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Precautions and Warnings With Alosetron

Specific Alosetron Precautions and Warnings

Some warnings and precautions to be aware of prior to taking this medication include the following:
  • Alosetron can cause constipation, which can lead to serious bowel complications, including a blockage in the bowel (obstruction), tearing (perforation), and a life-threatening condition known as toxic megacolon (when the intestines become abnormally wide). Although rare, in some cases these problems have resulted in a hospital stay, surgery, blood transfusion, and even death.

    If you become constipated during alosetron treatment, stop taking the medication and contact your healthcare provider. If your constipation does not improve after you stop alosetron, contact your healthcare provider again. Do not restart alosetron unless your healthcare provider specifically tells you it is okay to do so.
  • Alosetron has been reported to cause a condition known as ischemic colitis, which occurs when blood flow to the intestines is reduced. This can damage the intestines. Ischemic colitis can lead to a hospital stay, surgery, blood transfusion, and even death. Stop taking alosetron and contact your healthcare provider immediately if you develop signs of this serious condition, such as:
    • Bleeding from your rectum
    • Blood in your stool
    • New or worse abdominal (stomach) pain. 
  • Because alosetron has been associated with serious bowel side effects, it can only be prescribed by healthcare providers who enroll in a special program. This special program ensures healthcare providers know about the risks and benefits of using alosetron before prescribing it. You will have to get a special prescription from your healthcare provider to get alosetron filled. Alosetron prescriptions cannot be phoned or faxed to the pharmacy.
  • You healthcare provider will talk to you about your IBS symptoms, and explain the risks and benefits of alosetron before starting treatment. You will also be given a medication guide that describes the use of alosetron before you start treatment and with each refill. Make sure to read the guide and ask questions if there is anything you do not completely understand.
  • You will be asked to sign a Patient Acknowledgement Form indicating you understand the risks and benefits of alosetron use before you begin taking the medication. Your healthcare provider will go over the form with you.
  • Alosetron is a pregnancy Category B medication. This means it is probably safe for use during pregnancy (see Lotronex and Pregnancy).
  • It is unknown if alosetron passes through breast milk in humans. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the drug (see Lotronex and Breastfeeding).

Alosetron Drug Information

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