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FDA Warning Over Humira Ad

Dec 24, 2008 | Parker Waichman Alonso LLP

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.