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Saturday, September 18, 2010

Pegloticase Approved by FDA for Gout

Posted by Prahallad Panda on 2:47 PM Comments

Article first published as A New Gout Drug Pegloticase Approved by FDA on Technorati.

Gout, as we know is a very painful arthritic condition, involving in majority of cases the joint that joins great toe to the foot, called first metatarsophalangeal (MTP) joint. Later on, it affects other joints in an ascending manner, though not always. It is due to excessive amount of metabolite called uric acid in the circulation, derived from the metabolism of purine, a type of nuclear protein.
Uric acids are needle shaped crystals that gets deposited in the covering membrane of some joints and cause inflammation there, giving rise to painful reddish swelling called as gouty tophi. Aspiration of joint material for monosodium urate is confirmatory for the disease. Blood level more than 7.6 mgs% in male and more than 6 mgs% in female are indicative of the disease. But, disease may be found in a lower blood level of uric acid.
Gout, apart from joints; affect heart, kidneys and gall bladder etc. in long standing untreated cases. It is associated with diabetes and obesity. Some 3% of affected people do not respond to the conventional drugs like allopurinol and feboxostat. A new drug pegloticase, approved by FDA is an enzyme that acts on the uric acid to degrade it to harmless chemical that is excreted in urine.
Pegloticase is administered intravenously in every two weeks. It gives relief to majority of non-responders to the conventional drugs. It is not fully safe, as produces severe allergic reaction in about one fourth of cases during a trial; say the scientists. It may produce gout flare, nausea, injection site bruising, irritation of the nasal passages, constipation, chest pain and vomiting.
Physicians are also have been warned to be cautious in administering pegloticase to patients with congestive heart failure, because the drug was not studied in this patient population. They also have been advised to keep steroid and antihistaminic ready; or consider prior administration to reduce the allergic reactions.
It is perhaps better to keep this drug reserved for the non-responders to conventional drugs, rather than to go for its routine use.

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