Safety Alerts & Recalls

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Antipsychotic Medicines May Raise Blood Clot Risk
A recent study published in the British Medical Journal supports previous research suggesting that antipsychotic medicines raise the risk of blood clots in patients taking these medicines. The increased risk was more noticeable among new users of antipsychotics and those prescribed the newer atypical antipsychotic drugs. In general, blood clots remain uncommon, and the increase in risk found in the study equates to only a few new cases of blood clots per 10,000 patients treated with antipsychotic medicines. Antipsychotic medicines are used to treat conditions such as schizophrenia and bipolar disorder, but are sometimes used for other conditions such as preventing nausea and vomiting. Conventional (typical) antipsychotics include benperidol (brand name Anquil, Benquil), chlorpromazine (Largactil), flupentixol (Depixol, Fluanxol), fluphenazine (Modecate), haloperidol (Dozic, Haldol), levomepromazine (Nozinan), pericyazine (Neulactil), perphenazine (Fentazin), perphenazine with Amitriptyline (Triptaphen), pimozide (Orap), pipothiazine (Piportil Depot), prochlorperazine (Buccastem, Stemetil), promazine, sulpiride (Dolmatil, Sulpitil, Sulpor), trifluoperazine (Stelazine), and zuclopenthixol (Clopixol) Atypical antipsychotic medicines include amisulpride (brand name Solian), aripiprazole (Abilify), clozapine (Clozaril, Denzapine), olanzapine (Zyprexa), paliperidone (Invega), quetiapine (Seroquel), risperidone (Risperdal, Risperdal Consta), sertindole (Serdolect) and zotepine (Zoleptil). For more information, please visit: www.bmj.com/content/341/bmj.c4245.full
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Europe-Wide Review of Rosiglitazone (Avandia, Avandamet) Expected To Be Completed Soon
The Medicines and Healthcare products Regulatory Agency (MHRA) has reported that the ongoing Europe-wide review of the risks and benefits of rosiglitazone is expected to reach a conclusion within the next month. The review was prompted by concerns about the heart-related safety issues linked to rosiglitazone. The MHRA will notify the public if the safety information changes for rosiglitazone, the active ingredient found in Avandia and Avandamet. The MHRA has published "Rosiglitazone (Avandia): Questions and Answers for Patients" to help address the common questions and concerns that patients may have. To view this helpful guide, please visit: http://www.mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dDocName=CON093790&RevisionSelectionMethod=Latest To view a summary of the MHRA updates for rosiglitazone, please visit: http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/Safetywarningsandmessagesformedicines/CON088192
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Date Published Title Medicine Source
2010-09-23 Antipsychotic Medicines May Raise Blood Clot Risk Sertindole MediGuard CRT
2010-09-08 Europe-Wide Review of Rosiglitazone (Avandia, Avandamet) Expected To Be Completed Soon Rosiglitazone MHRA
2010-08-12 Ketoprofen (Oruvail Gel, Powergel) Can Cause Skin Rash on Exposure To Sun Ketoprofen MHRA
2010-08-12 European Medicines Agency Recommends Modafinil (Provigil) Restrictions Modafinil MHRA
2010-08-12 Cerezyme Shortage To Last Until At Least the End of September 2010 Imiglucerase Manufacturer
2010-08-12 Available Fabrazyme Supply for July to September Cut in Half Agalsidase Beta Manufacturer
2010-08-12 Saquinavir (Invirase) Can Effect Electrical Activity of the Heart Saquinavir Manufacturer
2010-08-12 Cardioxane May Increased Risk of Secondary Cancer in Children Dexrazoxane Manufacturer
2010-08-09 Further Research Needed to Evaluate Link Between Asthma/Asthma Inhalers and Prostate Cancer Risk Mometasone MediGuard CRT
2010-07-30 MHRA Update: Managing the Risk of Misuse of Pseudoephedrine and Ephedrine Chlorphenamine Maleate with Pseudoephedrine HCl MHRA
2010-07-30 Citalopram 10 mg and 20 mg Recalled By Kent Pharmaceuticals Limited Citalopram MHRA
2010-07-30 MHRA Provides Advice About the Use of Rosiglitazone (Avandia, Avandamet) in the Treatment of Diabetes Rosiglitazone MHRA
2010-07-20 Alupent Syrup No Longer Available After July 2010 Orciprenaline Manufacturer
2010-07-12 Sandoz Ltd Recalls Batches of Temozolomide Temozolomide MHRA
2010-07-12 Teva UK Limited Recalls Three More Batches of Glibenclamide 5mg Tablets Glibenclamide MHRA
2010-07-06 Hospira UK Ltd Recalls Several Batches of Temozolomide Temozolomide Manufacturer
2010-07-01 Goldshield Pharmaceuticals Recalls Phenindione 25 mg Tablets Phenindione Manufacturer
2010-06-25 Acetylcysteine: Aurum Pharmaceuticals Limited Warns About Ampoule Contamination Acetylcysteine Manufacturer
2010-06-18 Long-term Use of Isotretinoin Linked to Increased Risk of Ulcerative Colitis Isotretinoin MediGuard CRT
2010-06-14 Angiotensin-Receptor Blockers (ARBs) May Be Linked to Small Increased Risk of Cancer Telmisartan MediGuard CRT