FDA Approves Amitiza for
Irritable Bowel Syndrome
with Constipation IBS-C
Irritable Bowel Syndrome
with Constipation IBS-C
The U.S. Food and Drug Administration approved on April 29, 2008 Amitiza
(lubiprostone) for the treatment of Irritable Bowel Syndrome with
Constipation (IBS-C) in adult women aged 18 and over. There is currently no
prescription drug therapy for IBS-C. With this approval, Amitiza becomes the
only FDA-approved medical treatment for IBS-C available in the United States.
Irritable bowel syndrome is a disorder characterized by cramping, abdominal
pain, bloating, constipation, and diarrhea. IBS causes a great deal of
discomfort and distress to its sufferers. It affects at least twice as many
women as men.
The safety and efficacy of Amitiza was established in two major studies
involving 1,154 patients diagnosed with IBS-C. The majority of the patients
studied were women (approximately 8 percent were men). Patients enrolled
in the studies were experiencing at least mild abdominal discomfort or pain
that was associated with at least two of the following additional symptoms:
1) fewer than 3 spontaneous bowel movements per week (that did not
result from laxative use); 2) hard stools; or 3) moderate or severe straining
with bowel movements. In the studies some patients received Amitiza and
others were given a placebo. More patients treated with Amitiza reported
that their IBS symptoms were moderately or significantly relieved over a 12
week treatment period than patients who received placebo. The safety of
long term treatment was assessed in a study in which all patients were
treated with Amitiza for a duration that ranged 9 to 13 months.
The efficacy of Amitiza in men was not conclusively demonstrated for IBS-C.
Amitiza, like most prescription medications, is accompanied by some side
effects. Common side effects of Amitiza include nausea, diarrhea, and
abdominal pain. Other rare side effects include urinary tract infections, dry
mouth, syncope (fainting), peripheral edema (swelling of the extremities),
dyspnea (difficulty breathing), and heart palpitations.
Amitiza should be taken twice-a-day in 8 microgram doses with food and
water. Patients and their health care professionals should periodically
assess the need for continued therapy.
Amitiza is not approved for use in children and men. It is not to be
administered to patients suffering from severe diarrhea or patients with
known or suspected bowel obstructions. Its safety and efficacy has not been
established in patients with renal or hepatic impairment, pregnant, or
nursing mothers.
Amitiza is also approved for the treatment of chronic idiopathic constipation
(CIC), but the dose for that indication is higher, 24 micrograms twice a day.
Amitiza is manufactured by Sucampo Pharmaceuticals, Bethesda, MD, and will
be jointly marketed by Sucampo and Takeda Pharmaceuticals America, Inc.,
Deerfield, IL.
SOURCE FDA Approves Amitiza for IBS-C, Only drug available in United States
for irritable bowel syndrome with constipation, FDA website May 2008
(lubiprostone) for the treatment of Irritable Bowel Syndrome with
Constipation (IBS-C) in adult women aged 18 and over. There is currently no
prescription drug therapy for IBS-C. With this approval, Amitiza becomes the
only FDA-approved medical treatment for IBS-C available in the United States.
Irritable bowel syndrome is a disorder characterized by cramping, abdominal
pain, bloating, constipation, and diarrhea. IBS causes a great deal of
discomfort and distress to its sufferers. It affects at least twice as many
women as men.
The safety and efficacy of Amitiza was established in two major studies
involving 1,154 patients diagnosed with IBS-C. The majority of the patients
studied were women (approximately 8 percent were men). Patients enrolled
in the studies were experiencing at least mild abdominal discomfort or pain
that was associated with at least two of the following additional symptoms:
1) fewer than 3 spontaneous bowel movements per week (that did not
result from laxative use); 2) hard stools; or 3) moderate or severe straining
with bowel movements. In the studies some patients received Amitiza and
others were given a placebo. More patients treated with Amitiza reported
that their IBS symptoms were moderately or significantly relieved over a 12
week treatment period than patients who received placebo. The safety of
long term treatment was assessed in a study in which all patients were
treated with Amitiza for a duration that ranged 9 to 13 months.
The efficacy of Amitiza in men was not conclusively demonstrated for IBS-C.
Amitiza, like most prescription medications, is accompanied by some side
effects. Common side effects of Amitiza include nausea, diarrhea, and
abdominal pain. Other rare side effects include urinary tract infections, dry
mouth, syncope (fainting), peripheral edema (swelling of the extremities),
dyspnea (difficulty breathing), and heart palpitations.
Amitiza should be taken twice-a-day in 8 microgram doses with food and
water. Patients and their health care professionals should periodically
assess the need for continued therapy.
Amitiza is not approved for use in children and men. It is not to be
administered to patients suffering from severe diarrhea or patients with
known or suspected bowel obstructions. Its safety and efficacy has not been
established in patients with renal or hepatic impairment, pregnant, or
nursing mothers.
Amitiza is also approved for the treatment of chronic idiopathic constipation
(CIC), but the dose for that indication is higher, 24 micrograms twice a day.
Amitiza is manufactured by Sucampo Pharmaceuticals, Bethesda, MD, and will
be jointly marketed by Sucampo and Takeda Pharmaceuticals America, Inc.,
Deerfield, IL.
SOURCE FDA Approves Amitiza for IBS-C, Only drug available in United States
for irritable bowel syndrome with constipation, FDA website May 2008
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PHYTONUTRIENTS AND DRUG PRODUCTS. THIS WEBSITE ALSO TALKS ABOUT SOME POPULAR HEALTH ISSUES AND DISEASES.
ARTICLES IN THIS WEB SITE IS FOR YOUR REFERENCE ONLY. IF YOU HAVE ANY QUESTION, YOU SHOULD CONSULT WITH YOUR
DOCTOR IMMEDIATELY. ALL RIGHTS RESERVED 2008. DO NOT COPY NOR TRANSFER ARTICLES TO OTHER WEBSITES NOR OTHER
FORMS OF PUBLICATIONS. Privacy Policy. ARTICLE INDEX
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