Abbott Laboratories is in more hot water over its Humira advertising. Federal regulators warned Abbott about its advertisements for the company’s psoriasis drug, saying the ad is misleading and makes claims not supported by scientific evidence. According to Dow Jones, the Humira (generic: Adalimumab) ad cited claims the medication is approved for patients with moderate to severe chronic plaque psoriasis. According to a U.S. Food and Drug Administration (FDA) letter dated December 16th to Abbott, Humira is only approved for a more limited patient population, said Dow Jones. The letter, said Dow Jones, was posted to the FDA’s Website yesterday.
The FDA said the Humira ad indicates the medication’s risks in “extremely” small type that “fails to adequately convey the serious risks connected to the product.” Of note, Humira carries a black-box warning, the FDA’s strongest, which discusses the risk of serious—some fatal—side effects such as tuberculosis and other infections, said Dow Jones. The FDA wants Abbott to stop the ad and respond to the agency by January 2 explaining if it intends to comply with the FDA request, said Dow Jones.
Meanwhile, two years ago, a study revealed that patients taking Humira faced a three-fold risk of developing several kinds of cancer and a two-fold risk of getting severe infections. Humira is in the same class of drugs as Enbrel and Remicade, which are anti-TNF drugs or TNF blocker drugs. TNF is a small protein called a cytokine, which has a major role in the regulation of the immune system. Anti-TNF drugs confine TNF and obstruct the reaction, which causes the abnormal joint inflammation. Humira is approved for the treatment of rheumatoid arthritis and in rheumatoid arthritis, TNF levels are very high, resulting in inflammation, swelling, pain, and joint damage.
A Mayo Clinic study published in the May 17, 2006 issue of the Journal of the American Medical Association, found an apparent link between Humira and other cancers, including skin, gastrointestinal, breast, and lung tumors. According to study author Eric Matteson, a professor at the Mayo Clinic in Rochester, Minnesota, physicians might well expect to see one additional case of cancer developing within six to 12 months of treatment for every 154 patients who take the drugs and could expect to see one serious infection, such as pneumonia, within three to 12 months for every 59 patients treated. Anti-TNF antibody drugs are one of the fastest-growing prescription classes in the nation. Humira was granted FDA approval on December 31, 2002.
Dow Jones noted that Humira is also approved to treat adult patients with moderate to severe chronic psoriasis, a skin disease characterized by red patches and flaky and scaly skin, who don’t generally respond to topical medications and is also approved to treat Crohn’s disease, a chronic infection of the intestines.
In September, we reported that Federal regulators ordered the makers of Humira, Cimzia, Enbrel, and Remicade to strengthen the existing warnings about opportunistic fungal infections linked to the drugs. At least 45 people are known to have died from such infections.
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July 11th, 2009 at 9:05 am
Dear sir,madam, reading your article, concerning the crohns disease drug HUMIRA,was very interesting,i myself have had moderate small-bowel crohns disease,for five years,and now my doctor wants to put me on HUMIRA,But i have been doing alot of reserch on this drug,and i think having crohns,is the less of the two evils.!! I have just wrote to ABBOTS in america,to ask them hows safe this drug is, they by passed the question and sent my email to ABBOTS in england to be answered, and they have not gave me any answers,so i am thinking to myself are they hiding from dangerous problms,with this drug
October 20th, 2009 at 10:02 am
I am on Humira – I have been on the drug for almost 2 years now. Without it, my Crohn’s flares up and it is evil (I spent a summer in the hospital b/c of it when i was 18 – it ended in surgery). To me, Humira is the lesser of 2 evils (I have had Crohns for 5 years, as well). I have my life back – i have been in remission ever since I’ve been on it. As for the warnings and side effects – I have had none. I also have Leukemia which I developed 3 yrs ago. Needless to say, my immune system is not the greatest as a result of all this – but amazingly enough, I very rarely get sick – even with the common cold! There are always risks when taking drugs, but I think sometimes people are too careful and miss out on getting their life back because they’re too scared to take a chance. But, I guess the severity of your Crohn’s would influence which you prefer…if you ARE suffering from Crohn’s disease, though, and can’t gain remission – give Humira a try!