[AF] avandia y ataques alcorazón

[Mariano Madurga]

La FDA sacó ayer una nota informando a este respecto: evaluará los datos
preliminares del ensayo RECORD y esdtiman que para julio 2010 decidirán
sobre Avandia (rosiglitazona).
Un abrazo,
Mariano Madurga
En: http://tinyurl.com/yhms7bv 
 Avandia (rosiglitazone): Ongoing Review of Cardiovascular Safety

*Audience*: Endocrinology, cardiology healthcare professionals, patients

[Posted 02/22/2010] FDA notified healthcare professional and patients that
it is reviewing the primary data from a large, long-term clinical study,
RECORD, on possible cardiovascular risks with the diabetes drug, Avandia
(rosiglitazone). In addition to the clinical trial, a number of
observational studies of the cardiovascular safety of rosiglitazone have
been published and FDA has been reviewing these on an ongoing basis.

These reviews are ongoing and no new conclusions or recommendations about
the use of rosiglitazone in the treatment of type 2 diabetes have been made
at this time. Once FDA completes its review of the data from the RECORD
study, the agency will present the totality of new and existing
cardiovascular safety data on rosiglitazone at a public meeting in July
2010. The Agency will provide an updated assessment of the risks and
benefits of rosiglitazone in the treatment of type 2 diabetes.

FDA recommends that healthcare professionals follow the recommendations in
the drug label when prescribing rosiglitazone. This includes a Boxed
Warning. Patients should continue taking rosiglitazone unless told by their
healthcare professional to stop. Patients who are concerned about the
possible risks associated with using rosiglitazone should talk to their
healthcare professional.

[02/22/2010 - Drug Safety Communication: Ongoing review of Avandia
(rosiglitazone) and Cardiovascular
Safety <http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm201418.htm> 1 - FDA]