Adalimumab (Humira) and Infliximab (Remicade)
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Adalimumab (Humira) and Infliximab (Remicade)
Why does the CAA disqualify these two medications? It seems the UK CAA are very good at telling you what is and isn't allowed, but doesn't explain the reasons why in a significant number of cases. Both medications can make some people sleepy, but that's nearly always only on the day of administration (once every two weeks for Humira, once every 1-2 months for Remicade). I don't really understand how this is debilitating enough to warrant disqualification.
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Not just transient sleepiness. From the drugs' own websites:
The following serious (sometimes fatal) side effects have been reported in people taking REMICADE®.
You should tell your doctor right away if you have any of the signs listed below:
HUMIRA can cause serious side effects, including:
•Serious infections. These include TB and infections caused by viruses, fungi, or bacteria. Symptoms related to TB include a cough, low-grade fever, weight loss, or loss of body fat and muscle.
•Hepatitis B infection in carriers of the virus. Symptoms include muscle aches, feeling very tired, dark urine, skin or eyes that look yellow, little or no appetite, vomiting, clay-colored bowel movements, fever, chills, stomach discomfort, and skin rash.
•Allergic reactions. Symptoms of a serious allergic reaction include hives, trouble breathing, and swelling of your face, eyes, lips, or mouth.
•Nervous system problems. Signs and symptoms include numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness.
•Blood problems. Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale.
•Heart failure (new or worsening). Symptoms include shortness of breath, swelling of your ankles or feet, and sudden weight gain.
•Immune reactions including a lupus-like syndrome. Symptoms include chest discomfort or pain that does not go away, shortness of breath, joint pain, or rash on your cheeks or arms that gets worse in the sun.
•Liver problems. Symptoms include feeling very tired, skin or eyes that look yellow, poor appetite or vomiting, and pain on the right side of your stomach (abdomen).
•Psoriasis (new or worsening). Symptoms include red scaly patches or raised bumps that are filled with pus.
Common side effects of HUMIRA include injection site reactions (redness, rash, swelling, itching, or bruising), upper respiratory infections (sinus infections), headaches, rash, and nausea. These are not all of the possible side effects with HUMIRA. Tell your doctor if you have any side effect that bothers you or that does not go away.
The following serious (sometimes fatal) side effects have been reported in people taking REMICADE®.
You should tell your doctor right away if you have any of the signs listed below:
- Infections (like TB, blood infections, pneumonia)—fever, tiredness, cough, flu, or warm, red or painful skin or any open sores. REMICADE® can make you more likely to get an infection or make any infection that you have worse.
- Lymphoma, or any other cancers in adults and children.
- Skin cancer—any changes in or growths on your skin.
- Heart failure—new or worsening symptoms, such as shortness of breath, swelling of your ankles or feet, or sudden weight gain.
- Reactivation of HBV—feeling unwell, poor appetite, tiredness, fever, skin rash and/or joint pain.
- Liver injury—jaundice (yellow skin and eyes), dark brown urine, right-sided abdominal pain, fever, or severe tiredness.
- Blood disorders—fever that doesn’t go away, bruising, bleeding or severe paleness.
- Nervous system disorders—numbness, weakness, tingling, changes in your vision or seizures.
- Allergic reactions during or after the infusion—hives, difficulty breathing, chest pain, high or low blood pressure, swelling of face and hands, and fever or chills.
- Lupus-like syndrome—chest discomfort or pain that does not go away, shortness of breath, joint pain, rash on the cheeks or arms that gets worse in the sun. The more common side effects with REMICADE® are respiratory infections (that may include sinus infections and sore throat), headache, rash, coughing and stomach pain.
- Psoriasis—new or worsening psoriasis such as red scaly patches or raised bumps on the skin that are filled with pus.
HUMIRA can cause serious side effects, including:
•Serious infections. These include TB and infections caused by viruses, fungi, or bacteria. Symptoms related to TB include a cough, low-grade fever, weight loss, or loss of body fat and muscle.
•Hepatitis B infection in carriers of the virus. Symptoms include muscle aches, feeling very tired, dark urine, skin or eyes that look yellow, little or no appetite, vomiting, clay-colored bowel movements, fever, chills, stomach discomfort, and skin rash.
•Allergic reactions. Symptoms of a serious allergic reaction include hives, trouble breathing, and swelling of your face, eyes, lips, or mouth.
•Nervous system problems. Signs and symptoms include numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness.
•Blood problems. Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale.
•Heart failure (new or worsening). Symptoms include shortness of breath, swelling of your ankles or feet, and sudden weight gain.
•Immune reactions including a lupus-like syndrome. Symptoms include chest discomfort or pain that does not go away, shortness of breath, joint pain, or rash on your cheeks or arms that gets worse in the sun.
•Liver problems. Symptoms include feeling very tired, skin or eyes that look yellow, poor appetite or vomiting, and pain on the right side of your stomach (abdomen).
•Psoriasis (new or worsening). Symptoms include red scaly patches or raised bumps that are filled with pus.
Common side effects of HUMIRA include injection site reactions (redness, rash, swelling, itching, or bruising), upper respiratory infections (sinus infections), headaches, rash, and nausea. These are not all of the possible side effects with HUMIRA. Tell your doctor if you have any side effect that bothers you or that does not go away.
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Suedehead.. I think the CAA is very sensible. Bad Medicine has listed the possible side effects of these medicines. Would you lkike to be sitting ebhind a pilot who might develop any of them?
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There seems to be a consensus among flight medicine examiners regarding these biologicals. Heard the same four years ago from my Doc at a german AMC that my
license would be lifted if I took Remicade or Humira. These medications are indeed heavy stuff...
license would be lifted if I took Remicade or Humira. These medications are indeed heavy stuff...
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A good question indeed from Suedehead.
Both of these Biologicals (as well as others) are permitted to be used by pilots under FAA, CASA, HKCAD, CAA (NZ).
The only restriction is that the pilot is usually grounded for a period of time (up to 8 weeks) to determine any possible side effects.
Do some research and present your findings to the CAA.
Both of these Biologicals (as well as others) are permitted to be used by pilots under FAA, CASA, HKCAD, CAA (NZ).
The only restriction is that the pilot is usually grounded for a period of time (up to 8 weeks) to determine any possible side effects.
Do some research and present your findings to the CAA.
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Suedehead,
I have been certified with both through the UK CAA and FAA. 4 weeks off and blood tests. PM me if I can provide further help.
Forgot to add, be careful with the advice on the CAA website, most of it is outdated, and the RGNs will tell you that when you call the Medical department.
I'm 29, with Crohns and Colitis.
SKP
I have been certified with both through the UK CAA and FAA. 4 weeks off and blood tests. PM me if I can provide further help.
Forgot to add, be careful with the advice on the CAA website, most of it is outdated, and the RGNs will tell you that when you call the Medical department.
I'm 29, with Crohns and Colitis.
SKP
Last edited by Steak&Kidney_Pie; 21st Nov 2013 at 01:32. Reason: Addition