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Weekly News Round Up - August 10, 2011

First Antidote Approved by the FDA to Treat Venomous Scorpion Stings

Painful scorpion sting may lead to ICU stay, especially in infants and small children; new antidote relieves symptoms of sting in 4 hours Read more...

Arachnophobia? Join the crowd. But the FDA has approved a treatment that might help lessen our fears. Anascorp, the first antivenom specifically for the painful sting of the Centruroides scorpion (bark scorpion), the most common type of scorpion in the US, has been approved. In the US, venomous scorpions are mainly found in Arizona. The severe stings can be life-threatening, especially in infants and small children, and often require an ICU stay. One clinical trial in 15 children with Anascorp was impressive, with all 8 children who received the antidote gaining relief from neurological signs of the stings within 4 hours. Only 1 in 7 children who received placebo had similar relief. In total, more than 1500 patients were evaluated in Anascorp studies.

Chronic, High-Dose Diflucan (fluconazole) in 1st Trimester May Lead to Birth Defects

Evidence of rare birth defects with long-term, high-dose fluconazole results in pregnancy category change Read more...

Fluconazole, a popular anti-fungal treatment, has been prescribed in the US for over two decades. Reported cases of birth defects associated with high-dose (400-800 milligram per day) and long-term (first trimester) fluconazole treatment have resulted in the FDA requiring a change in the pregnancy category from C to D for most indications. Pregnant women receiving high doses had life-threatening fungal infections. Pregnancy category D denotes there is positive evidence of human fetal risk but the drug benefits to the mother may outweigh the risks. The 150 milligram, single-dose treatment of vaginal yeast infections remains in pregnancy category C. Patients should talk with their healthcare provider if they are pregnant or planning to become pregnant while taking fluconazole.

Personalized Medicine for Asthmatics: Investigational Drug Lebrikizumab

Investigational agent blocks interleukin-13; may provide research insights into personalized medicine for asthma patients Read more...

Soon, the phrase “it’s all in your genes” may be applicable to asthma treatments, as well. A monoclonal antibody that blocks interleukin-13 (IL-13) is being investigated in asthma patients unresponsive to steroid treatment. Patients with high IL-13 levels, as measured by periostin (a protein produced by IL-13), had significant improvement in forced expiratory volume in one second (FEV1) compared to the placebo group. But lebrikizumab has a few hurdles to jump before it can hit the market: the drug is given by monthly injection which may be unacceptable by some patients, it is not clear if the biomarker periostin can be easily measured in a clinic setting, and as with many monoclonal antibodies, cost may be prohibitive. However, further research into IL-13 may provide additional treatment options.

Recombinant Human Growth Hormone (somatropin) Risk of Death: FDA Review Inconclusive

Study design flaws prevent FDA from conclusively stating if recombinant human growth hormone associated with death Read more...

The FDA reported that their review of recombinant human growth hormone (somatropin) has not conclusively revealed an increased risk of death associated with it’s use in short stature due to growth hormone deficiency. The Sante Adulte GH Enfant (SAGhE) study previously reported a small increased risk of death over long periods of use. The FDA study review found design flaws that prohibited result interpretation. The FDA also reviewed the published medical literature and the FDA Adverse Events Reporting System and found no correlation between recombinant human growth hormone and an increase in mortality.

NIH-funded Study: Soy Supplements Have No Positive Effect on Bone Loss or Menopausal Symptoms

Long-term trial demonstrates soy isoflavones do not protect bones and increase hot flashes in menopause Read More

Hot flashes in this weather? Unthinkable. Menopausal women using soy supplements may want to rethink their strategy for averting bone loss and other menopausal symptoms, such as hot flashes, night sweats, insomnia and loss of libido. A new study, completed in 248 women and evaluated during the second year of the trial showed that bone density levels, when compared to the placebo group, were unchanged. Additionally, the number of women reporting hot flashes increased in the soy group (48%) compared to those taking placebo (32%). Other menopausal symptoms remained unchanged.