[UPDATE 07/27/2007] FDA announced that it is permitting the restricted use of tegaserod (Zelnorm) under a treatment investigational new drug (IND) protocol to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in women younger than 55 who meet specific guidelines.
In some instances, patients with a serious or life-threatening disease or condition who are not enrolled in a clinical trial may be treated with a drug not approved by the FDA. Generally, such use is allowed within guidelines called a treatment IND, when no comparable or satisfactory alternative drug or therapy is available. These patients must meet strict criteria and have no known or pre-existing heart problems and be in critical need of this drug. Tegaserod will remain off the market for general use. Physicians with IBS-C or CIC patients, who meet the IND criteria should contact Novartis at 888-669-6682 or 800-QUI-NTILE. Those who do not qualify for the tegaserod treatment protocol may contact FDA's Division for Drug Information about other options at 888-463-6332. For more information visit the FDA website at: [Web] and [Web].
[Posted 03/30/2007] FDA notified healthcare professionals and patients that Novartis has agreed to discontinue marketing tegaserod (Zelnorm), a drug used for the short-term treatment of women with irritable bowel syndrome with constipation and for patients younger than 65 years of age with chronic constipation. FDA analysis of safety data pooled from 29 clinical trials involving over 18,000 patients showed an excess number of serious cardiovascular adverse events, including angina, heart attacks, and stroke, in patients taking tegaserod compared to patients given placebo. Patients taking tegaserod should contact their healthcare professional to discuss treatment alternatives and seek emergency medical care if they experience severe chest pain, shortness of breath, sudden onset of weakness or difficulty walking or talking, or other symptoms of a heart attack or stroke. Healthcare professionals should assess their patients and transition them to other therapies as appropriate. For more information visit the FDA website at: [Web] and [Web].
TEGASEROD (te GAS a rod) is used to treat women who have irritable bowel syndrome (IBS) with constipation as their main problem. It may also be used for relief of chronic constipation in patients (men and women) less than 65 years of age.
NOTE: This drug is no longer available in the United States. Patients currently taking Tegaserod should contact their prescriber about stopping this medicine and finding alternative therapies. If you have questions about the discontinuation of Zelnorm you may call 1-888-669-6682.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
Take this medicine by mouth with a glass of water. Take it on an empty stomach shortly before you eat a meal. Follow the directions on the prescription label. Take your doses at regular intervals. Do not take your medicine more often than directed.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, just skip that dose. Wait until your next dose, and take only that dose. Do not take double or extra doses.
What may interact with this medicine?
medicines for bowel problems or bladder incontinence (these can cause constipation)
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Diarrhea is a common side effect that usually happens in the first week of starting the medicine. This will usually last only a few days and will not come back. You should not start taking this medicine if you already have diarrhea or have diarrhea most of the time. Severe or prolonged diarrhea can lead to dehydration, a lack of fluids within your body. If you experience severe cramping, stomach pain, lightheadedness, dizziness or fainting accompanied by diarrhea, tell your doctor or health care professional immediately.
If you get new or worsening stomach pain with or without blood in your stools, call your doctor or health care professional right away.
This medicine may not work for all patients. It may take several weeks for you notice any relief from your symptoms. If this medicine is stopped, it is likely that that your symptoms will return within 1 to 2 weeks.
Your diet and stress levels may affect your course of therapy. If you eat something that seems make constipation worse or if you have significant levels of stress in your life, be sure to discuss this with your health care professional.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health professional as soon as possible:
diarrhea accompanied by severe stomach cramps with or without rectal bleeding, other stomach pain or dizziness
new or worsening stomach pain
sudden onset of chest pain
worsening or prolonged diarrhea
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store at room temperature between 15 and 30 degrees C (59 and 86 degree F). Protect from heat and moisture. Throw away any unused medicine after the expiration date.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
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