dradam121
28.09.10, 21:52
Jak widac z ponizszego AVANDIA ma periepalki, na calym swiecie.
September 23, 2010 (Updated September 24, 2010) (Silver Springs, Maryland and London, United Kingdom) — The US FDA has decided that rosiglitazone (Avandia, GlaxoSmithKline) can remain available, but only under a very stringent restricted-access program. However, the European Medicines Agency (EMA) has recommended the suspension of the marketing authorizations for all rosiglitazone-containing antidiabetes medications licensed in the EU--Avandia, Avandamet, and Avaglim.
"These medicines will stop being available in Europe within the next few months," the agency said in a statement. "Patients are advised not to stop their treatment without speaking to their doctor. Doctors should stop prescribing rosiglitazone-containing medicines, and patients taking rosiglitazone-containing medicines should be reviewed in a timely manner to amend their treatment."
As previously reported by heartwire , rosiglitazone has been under mounting scrutiny both in the US and Europe, culminating in an FDA advisory hearing where 12 out of 33 panel members voted to recommend removal of the drug from the US market and an additional 10 panelists voted to recommend that rosiglitazone stay on the market, but with severe restrictions on its use.
In response to both the FDA and EMA statements issued today, GlaxoSmithKline said that the EMA has "stated that the suspension will remain in place unless convincing data are provided that identify a group of patients in whom the benefits of the medicine outweigh its risks." In the US, all rosiglitazone-containing medicines will remain available with additional safety labeling and restrictions for use, which includes the FDA requiring a risk evaluation and mitigation strategy (REMS) program with additional measures to ensure the safe use of the medicine.
Mlodszy braciszek Avandii , ACTOS natomiast ma sie dobrze.
Mam zagadke dla czytelnikow :ktory lek dofinansowuje NFZ ?
Pytanie za $100 . I dlaczego ?
