FDA Adds Black Box Warning to "Conventional" Antipsychotic Drugs

Peter Wetherall

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Today the FDA, by its new authority under the Food and Drug Amendments Act of 2007 (FDAAA), required drug manufacturers of "conventional" antipsychotics to change their label to warn about an increased risk of death in elderly patients being treated for symptoms associated with dementia (an off label use).  Similar warnings were included in the warnings of "atypical" antipsychotics in 2005.   
Antipsychotic drugs are commonly categorized into two classes, the older "conventional" antipsychotics and the newer "atypical" antipsychotics.  Both classes of the drugs are dopamine receptor antagonists that work by blocking the naturally occurring dopamine in the brain.  
It should be noted that these dopamine blocking drugs, as well as other similar prescription medications such as Reglan (prescribed for chronic heartburn) have been found to cause drug-induced neurological disorders such as Tardive Dyskinesia, particularly in the elderly, females and diabetics.    Tardive Dyskinesia is a severe and often drug-induced permanent neurological disorder that is characterized by involuntary muscle movements of the face, lips, hands, and feet.   It is a disfiguring condition and can be life-threatening.
Medical literature has long reported that the current warning for Reglan understates the risk of Tardive Dyskinesia to the elderly, females and diabetics.  The literature also reports that the risk of Tardive Dyskinesia increases over time.    Yet, the warning label for Reglan has never been updated to reflect this well  documented problem, thus, creating a false sense of security in the safety of these types of drugs among prescribing doctors. Hopefully the FDA will also force a label change to reflect the very real risk of  Tardive Dyskinesia either under its new found power or through the efforts of Plaintiff attorneys who are bringing this problem to light.