Accutane for Acne: The Devastating Side Effects

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Accutane is a prescription medication for severe acne produced and distributed by Roche Pharmaceuticals. Since 1982 when it was approved by the FDA, 5 million Americans and 8 million people in other countries have been prescribed Accutane.

No Longer Available in the United States

Roche was making up to $1.2 billion annually from this popular acne drug until June 2009 when they voluntarily withdrew it from the US market. Over 1000 pending federal lawsuits along with $56 million awarded in compensation to victims of the drug’s serious side effects have been contributing factors to Roche’s decision to withdraw the drug from the US market.

Isotretinoin, the generic form of Accutane, is still available in the United States. Other Accutane generics are sold under the names Claravis, Sotret, and Amnesteen. Accutane has also been withdrawn from the market in 11 other countries including France, Denmark, Austria, Germany, Portugal, Norway and Spain. Roche continues to sell Accutane in Canada, and in other parts of the world where it is known as Roaccutane.

Suicide, Depression & Psychosis

As of 2002, the US FDA’s Adverse Event Reporting System (AERS) contained 3,104 reports (US and foreign) of adverse psychiatric effects after using Accutane. The FDA was aware of 173 reports of suicide (both US and foreign) in association with accutane as of 2002. Compared with all drugs in the FDA’s AERS database to June 2000, accutane ranked within the top 10 for number of reports of depression and suicide attempts.

Scientific Studies Link Accutane to Suicide, Depression & Psychosis

Those who would like to review the scientific literature that links accutane to depression, suicide and psychosis can examine the references section at the end of this article. Worth noting are the studies done by Barak et al, Robusto, Ng, and Byrne.

Of special note is “Overview of Existing Research and Information Linking Isotretinoin (Accutane), Depression, Psychosis and Suicide” by researcher J. O’Donnell. He concludes, “There is no contesting that this drug is effective at clearing up the most severe forms of acne, but the public must be informed of the proper limited indication for its use, because depression and suicide can follow in patients with no prior history of psychiatric symptoms or suicide attempts.”

Scientific Animal & Human Studies
Explain How Accutane Causes Depression

In one study, mice who were fed 13-cis-retinoic acid (the active ingredient in accutane) showed an increase in depression-related behaviors (O’Reilly et al). Another study done on mice showed that 13-cis-retinoic acid results in a significant decrease in cell proliferation in the hippocampus and severely disrupts capacity to learn a spatial radial maze task. Crandall et al conclude: “The results demonstrate that the regions of the adult brain where cell proliferation is ongoing are highly sensitive to disruption by a clinical dose of 13-cis-RA.”

Recent human studies also explain the correlation between Accutane and depression. In one study, brain imaging was used to measure changes in the brain after patients took Accutane for a 4 month period. Bremner et al. conclude that Accutane treatment is associated with decreased brain metabolism in the orbitofrontal cortex, a brain area known to mediate symptoms of depression.

Inflammatory Bowel Disease and Ulcerative Colitis

In February 2010 Roche was ordered to pay $25 million to a man suffering from ulcerative colitis after taking Accutane. His symptoms were so severe that he had to have his colon removed. In 2008, a court awarded a woman $10.5 million after Accutane gave her ulcerative colitis; she also needed to get her colon removed. In 2007, a man was awarded $7 million and a woman was awarded $2.6 million; both suffered from inflammatory bowel disease after taking Accutane.

Accutane Goes Hollywood

Trial will soon be  underway for Hollywood actor James Marshall. He is alleging that Accutane caused his inflammatory bowel disorder, leading to the end of his acting career as well as the removal of his colon. Martin Sheen, Brian Dennehy and  Rob Reiner will testify.

Scientific Proof that Accutane Causes Inflammatory Bowel Disease

In 2009, the Los Angeles Times reports that researchers from the University of North Carolina presented evidence showing a higher rate of bowel disorders in isotretinoin (Accutane) users.

Accutane Linked to Severe Skin Disorders

Yes, Accutane may cure your severe acne, but it may also cause an even more severe skin condition. Health Canada warns that Accutane could cause severe skin reactions that could lead to hospitalization, disability, and death.

Taking Accutane can lead to Stevens-Johnson Syndrome, in which the outer layer of skin becomes separated from the dermis, or underlying skin layers. It has also been associated toxic epidermal necrolysis, a more severe form of Stevens-Johnson Syndrome.

