Safety Alerts & Recalls

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Latest Alerts

Possible Risk of Severe Liver Injury with Dronedarone (Multaq)
The Medicines and Healthcare products Regulatory Agency (MHRA) has notified healthcare professionals about cases of rare, but severe liver injury, including two cases of acute liver failure leading to liver transplant, in patients treated with the heart medication dronedarone (Multaq). As a precaution, patients receiving dronedarone should have their liver function monitored before and during treatment. The product information (SmPC and patient information leaflet) will be updated to include this new safety information. Dronedarone is sold under the brand name Multaq and is used to treat patients who have had or are currently experiencing a problem with their heartbeat. Dronedarone prevents the abnormal heartbeat from coming back and slows down the rate of the heart. For more information, please visit: http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&ssDocName=CON105950
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MHRA Issues Advice On The Effectiveness of the Implanon Contraceptive Implant
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued advice for women and healthcare professionals to support the safer use of the Implanon contraceptive implant. The MHRA have provided the recommendations following recent media coverage regarding this method of contraception. In order to work effectively, Implanon must be correctly implanted under the skin by an appropriately trained health professional. Once implanted under the skin of the inside upper arm, women should be shown how to feel its location. When used correctly Implanon is a safe, effective and reliable form of contraception, which should prevent pregnancy for up to three years. There have been reports of problems with the insertion and removal of the implant. In some women who have had an unintended pregnancy, it was found to have not been inserted at all. A new version of Implanon, called Nexplanon, has recently been introduced to reduce the risks associated with difficulties in the insertion and removal of its predecessor. Nexplanon has an easier to use applicator, and once inserted, it can be located on an X-ray or CT scan. For further information, please visit: http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/Safetywarningsandmessagesformedicines/CON105661
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Date Published Title Medicine Source
2011-01-24 Possible Risk of Severe Liver Injury with Dronedarone (Multaq) Dronedarone MHRA
2011-01-06 MHRA Issues Advice On The Effectiveness of the Implanon Contraceptive Implant Etonogestrel MHRA
2011-01-04 Teva Recalls Several Batches Of Gabapentin 300mg Capsules Gabapentin MHRA
2011-01-04 Warning Issued About Risk Of Skin Cancer In Patients Treated With Voriconazole Voriconazole Manufacturer
2011-01-04 Patient Information Leaflets Not Updated In Several Batches Of Simvastatin Tablets Simvastatin MHRA
2011-01-04 Pharmacy Level Recall of Several Batches Of Pravastatin Tablets MHRA
2010-12-15 Warning Issued About Risk of Osteonecrosis of the Jaw in Patients Treated with Bevacizumab Bevacizumab Manufacturer
2010-12-15 Warning Issued About Risk of Osteonecrosis of the Jaw in Patients Treated with Sunitinib Sunitinib Manufacturer
2010-12-14 Europe-wide Review Shows Insufficient Evidence To Prove Link Between Oral Biphosphonates And Oesophageal Cancer Ibandronic Acid MHRA
2010-12-14 Certain Medicines May Interact With Tamoxifen, Making It Less Effective Against Breast Cancer Tamoxifen MHRA
2010-12-14 Spiriva Respimat - Further Safety Studies Ongoing Tiotropium MHRA
2010-12-14 Patients New to Saquinavir Should Start at a Reduced Dose Saquinavir MHRA
2010-12-14 Fibrate Medicines Should Not be Used as a First-Line Treatment Gemfibrozil MHRA
2010-12-02 Merck Sharp & Dohme Limited Recalls Several Batches of ViraferonPeg 50 micrograms Pre-filled Pen Peginterferon Alfa-2B MHRA
2010-11-29 EBEWE Pharma Issues Voluntary Recall of Fluorouracil Injection Vials Fluorouracil MHRA
2010-11-29 EBEWE Pharma Issues Voluntary Recall of Methotrexate Injection Vials Methotrexate MHRA
2010-11-16 Codeine Cough Medicine: MHRA Limits to Adult Use Only MHRA
2010-11-15 Merck Serono UK Warns About Label Error for GONAL-f Follitropin Alfa MHRA
2010-11-12 HRA Pharma Sets Up Pregnancy Registry for ellaOne Ulipristal Manufacturer
2010-11-12 Dosing for New Ebixa Oral Solution Pump Device May Confuse Some Patients Memantine Manufacturer