Krystexxa (pegloticase) approved by the FDA for gout

The U.S. Food and Drug Administration approved Krystexxa (pegloticase) to treat the painful condition known as gout in adults who do not respond to or who cannot tolerate conventional therapy.

This drug is not your typical gout drug. Read on:

For patients with gout, the conventional therapy is to receive drugs that lower the amount of uric acid in the blood, as, for example, the xanthine oxidase inhibitors Zyloprim (allopurinol) and Uloric (febuxostat). Krystexxa is an enzyme that lowers uric acid levels by metabolizing it into a harmless chemical that is excreted in the urine. The drug is administered to patients every two weeks as an intravenous infusion.

Two six-month clinical trials of 212 total patients demonstrated that the drug lowered uric acid levels and reduced deposits of uric acid crystals in joints and soft tissue.

Since one out of every four patients in the clinical trials experienced a severe allergic reaction when receiving an infusion of Krystexxa, health care providers should dispense a corticosteroid and an antihistamine to their patients beforehand to minimize the risk of such a reaction. Other reactions during the clinical trials included gout flare, nausea, injection site bruising, irritation of the nasal passages, constipation, chest pain and vomiting.

Toothpaste out of the elbow! (yucky!)

OK, this is not technically toothpaste. However, it sure looks like it. This is an image of a man's elbow and it's from the New England Journal of Medicine (NEJM).

A 77-yr-old man renal-cell carcinoma (kidney cancer) presented with painful swelling of his elbow. This white chalky substance was a result of an acute flare of previously asymptomatic, chronic tophaceous gout. Hence, this image receives a heading titled, "Gouty Tophi." To read more, visit the NEJM here.

Colchicine receives FDA approval? It's about time!

This may sound a bit odd, but "FDA Approves Colchicine for Acute Gout, Mediterranean Fever." Wait a minute, isn't colchicine a really old drug? Yes, but I guess it's technically been used off-label for all these years. According to the FDA:

Oral colchicine has been used for many years as an unapproved drug with no FDA-approved prescribing information, dosage recommendations, or drug interaction warnings.

So, if that little piece of trivia tickles your brain, then read this full FDA press release about the recent approval of colchicine:

The U.S. Food and Drug Administration has approved Colcrys to treat acute flairs in patients with gout, a recurrent and painful form of arthritis, and patients with familial Mediterranean fever (FMF), an inherited inflammatory disorder. The medication’s active ingredient is colchicine, a complex compound derived from the dried seeds of a plant known as the autumn crocus or meadow saffron (Colchicum autumnale).

Colchicine has been used by healthcare practitioners for many years to treat gout but had not been approved by the FDA. The FDA has an initiative underway to bring unapproved, marketed products like colchicine under its regulatory framework. This initiative promotes the goal of assuring that all marketed drugs meet modern standards for safety, effectiveness, quality and labeling.

Physicians historically have given colchicine hourly for acute gout flares until the flare subsided or they had to stop treatment because the patient began experiencing gastrointestinal problems. A dosing study required as part of FDA approval demonstrated that one dose initially and a single additional dose after one hour was just as effective as continued hourly dosing for acute gout flares, but much less toxic. As a result, the drug is being approved for acute gout flares with the lower recommended dosing regimen.

The FDA is alerting healthcare professionals to this new dosing regimen and also warning about the potential for severe drug interactions when patients take colchicine.

The medicinal value of using colchicum was first identified in the first century A.D. and its use for treating acute gout dates back to 1810. Physicians have prescribed the medication since then. Although single-ingredient colchicine has not been approved by the FDA until now, a combination product containing colchicine and an agent that increased the excretion of uric acid in the urine was approved by the FDA in 1939.

FMF is the most common of the hereditary periodic fever syndromes and is characterized by recurrent episodes of fever, arthritis and painful inflammation of the lining layers of the lungs and abdomen. Though rare in the United States, it is more common in Mediterranean countries. Physicians have prescribed colchicine for FMF for many years based on studies showing that it reduced the frequency of attacks but use of colchicine for FMF had never been approved. With this approval, Colcrys becomes the first drug approved to treat FMF.

Colcrys is manufactured by Mutual Pharmaceutical Company, Inc., Philadelphia.

How's that for an interesting mix of fascinating trivia coupled with some FDA news?