Birth Defects and Miscarriage

Roche openly admits to Accutane’s dangers to women of childbearing age. Women of childbearing age who take Accutane must use two forms of birth control to prevent pregnancy. Unfortunately, pregnancies do still occur. Congressman Bart Stupak states that according to a 1990 report by the FDA: “the magnitude of fetal injury and death has been great and permanent, with 11,000 to 13,000 Accutane-related abortions and 900 to 1,100 Accutane birth defects.” It is widely known and openly admitted by Roche that Accutane can cause birth defects and miscarriages.

High Cholesterol

In a 2006 study by Zane et al., it was found that Accutane causes an elevation in cholesterol, triglycerides and liver enzymes.

Erectile Dysfunction & Sexual Side Effects

A 2005 study by Sanchez & Dorantes links Accutane to erectile dysfunction.

Kevin Pezzi MD dedicates part of his website to the sexual side effects of accutane. Dr. Pezzi has heard of hundreds of cases linking Accutane to long-term sexual dysfunction.

SAFE, EFFECTIVE TREATMENT OF ACNE AND ACCUTANE SIDE EFFECTS

Classical homeopathy treats acne effectively and naturally with no side effects. Homeopathy can also effectively treat the side effects of Accutane. Visit my website to learn more about the homeopathic treatment of acne or contact the clinic to make an appointment.

References

Barak, Y et al. “Affective Psychosis following Accutane (Isotretinoin) Treatment,” Int Clin Psychopharmacol. 2005 May;20(3):182.

Bremner, JD et al. “Functional Brain Imaging Alterations in Acne Patients Treated with Isotretinoin.” Am J Psychiatry. 2005 May;162(5):983-91.

Byrne, A. “Isotretinoin Therapy and Depression – Evidence for an Association.”Int J Psych Med 1998; 15(2):58-60.

Crandall, J. “13-cis-retinoic acid suppresses hippocampal cell division and hippocampal-dependent learning in mice,” Proc Natl Acad Sci U S A. 2004 Apr 6;101(14):5111-6. Epub 2004 Mar 29.

Feeley, Jef and Sophia Pearson, “Roche Pulls Accutane off Market after Jury Verdicts,” Bloomberg, Jun 26, 2009.

Feeley, Jef. “Roche to Face Hollywood Stars in Accutane Trial,” Bloomberg, July 30, 2010.

Fresco, Adam, “Call for Ban on Acne Drug Linked to Suicide,” The Sunday Times, September 21, 2005.

Hull, PR and C D’Arcy “Isotretinoin use and Subsequent Depression and Suicide: Presenting the Evidence,” Am J Clin Dermatol. 2003;4(7):493-505.

Ng, CH. “Acne, Isotretinoin Treatment and Acute Depression,” World J Biol Psychiatry. 2001 Jul;2(3):159-61.

O’Donnell, J, “Overview of Existing Research and Information Linking Isotretinoin (Accutane), Depression, Psychosis and Suicide,” Am J Ther. 2003 Mar-Apr;10(2):148-59.

O’Reilly et al. “Chronic Administration of 13-cis-retinoic acid increases depression-related behavior in mice.” Neuropsychopharmacology. 2006 Sep;31(9):1919-27. Epub 2006 Jan 4.

Ro/Accutane Action Group www.accutaneaction.com

Robusto, O. “Depression Caused by an Anti-Acne Agent,” Acta Med Port. 2002 Jul-Aug;15(4):325-6.

Saiontz & Kirk, P.A. “Accutane Lawsuits” Aboutlawsuits.com, May 2010.

Sanchez, A Tirado and Dorantes, Leon. “Erectile Dysfunction and Isotretinoin Therapy.” Actas Urol Esp. 2005 Nov-Dec;29(10):974-6.

Tesoriero, Heather Won, “Jury Awards 10.5 Million Over Accutane,” Wall Street Journal. April 23, 2008.

Voreacos, David  and John Martin. “Roche Ordered to Pay $25 Million to Accutane User.” Bloomberg. February 16, 2010.

Wysowski et al. “An Analysis of Reports of Depression and Suicide in Patients Treated with Isotretinoin.” J Am Acad Dermatol. October 2001: 515-519.

Zane, Lee T et al. “A Population-Based Analysis of Laboratory Abnormalities During Isotretinoin Therapy for Acne Vulgaris.” Arch Dermatol. 2006;142:1016-1022.

By Sonya McLeod
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