Safety Alerts & Recalls

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Healthcare Professionals Advised Of The Restriction Of Use For Levofloxacin Due To Safety Issues
The Medicines and Healthcare products Regulatory Agency (MHRA) has written to healthcare professionals to inform them that, when other medicines have been prescribed or have been ineffective, the antibiotic levofloxacin (Tavanic) should only be used to treat: -- acute bacterial sinusitis; -- acute worsening of chronic bronchitis; -- community acquired pneumonia; -- complicated skin and soft tissue infections. This restriction follows a review of safety and efficacy data which suggested that the safety profile of levofloxacin was unfavourable as first-line treatment for these indications. The risks contributing to this assessment included: serious liver damage; abnormal heart rhythms; severe skin reactions and tendon rupture. Levofloxacin also known by the brand name Tavanic belongs to the class of antibiotics called Quinolones. For more information please visit: http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON185630
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MHRA Warns There May be a Link Between Gliptin Diabetic Drugs and Acute Pancreatitis
The Medicines and Healthcare products Regulatory Agency (MHRA) has written to healthcare professionals to inform them that it has received reports that there may be a link between drugs in the dipeptidylpeptidase (DPP-4) inhibitor class of antidiabetic drugs (‘gliptins’) and acute pancreatitis (inflammation of the pancreas). Gliptins are used to treat diabetes. Drugs in this class include saxagliptin (Onglyza), linagliptin (Trajenta), sitagliptin (Januvia, Janumet), and vildagliptin (Galvus, Eucreas). It is important that patients be informed of the characteristic symptoms of acute pancreatitis – persistent, severe abdominal pain (sometimes radiating to the back) – and that they be encouraged to tell their doctor if they develop such symptoms. If pancreatitis is suspected the gliptin and other potentially suspect medicinal products should be discontinued. For more information please visit: http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON185628
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Date Published Title Medicine Source
2012-09-27 Healthcare Professionals Advised Of The Restriction Of Use For Levofloxacin Due To Safety Issues Levofloxacin MHRA
2012-09-27 MHRA Warns There May be a Link Between Gliptin Diabetic Drugs and Acute Pancreatitis Sitagliptin MHRA
2012-09-25 Single Batch of Tubilux Infected Eyes Eye Drops Recalled Over Incorrect Information Leaflet Chloramphenicol MHRA
2012-09-21 Caution Advised When Making Up Diflucan Suspension Fluconazole MHRA
2012-09-17 Teva UK Limited Recalls Single Batch of AllerTek Tablets Due to Failing Stability Tests Cetirizine MHRA
2012-09-17 Wockhardt UK Recalls Single Batch of Hypurin Porcine Isophane Insulin Due To Packaging Error Pork Velosulin MHRA
2012-09-07 Healthcare Professionals Informed Of Potential Lack Of Sterility With DepoCyte Injection Cytarabine Manufacturer
2012-09-07 Healthcare Professionals Advised of Change in Strength and Dosing Instructions For Tamiflu Suspension Oseltamivir Manufacturer
2012-08-31 Kappin Limited Recalls One Batch of Each Strength of Evotrox Suspension Over Concerns With The Drug Product Quality Levothyroxine Sodium MHRA
2012-08-24 Healthcare Professionals Advised That Epistatus Syringes To Have New Tips Midazolam MHRA
2012-08-24 GlaxoSmithKline Recalls Multiple Batches of Zovirax Suspension 200mg/5ml Due To The Incorrect Dosing Instructions in The Patient Information Leaflet Aciclovir MHRA
2012-08-24 Healthcare Professionals Informed of Updated Interaction Advice for Simvastatin Simvastatin MHRA
2012-08-24 Healthcare Professionals Advised of the Withdrawal of Calcitonin Nasal Spray Due To Increased Cancer Risk Salcatonin MHRA
2012-08-23 Single Batch of Paracetamol Tablets Recalled Due to Incorrect Blister Foil Paracetamol MHRA
2012-08-21 Parents and Carers Advised Not to Use Echinacea Products in Children Under The Age Of 12 Years Echinacea Purpurea MHRA
2012-08-15 Healthcare Professional Advised of the Updated Safety Warnings for Pradaxa Dabigatran MHRA
2012-08-15 Healthcare Professionals Advised of Restrictions to the Maximum Dose of Ondansetron Injection in order to Reduce Risk of Abnormal Heart Rhythms Ondansetron MHRA
2012-08-15 Healthcare Professionals Informed to Not Use Volibris in Patients with Idiopathic Pulmonary Fibrosis Ambrisentan Manufacturer
2012-08-15 Healthcare Professionals Advised of Severe Skin Reactions Being Reported with Vectibix Use Panitumumab Manufacturer
2012-06-29 Aspire Pharma Launches Generic Version of Leflunomide Leflunomide Manufacturer