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Accutane FDA Warning
Representative Bart Stupak's Statement on Accutane - Oct.
5, 2000
I want to thank you all for coming here today. This is one
press conference Laurie, Ken and I, and the other families
who have joined me, wish we never had to attend. The information
on my website and the press packet you have received relate
to my concern about the potential risks of Accutane. I want
to explain to you today the reasons for my family's concern
about Accutane, manufactured by Roche Laboratories. After
everyone has had an opportunity to comment, we will take questions.
To begin with, I would like to give you some background on
how this all came about. My son BJ died in May of this past
year. His death, like the death of any child, is a parent's
greatest heartache and we were devastated. Our son BJ loved
life. He was involved in sports, many school activities, Treasurer
of the student body and President-elect of the student council
at Menominee High School in Menominee, Michigan. BJ had many
friends. He was a happy teenager who had great potential for
life. He showed no signs of depression or loss of enthusiasm
for life.
BJ committed suicide. As Laurie removed BJ's personal items
and was in the process of disposing of the few Accutane pills
that were left from his prescription, she questioned whether
Accutane was related to BJ's death. Laurie went on the Internet
and typed in the word Accutane. She came across the MedWatch
alert that had been issued by the FDA in February of 1998,
and it raised questions that require answers on the use of
this prescription medication and its relation to the death
of children.
The MedWatch stated that due to the adverse event reports
the FDA had received on Accutane, the FDA felt there was sufficient
cause to strengthen the warning on the Accutane label to include
the risk of psychosis and suicidal thoughts and actions.
The FDA in February of 1998 stated in a Memorandum the adverse
events that had been reported from the use of Accutane. The
Memorandum showed that there were 31 cases of suicide, suicide
attempt or suicide ideation that were associated with the
use of Accutane. Of that number, 12 were suicides, 9 of them
male, 2 female, and 1 unknown, and the median age was 17.
The average onset of the event was 88 days after the patient
had started on the prescribed use of Accutane. As the FDA
Memorandum stated: "(f)or the majority, there was no
antecedent history of depression and the patients were not
noted or known to be depressed in the time period prior to
their suicide."
I also found that Roche had received a warning letter in
March 1998 from the FDA because Roche was marketing the drug
as a treatment for depression, under the theory that it could
help people who were suffering from depression and poor self-image
as a result of their acne. The FDA warning letter to Roche
stated that this promotion was false and misleading, and that
Accutane had never been approved for treatment of depression.
In fact, quite the opposite was true, as you will read in
the warning letter which is enclosed in the press packet.
In pertinent part, the FDA states:
Roche, however, has not systematically studied the ability
of Accutane to modify or prevent such illnesses as depression
and has presented no basis for asserting that Accutane is
effective in improving the psychosocial and emotional well-being
of such patients. This claim is particularly troublesome in
light of information recently presented in a Dear Doctor letter,
that Accutane may cause depression, psychosis, and rarely,
suicidal ideation, suicide attempts and suicide.
As parents, Laurie and I took the information we had found
very seriously. As I said earlier, BJ had not shown signs
of depression, and if we had known that this drug could cause
depression, suicide ideation, or suicide, BJ would never have
come into contact with Accutane. The warnings on BJ's Accutane
package contained none of these risks. The only warnings contained
on the package were for the side effects of : headaches, nausea,
vomiting, blurred vision, changes in mood, severe stomach
pain, diarrhea, rectal bleeding, persistent feeling of dryness
of the eyes, and yellowing of the skin or eyes and/or dark
urine. Nothing about depression, suicide ideation or suicide.
All Accutane package labeling currently state that before
a woman takes Accutane she must read, understand, and sign
a consent form.
As a parent, I would have wanted to know of the risk of depression,
suicide ideation and suicide, before allowing my child to
take this drug. As a legislator, I believe that the public
has a right to know of all risks associated with prescription
drugs. There needs to be a thorough study implemented to determine
the connection between Accutane, depression, suicide ideation
and suicide. The study should be conducted by an independent
third party, not by the FDA or Roche.
I am speaking out now because of my concern raised by the
information I discovered. I believe the public needs to make
its own informed decision about the risks associated with
Accutane.
I can say that what Laurie and I turned up on our own caused
us concern that there appeared to be a link. The MedWatch
in 1998 indicates that the FDA had enough concern regarding
a link to advise the inclusion of an additional warning. In
mid-September the FDA provided an Advisory Panel with a figure
of 37 suicides attributed to the use of Accutane since 1983.
The FDA raised their figure to 44 suicides over the same period
after Roche corrected the FDA's number. My staff and I have
painstakingly gone through the FDA's Adverse Event Reports
connected with Accutane, and we found 54 suicides since 1998,
the same year the FDA issued its MedWatch. Another 30 deaths
that are most probably suicides occurred between 1983-1997,
a time where the record-keeping was a little less precise.
A total of 84 suicides and BJ's is not part of the adverse
event reports. The compilation of statistics that we put together,
and an explanation of our methodology to minimize inaccuracies
is in the press packet as well.
As you can tell, our numbers, the FDA's numbers, and Roche's
numbers are different and vary greatly- the FDA's numbers
show an average of 2 suicides a year, our numbers show that
in the last two and half years, there have been almost 2 suicides
a month associated with the use of Accutane. I know that none
of these numbers are complete, because there was no report
on BJ. In fact, the FDA has indicated that the actual number
of suicides as a result of Accutane could be as much as ten
times higher than the reported numbers.
I believe that the statistics I mentioned previously are
alarming enough to inform the public of the risk that may
be associated with the use of Accutane and the recommendations
contained in the press packet you received calling for an
independent study and a uniform and immediate warning and
notification system. The copies of the package labeling in
the press packet that were received from Roche show that they
still do not uniformly warn of the risks and the adverse side
effects identified as depression, suicide ideation and suicide.
BJ's package labeling never included any warning as to the
risk of depression, suicide ideation and suicide. There is
a concern here of a potential risk to the health and safety
of our children.
Accutane FDA Warning
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