Drug safety news round up – #Tysabri, #Vioxx and #Gilenya

In Drug Safety by aliceLeave a Comment

There are some interesting drug safety cases coming out in the news of late. Some ones I've notices that I thought were interesting so far this week include:

Vioxx

The latest Vioxx news sees a Merck settlement in Canada which could Merck $37million out of pocket though they are adamant of no wrongdoing and highlighting the safety work done in clinical trials, post approval safety monitoring and voluntary withdraw in 2004.

http://www.fiercepharma.com/story/merck-pay-37m-canadian-vioxx-case/2012-01-20

Tysabri

FDA has provided new labeling requirements for Tysabri to help identify and personalise treatment for a small at risk group. This is great news for Biogen and Elan as in the past this medicine may have been taken off the shelves can now remain, with the added advantage of an improved safety profile also.

http://www.pharmatimes.com/Article/12-01-23/New_Tysabri_label_to_personalise_treatment.aspx

Gilenya

And finally, the EMA is reviewing the benefit risk profile of Gilenya following reported heart problems and unexplained deaths in Gilenya patients.

http://www.pharmatimes.com/Article/12-01-23/EMA_reviews_Gilenya_deaths_links_backs_Novartis_Cushing_s_drug.aspx

 

vioxx, tysabri, gilenya, drug safety, pharmacovigilance

 

 

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