Rheumatoid Arthritis Drugs, Side Effects and Histoplasmosis
Rheumatoid arthritis is an inflammatory condition that affects about two million Americans. The exact cause is unknown, but it is believed to be the body's immune system attacking the tissue that lines your joints. It is more common in women than in men and generally concerns adults between the ages of 20 and 50. There is no cure for rheumatoid arthritis, but there are medications known as Tumor Necrosis Factor (TNF) blockers that stimulate or restore the ability of the immune system to fight arthritis and rheumatic disease.
TNF is a cytokine (chemical substances which deliver messages between cells in the body) that plays a role in the inflammatory process. Excess TNF-alpha has been associated with rheumatoid arthritis and other forms of inflammatory arthritis. TNF blockers bind to tumor necrosis factor-alpha, rendering it inactive, and interfering with inflammatory activity, ultimately decreasing joint damage, reducing pain, morning stiffness and tender or swollen joints. TNF blocker drugs include:
- Enbrel (Etanercept)
- Remicade (Infliximab)
- Humira (Adalimumab)
- Cimzia (Certolizumab pegol)
These rheumatoid arthritis drugs have been linked to a possibly fatal fungal infection called histoplasmosis. Histoplasmosis, which is also known as Darling's disease, is caused by the fungus Histoplasma capsulatum. Its symptoms vary greatly, but the disease primarily affects the lungs. Occasionally, other organs are affected. This form of the disease is called disseminated histoplasmosis, and it can be fatal if untreated.
The FDA has issued an order requiring a black box warning label for the risk of histoplasmosis. To date, several cases of the lung infection have been reported, with a fatality rate of around 20%.
Enbrel (Etanercept)
In November 1998, Enbrel became the first of the TNF blocker drugs approved by the FDA. Enbrel is administered as a subcutaneous (under the skin) injection once or twice weekly (3 or 4 days apart). Enbrel can be used in combination with methotrexate in patients who do not respond to methotrexate alone.
Enbrel has been approved to treat:
- moderate to severe rheumatoid arthritis
- moderate to severe juvenile rheumatoid arthritis
- psoriatic arthritis
- ankylosing spondylitis
- chronic moderate to severe plaque psoriasis
Enbrel may increase the risk of serious infections. In patients being treated with Enbrel, there also have been reports of:
- multiple sclerosis
- myelitis (inflammation of spinal cord)
- optic neuritis (inflammation of optic nerve)
- pancytopenia (low blood counts for red cells, white cells, platelets)
Remicade (Infliximab)
Remicade was the second of the TNF blocker drugs approved by the FDA in November 1999. Remicade is administered as an intravenous infusion (I.V.) which takes about 2 hours to infuse. Remicade is approved alone or in combination with methotrexate to treat moderate to severe rheumatoid arthritis as well as active psoriatic arthritis.
Common Remicade side effects include:- upper respiratory infections
- urinary tract infections
- headache
- nausea
- cough
- diarrhea
- weakness
- fever
- back pain
- skin conditions
- infusion site reactions
A number of users who were receiving TNF blockers, such as Remicade, have experienced fungal infections, such as histoplasmosis, blastomycosis and cocciioidmycosis. In several of these cases the infection resulted in death.
In September 2008, the FDA issued an alert to healthcare providers to provide new information about the risk of Remicade fungal infections. At that time the agency also indicated that new information will be added to the Remicade black box warning to ensure that doctors and consumers are aware of the risk, especially for those who live in or visit areas where fungus is prevalent.
Unfortunately, many cases of fungal infections from Remicade go undiagnosed by doctors, since the symptoms are similar to the flu. Symptoms for Oklahoma consumers of the rheumatoid arthritis drug could include cough, fever, fatigue, loss of weight, sweating and shortness of breath.
Humira (Adalimumab)
Humira was approved by the FDA in December 2002 as a new rheumatoid arthritis drug. Humira is given by subcutaneous (under the skin) self-injection once every two weeks. It was first available in a single use, pre-filled syringe. A single use, disposable delivery system has also been developed and is known as the Humira Pen. Because it suppresses the body's inflammation abilities (which fights off infections), Humira has been associated with serious infections such as tuberculosis, sepsis, and fungal infections. Humira also may worsen the symptoms of diseases of the nervous system (e.g., demyelinating disorders).
Cimzia (Certolizumab pegol)
On May 14, 2009, Cimzia was approved by the FDA to treat adult patients who have moderately to severely active rheumatoid arthritis. Serious TNF blocker side effects have developed in patients taking Cimzia. The prescribing information available for Cimzia side effects warns about:
- serious infections, including tuberculosis
- cancer, including lymphoma
- nervous system problems, including multiple sclerosis
- allergic reactions
- blood problems
- new or worsening heart failure
- immune reactions, including lupus-like syndrome
If you or a loved one has been diagnosed in Oklahoma with histoplasmosis or has been hospitalized while taking any tumor necrosis factor alpha blocker, or TNF blocker drugs, such as Remicade, Enbrel, Cimzia or Humira, McIntyre Law is here to help. Contact an Oklahoma City rheumatoid arthritis lawyer with McIntyre Law for a free evaluation.
