New Gout Drug Krystexxa Works but Risky Reports FDA
June 13, 2009 by Nancy
Filed under Featured Story
The Food and Drug Administration reported Friday the new gout drug, Krystexxa, appears to treat gout but has risky side effects.
About 24 percent of patients taking Krystexxa suffered a serious side effect. That is in comparison with 12 percent of patients taking a placebo pill. Six deaths were reported among the patients taking the drug compared to three deaths among patients taking placebo. The FDA noted many of them had pre-existing heart conditions.
Krystexxa is an injectable enzyme made to lower the body’s uric acid levels when given either once or twice a month. The drug appears to relieve swollen joints and pain flare ups associated with gout which is caused by a buildup of uric acid in the body.
The FDA is planning to ask a panel of outside arthritis experts next week to give their comments on the drugs risks and benefits.
Gout affects about 8 millions Americans and is most common in men over 40 according to the FDA.
The new gout drug is produced by Savient Pharmaceuticals.
FDA Says Throw Away Clarcon Products
June 9, 2009 by Nancy
Filed under Featured Story, News Talk
The FDA says to throw away Clarcon products according to a warning issued today because of high levels of disease causing bacteria found in a recent inspection.
According to the agency, samples of over the counter topical antimicrobial skin sanitizer and skin protectant products revealed high levels of various bacteria, including some associated with unsanitary conditions.
The Food and Drug Administration said it is particularly concerning because the products are promoted as antimicrobial agents that claim to treat open wounds and damaged skin and to protect against various infectious diseases.
The FDA said in their statement that Clarcon Biological Chemistry Laboratory Inc., of Roy, Utah, issued a voluntary recall of some skin sanitizers and skin protectants marketed under several different brand names.
Examples of Clarcon products the FDA says to throw away include Citrushield Lotion, Dermassentials Derma Barrier, Dermassentials by Clarcon, Antimicrobial Hand Sanitizer, Iron Fist Barrier Hand Treatment, Skin Shield Restaurant, Skin Shield Industrial, Skin Shield Beauty Salon Lotion, Total Skin Care Beauty and Total Skin Care Work.
