I found a Canadian health advisory for Humira that I thought may interest readers:
HEALTH CANADA ADVISORY
January 13, 2006
Health Canada has issued new warnings concerning the use of Humira(adalimumab). To read the full Health Canada Advisory, visit Health Canada's web site at: http://www.hc-sc.gc.ca.
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Allergic reactions: In rare cases, some people may develop an allergic reaction to this medication. Signs of an allergic reaction include a severe rash, hives, swollen face or throat, or difficulty breathing. If these occur, contact your doctor immediately. The needle cover on the pre-filled syringe contains dry natural rubber. Before you start injections, tell your doctor if you have an allergy to rubber or latex.
Blood disorders: Rarely, people taking this medication have become deficient in certain types of blood cells. If you notice signs of infection (such as fever, shaking or chills, fast heartbeat, or quick breathing) or bleeding (such as easy bruising, blood in the stools, black tarry stools, or vomiting blood or material that looks like coffee grounds), seek immediate medical attention.
Cancer: Compared to the general population, people taking adalimumab have a slightly greater risk of developing a cancer of the immune system (known as lymphoma). However, the risk is still small. In general, people with severe rheumatoid arthritis who take medications that suppress the immune system over long periods of time may also have a higher risk of developing lymphoma, even if they don't take adalimumab. If you experience any of the following or other unusual symptoms, contact your doctor immediately:
- chills
- decreased appetite
- fever
- night sweats
- one or more enlarged lymph node
- unusual fatigue
- weight loss
Signs and symptoms of lymphoma can vary depending on the extent of the disease and the parts of the body involved (e.g., chest, abdomen or bowel).
Heart failure: Adalimumab may cause congestive heart failure (CHF) or worsen existing CHF. People with CHF should be monitored closely by their doctors. Symptoms to watch out for include swelling of the feet and ankles and shortness of breath. If you notice these symptoms, contact your doctor immediately.
Infections: This medication, or other TNF blockers, can increase the risk of developing infections such as tuberculosis and those caused by bacteria and fungi. If you notice signs of an infection such as fever, chills, pain, swelling, or pus, contact your doctor as soon as possible. Tell your doctor if you have a history of infections that keep coming back, or other conditions that might increase your risk of infections, including fungal infections. This medication should not be used in combination with anakinra, as this can increase the risk of severe infections.
Immune system disorders: Some people who take this medication have developed lupus-like syndrome, an autoimmune disease (a condition where the body is attacked by its own immune system). Symptoms of lupus-like syndrome include chest pain, joint pain, difficulty breathing, and a skin rash (usually on the cheeks and arms) that is sensitive to the sun. If you develop these symptoms, contact your doctor as soon as possible.
Liver problems: Very rarely, people taking adalimumab may experience liver problems. Symptoms of liver problems include:
- abdominal pain
- dark urine
- fatigue
- loss of appetite
- yellow eyes or skin
If you notice these symptoms, contact your doctor immediately. People infected with hepatitis B (an infection that can damage the liver) may have a relapse of their condition while taking this medication. If you are at risk for hepatitis B, your doctor may want to test you for this infection before starting treatment with adalimumab, and will follow your condition closely while you are taking the medication. If you notice symptoms of a liver problem (see above), contact your doctor immediately.
Nervous system diseases: Rare cases of disorders that affect the nervous system have been reported by people taking adalimumab or other TNF blockers. If you are experiencing numbness and tingling, vision problems, weakness in your legs, and dizziness, contact your doctor immediately.
Pregnancy: This medication is not recommended for use during pregnancy. This medication should not be used during pregnancy unless the benefits outweigh the risks.
Breast-feeding: It is not known if adalimumab passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using this medication has not been established for children.
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