Safety Alerts & Recalls

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Latest Alerts

Ciclosporine: Patients Should Be Monitored When Switched To Different Brand or Formulation
Mylan has announced that its version of ciclosporin has been granted marketing licenses in the UK and will be sold under the name Capimune. Capimune has been shown to be equivalent to the ciclosporin product sold under the name Neoral. In a recent Dear Healthcare Professional, Mylan, the maker of Capimune, reminded doctors and other medical professionals that patients should not be transferred from one oral formulation or brand of ciclosporin to another without appropriate monitoring of ciclosporin blood level concentrations, kidney function, and blood pressure. Ciclosporin is indicated for the prevention and treatment of transplant rejection, psoriasis, atopic dermatitis, rheumatoid arthritis, and nephrotic syndrome. Ciclosporin is a critical-dose drug where dosing is very specific for an individual patient and is based on monitoring blood levels and side effects. Ciclosporin can be prescribed as a capsule or as an oral solution and under the names Neoral, Sandimun, Deximune, and now Capimune. For more information, please visit: http://www.mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dDocName=CON099716&RevisionSelectionMethod=Latest
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Report of Intestinal Problems With Relistor
Wyeth Europa Limited and Pfizer Limited recently notified healthcare professionals about post marketing cases of gastointestinal (GI) perforation reported in patients receiving Relistor (methylnaltrexone). Gastrointestinal perforation is a hole that develops through the entire wall of the stomach, small intestine, large bowel, or gallbladder. Healthcare professionals are being advised to use Relistor with caution in patients with a history of GI tract lesions, such as those lesions caused by cancer, peptic ulcers, or GI tract obstruction. Relistor contains the active ingredient methylnaltrexone and is indicated for the treatment of opioid-induced constipation in patients with advanced illness who are receiving palliative care. Relistor is given as a subcutaneous injection under the skin and is only used when a patient does not respond to usual laxative therapy. For more information, please visit: http://www.mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dDocName=CON096892&RevisionSelectionMethod=Latest
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Date Published Title Medicine Source
2010-11-12 Ciclosporine: Patients Should Be Monitored When Switched To Different Brand or Formulation Ciclosporin Manufacturer
2010-11-12 Report of Intestinal Problems With Relistor Methylnaltrexone Manufacturer
2010-11-12 MHRA Warns About Potential Drug Name Mix-Up Mercaptamine MHRA
2010-11-05 Vitamin E Linked to Certain Types of Stroke MediGuard CRT
2010-11-02 Mixtard 30 No Longer Available After December 31, 2010 Mixtard Manufacturer
2010-10-28 Some GlucaGen HypoKits May Have Cracked Vials Glucagon MHRA
2010-10-28 Possible Risk of Dosing Errors with Xyrem Due to a Confusion on Measuring Syringe Sodium Oxybate Manufacturer
2010-10-28 Formulations of Almus and Evotrox Solutions Have Changed Levothyroxine Sodium Manufacturer
2010-10-28 Cerezyme Supply Limits Extended to June 2011 Imiglucerase Manufacturer
2010-10-27 Long-Acting Beta-2 Agonists: Reminder for Use in Children and Adults Symbicort MHRA
2010-10-27 Corticosteroid Inhalers and Nasal Sprays Can Alter Your Mood Mometasone MHRA
2010-10-22 Hormone Replacement Therapy After Menopause Associated with Higher Risk of Aggressive Form of Breast Cancer Estrogens Conjugated with Medroxyprogesterone MediGuard CRT
2010-10-22 Hormone Replacement Therapy After Menopause Associated with Higher Risk of Aggressive Form of Breast Cancer Angeliq MediGuard CRT
2010-10-21 All Avandia and Avandamet Product Recalled From Pharmacies and Clinics Rosiglitazone MHRA
2010-10-13 Roaccutane: Risk of serious skin reactions with acne medicine Isotretinoin Manufacturer
2010-10-11 Codeine Cough Medicine: MHRA Limits to Adult Use Only MHRA
2010-09-30 Certain Batches of Erythroped Have a Shorter Shelf Life Erythromycin MHRA
2010-09-28 Manufacturer Recalls ALL Lots of Octagam Octagam MHRA
2010-09-24 European Medicines Agency To Review Safety of Bisphosphonates Ibandronic Acid EMEA
2010-09-23 Europe-Wide Suspension of Marketing Authorisation for Rosiglitazone Products (Avandia, Avandamet) Rosiglitazone MHRA