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Risiko für schwere Hypersensitivitätsreaktionen, darunter auch Stevens-Johnson-Syndrom (SJS) und akute anaphylaktische Reaktionen / Schock mit Febuxostat [Adenuric]

23. Mai 2012 – Die Berlin Chemie AG informiert heute mittlels einem „Rote Hand“ Brief in  Übereinstimmung mit der Europäischen Arzneimittelbehörde (European Medicine Agency (EMA)) und dem Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), und nach Überprüfung der gesammelten Daten zur Sicherheit des Arzneimittels Febuxostat [Adenuric]  im Rahmen der Überwachung nach Markteinführung wie folgt:

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European Medicines Agency (EMEA) recommends revocation of marketing authorisation for bufexamac containing medicines.

April 27, 2010 – From an announcement by the EMEA we learn that bufexamac-containing medicines were to be taken off EU markets because of high risk of contact allergies.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that marketing authorisations for bufexamac- containing medicines be revoked.

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Cardiovascular Risk with Sibutramine [Meridia] in Patients with a History of Cardiovascular Disease

April 11, 2010 – FDA is alerting healthcare professionals that Sibutramine [Meridia] is contraindicated in patients with a history of cardiovascular disease because the drug increases their risk of heart attack and stroke. Sibutramine [Meridia] is used to manage obesity.

In November 2009,

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European Medicines Agency (EMEA) recommends withdrawal of Benfluorex from the market in European Union

December 31, 2009 – The European Medicines Agency (EMEA) has recommended the withdrawal of all medicines containing Benfluorex in the European Union, because their risks, particularly the risk of heart valve disease, are greater than their benefits.

Doctors should stop prescribing Benfluorex-containing medicines and consider alternative treatments.

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European Medicines Agency (EMEA) Pandemic Influenza (H1N1) Portal: Celvapan Approved

November 7, 2007 – According to the Pandemic Influenza (H1N1) Portal by the European Medicines Agency (EMEA), Celvapan has recently been approved.

Celvapan is a vaccine that is given by injection into the shoulder muscle in two doses, at least three weeks apart.

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