FDA Strengthens Warnings on Four Drugs: Remicade, Humira, Cimzia, & Enbrel
September 4, 2008
The Food and Drug Administration (FDA) today ordered stronger warnings on the labels of four popular drugs for arthritis and Crohn’s disease to notify patients about the risk of serious fungal infections. The four drugs now required to carry stronger warnings include: Johnson & Johnson’s Remicade; Abbott Laboratories’ Humira; UCB SA’s Cimzia; and Amgen’s and Wyeth’s co-marketed drug Enbrel.
The FDA made its decision to strengthen the drugs’ warning labels after reviewing more than 240 reports of histoplasmosis in patients taking Remicade, Humira, Enbrel, or Cimzia. Histoplasmosis is a fungal infection that starts as a respiratory infection and can spread throughout the body.
Of the 240 patients in the study, 21 patients were not diagnosed with histoplasmosis right away, leading to delayed treatment, prolonged hospital stays, and 12 deaths. Additionally, 33 patients whose treatments were not delayed also died. The 240 histoplasmosis patients ranged in age from 8 to 86 years. None of the deaths, however, involved children.
The FDA issued the new warnings using powers Congress granted the agency last year. The primary reason for the new warnings is concern that doctors and other health-care professionals are not properly diagnosing serious fungal infections in patients taking the drugs.
Although some of the drugs already carry a black box warning, which is the strongest possible warning, the FDA says doctors still are not recognizing cases of histoplasmosis and other invasive fungal infections. As a result, the FDA will now require all four drugs to carry “more uniform” boxed warnings about fungal infections, highlighting histoplasmosis.
For now, the FDA wants patients and doctors to be on the lookout for signs and symptoms of histoplasmosis, including persistent fever, cough, shortness of breath, and fatigue. Additionally, the FDA has advised patients to call their doctors immediately if they experience these signs and symptoms.
Dangerous Drug Injury Lawyers
If you or a loved one took Remicade, Humira, Enbrel, or Cimzia, and experienced serious side effects, you may be entitled to compensation for your injuries. Contact us today to learn more about your legal rights and options. You may also find important information about unsafe medications on our dangerous drugs pages.