History of the Accutane Depression Controversy

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      Accutane/Isotretinoin and Depression:
      Mechanism of action still unknown, mechanism of adverse effects still unknown.

      -The FDA approved Accutane to treat severe acne that is unresponsive to other treatments.

      -One of the original discoverers of isotretinoin’s efficacy in treating acne, Dr. Frank Yoder, sent a warning of its potential dangers.

      “I wish to express my concern and anxiety over the potential tragedy that might arise from abuse
      and misuse of Accutane…the potential toxicity of this drug has been seriously under-

      F. W. Yoder, “Isotretinoin: A Word of Caution,” JAMA: The Journal of the American Medical Association, vol. 249, no. 3, p. 350, Jan. 1983.

      -The fact that symptoms of depression had been reported was included in the Accutane package insert.

      The consumer advocacy group, Public Citizen, called for Accutane to be banned.

      -The FDA forced Roche to include a warning that some users have reported adverse reactions including depression, psychosis, and “rarely, suicidal ideation, suicide attempts and suicide.”
      Roche did not adhere to this requirement until 2002.

      -After two decades of controversy over the link between Accutane and depression, birth defects, and severe psychological side effects associated with the drug, a congressional hearing to review Accutane’s safety was held.

      A transcript can be found here: http://www.gpo.gov/fdsys/pkg/CHRG-106hhrg73924/content-detail.html

      -On May 14, 2000, former Congressman Bart Stupak’s son committed suicide towards the end of his course of Accutane. This prompted a second hearing in 2002.

      -During the second Congressional hearing, Hoffman La-Roche executives were questioned as to why the company withheld knowledge indicating the likelihood of Accutane to cause depressive symptoms.

      A video of the hearing: http://www.c-span.org/video/?174192-3/safety-accutane

      -Former FDA doctor, David Graham, says Accutane represents a “regulatory failure” and that “sales should be restricted immediately” during a Senate hearing regarding the FDA’s ability to safeguard the public.

      -The Alliance for Human Research Protection asked Keith Altman, Adverse Drug Reaction Statistics Analyst, to analyze FDA’s Medwatch database for drug-linked suicides by children under 18 years of age. He found that between 1989 and June 2003, there were 216 reported drug-linked suicides in under 18 year olds. Of these, 72 suicides were linked to Accutane. The next highest number of suicides – 55–involved Prozac. Considering MedWatch reflects approximately 1% of actual adverse drug events, 72 Accutane suicide reports represent 7,200 suicides, and 55 Prozac-related suicide reports represent 5,500 suicides.

      -The iPLEDGE program was implemented with a focus on educating women of the high risk of severe birth defects which isotretinoin is capable of causing. Today, there is scant evidence that the program is being enforced.

      -Roche withdrew brand name Accutane from the U.S. market while under heavy fire from personal injury lawsuits.

      -A journal –published review of the available scientific evidence and adverse event reports found a high likelihood of a causal link between isotretinoin treatment and psychological adverse events. The authors determined an extremely high correlation between isotretinoin and depression compared to alternative prescription acne treatments and noted that isotretinoin is the only non-psychotropic drug in the FDA’s top ten list of drugs associated with depression.

      V. P. Kontaxakis, D. Skourides, P. Ferentinos, B. J. Havaki-Kontaxaki, and G. N. Papadimitriou, “Isotretinoin and psychopathology: a review,” Annals of General Psychiatry, vol. 8, p. 2, 2009.

      After sudden and sometimes permanent side effects of isotretinoin (sold in parts of Europe as Roaccutane) were described by the victim or victim’s family as the sole factor in many instances of suicide, members of British Parliament called for “rigorous up-to-date research to ascertain why some groups of patients are more vulnerable to its severe side effects than others.”

      It is common knowledge that Accutane / isotretinoin continues to be routinely prescribed to treat mild and moderate acne, contrary to the supposed tight FDA-imposed restriction that it only be an option in the most severe cases of acne.

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