FDA Warnings: All Show No Substance
On April 7, 2005, the FDA required Pfizer to put a “black box” warning on Celebrex labels. This is the strongest warning available to the FDA, and requires doctors to prescribe Celebrex as a last resort for patients suffering from pain. The drug is also contraindicated for those post-coronary artery bypass surgery.
This all sounds good, but the fact is that many doctors and patients will never receive this warning. Even with all the news surrounding Celebrex and the entire class of Cox-2 Inhibitors, some doctors and many patients are too busy to read and understand the new warnings. “Dear Healthcare Professional” letters are sent out to doctors for every label change. There is a serious question how many doctors have the time in their busy schedules to actually read all of them.
Furthermore, drug companies like Pfizer send out field representatives to promote their drugs directly to doctors. Unfortunately, these representatives have only the drug company’s best interest in mind when determining what information to spread. Doctors in turn often rely on this information in prescribing drugs to their patients. The end result is that doctors often are not made aware of new label changes because of their demanding time schedules and their continuing-education system being commercially controlled by drug companies. In the end, the “black box” warning is all glitz and no guts. (See Related Article, Tough Warning Labels, Weak Results).