الخميس, 24 أيار 2012   3. رجب 1433

 

 

 

 

 

 

 

 

صورة واجمل تعليق

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  متى سيتم صرف الادوية بهذه الطريقة ؟؟؟ وهل تعتقدون ان هذه الطريقة ستنجح لدينا في الدول العربية ؟؟؟ ثم ما هو مصير الصيدلاني ؟؟؟…

 

 

 

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القائمة البريدية



 
Regulators in France said Thursday that Takeda's Actos (pioglitazone) will be withdrawn from the market after a study commissioned by the agency showed that the treatment carried a slight increased risk of bladder cancer.
 
 
After a meeting to consider the risks and benefits of the diabetes drug, AFSSAPS said doctors should no longer prescribe the agent .
 
 
The agency also called for Takeda’s Competact (pioglitazone/metformin), which was approved in 2006, to be pulled from the market.
 
 
 Takeda last year withdrew its application to market a once-daily version of the drug in Europe after regulators said they were unlikely to grant approval without additional data on the long-term efficacy of the metformin component of the product.
 
 
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), which initiated a review of pioglitazone-containing medicines in March 2011, said it is is currently reviewing all relevant data to assess their impact on the balance of benefits and risks of these drugs.
 
 
The agency indicated that this review will also now include the results of the AFSSAPS study, and will discuss this issue at their next meeting starting June 20. However, while the review is ongoing, CHMP is not recommending any changes in the use of pioglitazone-containing drugs.
 
 
Takeda vice president of medical and scientific affairs Robert Spanheimer said the company has not yet had time to examine the French study and its conclusions, but noted that two ongoing prospective trials being conducted have so far shown no risk of bladder cancer or other cancers associated with Actos..
 
 
Actos, which was approved in Europe in 2000 as an option for people with diabetes who didn't benefit from metformin, had sales of 388 billion yen ($4.8 billion) in the last fiscal year. The agent's safety is also under investigation in the US, where the FDA launched a probe into its bladder cancer risk in September last year