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 timeline
December 2002
Humira is approved by FDA. (link to FDA)
May 2006
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)
February 2007
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)
February 2008
Humira introduces a Patient Medication Guide – separate from the label and for the benefit of the patients. (Patient Medication Guide)
June 2008
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)
September 2008
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)
December 2008
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)
August 2009
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
November 2009 marked some of the most serious changes in the Humira label.
- Black Box of the label was strengthened to include a serious risk of opportunistic infections including histoplasmosis and bacterial sepsis, and the risk of lymphoma and other cancers in children and young adults. (Nov 2009 Label)
- In the Warnings Section under Full Prescribing Information, after years of stating that taking Humira concomitantly with Methotrexate and other immunosuppressants was just fine, the increased risk of infection leading to hospitalization and even death in those that do so is added. (Nov 2009 – Methotrexate & Histoplasmosis Warning)
- Also in the Warnings Section under Full Prescribing Information, the seriousness and difficulty in diagnosing histoplasmosis and other opportunistic infections is highlighted, as well as the recommended treatment. (Nov 2009 – Methotrexate & Histoplasmosis Warning)
- The risk of acute or chronic leukemia is added to Section 5.2 Malignancies. (Nov 2009 – Leukemia Warning)
- Under Adverse Events, incidences of patients reporting new onset or worsening psoriasis is added to Section 6.2 Postmarketing Experience. (Nov 2009 – Psoriasis)
April 2010
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)
May 2010
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)
July 2010
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)
March 2011
A number of updates took place during March 2011.
- Abbott updates the REMS and the Invasive Fungal Infection Educational Pamphlet. (March 2011 Label – REMS)
- The risk of hepatosplenic T-cell lymphoma (HSTCL), an extremely rare cancer, is added to the Black Box. (March 2011 Label – Black Box)
- Section 2.5 Monitoring And Assessing Safety was added, advising that patients should be tested for TB before and during treatment with Humira. (March 2011 Label – Section 2.5)
- Sections 5.1 and 5.11 were strengthened to include the risk of increased serious infection when taking Humira concomitantly with Abatacept in patients with RA. (March 2011 Label – Section 5.1)
- The statement that had been included in all previous labels, “the role of TNF and cancer is not know,” is removed in Section 5.2 Malignancies. The malignancy risk is now outlined to include lymphoma, non-melanoma skin cancer, and cancer risk in children and young adults. (March 2011 Label – Section 5.2)
- The risk of acute liver failure is added to Section 6.1 Adverse Reactions – Clinical Studies Experience. (March 2011 Label – Section 6.1)
April 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)
September 2011
The risks of Legionella and Listeria are added to the Black Box. (link to FDA) (September 2011 Label) (September 2011 Label – Legionella)
November 2011
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)
December 2011
The risk of optic neuritis is added to the Neurological warnings in the label. (December 2011 Label) (December 2011 Label – Optic Neuritis)
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.