Rosiglitazone prescribing information updated
The European Medicines Agency (EMEA) has recommended (PDF) new warnings and contraindications for rosiglitazone after it adopted the October 2007 findings of the Committee for Medicinal Products for Human Use (CHMP).
The CHMP recommended that rosiglitazone:
- Must not be used in patients with an acute coronary syndrome, such as angina or some types of myocardial infarction
- Should be avoided in patients with ischaemic heart disease and/or peripheral arterial disease
These new warnings are more restrictive than previous advice that recommended careful evaluation of the patient's individual risk.
Action: Clinicians should be aware of these new recommendations and ensure that patients who remain on treatment with rosiglitazone are not contraindicated following this update.
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