Editorial Note: An article in Forbes this week suggested Humira is set to become the biggest selling drug of all time. The timeline below, found by Harriet Rosenberg on the JusticeSeekers’ website, covers the timeline of its elevation to the blockbuster Hall of Fame.
This post and several to come are part of a sequence outlining how we can all help make Humira a better medicine by use of an AbbVie.
Humira is approved by FDA. (link to FDA)
The Journal of the American Medical Association (JAMA) reports 3-fold increased risk of cancer in people taking TNF-blockers such as Humira. (JAMA Article)
Humira introduces a new label design as ordered by the FDA for the benefit of physicians that identifies the current changes to the label. (February 2007 Label)
Humira introduces a Patient Medication Guide – separate from the label and for the benefit of the patients. (Patient Medication Guide)
The FDA releases an Early Communication letter regarding the possible association between the use of Humira and the development of lymphoma and other cancers in children and young adults. (link to FDA)
The FDA orders stronger warnings for Humira and the risk of opportunistic infections, including histoplasmosis. Included in their requirement that the Black Box be changed to include these warnings, Abbott Labs was ordered to comply with a Risk Evaluation Mitigation Strategy (REMS) due to the seriousness of the risk. (link to FDA)
The FDA reprimands Abbott Labs for airing a misleading advertisement for treatment of plaque psoriasis with Humira. Abbott is accused of misbranding Humira and misleadingly minimizing the serious risks associated with Humira. (link to FDA)
The FDA orders a Black Box warning for the increased risk of lymphoma and other cancers in children and young adults. (link to FDA)
November 2009 marked some of the most serious changes in the Humira label.
Abbott implements the REMS requirement for Humira, as ordered by the FDA for a drug that poses a potential serious safety risk. (link to REMS)
Abbott releases the Dear Healthcare Provider letter (6 months after adding the risk to the Black Box) outlining the serious risk of histoplasmosis and other opportunistic infections. (Dear Doctor Letter)
Under Section 5.5 Neurological Reactions, the risk of demyelinating disease is expanded to include multiple sclerosis, peripheral demyelinating disease, and Gullain-Barre syndrome. (July 2010 Label) (July 2010 – Section 5.5)
A number of updates took place during March 2011.
The FDA issues a Drug Safety Communication Letter warning of the serious risks of Humira and the development of the rare T-cell lymphoma, HSTCL. (link to FDA)
The FDA issues a Drug Safety Update and the announcement of enhanced surveillance regarding the risks of Humira and people under 30 years of age. (link to FDA)