LOTRONEX ACTION GROUP
www.lotronexactiongroup.org w [email protected]
Dr.
Bernard Schwetz D.V.M, Ph.D.
Acting
Principal Deputy Commissioner,
Food and
Drug Administration
5600
Fishers Lane
Rockville,
MD 20857
Dear Dr. Schwetz:
The
Lotronex Action Group, an international organization representing former users
of the drug alosetron (Lotronex, GlaxoSmithKline), hereby petitions the Food
and Drug Administration (FDA), pursuant to the Federal Food, Drug and Cosmetic
Act 21, U.S.C. Section 355(e)(3), and 21 C.F.R. 10.30, to immediately work with
the manufacturer GlaxoSmithKline to permanently provide access and safe
distribution of the drug to those diagnosed with diarrhea-predominant Irritable
Bowel Syndrome.
The
Lotronex Action Group believes the drug to be safe, if dispensed properly, and
that the benefits of Lotronex far outweigh the potential risk for adverse side
affects. [1]
Safety
We have
utilized the data from a survey conducted by the Irritable Bowel Syndrome Self
Help Group by former and current Lotronex users. [2]
The
results re: side effects from taking Lotronex:
Constipation (123) 25%
Diarrhea (10) 2%
Ischemic Colitis (4)
1%
Nausea (13) 3%
Sleep Disorder (3) 1%
Other (15) 3%
None
(288) 59%
Total
Selections = 485
DrugVoice conducted research with over 2,000 IBS patients,
many of who were former Lotronex users [3]. Research revealed a large number of
users who experienced life-changing benefits from Lotronex. Others, however either did not benefit or
experienced side effects that forced them to discontinue the medication or
reduce their dosage. These results
indicate that an important need for Lotronex exists, but that it is critical to
monitor and target its use to the appropriate patient population.
Conclusions
Symptoms
of diarrhea-predominant IBS include urgent and explosive bowel movements,
abdominal cramping, gas and nausea. Research suggests that IBS is one of the
most common functional GI disorders.
But although IBS is not a life-threatening disease, it can severely
diminish a person’s quality of life.
Members
of the Lotronex Action Group, along with many other IBS sufferers, have reported
a complete cessation of their IBS symptoms while taking Lotronex. The Lotronex Action Group acknowledges that
Lotronex has not helped everyone and that some who took the medication
experienced side effects. However, it
is the strong belief of the Lotronex Action Group that Lotronex is safe if
dispensed properly, with benefits far outweighing the potential risk for
adverse side affects.
The FDA
will have best served patients with diarrhea-predominant Irritable Syndrome by
working with the manufacturer GlaxoSmithKline to permanently provide access and
safe distribution of this drug.
ENVIRONMENTAL
IMPACT STATEMENT
Nothing
requested in this petition will have an impact on the environment.
CERTIFICATION
We certify
that, to the best of our knowledge and belief, this petition includes all
information and views on which this petition relies, and that it includes
representative data and information known to the petitioners, which are
unfavorable to the petition.
Yours
sincerely,
Corey Miller
Coordinator
Tom R.
Bell, Psy.D.
Email: [email protected]
URL: http://www.lotronexactiongroup.org/
[1]
Supported electronic petition with 1,105 signatures at www.lotronexactiongroup.org
(03/21/01)
[2] A non-profit
Internet self help health site about Irritable Bowel Syndrome www.ibsgroup.org and www.IBSwatch.com (12/00-03/01)
[3] A consumer research and strategic advisory firm
www.DrugVoice.com (06/00-12/00)