Manufacturer: Amgen and Wyeth
Date approved: 1998
Status: Prescription only – Black Box Warning
Approved uses: Rheumatoid arthritis, psoriasis, ankylosing spondylitis, psoriatic arthritis, and juvenile rheumatoid arthritis.
Off-Label uses: None
• Dry cough
• weight loss
• night sweats;
• fever with chills
• body aches
• flu symptoms;
• signs of skin infection such as itching
• or oozing; pale skin
• easy bruising or bleeding
• unusual weakness; black bloody or tarry stools
• feeling short of breath even with mild exertion
• rapid weight gain
• joint pain or swelling with fever
• swollen glands
• muscle aches
• chest pain
• unusual thoughts or behavior and/or seizure (convulsions); patchy
Enbrel (Etanercept) is an immunosuppresant, approved by the FDA for the treatment of rheumatoid arthritis, and juvenile arthritis. It is administered through a subcutaneous injection.
The most common side effects of Enbrel are dry cough, fever, weight loss, night sweats; fever with chills, body aches, flu symptoms. Patients taking Enbrel are at increased risk for serious adverse effects, including serious infections that can lead to hospitalization or death. Because Cimzia affects the immune system, it can lower the body’s ability to fight infections, such as tuberculosis and other opportunistic infections. Enbrel is a blocker of TNF (tumor necrosis factor) and may cause lymphomas (a form of cancer) and other malignancies.
Recently, Enbrel was given a Black Box Label Warning by the FDA. The Black Box Warning is the strongest warning label a drug can have applied to it. Drugs that carry a high risk of serious side effects or potentially deadly adverse reactions are given this warning. This label is given only after medical studies have indicated that there are serious risks associated with the side effects of the medication.
FDA Announces Black Box Label Warning for Enbrel
In early September, 2008, the FDA announced it would require stronger warnings for four medications commonly used in the treatment of rheumatoid arthritis. The warning label is known as the “Black Box” label, a warning given to drugs that carry a high risk of serious side effects or potentially deadly adverse reactions. This label is given only after medical studies have indicated that there are serious risks associated with the side effects of the medication. It is the strongest warning the FDA can require for a prescription drug.
The medications in question belong to a category of drugs known as immunosuppressants. These drugs suppress the immune system’s reaction to illnesses, decreasing the body’s ability to fight off disease and infections. Serious complications can develop as a result of taking these medications regularly, as the immune system loses its ability to fight off infections and diseases.
The FDA’s announcement suggested that while the medication can provide relief from the symptoms of rheumatoid arthritis, Crohn’s disease, and juvenile arthritis, the possibility for infection due to the weakened state of the immune system was potentially deadly in several cases.
Specifically, the FDA is concerned about information that appears to have been largely overlooked by the medical community. A distinct fungal infection known as histoplasmosis was reported in numerous patients taking the drugs. Of 240 reported cases of infection, approximately 20 percent(45/240) of the patients died.
Specifics on Histoplasmosis
The infection is primarily a respiratory infection with symptoms similar to the flu. If left untreated, the infection can spread to other organs of the body, at which point the outlook becomes very grim. In fact, officials from the FDA discovered evidence indicating that some patients had received a late diagnosis of infection; of those patients, more than half died.
The FDA urged patients taking Enbrel to contact their primary caregiver if they developed a persistent fever, cough, shortness of breath or fatigue, all of which could be signs of the fungal infection. Additionally, the FDA advised the medical community to consider the possibility of antifungal drug use in patients showing signs of possible infection, as well as the possibility of stopping the use of the immunosuppresants.
Quality Legal Advice
Anyone taking Enbrel should be aware of the risks posed by this medication. As it is already considered by the FDA to carry a potentially deadly risk factor, patients should be aware that they may be entitled to compensation for any damages incurred from taking this medication. Patients are advised to contact an experienced Enbrel Attorney about a potential Enbrel Lawsuit.