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FDA orders stronger warnings for 4 arthritis drugs

Associated Press/AP Online

By RICARDO ALONSO-ZALDIVAR

WASHINGTON - The Food and Drug Administration ordered stronger

warnings Thursday on four medications widely used to treat rheumatoid

arthritis and other serious illnesses, saying they can raise the risk

of possibly fatal fungal infections.

The drugs - Enbrel, Remicade, Humira and Cimzia - work by suppressing

the immune system to keep it from attacking the body. For patients

with rheumatoid arthritis, the treatment provides relief from swollen

and painful joints, but it's " a double-edged sword, " said the FDA's

Dr. Siegel. That's because the drugs also lower the body's

defenses to various kinds of infections.

Siegel, who heads the office that oversees arthritis drugs, said the

FDA became concerned after discovering that doctors seemed to be

overlooking a particular 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 - about 20 percent.

The infection, which mimics the flu, is prevalent in much of the

middle part of the country. It can have particularly grave

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 case of a woman

taking one of the drugs who died of histoplasmosis. Delving into the

case, doctors at the FDA found that the woman had been sick with the

fungal infection for a long time. " This case led us to be concerned

that there may be other situations in which physicians may not

recognize histoplasmosis, " said Siegel.

FDA officials searched the agency's database and found 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 diagnosis,

and 12 of them - more than half - ultimately died.

Siegel said the FDA's order Thursday means that the risk of

histoplasmosis will be flagged in a " black box, " the strongest warning

information in a drug's prescribing literature. The four medications

already have black box warnings about the risk of infections, but the

language varies from drug to drug.

Patients should call their doctors if they develop persistent fever,

cough, shortness of breath or fatigue, which can be signs of the

fungal infection.

And the FDA is also urging doctors to consider aggressive use of

antifungal drugs in patients who develop such symptoms, even if the

infection has not been confirmed by a laboratory test. Siegel said

such a decision should not be taken lightly, since antifungal drugs

can also have dangerous side 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 mainstay for treating rheumatoid arthritis, a disabling

disease in which the immune system attacks the joints. They are also

used to treat Crohn's disease, juvenile arthritis, certain types of

psoriasis, and other immune system disorders. All are taken by

injection.

Separately, the FDA is investigating a possible link between the four

medications and cancer in young patients. The agency said 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 sales of over $1 billion annually for each. Cimzia

is newer and less widely used.

Humira is sold 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 & , and Kenilworth, N.J.-

based Schering-Plough Inc.

Abbott shares fell $1.36, or 2.4 percent, to close at $56.64 Thursday;

Amgen fell $2.22, or 3.5 percent, to $60.88; Wyeth fell $1.54, or 3.6

percent, to $41.47; and & fell $1.06 to $70.45.

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