Food and Drug Administration-approved
information and public advertisements frequently mislead the public about the
actual neurodegenerative risks from second-generation antipsychotics, according
to an article in the American Journal of Public Health.
Frederick Jacobsen, a clinical
professor of psychiatry at the George Washington University School of Medicine
and Health Sciences, reviewed information materials put out by the FDA about
second-generation antipsychotics (SGAs), and found that these materials routinely
misrepresented the serious potential for neurological damages and tardive
syndromes such as tardive dyskinesia -- a permanent, Parkinson's-like motor
dysfunction that can be caused at high rates by long-term use of antipsychotic
drugs.
"Package inserts label tardive
syndromes 'potentially reversible' while uniformly omitting patient counseling
for long-term neurodegenerative side effects," stated Jacobsen. "I
have documented that package insert sections of all SGAs approved for affective
illnesses in the United States ignore or minimize tardive syndromes. Patient
Counseling Information omits reference to tardive dyskinesia, signifying that
physicians do not need to discuss long-term neurotoxicity with patients,
whereas Medication Guides shift responsibility for knowledge and recognition of
these potentially irreversible side effects back to patients. Current SGA media
advertisements suggest a likelihood of remedy for this chronic neurotoxicity
absent informed consent."
"Patients deserve better information
and education regarding the long-term side effects of SGAs, particularly
tardive syndromes, in FDA-approved package inserts, media advertisements, and
elsewhere," concluded Jacobsen.
Jacobsen, Frederick M.
“Second-Generation Antipsychotics and Tardive Syndromes in Affective Illness: A
Public Health Problem With Neuropsychiatric Consequences.” American Journal of
Public Health 105, no. 2 (February 1, 2015): e10–16.
doi:10.2105/AJPH.2014.302439. (Abstract)
(Full text)
--Rob Wipond,
News Editor
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entry was posted in Adverse Effects, Antipsychotics, Featured News, In the News, Informed Consent, Legislation & Regulation. Bookmark the permalink.
Thank You Mr Wipond and MIA.