Never use Accutane; it can Kill You
by Kevin Caruso
I have received many e-mails from people who have had horrible experiences with Accutane. And the most disquieting e-mails are from those who lost a loved one to suicide because of the drug.
This report is thus dedicated to everyone who has lost a loved one to suicide because of Accutane or who has had their life or the life of a loved one negatively affected because of this dangerous (and largely unnecessary) drug.
I would like to especially thank Gary and Barbara Moody, who recently lost their 17-year-old son, Jason, to suicide because of Accutane.
And Bonnie Moody, Jason’s 16-year-old sister, who is fighting with the courage, maturity, and tenacity of someone twice her age to inform people about the dangerous risks associated with Accutane.
I love you Gary, Barbara, and Bonnie.
You are heroes.
You are not only honoring Jason by helping to spread awareness about the dangers of Accutane, but are helping to prevent suicides.
Lastly, it should be noted that this report was inspired by 16-year-old Bonnie Moody, who is STILL a great sister to Jason and is STILL taking action to show her deep love for him and to fight for him, even though Jason is an angel in Heaven.
You are awesome Bonnie.
To everyone: Please carefully read this entire report. It can save your life, the life of a loved one, or the life of a friend.
Be informed.
Read the entire thing.
And then tell others about it.
Thanks,
Kevin Caruso
Never use Accutane; it can Kill You:
A Critical Report on the Dangers of Accutane
by Kevin Caruso
February 26, 2007
There are many reasons why you and your loved ones should not use Accutane; but the most important reason is this: it can cause you to die by suicide.
So, DO NOT use Accutane, under any circumstances, and DO NOT allow your loved ones to use Accutane.
Period.
There are innumerable SAFE alternatives to Accuatane, so you and your loved ones do not need to use it. Ever.
Now, let’s examine some important facts about Accutane.
The drug was introduced in 1982 and is manufactured by Roche. It is a strong acne medication and is supposed to be used for severe acne as a “treatment of last resort.” But many dermatologists prescribe Accutane for mild or moderate cases of acne without even trying an alternative treatment first.
Accutane can cause severe, and even tragic, side effects and psychiatric problems, including birth defects, miscarriage, fetal death, Crohn’s disease, central nervous system injuries, cardiovascular injuries, bone and muscle loss, ulcerative colitis, pancreatitis, immune system disorder, depression, and suicide.
In September 1983, Public Citizen, a national non-profit public interest organization, petitioned the FDA for warning labels because of the high risk of these side effects.
In 1986, Roche changed Accutane’s package insert to indicate that some users reported symptoms of depression.
In 1988, Public Citizen petitioned the FDA for a ban on Accutane.
By 1990, an FDA memo indicated that there had been 11,000 to 13,000 Accutane related abortions and 900 to 1,100 Accutane related birth defects.
In 1996, an FDA document indicated that more than 90 percent of females who were prescribed the drug did not have severe acne.
In 1997, French health authorities required Roche to add a warning to their package insert indicating the possibility of suicide to the list of Accutane’s possible side effects; but Roche did not inform the FDA about this action.
A few months later, the FDA issued a stern warning letter to Roche for failing to submit serious adverse event reports; unbelievably, Roche STILL had not informed the FDA about the French mandated warning about Accutane being a possible cause for suicide.
In 1997, A Roche doctor studies data on depression in Accutane patients, leading him to recommend users be supervised for signs of depression and, if necessary, referred for treatment.
In February 1998, the FDA concluded that Roche had not acted in good faith and recommended “active consideration of removal of Accutane from the market.”
They also advised doctors who prescribed Accutane to closely monitor their patients for signs of depression, and they required bold face warnings to physician package inserts which stated the following: "Psychiatric disorders: Accutane may cause depression, psychosis and, rarely, suicidal ideation, suicide attempts and suicide. Discontinuation of Accutane therapy may be insufficient; further evaluation may be necessary. No mechanism of action has been established for these events."
Below is the entire “Dear Doctor” letter that the FDA required Roche to distribute to all doctors who prescribed Accutane:
February 1998
Dear Doctor:
Please be advised of important changes to the prescribing information for Accutane (isotretinoin).
The information pertaining to Adverse Experience reports of depression, which has appeared in the ADVERSE REACTIONS section of the prescribing information, will now also appear in the WARNINGS section. The following revisions will be made:
- the WARNINGS section will now begin with the following paragraph in bold type:
"Psychiatric disorders: Accutane may cause depression, psychosis and, rarely, suicidal ideation, suicide attempts and suicide. Discontinuation of Accutane therapy may be insufficient; further evaluation may be necessary. No mechanism of action has been established for these events."
- the paragraph on depression in the ADVERSE REACTIONS section will become paragraph 5 of that section and will be revised as follows:
"In the post-marketing period, a number of patients treated with Accutane have reported depression, psychosis and, rarely, suicide ideation, suicide attempts and suicide. Of the patients reporting depression, some reported that the depression subsided with discontinuation of therapy and recurred with reinstitution of therapy."
It is important to note that reports of these Adverse Experiences are uncommon but, because of their potential consequences, clinicians should be attentive to any new behavioral signs and symptoms.
