Safety Labeling Changes July 2014

[melissaw72]

Got this in an email this morning.  Thought people would like to know.  From the email:

 

"The MedWatch July 2014 Safety Labeling Changes posting includes 73 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT."

 

Link to go to from the email:

 

 

http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm409189.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

[Aurochs]

A lot of these updates are for increased risk of angle-closure glaucoma with antidepressants. It appears that every antidepressant currently on the market (save the APs) will carry this warning from now on.

Trileptal now carries a warning for multi-organ sensitivity, which often presents as a viral infection (fever, rash, etc.). Read here for more information on that.

Other changes for psych drugs appear to be minor updates and things that were missing from previous labeling. Everybody already knows that amphetamines can cause bruxism, but this was apparently missing from the labeling for Adderall XR until recently.