FDA Approves New Gout Drug

[mikesimon]

WASHINGTON -- The FDA has approved pegloticase (Krystexxa) for treatment of gout in adults who are refractory to standard treatments.

Pegloticase is an enzyme that boosts metabolism of uric acid, breaking it down into a harmless chemical that is excreted in urine. The FDA said the drug can be administered every two weeks as an intravenous infusion.

The approval was based on results from two six-month long clinical trials that enrolled a total of 212 patients. The FDA said that in those studies, "the drug lowered uric acid levels and reduced deposits of uric acid crystals in joints and soft tissue."

In a statement, Badrul Chowdhury, MD, director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA's Center for Drug Evaluation and Research, estimated that 3% of gout patients get no relief from conventional therapy.

Although the drug demonstrated efficacy, its use was also associated with a severe allergic reaction in about 25% of patients treated with it. Noting that high rate of adverse events, the FDA recommends that "healthcare 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 trial included gout flare, nausea, injection site bruising, irritation of the nasal passages, constipation, chest pain. and vomiting.

The agency also cautioned that the drug has not been studied in patients with congestive heart failure.

The FDA approval included a Risk Evaluation and Mitigation Strategy that includes a medication guide for patients and materials for healthcare providers to communicate the risk of severe infusion and allergic reactions.

The drug is manufactured by Savient Pharmaceuticals of East Brunswick, N.J.

http://www.medpagetoday.com/ProductAlert/Prescriptions/22189?utm_content=GroupCL&utm_medium=email&impressionId=1284622172618&utm_campaign=DailyHeadlines&utm_source=mSpoke&userid=235671

[Sarajmt]

Thanks for the news on this.  My dh just got over a bout of gout.  But he won't quit drinking during the bouts so he doesn't do a lot to help himself. But it's a very painful condition.  I'll let him know about this.

onthefence:  Thanks for the info.  I'll pass that one along as well if he'll go to the doctor.

[onthefence]

Indomethacin (Indocin) works well for gout, and is non narcotic.

[teko]

I remember when my son was ill many years ago, he was given oxycotton  and the like, which at that time  were only given to terminally ill people. Now its given out like candy, leaving me to wonder what the doctors are doing to our bodies in order to heal one thing or to treat a symptom, but ensuring to develop other problems to ensure we come back at a later date with other issues brought on by these meds. Liver disease is one that is way up there now. I guess I have a hard time believing anyone is really trying to actually help us over putting the mighty dollar first. Does that mean I thin a conspiracy is going on? Yeah, I guess I kinda am afraid of that. I think doctors push drugs whether ya need em or not. One case in point would be the cholesterol drugs. You reach a certain age and bamm, now they stick you on them, not cause you got a problem but your at the age where you probably will have. I just dont no.

[Barb135]

Ahhh, good old "Pred" -- I've never had the pleasure, but I know some who are and have been for a long time.  Like all good things, if it's "overdone", it no longer works well.

[mikesimon]

I like steroids for all that stuff. Prednisone is a wonder drug - just don't take it too long - hear? Yep, you betcha!!
Mike

[Barb135]

I agree with teko in regards to the side effects and particularly the allergic reactions.  212 people isn't very many.  I don't have gout, and for those who do, maybe this would be a great advancement, but it sounds kind of scary.

Do we know if this drug, or a similar one, are approved/used in other countries, where maybe there have been larger studies done?  Or if it interacts with other drugs?  

[teko]

I am not sure these two studies are enough to unleash this med upon the public, especially with the side effects occuring in 25 percent of those taking it. I just worry because we seem to be getting these drugs that do great harm and then after hurting people end up being recalled. That does not sound like much of a study.