Safety Alerts & Recalls

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Latest Alerts

Pioglitazone (Actos, Competact) Combined With Insulin Linked To Increased Risk of Heart Failure
The Medicines and Healthcare Products Regulatory Agency (MHRA) has notified healthcare professionals regarding an increased risk of heart failure among patients treated with a combination of pioglitazone (Actos, Competact) and insulin. The risk is greatest among patients with existing risk factors for the development of heart failure, such as raised blood pressure, previous heart attack, or disease of the blood vessels supplying the heart. Pioglitazone is used in the treatment of type 2 diabetes and works by increasing the body’s sensitivity to insulin. It can be used alone (brand name Actos) or in combination with metformin (brand name Competact) and/or a sulphonylurea, or in combination with insulin. Product information for pioglitazone already contains warnings about its use in combination with insulin. Warnings are being added to the product information for all insulin products. For further information please visit:
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Update on the Risk Of Progressive Multifocal Leukoencephalopathy With Tysabri
The Medicines and Healthcare Products Regulatory Agency (MHRA) has published a safety update regarding the letter sent to healthcare professionals from the manufacturer of natalizumab (Tysabri), Biogen Idec. Specifically, the MHRA names the drugs linked to an increased risk of developing progressive multifocal leukoencephalopathy (PML) in patients taking Tysabri. Patients are at increased risk of developing PML if they have been treated in the past with a drug that suppresses their immune system. These drugs include azathioprine, cyclophosphamide, mitoxantrone and methotrexate. The risk of developing PML increases with the length of treatment with Tysabri, particularly when it is beyond two years. For more information please visit: To view the MediGuard Alert about the Tysabri manufacturer’s letter sent to healthcare professionals, please visit:
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Date Published Title Medicine Source
2011-03-11 Pioglitazone (Actos, Competact) Combined With Insulin Linked To Increased Risk of Heart Failure Pioglitazone and Metformin MHRA
2011-03-11 Update on the Risk Of Progressive Multifocal Leukoencephalopathy With Tysabri Natalizumab MHRA
2011-03-11 Further Restrictions and Cautions Announced For Modafinil (Provigil) Modafinil MHRA
2011-03-11 No Indication of an Increased Risk of Febrile Convulsions In Children Associated with Seasonal Flu Vaccines Influenza Vaccine MHRA
2011-03-11 Moxifloxacin (Avelox) Only To Be Used In Pelvic Inflammatory Disease When Other Antibiotics Unsuitable Moxifloxacin MHRA
2011-03-11 MHRA Issues Reminder About Dextropropoxyphene Dextropropoxyphene MHRA
2011-03-10 AstraZeneca To Stop Making Pulmicort CFC-free Inhalers Budesonide Inhalation MHRA
2011-03-10 Novartis Warns Of Blocked Needles In Some Packs Of Lucentis Ranibizumab MHRA
2011-03-08 Novartis Alerts Healthcare Professionals to The Association Of Eosinophilic Pneumonia With Daptomycin Use Daptomycin MHRA
2011-03-08 Pfizer Voluntarily Withdraws Sitaxentan From The Market Due To Risk Of Liver Injury Sitaxentan MHRA
2011-03-08 Increased Side Effects Reported With Off-Label Use Of Cidofovir (Vistide) Cidofovir MHRA
2011-03-08 Safety Information Updated About The Risk Of Progressive Multifocal Leukoencephalopathy With Natalizumab Natalizumab MHRA
2011-02-11 MHRA Warns About Increased Risk of Arterial Thrombotic Events with Omalizumab (Xolair) Omalizumab MHRA
2011-02-11 Health Professionals Warned About Increased Risk Of Blood Clots With Lenalidomide (Revlimid) Lenalidomide MHRA
2011-02-11 Prostate cancer treatment temporarily unavailable Zoladex MHRA
2011-02-04 Boehring Ingelheim Stops Manufacturing and Recalls All Remaining Unexpired Stock of Mobic Suppositories Meloxicam MHRA
2011-02-02 Health Professionals Warned About Risk of Severe Anaphylactic Reaction to RoActemra Tocilizumab MHRA
2011-02-01 Nplate Prescribing Information Updated with Revised Dose Adjustments and Warnings For Use In Liver Disease Romiplostim MHRA
2011-02-01 Pfizer Withdraws Thelin From The Market Sitaxentan MHRA
2011-02-01 Pharmacy Level Recall of Several Batches of Tegretol Retard Tablets Carbamazepine MHRA