FDA Warns of Cancer Risk for TNF Inhibitor Users

 

Enbrel®, Remicade®, Humira®, and Cimzia are drugs that are approved to combat a number of immune disorders, including rheumatoid arthritis, juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis. Enbrel® is currently marketed by Amgen, a subsidiary of Wyeth, soon to be acquired by Pfizer. Remicade® is marketed by Centocor, Inc. Humira is marketed by Abbott Laboratories.  Like Raptiva®, they work by suppressing a feature of the immune system, and in so doing can expose its users to a number of dangerous, potentially deadly problems, including serious infections and congestive heart failure.

 

According to the black box warning mandated by the Food and Drug Administration (FDA) in December 2008, the most serious likely infections include:

• Tuberculosis, including reactivation of latent tuberculosis
• Hepatitis B reactivation
• Invasive fungal infections, including disseminated fungal infections that may evade detection
• Other opportunistic bacterial, viral, and fungal infections

 

Hospitalization and death have occurred in numerous cases of infections following Enbrel®, Remicade®, Humira®, and Cimzia use. Prior to initiating treatment with one of these drugs, doctors should test patients for tuberculosis and other infections. Patients with chronic or recurrent infections may not be suitable for treatment with Enbrel®, Remicade®, Humira®, and Cimzia, and everyone taking these drugs should be monitored closely for dangerous infections.

 

A number of cases of new-onset congestive heart failure have also been reported to the FDA in connection with the use of these drugs.

 

Lymphomas and other cancers were seen more frequently in people taking Enbrel®, Remicade®, Humira®, and Cimzia than in control groups. The FDA announced on August 4, 2009 that a new black box warning will be added to TNF blockers including Enbrel®, Humira®, Remicade®, Cimzia, and Simponi. The warning will emphasize the risk of developing cancers such as lymphoma or leukemia when taking one of these drugs. The FDA's investigation was limited to TNF blocker use in children and adolescents.

 

Some people acquire or see a worsening of central nervous system disorders, such as transverse myelitis, multiple sclerosis, and optic neuritis.

 

If you have suffered any of these dangerous side effects, you may be eligible for compensation for your Enbrel®, Remicade®, Humira®, or Cimzia injuries. Schedule a free consultation with the pharmaceutical lawsuit attorneys at Schlichter, Bogard & Denton today.

 

How Enbrel®, Remicade®, Humira®, Cimzia and Simponi Work

 

Enbrel®, Remicade®, Humira®, and Cimzia are part of a class of drugs known as tumor necrosis factor (TNF) blockers. Tumor necrosis factor is a chemical signal that triggers inflammation. Inflammation is an important part of healing responses, and blocking surplus tumor necrosis factor can break the causal chain of many autoimmune disorders, reducing the frequency and severity of flare-ups. In the case of rheumatoid arthritis, research has shown that Enbrel® can not only stop inflammation, but also prevent progressive joint damage.

 

Elevated levels of tumor necrosis factor are found in all tissues involved in these immune disorders--joints affected by ankylosing spondylitis, rheumatoid, psoriatic, and juvenile idiopathic arthritis, and skin affected by plaque psoriasis--but they are not necessarily elevated throughout the body. Enbrel®, Remicade®, Humira®, and Cimzia depress the tumor necrosis factor levels throughout the body, which is why it can cause generalized suppression of the immune system and make it more difficult for your body to fight infection.

 

Precautions for Enbrel®, Remicade®, Humira®, Cimzia and Simponi Use

 

If you think you have an infection, you should not start taking Remicade®, Humira®, Cimzia, or Enbrel®. If someone close to you has an infection or you have open cuts or sores, you may also want to wait.

 

If you live in a high-risk area for fungal infections, you should consider the increased risk of fungal infection before starting Enbrel®, Remicade®, Humira®, or Cimzia use.

 

If you have or are at an elevated risk for central nervous disorders, you should be aware of the risks of new or worsened disorders.

 

Because most people who develop tuberculosis do not overcome the infection, but merely control it, any compromise in the effectiveness of the immune system can lead to a reactivation of this potentially lethal infection. If you have had or think you have had tuberculosis, or have spent time in areas where tuberculosis is common, you should be tested for latent tuberculosis infection before beginning Enbrel®, Remicade®, Humira®, or Cimzia use.

 

Additionally, Remicade®, Humira®, and Cimzia should not be used by those who have congestive heart failure.

 

If You Have Been Injured by Enbrel®, Remicade®, Humira®, or Cimzia

 

The serious infections, neurological disorders, or heart problems suffered as a result of Enbrel®, Remicade®, Humira®, and Cimzia use can lead to hospitalization, permanent disability, or death. You deserve compensation for injuries caused to either you or your loved ones. The product liability lawyers at Schlichter, Bogard & Denton are prepared to fight for the rights of Enbrel®, Remicade®, Humira®, Cimzia and Simponi users in all 50 states. Schedule a free, no-obligation pharmaceutical injury consultation today.