Archive for August, 2009
Questions Being Raised About the Importance of Diet on Gout
Posted by Victor Konshin in Diet on August 27, 2009
An article that will appear in the September Issue of the Journal of the American Dietetic Association calls into question the long held belief that those with gout need to maintain a “purine-restricted” diet. This article points out that some foods, such as some vegetables are very high in purines, yet research has consistently shown that consumption of these vegetables is strongly correlated with a reduction in uric acid levels and in gout attacks. Research has also shown that beer is strongly correlated with higher instances of gout even though modern beers often have very low levels of purines.
Although diet has long been assumed to be associated with hyperuricemia, this association remains to be verified. Studies that have reviewed the relationship of diet and hyperuricemia have found it to be a difficult and complex issue.
FDA Rejects New Gout Drug and Approve an Old One
Posted by Victor Konshin in Gout Treatments, New Research on August 4, 2009
It was starting to look like 2009 was the year going banner year for new gout drugs. That all came to a holt on Sunday as the FDA rejected the application for Savient Pharmaceuticals, Inc.’s drug, Krystexxa® (also called puricase or pegloticase). This new drug used an enzyme not found in humans that breaks down uric acid in the body. To prevent the body rejecting the foreign enzyme it is “locked up” in a molecular “cage”. This cage allowed uric acid to flow in but blocks the immune system from attacking the enzyme (see, New Gout Drugs – Coming to a Pharmacy Near You).
Interestingly, the FDA did not have any complaints about the drug itself and found that the drug was safe and effective. In fact, the FDA’s advisory board voted 14 to 1 to approve the drug. However, the FDA raised concerns that the drug that was studied was created using a different manufacturing process than the drug that would be released to the public. Due to concerns that this different manufacturing process could change the safety or effectiveness of the drug, the FDA rejected the drug until the manufacturer proves that the different manufacturing method resulted in a drug that was also safe and effective.
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