EMA Seeks Stronger Pradaxa Guidance for Bleeding Side Effects

EMA Seeks Stronger Pradaxa Guidance for Bleeding Side Effects

EMA Seeks Stronger Pradaxa Guidance for Bleeding Side Effects

Regulators in Europe have again asked Boehringer Ingelheim, the manufacturer of the blood thinner Pradaxa, to update the drug’s label with additional information regarding Pradaxa bleeding side effects. According to the European Medicines Agency (EMA), the new guidance should include more specific information on when Pradaxa must not be used, as well as advice on managing patients and reversing the anticoagulant effect if Pradaxa bleeding occurs.

© 2005-2017 Parker Waichman LLP ®. All Rights Reserved.