Amitiza Side Effects

Severe Side Effects of Amitiza

• Severe gastrointestinal side effects include acid reflux, rectal bleeding, gastritis, and weight gain or weight loss.
• Amitiza may cause sever urinary tract infections.
• Fybromyalgia and increased joint pain have been reported.
• In some cases, Amitiza has caused depression, anxiety, and fatigue in some patients.
• Amitiza may cause  severe allergic reactions in some patients which include facial swelling, difficulty breathing, and hives.

Common Side Effects of Amitiza

• Common gastrointestinal side effects include nausea (most common) and vomiting, flatulence or gas, diarrhea, and stomach pains.
• Headache is the most common nervous system side effect of Amitiza.
• Amitiza has caused trouble falling asleep and/or staying asleep in some patients.

Warnings & Recalls for Amitiza

Recalls

• On November 28th, 2008, Advantage Dose LLC recalled Amitiza Lubiprostone 24 mcg gelcaps due to failue to conform with current good manufacturing practices.  The recalled manufacturing lot number is 57436511 and the expiration date is 02/06/09.  View the FDA Enforcement Report here.

Warnings

• Amitiza is a pregnancy category class C drug.  In animal testing, fetal death occurred.  It is best to discuss the pros and cons of use with your physician during pregnancy.
• Do not take Amitiza if you have a bowel obstruction.
• There is currently no black box warning for Amitiza although some have called for a black box warning due to it's potential to cause abortions during pregnancy.

Amitiza Treatment and Use

Amitiza | Lubiprostone is a laxative often prescribed to adult patients with chronic constipation and adult women with irritable bowel syndrome.  It is manufactured by Sucampo Pharmaceuticals under Takeda Pharmaceuticals America, Inc.  It was approved for sale by the FDA on January 31st, 2006.

How does Amitiza Work?

Amitiza allows more fluid to go into the bowels, which softens stools and makes it easier to defecate.  It does not change the sodium and potassium levels in the serum during this process.

Dosage

Amitiza comes in 8 mcg (pink capsules) and 24 mcg (orange capsules) gelcap forms.

The initial dose for chronic idiopathic constipation is 24 mcg twice a day.  The initial dose for women with irritable bowel syndrome is 8 mcg twice a day.

Other Names for Amitiza

Brand name

• Amitiza

Generic name

• lubiprostone

Lawsuits & Legal Information for Amitiza