Enbrel

In November 2008, the maker of the Enbrel drug (known generically as etanercept) was required by the FDA to strengthen the drug's warnings about the risk of Enbrel side effects. Specifically, the label was updated to include a strengthened warning about the risk to some patients of developing opportunistic fungal infections while taking Enbrel.

Although the warning label already included warnings about the risk of serious infections, the FDA noted in its Safety Alert that cases of histoplasmosis and other invasive fungal infections were not recognized consistently, resulting in a delay in treatment for the patient. According to an FDA news release (September 4, 2008), at least 21 reports of fungal infection were not treated immediately and, of those, 12 patients died.

Symptoms of a systemic fungal infection include persistent fever, weight loss, sweats, cough, fatigue and shortness of breath. Patients who are taking Enbrel and notice these symptoms should seek medical attention because they could be experiencing serious side effects of Enbrel.

Enbrel is a tumor necrosis factor alpha blocker (TNF blocker) and is used to suppress the patient's immune system. It is used to treat moderate to severe rheumatoid arthritis, moderate to severe polyarticular juvenile idiopathic arthritis (formerly called juvenile rheumatoid arthritis), psoriatic arthritis, ankylosing spondylitis and moderate to severe plaque psoriasis.

The FDA had previously announced on May 1, 2008 that Enbrel's warning label was being updated to include a boxed warning alerting patients to the risk of infections including bacterial sepsis and tuberculosis.

Meanwhile, the FDA is investigating a possible association between the use of Enbrel and the development of lymphoma and other cancers in children and young adults. According to an FDA report (June 4, 2008), the agency is investigating approximately 30 reports over a 10-year period of cancer in children and young adults who used TNF blockers. Among the children and young adults who took Enbrel, cancers that were reported include lymphoma, leukemia, melanoma and solid organ cancers. The FDA has asked the makers of the TNF blockers to provide information about all cases of cancer in children who use those medications.

Enbrel is manufactured by Immunex Corporation and is marketed by Amgen and Wyeth Pharmaceuticals.