Safety Alerts & Recalls

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Swine Flu Vaccine Update
The February 2010 Medicines and Healthcare products Regulatory Agency (MHRA) Safety Update provides updates on reports of suspected adverse reactions received up to Jan 19, 2010 for vaccines in use to help prevent swine flu. Celvapan and Pandemrix are the swine flu H1N1 vaccines in use in the UK. As of Jan 17, 2010, more than 4 million doses of these vaccines (mostly Pandemrix) have been given in the UK, including at least 132 000 in pregnant women. The total number and the nature of suspected adverse effects reported are very much as expected. The most frequently reported suspected adverse effects are injection site reactions (such as pain, swelling, redness), or are well established adverse effects of many vaccines, including the swine flu vaccines (such as nausea, vomiting, dizziness, muscle pain, fever, fatigue, headache, swollen glands, flu-like illness). In general, these side effects are neither serious nor long-lasting. No unexpected new safety issues have been identified from reports received to date. For more information, please visit: http://www.mhra.gov.uk/Publications/Safetyguidance/DrugSafetyUpdate/CON071085?utm_source=dsu2010feb&utm_medium=email&utm_campaign=drugsafetyupdate
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Codeine Cough Medicine: MHRA Limits to Adult Use Only
The Medicines and Healthcare products Regulatory Agency (MHRA) has completed a review of the benefits and risks of over-the-counter oral liquids containing codeine for the treatment of cough in children. These products are currently available for supply by a pharmacist. The MHRA has concluded that the risks associated with over-the-counter oral liquid cough medicines containing codeine outweigh the benefits in children and young people under 18 years. Over-the-counter oral liquid medicines containing codeine should no longer be used to treat cough in children and young people under 18 years. However, these products will continue to be available for use by adults. The MHRA also issued a reminder that breastfed babies might very rarely develop side effects due to the presence of morphine in breast milk. The side-effects of nausea, vomiting, lack of appetite, and drowsiness are very rare and most women will be able to use medicines that contain codeine to obtain adequate analgesia when needed after labour without any problems for them or their baby. For more information, please visit: http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/Safetywarningsandmessagesformedicines/CON096796 and http://www.mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dDocName=CON096842&RevisionSelectionMethod=Latest
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Date Published Title Medicine Source
2010-03-17 Swine Flu Vaccine Update MHRA
2010-10-11 Codeine Cough Medicine: MHRA Limits to Adult Use Only MHRA
2011-03-14 Pfizer Recalls Several Batches Of Caverject Injection MHRA
2016-02-03 Los Profesionales Sanitarios Informados: Viekirax (Ombitasvir, Paritaprevir, Ritonavir) No Recomendado En Pacientes Con Determinados Problemas En El Hígado AEMPS
2016-07-06 Teva Pharmaceuticals USA Recalls Single Lot of Nabumetone 750 mg Tablets Nabumetone FDA
2017-12-08 Healthcare Professionals Reminded to Prescribe and Dispense Tacrolimus by Brand Name Only Tacrolimus MHRA
2017-12-08 Healthcare Professionals Advised of Dose-Dependent QT-Prolonging Effects of Quinine and Updated Medicine Interactions Quinine Sulphate MHRA
2017-12-08 Takeda Recalls One Batch of Calcichew-D3 caplets due to non-approved excipient being found Calcium MHRA
2017-12-08 Pfizer Recalls Batches of Atorvastatin and Lipitor Due to Potential of Out of Specification Result for Microbiological Testing Atorvastatin MHRA
2017-12-08 Healthcare Professionals Advised of the Risk of Severe Respiratory Depression with Gabapentin Gabapentin MHRA
2017-12-08 Healthcare Professionals Advised of the Contraindication of Daktarin oral gel in Patients Taking Warfarin Warfarin MHRA
2017-12-08 Healthcare Professionals Advised of Serious Cardiac-Related Adverse Reactions with High Doses of Loperamide Loperamide MHRA
2017-12-08 Strathclyde Pharmaceuticals Ltd recalls single batch of Xarelto 20mg film-coated tablets after reports of rogue blister strips of 15 mg tablets within packs of 20 mg tablets MHRA
2018-01-02 Puren Pharma ruft alle Chargen von Moxonidin-Actavis 0,3 mg und 0,4 mg Filmtabletten zurück Moxonidine AMK
2010-06-25 Acetylcysteine: Aurum Pharmaceuticals Limited Warns About Ampoule Contamination Acetylcysteine Manufacturer
2012-01-23 Meprobamate To Be Withdrawn From The European Market EMEA
2011-10-14 Ranbaxy Recalls Aciclovir, Fluconazole And Oldaram Tramadol Due To Substandard Patient Information Leaflets Aciclovir 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
2014-11-12 Glaxo SmithKline Recalls Zovirax Eye Ointment Over Impurities Aciclovir MHRA
2010-02-15 Possible Contamination of FABRAZYME Agalsidase Beta Manufacturer