Saturday, January 31, 2015

FDA Approved Ads Misinform Patients About Antipsychotics And Motor Dysfunction


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

Thank You Mr Wipond and MIA.

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