Please consult the revised complete product information for Accutane, which is enclosed. If you have any questions about Accutane, we encourage you to call the the toll-free number for Roche Medical Services at 1-800-526-6367. Also, if you are aware of any serious Adverse Experiences potentially associated with the use of Accutane, please report such information to Roche at the above number or to the Food and Drug Administration MedWatch program at 1-800-FDA-1088.
Sincerely,
Russell H. Ellison, M.D.
Vice President
Medical Affairs
Roche Laboratories Inc.
340 Kingsland Street
Nutley, New Jersey 07110-1199
Below is the FDA “Talk Paper” which was released in association with the February 1998 warnings about Accutane. Note that a “Talk Paper” is distributed by the FDA to its own personnel so that they will be prepared to respond with “consistency and accuracy” to questions from the public.
FDA “Talk Paper” for Accutane
February 25, 1998
IMPORTANT NEW SAFETY INFORMATION ABOUT ACCUTANE
FDA today is advising consumers and health care providers of new safety information regarding the prescription anti-acne drug Accutane (isotretinoin) and isolated reports of depression, psychosis and rarely suicidal thoughts and actions.
Accutane was approved in 1982 to treat only a very special type of acne – severe nodular acne that has not responded to other therapies.
Although the Accutane label already included information regarding depression as a possible adverse reaction, the agency felt health care providers and others needed additional information as a result of adverse event reports the agency has received.
FDA and the drug manufacturer are strengthening this label warning, even though it is difficult to identify the exact cause of these problems. Such problems could already be more common among the patient populations likely to be on the drug.
However, because some patients who reported depression also reported that the depression subsided when they stopped taking the drug and came back when they resumed taking it, the agency and the manufacturer felt the strengthened labeling was warranted as a precautionary measure.
Given the complex nature of depression and suicidal conditions, the new label information will advise health care providers that merely discontinuing the drug may be insufficient to remedy these adverse events, and that further evaluation may be needed.
In the event of Accutane-related adverse events, health care providers are urged to contact the manufacturer, Roche Laboratories at 1-800-526-6367 or FDA MedWatch at (phone) 1-800-FDA-1088, (fax) 1-800-FDA-0178 or (mail) FDA, HF-2, 5600 Fishers Lane, Rockville, MD 20852.
Consumers seeking the latest safety information about FDA-regulated medical products also can find it at http://www.fda.gov/medwatch/safety.htm on the MedWatch Website.
In March 1998, Health officials in Britain and Ireland require warnings of Accutane’s risk of psychiatric disorders.
In 1999, Roche responded to mounting complaints about Accutane causing suicidal thoughts and suicide by adamantly telling the FDA that none of the 168 reports of suicidal behavior could be linked to Accutane.
In 2000, the FDA stated that there were 147 known suicides linked to Accutane.
In 2000, Roche changed Accutane’s package warning label to include possible side effects involving depression, rare suicidal thoughts, suicide attempts, and suicide.
In May 2000, Bart Stupak, Jr., son of Congressman Bart Stupak, died by suicide by shooting himself in the head. Representative Stupak would later say that Accutane was the cause for his 17-year-old son’s suicide.
Stupak said that the Accuatane package did not include any warnings about the possibility of depression or suicide and that the doctor did not tell them about the possibility either.
The congressman and his wife, Laurie, said they considered every possible cause for their son’s suicide and "the only thing we can find is Accutane."
In 2002, the FDA informed a congressional committee that the agency had received reports of 3,104 adverse psychiatric events and 173 suicides associated with Accutane.
In 2002, the Accutane label is changed to warn of “depression, psychosis and, rarely, suicidal ideation, suicide attempts, suicide, and aggressive and/or violent behaviors.”
In November 2004, FDA researcher David Graham testified before Congress that Accutane should be carefully scrutinized to determine whether the drug should continue to be on the market in the United States. Graham describes Accutane as “a 20-year regulatory failure by the FDA.”
In December 2004, USA today stated that Roche ignored an internal doctor’s recommendation that people who take Accutane be monitored for signs of depression and that a warning be placed on the drug’s U.S. label stating this.
In 2005, a study was published in the American Journal of Psychiatry concening the effects of Accutane.
The study began by conducting brain scans on 28 acne sufferers. Next, the 28 subjects underwent psychological tests to ensure that they were not depressed.
Then, the patients received either Accutane or an antibiotic for four months.
Afterwards, the subjects underwent a second brain scan which was then compared to their original scan.
The results of the study clearly indicated that the Accutane patients had decreased activity in the area of the brain associated with mood regulation.
"What we can say is that Accutane affects brain function ... and the areas that are affected are the areas involved with depression," said Dr. J. Douglas Bremner, who led the research project at Emory University Hospital in Atlanta.
So, the evidence is overwhelming that Accutane may cause depression and may lead to suicide.
Again, DO NOT use Accutane under any circumstances; and DO NOT allow your loved ones to use Accutane under any circumstances.
Period.
Please click below to visit Jason Moody's suicide memorial to pay your repect to this young angel who died by suicide because of Accutane:
Jason Moody Suicide Memorial
If you or someone you know is suicidal, please go to the Home Page of this website for immediate help.
Thank you.
I love you.
Take care,
Kevin Caruso
