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Double the Risk of Suicide Not Enough to Warrant Black Box Warning

From MedHeadlines:

In January, the US Food and Drug Administration (FDA) began the process of evaluating 199 studies of anti-seizure drugs commonly prescribed for epilepsy and other disorders due to reports of suicidal behaviors in patients taking them. Their findings led them to request a black-box warning be placed on the prescription labels of all 11 drugs under evaluation because the risk of suicide doubled when taking these drugs. The findings of the FDA evaluation were presented for discussion to a 20-member panel of advisers who voted unanimously on Thursday to deny the request for the black-box warning.

A black-box warning is the strongest warning of danger available to the pharmaceutical industry. Instead, the panel approved sending medication guides to physicians that describe the increased risk of suicide posed by these medications.

The panel said the risk of suicide wasn’t high enough to warrant the black-box warning and that to allow it might deter physicians from prescribing it. The opinion of the panel is taken very seriously by the FDA and the agency usually follows its recommendations.

The drugs in question include both the brand name and the generic name of Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR), Felbamate, Gabapentin (Neurontin), Lamotrigine (Lamictal), Levetiracetam (Keppra), Oxcarbazepine (Trileptal), Pregabalin (Lyrica), Tiagabine (Gabitril), Topiramate (Topamax), Valproate (Depakote, Depakote ER, Depakene, Depacon) and Zonisamide (Zonegran). These drugs are often prescribed to treat epilepsy, migraine headaches, bipolar disorder, and several other conditions.

While the FDA does not think there is reason to alter or interrupt treatment if a patient is taking any of these medications, they do advise caregivers to pay special attention to changes in mood, behavior, and the actions of the individual patient.

Posted: 7/14/2008 4:42:00 PM

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Vitamin D tests soar as deficiency, diseases linked

From USA Today:

Testing for vitamin D levels, once uncommon, has skyrocketed as medical studies raise awareness about vitamin D deficiencies, according to three of the USA's largest medical diagnostic labs. Physicians agree that they're increasingly using the blood test to find out whether their patients are low on the vital vitamin.

Richard Reitz, a medical director with Quest Diagnostics of Madison, N.J., says tests ordered for vitamin D grew by about 80% from May 2007 to May 2008.

Burlington, N.C.-based Lab Corp. of America witnessed a 90% leap in D test requests from 2007 to 2008, says Eric Lindblom, the company's senior vice president of investor and media relations. Neither company would release the actual numbers for competitive reasons.

The Mayo Clinic in Rochester, Minn., another of the country's largest diagnostic labs, processed 424,582 tests in 2007, up 74% from 2006. Ravinder Singh, co-director for the endocrine lab at Mayo, expects that the clinic will tally more than 500,000 tests by the end of 2008.

The jump in vitamin D testing comes after a slew of emerging research — much of which has been published in the past few years — linking vitamin D deficiency with some infectious diseases, cancers, cardiovascular disease and autoimmune disorders, says Patsy Brannon, professor of nutritional sciences at Cornell University.

Other research indicates that many Americans are deficient in vitamin D, and that is also fueling the testing trend, says Catherine Gordon, director of the bone health program at Children's Hospital Boston.

Though specialists who treat bone-related conditions and the elderly regularly run D tests, now even primary-care physicians and pediatricians are ordering the blood analysis.

A normal vitamin D test result is 30 ng/mL (nanograms/milliliter) or above. If a reading dips below that, a patient is considered insufficient; under 20 ng/mL, and he or she is tagged deficient. Supplements and D-rich foods, such as fortified milk, may be recommended for patients with low D levels, Gordon says. The UV rays in sunshine also activate one form of vitamin D in the body, but increased sun exposure can lead to skin cancer.

Boston Medical School's Michael Holick, a professor of medicine, physiology and biophysics, says everyone should be taking 1,000 IUs (international units) of vitamin D a day, even though the Institute of Medicine recommends only 200 IUs a day for children and 400 IUs daily for adults.

But UCLA's Pregler says the million-dollar question remains: "Will supplementing D-deficient patients prevent disease?"

Posted: 7/14/2008 2:35:00 PM

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