Safety Alerts & Recalls

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Healthcare Professionals Advised About Risk Factors for Bleeding with Eliquis, Pradaxa and Xarelto
Bristol-Myers Squibb Pharmaceuticals, Bayer, Boehringer Ingelheim and Pfizer have written a joint letter to healthcare professionals advising them about the necessary precautions to reduce the risk of bleeding when prescribing Eliquis (apixaban), Pradaxa (dabigatran) or Xarelto (rivaroxaban). These drugs should not be prescribed to patients with active significant bleeding, any wound or condition likely to cause significant bleeding, or to those prescribed any other anticoagulant (a drug used to thin the blood). Prescribers are to pay particular attention to the recommended warnings and precautions for use to minimise the risk of bleeding. They are also advised to consider the kidney function of patients prescribed these drugs. Eliquis (apixaban), Pradaxa (dabigatran) and Xarelto (rivaroxaban) are anticoagulants taken by mouth and are prescribed in conditions where it is necessary to thin the blood. They are relatively new drugs that do not require the regular blood testing necessary in patients receiving older anticoagulants such as warfarin or heparin. For more information please visit: http://www.mhra.gov.uk/home/groups/pl-p/documents/drugsafetymessage/con321961.pdf
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Filgrastim and Pegfilgrastim Linked to Potentially Life-threatening Capillary Leak Syndrome
The Medicines and Healthcare products Regulatory Agency (MHRA) has written to healthcare professionals to advise them of a risk of capillary leak syndrome (CLS) linked to use of filgrastim (Neupogen, Nivestim, Tevagrastim, Ratiograstim, Zarzio) in chemotherapy and in a healthy donor being prepared for stem cell harvesting, and to the use of pegfilgrastim (Neulasta) in chemotherapy. CLS causes leakage of fluid from the circulatory system, leading to low blood pressure and tissue swelling, low blood protein levels and decreased blood plasma levels. Prescribers are advised to monitor patients and healthy donors for signs of CLS, and to warn patients to contact their doctor immediately if they develop symptoms. For more information please visit: http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON314895
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Date Published Title Medicine Source
2013-10-11 Healthcare Professionals Advised About Risk Factors for Bleeding with Eliquis, Pradaxa and Xarelto MHRA
2013-10-04 Filgrastim and Pegfilgrastim Linked to Potentially Life-threatening Capillary Leak Syndrome Filgrastim MHRA
2013-10-04 Prescribers Advised to Carry Out Genetic Tests Before Initiating Panitumumab Treatment Panitumumab MHRA
2013-10-04 Healthcare Professionals Advised that Test Dose of Intravenous Iron No Longer Recommended Iron Dextran MHRA
2013-09-27 Healthcare Professionals Advised of the Recall of Natzon Due to Packaging Error Buprenorphine MHRA
2013-09-26 Bristol-Myers Squibb and AstraZeneca recall Bydureon Injection Over Risk of Under-filled Vials Exenatide MHRA
2013-08-02 Teva Recalls Certain Batches of Warfarin 3mg Tablets Over Stability Concerns Warfarin MHRA
2013-06-14 Glaxo Wellcome Recalls Ventolin Syrup Over Potential Risk of Contamination with Glass Fragments Salbutamol MHRA
2013-06-06 Bristol-Myers Squibb Recalls Questran Sachets Over Contamination Concern Colestyramine MHRA
2013-06-06 New Study Links Statins to a Small Increase in the Risk of Muscle Disease or Injury Simvastatin MediGuard CRT
2013-05-29 Study Suggests Some Statin Drugs Increase Older Patients’ Risk of Diabetes Simvastatin MediGuard CRT
2013-05-03 MHRA Advises Caution over Strength and Use of Tresiba Insulin Insulin Degludec MHRA
2013-05-03 MHRA Advises Healthcare Professionals to Take Care when Prescribing or Dispensing Drugs with Similar Names Mercaptamine MHRA
2013-05-03 MHRA Advises Healthcare Professionals to Restrict Pletal use to a Second Choice Option Cilostazol MHRA
2013-05-03 MHRA Issues New Warnings About the Risk of Serious Heart Disorders with Protelos Strontium Ranelate MHRA
2013-04-25 Sanofi-aventis Recalls Brochlor Eye Ointment Over Sterility Concerns Chloramphenicol MHRA
2013-04-25 Cambridge Healthcare Supplies Recalls GoldenEye Eye Ointment Over Sterility Concerns Dibrompropamidine MHRA
2013-04-25 Healthcare Professionals Advised of Rare Cases of Bone Fracture with Long-Term Prolia Treatment Denosumab MHRA
2013-04-25 Healthcare Professionals Advised of the Withdrawal of Miacalcic Nasal Spray Due To Safety Risks Salcatonin MHRA
2013-04-25 Healthcare Professionals Advised Not to Use Pradaxa in Patients With Prosthetic Heart Valves Dabigatran MHRA