WEDNESDAY, Sept. 15 (HealthDay News) -- Krystexxa (pegloticase)
has been approved by the U.S. Food and Drug Administration for
adults with gout who do not respond to, or who cannot tolerate,
Gout results when the body produces too much uric acid, which
crystallizes in the joints or soft tissue. This leads to symptoms
including pain, stiffness, swelling and redness.
The condition has been strongly associated with other health
issues including obesity, high blood pressure, high cholesterol and
diabetes, the FDA said in a news release.
Krystexxa, given by injection every two weeks, metabolizes uric
acid into a harmless byproduct that is excreted in the user's
urine, the agency said. The drug's safety and effectiveness were
established in a pair of six-month clinical trials involving a
total of 212 people.
The FDA warned that since severe allergic reactions were a
common side effect of Krystexxa, a corticosteroid and antihistamine
should be given beforehand to minimize this risk. Other common
adverse reactions have included gout flares, nausea, bruising at
the injection site, nasal irritation, constipation, chest pain and
The agency said Krystexxa hadn't been evaluated in people with
congestive heart failure, and should be dispensed to such users
The drug is produced by Savient Pharmaceuticals, based in East
To learn more about gout, visit U.S.
National Library of Medicine.