The drugs � Enbrel, Remicade, Humira and Cimzia � work by suppressing the immune system to keep it from assaultive the consistence. For patients with rheumatoid arthritis, the treatment provides relief from swollen and painful joints, but it's "a double-edged sword," aforementioned the FDA's Dr. Jeffrey Siegel. That's because the drugs besides lower the body's defenses to various kinds of infections.
Siegel, wHO heads the office that oversees arthritis drugs, aforesaid the FDA became concerned after discovering that doctors seemed to be overlooking a picky kind of fungal infection called histoplasmosis. Of 240 cases reported to the FDA in which patients taking one of the four drugs developed this infection, a total of 45 died � almost 20%.
The infection, which mimics the flu, is prevalent in practically of the middle part of the country. It can make particularly grave accent consequences if it isn't caught early and spreads beyond the respiratory system to other organs of the body.
Siegel said the investigation began with a single event of a woman taking one of the drugs who died of histoplasmosis. Delving into the case, doctors at the FDA found that the charwoman had been sick with the fungous infection for a tenacious time. "This case light-emitting diode us to be concerned that there may be other situations in which physicians crataegus oxycantha not recognize histoplasmosis," aforesaid Siegel.
FDA officials searched the agency's database and constitute the 240 cases of patients taking the medications who had also developed the fungal infection. Of those, at least 21 appeared to involve a late diagnosing, and 12 of them � more than half � at last died.
Siegel aforesaid the FDA's order Thursday means that the risk of infection of histoplasmosis will be flagged in a "black box," the strongest warning information in a drug's prescribing literature. The quatern medications already have black box warnings about the risk of infections, but the speech varies from drug to drug.
Patients should call their doctors if they acquire persistent pyrexia, cough, shortness of breather or fatigue duty, which can be signs of the fungal infection.
And the FDA is as well urging doctors to count aggressive habit of antimycotic agent drugs in patients world Health Organization develop such symptoms, even if the infection has not been confirmed by a testing ground test. Siegel said such a determination should not be taken lightly, since antifungal drugs can likewise have grievous side personal effects. Doctors should consider stopping treatment with the immune-suppressing drugs if patients develop infections.
The four drugs belong to a class known as TNF-alpha blockers, and are considered a anchor for treating rheumatoid arthritis, a disabling disease in which the immune system attacks the joints. They are besides used to treat Crohn's disease, puerile arthritis, certain types of psoriasis, and other immune system disorders. All ar taken by injection.
Separately, the FDA is investigating a possible link between the four medications and cancer in edward Young patients. The agency aforesaid earlier this year it has received 30 reports of cancers, mainly lymphomas, in patients who began taking the medications when they were 18 or younger. That investigation is expected to take the rest of the year.
Three of the drugs, Enbrel, Humira and Remicade, are considered blockbusters, with gross revenue of over $1 one thousand million annually for each. Cimzia is newer and less widely used.
Humira is made by North Chicago, Ill.-based Abbott Laboratories Inc; Cimzia by Belgium-based UCB; Enbrel by Thousand Oaks, Calif.-based Amgen Inc. and Madison, N.J.-based Wyeth; and Remicade by Horsham, Pa.-based Centocor, a unit of measurement of Johnson & Johnson.
Abbott shares hide $1.29, or 2.3% to $56.64 Thursday
