The FDA's move to put tighter controls on combo pain drugs like Vicodin that contain hydrocodone with over-the-counter painkillers like aspirin have it again balancing its role as a regulator concerned about the safety and effectiveness of drugs with growing concerns about overdose deaths and addition.
AbbVie, Shire and Pfizer are unamused and unimpressed by a designer's use of the names of their drugs Vicodin, Adderall and Xanax as a fashion statement. The new T-shirts have struck a nerve even as regulators are in the midst of a national discussion on prescription drug abuse.
The FDA is enmeshed in a process to find the right balance on how to approve and regulate addictive painkillers and a vote expected today is just one small piece of that puzzle-piecing exercise.
In September, the generics subsidiary of Endo Health Solutions voluntarily recalled one lot of two pain drugs that it called "super potent" because both exceeded their prescribed weights. Now Endo has added 100 more lots to that removal.
The FDA wants to look over painkillers that include the ingredient known as hydrocodone amid an increase in abuse and federal drug agents' ongoing call for stricter prescribing guidelines, Bloomberg reported.