Remicade – Inflammatory Drugs – Increased Risk of Childhood Cancer
The Food and Drug Administration (FDA) has issued a “black box” warning for several of the top-selling arthritis and inflammatory drugs in the United States. Humira, Remicade, Enbrel and Simponi received the FDA’s sternest warning after reports surfaced suggesting the medications increase the risk of cancer in children.
The prescription drugs are FDA-approved to treat Crohn’s disease, inflammatory bowel disease and arthritis in children, adolescents and adults.
Side Effects of Arthritis Drugs, Including Remicade
After reviewing the medications for a year, the FDA concluded that children and adolescents who take the inflammatory drugs for more than two and a half years have an increased risk of developing cancer. Of the several dozen reports of childhood cancer, more than half of those were lymphoma cases – a serious form of cancer that attacks the immune system.
Parents of children who are taking one of the four medications should carefully monitor their children for any of the following symptoms of cancer:
- Difficulty breathing
- Facial swelling
- Loss of appetite
- Night sweats
- Painless lumps (enlarged lymph nodes)
- Weight loss
Children who demonstrate any of the aforementioned conditions should be taken to a physician for an evaluation. Parents should not stop administering the arthritis and inflammatory medications to their children unless instructed to do so by their physician.
In addition to working with the drug manufacturers to update their packaging, the FDA is mandating that the companies must supplement their medical guides with information about the increased cancer risk.
Histoplasmosis – Remicade, Humira, Enbrel Linked to Infection
Histoplasmosis is an infection caused by the inhalation of airborne spores of the Histoplasma capsulatum fungus. Histoplasmosis, also known as Darling’s disease, primarily affects the lungs; however, it sometimes spreads throughout the body and can cause severe damage.
Patients with histoplasmosis typically do not exhibit symptoms, which can hinder patients receiving necessary medical attention. Because the fungus spores are present in soil, histoplasmosis primarily affects farmers and other people working in or around soil in the Eastern and Midwestern areas of the United States.
The Food and Drug Administration is investigating claims against several rheumatoid arthritis drugs that are believed to make patients susceptible to histoplasmosis. Humira, Remicade and Enbrel treat arthritis patients by suppressing the immune system, which consequently leaves patients vulnerable to infection.
Approximately 240 cases of histoplasmosis have been reported in patients taking these drugs, with approximately 20 percent resulting in death. Patients taking one of these three drugs who demonstrate flu-like symptoms should seek immediate medical attention to prevent the potentially devastating consequences of histoplasmosis.
Humira, Enbrel and Remicade are used to treat some of the two million Americans suffering from rheumatoid arthritis. Although the drugs have had some success in providing relief for rheumatoid arthritis sufferers, they have recently been linked with a couple of serious side effects.
A new study conducted by the Mayo Clinic discovered a link between the use of Humira or Remicade and the increased likelihood of developing several kinds of cancer or a serious infection. The study determined that rheumatoid arthritis sufferers taking Humira or Remicade were three times as likely to develop cancer and two times as likely to develop a serious infection.
Previous studies evaluating the safety of Humira and Remicade focused specifically on the drugs’ ability to cause lymphoma, pneumonia or tuberculosis. The Mayo Clinic study was able to determine a link between use of the rheumatoid arthritis drugs and the development of several other cancer types, including skin cancer, gastrointestinal cancer, breast cancer and lung cancer.
Additionally, the Food and Drug Administration has received several reports of cancer – primarily lymphomas – in patients who began taking the rheumatoid arthritis medications before the age of 18. They are further investigating these claims.
Humira was manufactured by Abbott Laboratories, while Remicade was manufactured by Centocor. Neither drug manufacturer is ready to accept the results of the Mayo Clinic study, claiming the research is flawed. The manufacturers also claim that even with the possibility of side effects, the drugs still have a favorable “benefits-to-risks ratio.”
The controversy surrounding Humira and Remicade side effects is just beginning as additional studies are underway to verify the initial findings of the Mayo Clinic study.
In addition to pending investigations against Humira and Remicade, several agencies are looking into claims against Enbrel, a medication used to treat rheumatoid arthritis, plaque psoriasis and various other autoimmune diseases. Several patients taking Enbrel have developed life-threatening infections, including tuberculosis, bacterial sepsis and histoplasmosis.
The Food and Drug Administration has issued its sternest warning, the black-box warning, for the drug, Enbrel is an injectable tumor necrosis factor (TNF) inhibitor sold by Amgen Inc. and Wyeth.
Remicade Side Effects
The FDA continues to evaluate reports linking Remicade with the development of cancer in children and young adults. Thus far, the FDA has received 30 reports of Remicade-linked cancer, most of which were lymphomas.
In addition to Remicade, the FDA continues to monitor the safety of Humira and Enbrel, all three of which have been marketed to children and young adults as a treatment for rheumatoid arthritis.
Drug manufacturers are responsible for ensuring the safety and efficacy of their products before marketing them for public consumption. Failure to do so is considered negligent and grounds for personal injury litigation. The Pensacola personal injury attorneys of Aylstock, Witkin Kreis & Overholtz handle national litigation across the United States for victims injured by defective pharmaceuticals and medical devices. They have successfully represented and obtained substantial compensation for a number of patients who have been harmed by defective drugs. Contact AWKO law today at (844) 794-7402 to get more information about your rights as a Remicade injury victim.