The Food and Drug Administration today called for the makers of four medications used to treat arthritis and other conditions to strengthen their warnings to consumers. The drugs in question are Humira, Cimzia, Enbrel, and Remicade.
The FDA says patients who take the medications need to be better advised of the risk of developing opportunistic fungal infections. Some individuals with such fungal infections have died.
Under the Food and Drug Administration Amendments Act of 2007, the FDA can now require drug manufacturers to make safety-related changes to prescribing information or labeling. Manufacturers must now submit proposed safety label changes to the FDA within 30 days or provide a reason why they do not believe the changes are necessary.
Source: http://www.fda.gov/bbs/topics/NEWS/2008/NEW01879.html
