Special Alerts:
[Posted 06/03/2008] FDA issued an Early Communication About an Ongoing Safety Review to inform healthcare professionals that the Agency is investigating a possible association between the use of Tumor Necrosis Factor (TNF) blockers and the development of lymphoma and other cancers in children and young adults. FDA is investigating approximately 30 reports of cancer in children and young adults. These reports were submitted to FDA's Adverse Event Reporting System over a ten-year interval, beginning in 1998 through April 29, 2008. These reports describe cancer occurring in children and young adults who began taking TNF blockers (along with other immuno-suppressive medicines such as methotrexate, azathioprine or 6-mercaptopurine), when they were ages 18 or less, to treat juvenile idiopathic arthritis, Crohn's disease or other diseases. Approximately half of the cancers were lymphomas, including both Hodgkin's and non-Hodgkin's lymphoma. Long-term studies are necessary to provide definitive answers about whether TNF blockers increase the occurrence of cancers in children because cancers may take a long time to develop and may not be detected in short-term studies. Until the evaluation is completed, healthcare providers, parents, and caregivers should be aware of the possible risk of lymphoma and other cancers in children and young adults when deciding how to best treat these patients. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#TNF and http://www.fda.gov/cder/drug/early_comm/TNF_blockers.htm.
There may be other drugs that can interact with adalimumab. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
Get emergency medical help if you have any of these
Serious and sometimes fatal infections may occur during treatment with adalimumab. Contact your doctor right away if you have signs of infection such as:
fever, chills, sore throat, flu symptoms, weight loss;
joint pain or swelling with fever, swollen glands, muscle aches, nausea, vomiting, unusual thoughts or behavior, and/or seizure (convulsions);
patchy skin color, red spots, or a butterfly-shaped skin rash over your cheeks and nose (worsens in sunlight);
chest pain, ongoing cough, coughing up blood; or
easy bruising or bleeding, pale skin, unusual weakness.
Call your doctor at once if you have any of these other serious side effects:
feeling short of breath, even with mild exertion;
swelling of your ankles or feet;
red, purple, or scaly skin rash, hair loss, joint or muscle pain, mouth sores;
confusion, seizure (convulsions);
pain or burning when you urinate;
numbness or tingly feeling, weakness in your legs; or
jaundice (yellowing of the skin or eyes).
Less serious side effects are more likely to occur, such as:
pain, redness, itching, swelling, or bleeding where you injected the medication;
headache;
stuffy nose, sinus pain; or
nausea, stomach pain.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.
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