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Drugs & Clinical Trials Topic
FDA Supports Compounding of Off-Label Drug to Prevent Preterm Labor
Recently, the U.S. Food and Drug Administration (FDA) approved the new drug Makena (17-hydroxyprogesterone caproate) for the prevention of preterm labor. This is the first FDA-approved drug for this indication, but the active ingredient in the drug has been a standard of care for preventing preterm labor for nearly a decade. Until now, it has been compounded by pharmacies consequent to an individual medication order; this is not an approved practice in the eyes of the FDA, since the drug was never approved for use in preterm labor. Makena was originally met with triumph, but it soon felt like a tragedy to countless physicians and patients when KV Pharmaceuticals, the manufacturer of Makena, announced that it would sell Makena for $1500 per injection. When compounded individually, the drug is available for $10 to $20 per injection. Up to 20 injections are needed per pregnancy. The FDA announced on March 30, 2011, that it will allow pharmacies to continue compounding individual orders for hydroxyprogesterone caproate injections without repercussions.
Colic and Probiotics – A Cure for the Crying?
Colic is a syndrome that appears in up to 20% of infants. It is generally defined by a set of criteria in which a baby between the ages of 2 weeks and 16 weeks cries inconsolably for at least 3 hours a day for at least 3 days a week, lasting at least 3 weeks. Colic has no defined etiology, and no effective treatments. But, any parent who has suffered through a baby with colic would be willing to try almost any remedy to soothe a crying baby.
Faster. Higher. Stronger. Braver.
Athletes the world over are continuously searching for new ways to one-up their competition. Better training, improved technique, innovative coaching. In sports, if not always in life, there are clear winners and losers, and, often, the winners are the ones who can combine natural talent with the best and brightest advantages training and coaching have to provide. When the advantage comes from the latest and greatest gadget or gear, coaching style, or training regimen, competitors are just sorry they did not find it first. But, when the advantage comes from performance-enhancing drugs, the line between winners and losers gets a little blurry. And now, there are some sports gurus and bioethicists who wonder if legalizing performance-enhancing drugs is, in fact, a fair play.
Cartoon – Alcohol and Aggression
Judging by all the destruction caused by the test subject, drinking more does make one more aggressive. A recent study published in the Journal of Studies on Alcohol and Drugs found a positive correlation between alcohol dose and aggression in human subjects. Aggressiveness was measured by shock intensity and duration administered to one's "opponent" in a competitive reaction-time task. The opponents were fictional and no actual shocks were administered. Essentially, the more alcohol one drank, the more frequent and longer shocks they applied. This finding was observed throughout both genders.
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