RT Journal
A1 Yarows SA
T1 THe fda's defensive status and how it affects patient care
JF Archives of Internal Medicine
JO Archives of Internal Medicine
YR 2011
FD July 11
VO 171
IS 13
SP 1217
OP 1217
DO 10.1001/archinternmed.2011.291
UL http://dx.doi.org/10.1001/archinternmed.2011.291
AB 
Unfortunately, while some of our patients are being protected by this posture, others are also being hurt. Drugs, such as propoxyphene, cough medicines, and colchicine, are being removed from the market because of lack of safety data, new perceived risks, or brokered deal making; however, many other drugs ingested (ie, testosterone, herbs, vitamins) do not have long-term safety data and are continued on the market. This severely limits treatment options for our patients. In addition, multiple new Black Box warnings are being added to products. There has been an increase in drug label adverse drug events of 200% over the past 50 years and a 41% increase since the 2006 new Federal Drug Administration labeling guidelines discouraging exhaustive lists of adverse events.1 These Black Box and additional warnings result in fear by the patients that requires extensive discussion on the application of this warning to them, further straining the limited, busy office visit time. The warnings give a plethora of new opportunities for litigation attorneys, as seen on television and other media advertisements. Unfortunately, these warnings are not amended as new data contradict the warnings, such as the safety of metformin in chronic kidney disease and congestive heart failure or the lack of clinically significant coronary events as a result of the concurrent combination of clopidogrel bisulfate and omeprazole.2- 3