Safety Alerts & Recalls

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Latest Alerts

Healthcare Professionals Advised of Link with Xeloda to Rare but Sometimes Fatal Skin Reactions
Roche Products has written to healthcare professionals to advise them that very rare cases (less than one in 10,000) of severe skin reactions such as Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), which have proved fatal in some cases, have been reported during treatment with Xeloda (capecitabine). Treatment should be stopped immediately if such a skin reaction occurs. Patients should be told to seek urgent medical advice if any of the symptoms of severe skin reactions occur. Xeloda contains the medication capecitabine and is used in the treatment of cancer of the stomach, colon, rectum and breast. For more information please visit: http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON364168 and http://www.mhra.gov.uk/home/groups/pl-p/documents/drugsafetymessage/con364180.pdf
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Healthcare Professional Advised of Link with Temodal to Liver Damage Including Fatal Liver Failure
Merck Sharp & Dohme has written to healthcare professionals to advise them that cases of liver damage, including fatal liver failure, have been reported in patients receiving Temodal (temozolomide). Liver damage may occur several weeks after treatment with Temodal has begun, or after treatment has stopped. Healthcare professionals are therefore advised to perform liver function tests before starting treatment with Temodal and after each cycle of treatment. Temodal contains the medication temozolomide and is used to treat brain cancer. For more information please visit: http://www.mhra.gov.uk/home/groups/pl-p/documents/drugsafetymessage/con364179.pdf and http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON364167
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Date Published Title Medicine Source
2014-01-31 Healthcare Professionals Advised of Link with Xeloda to Rare but Sometimes Fatal Skin Reactions Capecitabine Manufacturer
2014-01-31 Healthcare Professional Advised of Link with Temodal to Liver Damage Including Fatal Liver Failure Temozolomide Manufacturer
2014-01-31 Healthcare Professionals Advised of Link with Iclusig to Increased Risk of Stroke, Heart Attack and Blood Clots Manufacturer
2014-01-08 Caution Advised Over Dose Error in the Patient Information Leaflet for Teva’s Irbesartan/hydrochlorothiazide Tablets Hydrochlorothiazide with Irbesartan MHRA
2014-01-06 Roche Advises Healthcare Professionals Not to Prescribe Lariam for Malaria Prevention to Patients with Active or Historical Psychiatric Disturbance Mefloquine Manufacturer
2014-01-06 Healthcare Professionals Advised of Risk of Intraoperative Floppy Iris Syndrome During Cataract Surgery in Patients Taking Risperidone or Paliperidone Risperidone Manufacturer
2014-01-06 Servier Updates Advice to Healthcare Professionals About Risk of Liver Damage with Valdoxan Agomelatine Manufacturer
2014-01-06 MHRA Advises Against Use of Sodium Valproate in Pregnancy Valproic Acid MHRA
2014-01-06 Guidance for Healthcare Professionals Issued on Switching Between Brands of Antiepileptic Drugs Phenytoin MHRA
2014-01-06 ALK-Abelló Recalls Jext Injections Over Potentially Faulty Auto Injectors Primatene MHRA
2014-01-06 Healthcare Professionals Advised About Risk of Haemophagocytic Syndrome with Gilenya Treatment Fingolimod Manufacturer
2014-01-06 Healthcare Professionals Advised to Screen Patients for Hepatitis B Before Starting Treatment with MabThera Rituximab Manufacturer
2014-01-06 Healthcare Professionals Advised of the Discontinuation of Nizoral 200mg Tablets Ketoconazole Manufacturer
2014-01-06 MHRA Advises Healthcare Professionals of Labelling Error on Matrifen 100mcg/hr Patches Fentanyl MHRA
2013-12-24 Accord Healthcare Recalls a Single Batch of Irbesartan 300mg Tablets Due to Incorrect Strength Labelling Irbesartan MHRA
2013-12-17 Novartis Recalls Selected Batches of Tixylix Over Potentially Faulty Tamper Seals Glycerol MHRA
2013-11-01 GlaxoSmithKline Recalls Five Batches of Imigran Injections Over Defective Needles Sumatriptan MHRA
2013-10-31 Novo Nordisk Recalls Multiple Batches of NovoMix 30 Penfill and NovoMix 30 Flexpen Over Incorrectly Filled Cartridges Insulin Aspart and Insulin Aspart Protamine MHRA
2013-10-25 Wockhardt Recalls Several Generic Medicines After Manufacturing Sites Closed Ursodeoxycholic Acid MHRA
2013-10-11 Healthcare Professionals Advised About Pregnancy Prevention Measures for Imnovid MHRA