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The
following FAQs are intended to provide information in lay terms for
people who used the drug Lotronex. This material is not intended to be a
legal document and is for informational purposes only. Please contact
our offices if you require further information.
What is Lotronex?
What is irritable
bowel syndrome (IBS)?
How does Lotronex work?
Who should take Lotronex?
Why is Lotronex controversial?
Why was Lotronex
pulled off the market?
What is ischemic colitis?
Why was Lotronex
allowed back on the market?
What are the
risks of Lotronex?
Do the benefits
of Lotronex outweigh its risks?
What should I do
if I think I'm suffering from Lotronex side effects?
What is Lotronex?
Lotronex is GlaxoSmithKline's brand name for its drug alosetron, which
is used to treat some cases of irritable bowel syndrome. Lotronex was
introduced in February 2000 but pulled off the market nine months later
because of serious side effects. However, in June 2002, the U.S. Food
and Drug Administration allowed Lotronex back on the market under new
restrictions.
What is irritable bowel
syndrome (IBS)?
IBS
is a chronic and painful condition marked by diarrhea, constipation or
both. In severe cases, people may be unable to control their bowels,
preventing them from leading a normal life at work or at home.
How does Lotronex work?
Lotronex slows the movement of stools through the body. It does not cure
IBS, and it is approved only for certain types of IBS.
People who are helped by Lotronex may find it eases stomach pain,
reduces the sudden need to have a bowel movement, and reduces diarrhea.
Who should take Lotronex?
The
FDA has approved Lotronex specifically for women with IBS in cases where
all of the following apply:
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The major problem is diarrhea rather then constipation.
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The condition has been present for at least six months.
-
A
doctor has ruled out other medical problems.
-
Other treatments have failed to help.
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The condition causes painful cramps or bloating, or the inability to
control bowel movements.
Why is Lotronex controversial?
GlaxoSmithKline and the FDA have been blamed for rushing the drug to
market, despite known side effects. Critics say that the safety of
patients has not been adequately protected.
Some
patients believe that by letting them lead a normal life, Lotronex'
benefits are worth the serious risk of side effects.
Why was Lotronex pulled
off the market?
Lotronex was blamed
for severe gastrointestinal problems in 141 people -- including 96 who
were hospitalized and five who died.
The
drug's side effects include constipation severe enough to rupture
bowels, requiring the removal of part or the entire colon, or even
causing death.
What is ischemic colitis?
Ischemic
colitis is another side effect of Lotronex, where blood flow to the
colon is restricted causing gangrene and death.
Why was Lotronex
allowed back on the market?
Patient groups protested Lotronex’ removal. The FDA could have
re-approved Lotronex as an experimental drug, under tight restrictions,
but GlaxoSmithKline refused.
So
in a move that some see as caving in to the drug maker, the FDA
re-approved Lotronex under less stringent restrictions.
Part
of the re-approval involved a program to educate patients and curtail
inappropriate prescriptions. But the program is run by GlaxoSmithKline,
which has been called a clear conflict of interest.
Do the benefits
of Lotronex outweigh its risks?
Some
IBS patients think so. But IBS, though debilitating, is not
life-threatening -- while the side effects of Lotronex can be. Each
patient must make his or her own informed decision, the FDA says.
What should I do if I think I'm suffering from Lotronex side effects?
Talk
to your doctor promptly. Ischemic colitis, in particular, can strike
with little or no warning.
And
if you or a loved one has been injured by taking Lotronex, contact the
office of Monheit Law promptly to see if you have a legal case.
Each
state sets strict deadlines for people who have been injured to a o
lawsuit, and the deadlines vary from state to state. So it's important
that you get legal advice as soon as possible.
Do I have a
Lotronex case?
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