRA
2010-01-21 EMA Ends Marketing Authorisation For Sibutramine (Marketed as Reductil) Sibutramine MHRA
2010-01-29 Recall of Several Batches of IntronA Interferon Alfa 2B MHRA
2010-01-29 EMEA Recommends Additional Measures to Better Manage Risk of Progressive Multifocal Leukoencephalopathy (PML) with Tysabri Natalizumab MHRA
2010-02-15 Possible Contamination of FABRAZYME Agalsidase Beta Manufacturer
2010-02-15 Possible Contamination of CEREZYME Imiglucerase Manufacturer
2010-02-15 Possible Contamination of THYROGEN Thyrotropin Alfa Manufacturer
2010-02-15 Warning About Serious Skin Reactions with Use of PHENYTOIN in Asians Phenytoin MHRA
2010-02-15 MHRA Review of METHYLPHENIDATE and Risk of Genetic Damage and Update to Patient Information Leaflet Methylphenidate MHRA
2010-02-17 Statin Benefits Still Outweigh New Safety Information Simvastatin MediGuard CRT
2010-03-04 Winthrop Recalls Single Batch of Alimemazine Tartrate 7.5 mg/5 ml Syrup in 100 mL bottles Alimemazine MHRA
2010-03-05 MHRA Sends Safety Message About Avandia and Avandamet Rosiglitazone MHRA