Safety Alerts & Recalls

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Latest Alerts

Re-supply of NebuChamber Inhalation Aid for Pulmicort
AstraZeneca announced that a newly designed NebuChamber mouthpiece and facemask are available for the Pulmicort (budesonide) CFC-free Inhaler. The NebuChamber is a spacer device that is used together with the Pulmicort CFC-Inhaler to help patients correctly administer their dose. The facemask can be used for young children or others unable to breathe through the mouthpiece. In April 2009, AstraZeneca recalled all stocks of NebuChamber spacers from distributors, hospitals and pharmacies as a precautionary measure because it was possible for the mouthpiece to be fitted to the spacer in the wrong direction and possibly prevent patients from inhaling the product because the mouthpiece contains a one-way valve. The new NebuChamber mouthpiece has been re-designed to ensure that it only connects in the correct direction on the spacer. The facemask has also been re-designed to accommodate the new mouthpiece. The NebuChamber packaging and leaflet have been updated to give more detailed information. For more information, please visit: http://www.mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dDocName=CON070958&RevisionSelectionMethod=Latest
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MHRA Issues Orlistat (Alli, Xenical) Safety Update
The February 2010 Safety Update from the Medicines and Healthcare products Regulatory Agency (MHRA) describes several safety updates for orlistat, the active ingredient in the brand name products Alli and Xenical. Alli and Xenical are used for weight loss in combination with a reduced-calorie, lower-fat diet. Xenical has been licensed since 1998 and is available in 120 mg capsules as a prescription-only medicine. Alli was licensed in January 2009 and is available in 60 mg capsules without a prescription under the supervision of a pharmacist. 1) Updated Safety Information for Alli A recent Europe-wide review of the safety information for Alli has led to a number of updates, which bring the product information in line with that for Xenical. The updated information for Alli alerts pharmacists and consumers to the risk of a rare kidney problem called oxalate nephropathy, drug-drug interactions with levothyroxine, drug-drug interactions with antiepileptic drugs, and reports of pancreatitis that have been reported in an unknown number of patients taking Alli. Patients with kidney disease, patients taking thyroid medications (including levothyroxine) or antiepileptic drugs and patients with a history of pancreatitis should consult a doctor before starting Alli. 2) Reports of Counterfeit Alli Capsules in the USA Some consumers may be at risk after reports in the USA of counterfeit Alli that contained sibutramine rather than orlistat. Although the counterfeit product has not been found in the UK, it is still potentially available to UK customers via the Internet. Consumers should not buy medicines from unregulated websites. 3) Review of Liver Toxicity with Orlistat In July 2009, there was a Europe-wide review of a possible association between orlistat and serious liver problems. The review included non-clinical, clinical trial, and post-marketing safety data provided by the license holders and a review of suspected adverse reaction reports submitted to the MHRA. The European review concluded that there is there is not enough evidence to show that Xenical or Alli are associated with more serious liver disorders than those already listed in the product information, and that no further action was recommended at this time. 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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Date Published Title Medicine Source
2010-03-17 Re-supply of NebuChamber Inhalation Aid for Pulmicort Budesonide Inhalation MHRA
2010-03-17 MHRA Issues Orlistat (Alli, Xenical) Safety Update Orlistat MHRA
2010-03-17 Update on Antiviral Medications Used for Swine Flu Zanamivir MHRA
2010-03-17 Swine Flu Vaccine Update MHRA
2010-03-17 Tacrolimus Formulations Not Interchangeable Tacrolimus MHRA
2010-03-16 Teva UK Limited Recalls Several Batches of Glibenclamide 5mg Tablets at Pharmacy Level Glibenclamide Manufacturer
2010-03-05 MHRA Sends Safety Message About Avandia and Avandamet Rosiglitazone MHRA
2010-03-04 Winthrop Recalls Single Batch of Alimemazine Tartrate 7.5 mg/5 ml Syrup in 100 mL bottles Alimemazine MHRA
2010-02-17 Statin Benefits Still Outweigh New Safety Information Simvastatin MediGuard CRT
2010-02-15 MHRA Review of METHYLPHENIDATE and Risk of Genetic Damage and Update to Patient Information Leaflet Methylphenidate MHRA
2010-02-15 Warning About Serious Skin Reactions with Use of PHENYTOIN in Asians Phenytoin MHRA
2010-02-15 Possible Contamination of THYROGEN Thyrotropin Alfa Manufacturer
2010-02-15 Possible Contamination of CEREZYME Imiglucerase Manufacturer
2010-02-15 Possible Contamination of FABRAZYME Agalsidase Beta Manufacturer
2010-01-29 EMEA Recommends Additional Measures to Better Manage Risk of Progressive Multifocal Leukoencephalopathy (PML) with Tysabri Natalizumab MHRA
2010-01-29 Recall of Several Batches of IntronA Interferon Alfa 2B MHRA
2010-01-21 EMA Ends Marketing Authorisation For Sibutramine (Marketed as Reductil) Sibutramine MHRA
2009-12-16 Recall of Several Batches of Dentinox Cetylpyridium and Lidocaine MHRA
2009-12-11 Recall on Several Heartburn Products Cimetidine MHRA
2009-12-11 Recall on Several Heartburn Products Peptac MHRA