Safety Alerts & Recalls

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MHRA Reminds Prescribers that Certain Flu Vaccines Should Not be Used in the Under-Fives
The Medicines and Healthcare products Regulatory Agency (MHRA) has reminded prescribers that Enzira and CSL Biotherapies influenza vaccines should not be given to children under the age of five years. These vaccines are not authorised for use in this age group because they are associated with an increased risk of febrile convulsions (fits associated with a fever). The MHRA has also advised prescribers that Viroflu and Inflexal V influenza vaccines should be used with caution in children aged less than five years. These vaccines have been linked to an increase in fever, but not febrile convulsions. For further information please visit:
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Periogard Oromucosal Solution Recalled Due to Microbial Contamination
Colgate-Palmolive (UK) Ltd is recalling several batches of Periogard 0.2% Oromucosal Solution (chlorhexidine digluconate) because microbial contamination has been detected in some batches. There have been no reports of illness associated with this issue. However, Burkholderia, the particular species involved, can cause infection in individuals with a compromised immune system, or in those with chronic lung conditions such as cystic fibrosis. There is little medical risk to healthy individuals. Periogard 0.2% Oromucosal Solution is used for the short-term treatment of inflammation of the gums and lining of the mouth. To view a complete list of affected batch numbers and for more information please visit:
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Date Published Title Medicine Source
2011-11-07 MHRA Reminds Prescribers that Certain Flu Vaccines Should Not be Used in the Under-Fives Influenza Vaccine MHRA
2011-11-03 Periogard Oromucosal Solution Recalled Due to Microbial Contamination Chlorhexidine MHRA
2011-11-01 Two Batches of Preflucel Flu Vaccine Recalled Due to Adverse Events Influenza Vaccine MHRA
2011-10-26 Xigris [drotrecogin alfa (activated)] Withdrawn From Market Due to Failure to Show Benefit MHRA
2011-10-25 Astellas Recalls Two Batches of Advagraf Due to Possible Incorrect Dose Tacrolimus Manufacturer
2011-10-18 Licensed Version of Buccal Midazolam Now Available to Treat Prolonged Seizures Midazolam MHRA
2011-10-18 MHRA Recommends Restricted Prescribing of Multaq Due to Safety Concerns Dronedarone MHRA
2011-10-14 Ranbaxy Recalls Aciclovir, Fluconazole And Oldaram Tramadol Due To Substandard Patient Information Leaflets Aciclovir MHRA
2011-10-11 Nplate Linked to Increased Risk of Leukaemia in Patients with Myelodysplastic Syndrome Romiplostim MHRA
2011-09-29 Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Found to Increase Risk of Heart Attack and Stroke Nabumetone MHRA
2011-09-29 Product Information Updated Regarding Use of all Antipsychotic Medications During Pregnancy Risperidone MHRA
2011-09-29 Interaction of Fusidic Acid With Statins Linked To Serious Muscle Damage Fusidic Acid MHRA
2011-09-16 European Review Confirms Effectiveness of Reboxetine In Severe Depression Reboxetine MHRA
2011-09-09 Sprycel Linked To Raised Blood Pressure In The Lungs Dasatinib MHRA
2011-09-09 Health Professionals Advised Of Link With MabThera To Fatal Infusion Reactions In Patients With Rheumatoid Arthritis Rituximab MHRA
2011-08-27 All Batches of Nurofen Plus Recalled Due to Rogue Tablets Found In Some Packs Solpaflex MHRA
2011-08-14 UCB Pharma To Recall Vimpat Syrup Due To Quality Defect Lacosamide MHRA
2011-08-05 Prescribers Reminded: Use Multaq (Dronedarone) Only for Recommended Indications Dronedarone Manufacturer
2011-08-05 Genzyme Warns: Supply Shortages of Thyrogen Are To Continue Thyrotropin Alfa Manufacturer
2011-08-04 New Study: Antidepressant Use And Risk of Adverse Outcomes In Older People Paroxetine MediGuard CRT