If you are a patient taking the drug, be ready for something new here with needing to sign an informed consent statement that you understand all the potential risks of taking the drug, otherwise, you get no refills and will need to change to another medication. In addition if you are prescribed Avandia as a new patient, your doctor has to certify that other medications are not working for you.
In Europe, Avandia is out, no more sales. In addition, if you are taking a combination drug with Avandia as component, same rules apply. The drug already had a black box warning so now I guess we could call this the “black box plus” addendum and I would think that prescriptions for the drug would start to decline pretty rapidly. BD
The Food and Drug Administration said Thursday that it will sharply limit access to the anti- diabetes drug Avandia because of concerns about an increased cardiovascular risk associated with the drug.
Patients who are now taking the drug will have to sign an informed consent statement acknowledging that they understand all the risks before they will be allowed to continue refilling prescriptions. New patients will not be able to receive the drug unless their doctor certifies that they are unable to control their blood sugar levels with other medications and that they are unable to take Avandia's primary competitor, Actos, for medical reasons.