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The Gout Dugout Newsletter, Issue #006. Febuxostat is approved in the EU; It's cherry time
June 02, 2008
Welcome to this month's Gout Dugout, the ten minutes' read that could give you useful ideas for dealing with gout.
FEBUXOSTAT RECEIVES EU MARKETING APPROVAL
A few days after May's Gout Dugout was dispatched, it was announced that Febuxostat has been approved for distribution in the European Union (EU). I didn't send out a flash email because its marketing can only begin now and this will take time. But if you live in an EU country you can certainly find out if your doctor knows and discuss with him/her whether Febuxostat is right for you.
In the EU its brand/trade name will be Adenuric.
Febuxostat has been approved for gout patients with chronic hyperuricemia (high uric acid levels) and gout. You will have to have to have MSU crystals and high levels of uric acid (UA).
So if you have gout with normal UA levels, or levels that are not judged high (probably below 6.8 mg/dL a defined limit of UA solubility), then you probably won't be prescribed it. Similarly people with severe kidney or liver problems won't get it. It will be a prescription medication.
Febuxostat is not a pain reducer or remover, it's for long term treatment. It's been judged against Allopurinol. They are both xanthine oxidase inhibitors, and so work on the supply rather than the excretion side of the uric acid problem.
And what if you have other medical problems like kidney stones, heart disease, diabetes or hypertension? And what if you are on other drugs? eg. for hypertension. The Febuxostat public summary implied that it's not recommended for patients with severe kidney or liver problems (it's not been tested in these patient groups). And it said that it's not recommended for children or people who have had organ transplants.
If you live in a EU country you will have to ask your doctor. And especially if you have mild kidney or liver problems as well as gout.
The good news is that in its trials Febuxostat has outperformed Allopurinol. More patients reduced their UA levels down to the target 6 mg/dL(357 mmol/ìmol), than those on Allopurinol. And more trial participants reached the target level more quickly than those on Allopurinol. It also reduced tophi in some patients.
As with Allopurinol gout flares are likely on a course of Febuxostat, so preventive gout attacks medications are recommended to be taken along with Febuxostat. If you get a gout attack, it's recommended you continue with Febuxostat.
But, and you knew this was coming, it hasn't reduced UA levels to the target in all study patients and hitting this target doesn't mean that gout is cured.
The recommendation (from the European Medicines Agency Committee for Medicinal Products for Human Use) is that UA levels will need to be checked every two weeks on a course of Febuxostat, so clearly they expect quick uric acid level changes.
The recommended dosage is an 80 mg tablet once a day but if blood uric acid levels do not fall after 2-4 weeks the dosage may be increased to 120 mg daily.
It's been a very long time since a major new gout drug has been introduced. My desk reference book says Allopurinol was introduced in 1963, the year President John Kennedy was assassinated. That's 45 years ago. This is a huge amount of time for a new major drug to tackle a major medical problem in a particular way (i.e. reducing the production of uric acid). Let's hope the next major one won't take another 45 years.
The US FDA has not yet approved Febuxostat. But if you live in the United States, you can certainly inform your physician that Febuxostat is now approved for marketing in European Union countries.
REMEMBER, IT'S CHERRY TIME
Cherries have, or will soon arrive in most parts of North America and Europe and will be available for about three months. They should be in stock in supermarkets and at road side stalls if you are lucky enough to live in a cherry growing area.
If you are new to gout and you don't know about cherries gout fighting abilities,
please click here to visit www.best-gout-remedies.com's cherries page
At the risk of sounding like a food nanny, here are just a few tips about buying and storing cherries, most of which you probably know anyway.
FREEZING I've read cherries freeze well and keep for up to a year so freeze as many as you can. Wash, rinse and dry before freezing. Freeze them in a freezer bag with as little air in it as possible. Freeze them in one serving amounts (say 20-25 cherries), so that none are wasted. If you are very punctilious about it put a date frozen label on each bag so that at a later date you can eat those frozen first (i.e the oldest) and it will maybe remind you when one year is up.
Pit (i.e. remove the stone) the cherries before freezing to store more in less space. Cut them in half (best utensil is a paring knife) to remove the stone. In some countries you can buy a cherry pitter – search online for a mail order purchase if you don't have time to "cherry-pick" kitchen utensil shops.
BUYING Remember the darker the colour, the more flavonoids, which includes the anthocyanidins reckoned to be the gout fighters that inhibit xanthine oxidase and thus reduce uric acid production. i.e. the route Febuxostat takes to reduce UA levels. (Cherries have been studied as UA level reducers, but nothing like to the extent of drugs like Febuxostat).
Rock hard cherries are not ripe – avoid because cherries don't ripen after picking. Both sweet and sour cherries should be medium firm. All the best,
P.S. You may distribute this newsletter freely and free-of-charge, providing any links in it remain unchanged and it remains intact.Partial copying is not allowed.NB. The contents of this newsletter contain medical information, not medical advice. Please always discuss remedies with your doctor or other health care professional before implementing any treatment.
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