Biologics for Inflammatory Bowel Disease
What To Think About
Drug safety
Warnings about serious side effects of biologics have been issued. The U.S. Food and Drug Administration (FDA) and the drug's manufacturers have warned about:
- An increased risk of a serious infection. Biologics affect the body's ability to fight all infections. So if you get a fever, cold, or the flu while you are taking this medicine, let your doctor know right away.
- An increased risk of blood or nervous system disorders. Call your doctor if you have symptoms of blood disorders (such as bruising or bleeding) or symptoms of nervous system problems (such as numbness, weakness, tingling, or vision problems).
- An increased risk of Reference lymphoma Opens New Window (a type of blood cancer) in children and adolescents who take this medicine for longer than 2½ years (30 months). Adults, children, and adolescents who take this medicine also have a higher risk for leukemia and other cancers.
- An increased risk of liver injuries. Call your doctor if your skin starts to look yellow, if you are very tired, or if you have a fever or dark brown urine.
- An increased risk of Reference psoriasis Opens New Window.
In very few cases, natalizumab has caused a serious and life-threatening brain infection called PML (progressive multifocal leukoencephalopathy). Natalizumab is tightly controlled because of this. If you take natalizumab, you will need to enroll in a program called the Crohn's Disease–Tysabri Outreach Unified Commitment to Health (CD-TOUCH) Prescribing Program.
Your risk for getting PML increases if you have any of these risk factors:
- You have been taking natalizumab for longer than 2 years.
- You have taken other immunosuppressant medicines, such as methotrexate or cyclophosphamide.
- You have ever been infected with the JC virus. There is a test your doctor can do to see if you have Reference antibodies Opens New Window to the JC virus in your blood.
Taking medicine
Medicine is one of the many tools your doctor has to treat a health problem. Taking medicine as your doctor suggests will improve your health and may prevent future problems. If you don't take your medicines properly, you may be putting your health (and perhaps your life) at risk.
There are many reasons why people have trouble taking their medicine. But in most cases, there is something you can do. For suggestions on how to work around common problems, see the topic Reference Taking Medicines as Prescribed.
Advice for women
If you are pregnant, breast-feeding, or planning to get pregnant, do not use any medicines unless your doctor tells you to. Some medicines can harm your baby. This includes prescription and over-the-counter medicines, vitamins, herbs, and supplements. And make sure that all your doctors know that you are pregnant, breast-feeding, or planning to get pregnant.
Checkups
Follow-up care is a key part of your treatment and safety. Be sure to make and go to all appointments, and call your doctor if you are having problems. It's also a good idea to know your test results and keep a list of the medicines you take.
Complete the new medication information form (PDF)
(What is a Reference PDF Opens New Window document?) to help you understand this medication.
| By: | Reference Healthwise Staff | Last Revised: November 5, 2012 |
| Medical Review: | Reference E. Gregory Thompson, MD - Internal Medicine
Reference Arvydas D. Vanagunas, MD - Gastroenterology |
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This information does not replace the advice of a doctor. Healthwise, Incorporated disclaims any warranty or liability for your use of this information. Your use of this information means that you agree to the Reference Terms of Use. Reference How this information was developed to help you make better health decisions.

