Safety Alerts & Recalls

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New Study Confirms Link Between Pioglitazone and Bladder Cancer
A probable link between the use of pioglitazone (Actos, Competact) and an increased risk of bladder cancer has been confirmed by a study published in the British Medical Journal (BMJ). Prescribers have been aware of the potential link for some time, and have taken this into consideration when prescribing the drug, but this study confirms the link and the size of the risk. The medical records of a large number of patients with type 2 diabetes were compared to determine if the small number who contracted bladder cancer were more likely to have taken pioglitazone to control their diabetes than other drugs. The study found that patients who took pioglitazone were more likely to have contracted bladder cancer than those who did not. The risk of bladder cancer was highest among patients who had been taking pioglitazone for more than two years. No link to an increased risk of bladder cancer was found among patients taking a similar drug, rosiglitazone. The chances of contracting bladder cancer are small – 73 cases per 100,000 people aged 65 or over each year in the UK. There is evidence to suggest an increased risk of bladder cancer among patients with type 2 diabetes, regardless of which medication they take. So, while there is an increased risk of bladder cancer among patients with type 2 diabetes who take pioglitazone, the chance of these patients contracting bladder cancer remains small. For more information please visit: http://www.bmj.com/content/344/bmj.e3645
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Healthcare Professionals Warned That Gilenya is Not Recommended for Patients With a Known Risk of Heart Attack or Stroke
The Medicines and Healthcare products Regulatory Agency (MHRA) has warned prescribers that Gilenya (fingolimod) is not recommended for use in patients at high risk of heart attack or stroke. This includes patients with abnormal heart beat, heart disease or heart failure, stroke, uncontrolled raised blood pressure, and those taking medication for an abnormal heart rate or rhythm. Prescribers are also advised of updated monitoring requirements during the first few hours and possibly overnight following the first dose. These limitations and precautions for use of Gilenya are needed to help minimise the risk of the serious side effect of low heart rate and abnormal heart rhythms. Gilenya, which contains the medication fingolimod, is used to treat relapsing-remitting multiple sclerosis in patients whose disease has failed to respond to beta-interferon or is severe and rapidly getting worse. For more information please visit: http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON152723
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Date Published Title Medicine Source
2012-06-05 New Study Confirms Link Between Pioglitazone and Bladder Cancer Pioglitazone and Metformin MediGuard CRT
2012-05-31 Healthcare Professionals Warned That Gilenya is Not Recommended for Patients With a Known Risk of Heart Attack or Stroke Fingolimod MHRA
2012-05-31 Healthcare Professionals Advised Not to Use Protelos In Patients at Risk of Blood Clots Strontium Ranelate MHRA
2012-05-31 Health Professionals Advised of Initiatives to Encourage the Reduction in Prescribing of Antipsychotic Drugs in Elderly Patients with Dementia Risperidone MHRA
2012-05-31 Health Professionals Alerted to the Association Of All EGFR Inhibitors with Keratitis And Ulcerative Keratitis Erlotinib MHRA
2012-05-31 Healthcare Professionals Reminded of Risk Minimisation Measures for Protopic Ointment Tacrolimus Manufacturer
2012-05-31 Healthcare Professionals Warned of the Association of Adenurix and Serious Allergic Reactions Febuxostat Manufacturer
2012-05-30 Oral Tacrolimus Medicines Must Be Prescribed and Dispensed by the Brand Name Tacrolimus MHRA
2012-05-24 Anapen Injection Recalled Due To Potential Fault With Autoinjector Primatene MHRA
2012-05-17 Fulsovin 125mg/5ml Oral Suspension Recalled Over Stability Concerns Griseofulvin MHRA
2012-05-10 Teva and Numark Branded Levothyroxine 100mcg Tablets Recalled Levothyroxine Sodium MHRA
2012-05-04 Safety and Effectiveness of Priadel Liquid Unaffected Despite Cloudy Appearance Lithium FDA
2012-04-24 Dosing Pipette For Epistatus Buccal Liquid Now Changed Back to 1.0ml Size Midazolam MHRA
2012-04-23 Long Term Proton Pump Inhibitor Use Linked to Increased Risk of Bone Fracture Omeprazole MHRA
2012-04-23 Prolonged Use of Proton Pump Inhibitors Linked to Low Blood Magnesium Levels Omeprazole MHRA
2012-04-05 Benlysta Linked To Severe Or Life-Threatening Allergic and Infusion Reactions Manufacturer
2012-04-05 Blood Testing Recommended with Samsca Due to the Risk of Sodium Levels Rising Above the Expected Rate After Administration Tolvaptan Manufacturer
2012-04-05 New Contraindications and Warnings for Protelos Strontium Ranelate EMEA
2012-04-05 Teva Extends Prednisolone Recall to EC Tablets Packed in Pots Prednisolone MHRA
2012-03-30 Onglyza Found To Be Associated with Serious Allergic Reactions and Pancreatic Inflammation Saxagliptin Manufacturer