Pharmaceutical

Humira generates most adverse event reports in FDA database

fda logo Humira generates most adverse event reports in FDA database Drugs that treat autoimmune disorders like psoriasis, rheumatoid arthritis and Crohn’s disease generate the largest number of adverse event reports to the Food and Drug Administration (FDA), according to an analysis by the Milwaukee Journal Sentinel and MedPage Today. These immune-suppressing drugs make users more prone to serious infections such as tuberculosis, invasive fungal infections, and cancers of the immune system. Among these drugs, Humira has generated the most adverse events.

Humira is manufactured by AbbVie Inc. and was first approved by the FDA in 2002. It is now approved to treat 10 conditions including rheumatoid arthritis, juvenile arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, hidradenitis suppurativa, ulcerative colitis, plaque psoriasis, and some eye infections. It was recently approved to treat fingernail psoriasis.

U.S. prescriptions for Humira have jumped from 1.5 million in 2011 to 2.4 million in 2015. Since 2013, Humira has been linked to more than 209,000 reports of adverse events including more than 4,200 deaths.

In April 2011, the FDA warned that some patients taking Humira, mainly adolescents and young adults who were being treated for Crohn’s disease, were at an increased risk of a rare cancer called hepatosplenic T-Cell lymphoma, or HSTCL. This rare cancer of the white blood cells is aggressive and usually fatal. Those at greatest risk were also the immunosuppressant drugs azathioprine and/or mercaptopurine.

In August 2009, the FDA warned that Humira was linked to an increased risk of lymphoma and other cancers in children and adolescents. The discovery led the agency to require Humira and similar drugs to add an update to the black box warning on the drugs.

Source: Journal Sentinel