Health Highlights: March 23, 2009
Mar. 24 -- Here are some of the latest health and medical news developments, compiled by editors of HealthDay:
FDA Ordered to Re-examine Limits on 'Morning-After' Pill
A U.S. District Court judge has ordered the Food and Drug Administration to rethink its plan to limit the non-prescription "morning-after" pill to women who are at least 18 years old, the Washington Post reported Monday.
In 2005, the agency announced that it would limit over-the-counter access to the pill, also known as Plan B, to women 18 and older. U.S. District Judge Edward R. Korman said the FDA must reconsider whether to make the drug available to all women, regardless of age, without a prescription.
The "record is clear that the FDA's course of conduct regarding Plan B departed in significant ways from the agency's normal procedures regarding similar applications to switch a drug from prescription to non-prescription use," the newspaper quoted from Korman's 52-page ruling.
The plan B pill is intended to prevent pregnancy up to 72 hours after a woman has unprotected sex.
Groups critical of the FDA's original decision praised the judge's ruling.
"The message is clear: The FDA has to put science first and leave politics at the door. We are encouraged that the FDA under new leadership, when they look at the evidence, will remove the unique barriers that have been in place and [Plan B] will finally be available to all women without any barriers," the Post quoted Suzanne Novak, senior staff attorney for the Center for Reproductive Rights, as saying.
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Symbyax Approved for Treatment-Resistant Depression
The bipolar depression drug Symbyax has received U.S. approval as a therapy for patients with treatment-resistant depression, Eli Lilly & Co. announced Monday.
The FDA approval applies to use in adult patients who haven't responded to two separate rounds of therapy with different antidepressants, the Indianapolis Business Journal reported.
"Living with major depressive disorder is difficult and distressing for anyone, but even more so for patients whose symptoms continue despite treatment," Lilly medical director Dr. Sara Corya said in a company news release. "Now, after two failed attempts with other antidepressants, doctors and patients have a new treatment option."
