Accutane for Acne: The Devastating Side Effects
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 Accutane has also been withdrawn from the market in 11 other countries including France, Denmark, Austria, Germany, Portugal, Norway and Spain.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. Learn more about the homeopathic treatment of acne.
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.
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.
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.
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.
Corrupt drug company GlaxoSmithKline to distribute swine flu vaccine in Canada
Yesterday it was announced that Health Canada has approved GlaxoSmithKline’s swine flu (H1N1) vaccine , Arepanrix, for use in Canada. The mainstream media, drug companies, doctors, and Health Canada says that the swine flu vaccine is safe, but there is evidence to the contrary. I also strongly assert, with good reason, that the swine flu vaccine is not safe for pregnant women and young children.
GlaxoSmithKline assures us that the swine flu vaccine is safe. Let’s look at their track record to see whether they are a good, honest company, or not:
Paxil is an antidepressant drug that GlaxoSmithKline first introduced to the market in 1992. A few days ago a US jury ordered the company to pay 2.5 million to a woman who took the drug during pregnancy and consequently her son was born with serious heart defects. There are 600 similar cases pending that blame Paxil for heart problems and other birth defects. At the trial, an executive of the drug company talked about burying negative studies of Paxil. A company memo was presented as evidence during the trial.
In 2000, GSK pulled a drug for irritable bowel syndrome, Lotronex, off the market because it was linked to severe side effects and several deaths. It had only been on the market for 8 months, and in that time had caused 4 deaths and nearly 200 serious gastrointestinal events.
In 2001, an article in Bio-Medicine links GSK’s anti-smoking medication Zyban with 5000 adverse reactions and 40 deaths.
In 2003, the Italian branch of GlaxoSmithKline faced fraud and bribery charges for providing financial incentives to physicians to favour their products.
In 2005, the drug company was forced by the FDA to put new warnings on the labels of three of their asthma medications: Advair, Serevent, and Foradil. These asthma medications all contain long-acting beta 2-adrenergic agonists (LABA), which are linked to an increased risk of severe asthma episodes and death.
Also in 2005, GSK paid over $150 million dollars in a drug pricing fraud case. It was alleged that the company was engaged in a scheme to set and maintain fraudulent and inflated prices for anti-emetic drugs Zofran and Kytril.
In 2007 the FDA issued a warning about the GlaxoSmithKline diabetes drug Avandia. Avandia has the propensity to worsen heart failure in patients who already have significant heart failure. GSK has faced hundreds of lawsuits over Avandia. Patients who are suing GSK say that the company knew about the drug’s risk but did not warn consumers until until the FDA forced its hand.
In 2008 the Argentinian authorities started an investigation of a possible link between the deaths of 14 children and an experimental vaccine they were taking in a clinical trial run by GlaxoSmithKline.
In the summer of 2009, a “media backgrounder” written by GlaxoSmithKline talks about how they are testing the HPV vaccine Cervarix on a large number of different women. The vaccine has not been approved yet but they are using women as guinea pigs in their trials.
What lawsuits will we hear about after enough people have been vaccinated by their new swine flu vaccine, Arepanrix? GlaxoSmithKline can laugh all the way to the bank, because it will be taxpayers, not the company, who will be paying for any vaccine damages. That’s a pretty sweet deal for GSK!
GlaxoSmithKline expects to earn revenue of about 2.1 billion from the sale of their H1N1 vaccine. When they tell you the vaccine is safe, are they thinking about your safety, or are they thinking about their profits?
By Sonya McLeod
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