What Happens If There Is A Black Box Warning?

You have probably heard of a Black Box Warning and probably wondered what it is. It is the most restrictive FDA warning short of a product drug being taken off the market. It is the most severe type of Federal Drug Administration warning over the safety concerns of a medication. For example, Levaquin has a black box warning advising of the serious effects to tendon ruptures and Reglan has a black box warning advising that over 90 day use may cause Tardive Dyskinesia. The purpose of a Black Box Warning is to alert consumers that a particular medication may cause serious side effects. The Black Box Warning appears on printed materials inside the drug’s packaging and is given to doctors who may prescribe the drug. It is also in the drug’s magazines print advertising. It is surrounded by a printed black rectangle and that is why it has been named “Black Box Warning.” The FDA has the power to require these warnings of a drug company. Drug companies have nothing to do with the placement of a Black Box Warning. Statistics have shown that after a drug gets a Black Box Warning, 90% of the doctors prescribe it with less frequency than prior to the warning. No doctor wants to prescribe a Black Box Warning drug because of the increased likelihood of a malpractice lawsuit if side effects develop.

Black box warnings are included in Cipro, Levaquin, Avandia for an increased chance of heart failure or heart attack, Zoloft, Paxil and Lexapro for suicide in young adults.