Marketing Authorization for Medtronic InductOs Device Suspension
European Medicines Agency Recommend Suspension of Marketing Authorization for Medtronic's InductOs. The European Medicines Agency (EMA) has recommended the suspension of marketing authorization for Medtronic's InductOs, an implant to help bone development, until issues are resolved at a U.S. plant where a component of the implant is … [Read more...] about Marketing Authorization for Medtronic InductOs Device Suspension
Restrictions on Epilepsy Drug Trobalt
Epilepsy Medication Trobalt Strictly Recommended On Friday, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended restricting the epilepsy medication Trobalt (retigabine) because of side effects, including impaired vision. The EMA now recommends that physicians prescribe … [Read more...] about Restrictions on Epilepsy Drug Trobalt
Use of Multaq Should be Curbed
Multaq Safety Issues. Multaq safety worries have prompted regulators to issue new restrictions for the drug. According to a report from The Wall Street Journal, concerns about Multaq's impact on the heart, lungs and liver might soon prompt the U.S. Food & Drug Administration (FDA) to take similar steps in the … [Read more...] about Use of Multaq Should be Curbed
Avandia Decision Coming in September
Avandia Decision Coming in September. European regulators will decide by September if Avandia will be allowed to stay on the market there. The European Medicines Agency (EMEA) said yesterday that it is still reviewing GlaxoSmithKline’s controversial diabetes drug, which has been linked to an increased risk of heart attacks. Since … [Read more...] about Avandia Decision Coming in September
Tysabri Labeling Changes Sought by European Regulators
Tysabri Labeling Changes. The European Medicines Agency wants to raise awareness of a deadly brain infection associated with the drug Tysabri. It recommended Thursday that the product information for Tysabri (natalizumab) be updated to include more information about the risk of progressive multifocal leukoencephalopathy … [Read more...] about Tysabri Labeling Changes Sought by European Regulators
Tysabri PML Cases Get Attention of European Drug Agency
Tysabri PML Cases Get Attention. European health regulators are taking a hard look at two cases of a potentially lethal brain infection linked to the drug Tysabri. About 31,800 people take Tysabri, which is also used to treat Multiple Sclerosis and Crohn’s disease, a digestive condition. Earlier this month, Elan and Biogen Idec, … [Read more...] about Tysabri PML Cases Get Attention of European Drug Agency
Avelox, Similar Antibiotics Face European Restrictions Due to Liver Damage
Avelox European Restrictions Due to Liver Damage. Restrictions Due to Liver Damage Moxifloxicin, a fluoroquinolone antibiotic sold as Avelox by Bayer, is being subjected to new warnings and restrictions by the European Medicines Agency (EMA) because of its association with adverse liver reactions. Moxifloxacin is used to … [Read more...] about Avelox, Similar Antibiotics Face European Restrictions Due to Liver Damage
European Drug Agency Backs Heart Warning
European Drug Agency Heart Warning. The European Medicines Agency said Thursday it would require stronger warnings about the cardiovascular risks associated with the Cox-2 class of arthritis painkillers. It stopped short of calling for the drugs, which are also being scrutinized by the Food and Drug Administration, to be … [Read more...] about European Drug Agency Backs Heart Warning
European Regulators Toughen Crestor Rules
Crestor Side Effects Injury Lawsuits. European drug regulators have tightened up the prescribing rules for Crestor, AstraZeneca's cholesterol lowering treatment, following problems with side effects. Doctors have been told they should start with low doses of the drug and must seek specialist advice before prescribing the … [Read more...] about European Regulators Toughen Crestor Rules
