Posted by ed_uk2010 on January 24, 2015, at 8:54:47
In reply to Re: EMA Suspends Use Of Dozens Generics Flawed Studies, posted by Zyprexa on January 24, 2015, at 3:44:24
Hi
Thanks for posting Phillipa.
>Could that be why there is a back order on my 10mg olanzapine from Teva?
It seems very unlikely to be related.
I looked through the entire list of products (marketed in Europe) that were studied at that company. There is no brand of olanzapine on the list at all. Also, it seems that TEVA contracted out very little research to the company in question. There are a few TEVA products on the list, but not olanazapine. TEVA market olanzapine is many European countries and none of these products appear on the list. It therefore seems unlikely to me that any of TEVA's olanzapine generics were studied at that site.
Anyway, aren't you in the US? The US FDA have not recalled any medicines studied at that site. The European Medicines Agency are looking into the issue but only France, Germany, Belgium and Luxembourg have so far recalled any products. It was the French drugs regulator who found problems at their inspection. The US inspection appeared to go well.
I noticed the subject line for this thread isn't actually correct. The EMA have recommended that individual European countries consider suspending the generics on the list where alternatives exist from other manufacturers. So far, the EMA have not enforced any suspensions.
The British medicines authority (the MHRA) made a statement yesterday...
Following the European Medicines Agencys (EMA) Committee for Medicinal Products for Human Use (CHMP) recommendation today to suspend the licences for some medicines licensed in the European Union (EU) that were based on clinical trials conducted at GVK Biosciences site in Hyderabad, India, Dr Samantha Atkinson, Deputy Director of MHRAs Inspection, Enforcement and Standards (IE&S) Division said:
This is a precautionary measure. There is no evidence to suggest that these medicines are not safe and effective and people should continue to take their medicines as prescribed.
This recommendation will now be considered by the European Commission and it will make the final decision as to whether the suspensions should be imposed. If the recommendation is adopted by the Commission, we will work with our colleagues at the Department of Health to ensure people have access to the medicines they need.
Personally, I expect the British authorities will decide to remove those generics from the market where alternatives are available, pending further study data. Where alternatives are not available, I think they will keep the products on the market and request further studies ASAP to check the data originally generated at GVK Biosciences.
poster:ed_uk2010
thread:1075444
URL: http://www.dr-bob.org/babble/20150102/msgs/1075456.html