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 risks of Legionella and Listeria are added to the Black Box. (link to FDA) (September 2011 Label) (September 2011 Label – Legionella)
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)
The risk of optic neuritis is added to the Neurological warnings in the label. (December 2011 Label) (December 2011 Label – Optic Neuritis)
Copyright © Data Based Medicine Americas Ltd.
Think about how many people between 2002 and 2008 went to a doctor and was prescribed Humira and are no longer with us. It took the FDA 6 years to figure out that this drug had serious problems. Makes me sick to think about how patients were treated like guinea pigs. Since 2013 4200 people have died from Humira according to the FDA’s own data base. That is almost 4 people a day. Remember that the next time you see a Humira commercial.
The week before Thanksgiving 2015 I was given Humira for my ankylosis spondylitis.my wife went to California leaving me and my dog alone for the week.within two days I had almost every bad reactions listed in the pamphlet.i called my Rhuematoligist and advised the nurse of this.she asked the dr who had told me not to worry about anything, and all he told her to tell me was to go back to only Prednisone.no going to hospital or anything.i spent a week in agony until my wife came back to take care of me.in late December I started getting chest pains and trouble breathing.finally on December 26 2015 we went to the hospital and I had around 20 Pulmonary embolisms and was about an hour from death.i have so many Autoimmune diseases it took me awhile to connect my new deadly blood disorder antiphospholipid antibody syndrome to my taking Humira.needless to say I did not go back to that doctor.after 3 years on coumadin and the constant bleeding and making sure I have bandages and gauze and tape I complained to Abbie vie who is part of the company who makes it.i want restitution for my former and future medical bills and for my funeral which is inevitable.i told them I did not want to sue but I would.just got ny records and must write another letter besides the one I sent along with some records and I gave them permission to contact that dr.humira only recently talks about blood disorder,problems.i have PTSD when I see the commercial.i freak out screaming at the TV.lets see what they offer.it was obvious they have a process for this.be very wary of using this drug.i have lots of pictures of my bruises that come from nowhere and I just bleed out of nowhere and it’s hard to stop.God forbid I actually get cut.DO NOT USE THIS DRUG.