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."
To get this FDA approval, Lilly had to change the drug label information to include stronger language about the risk of weight gain and diabetes.
Symbyax, a combination of Lillys drugs Zyprexa and Prozac in one pill, was approved by the FDA to treat bipolar depression in 2003, the Indianapolis Business Journal reported.
In related news, the FDA approved the use of Zyprexa and Prozac, in separate pills, to treat bipolar depression and treatment-resistant depression.
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Westco Peanut Products Recalled
Consumers shouldn't eat any peanuts or peanut products sold by Westco Fruit and Nuts Inc. (Westco/Westcott), because they may be contaminated with salmonella, the U.S. Food and Drug Administration said Monday.
Peanuts used in the Westco products may have come from the Peanut Corporation of America (PCA). The PCA plant in Blakely, Ga., has been identified as the source of a nationwide salmonella outbreak that's sickened 691 people and may have contributed to nine deaths.
The FDA told Irvington, N.J.-based Westco/Westcott to voluntarily recall all its products containing peanuts from PCA. Westco/Westcott sold these peanuts in various sizes and packaging configurations, and also used them as an ingredient in a variety of mixed nut products and trail mix produced between Nov. 19, 2008, and mid-Feb. 2009.
Consumers who have Westco/Westcott peanuts or peanut products in their homes should dispose of the products by placing them in a plastic bag with bleach. Seal the bag properly and place it in a trash bin. Consumers should then was their hands, the FDA said.
Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
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J&J Baby Products Safe: Chinese Officials
Cancer-causing agents were not used as additives in Johnson & Johnson baby products, China's State Food and Drug Administration announced on its Web site.
The officials launched an investigation after a U.S. activist group said dozens of the products contained formaldehyde and 1,4-dioxane, the Associated Press reported. The products were also declared safe by the General Administration of Quality Supervision, Inspection and Quarantine.
Last week, the report by Campaign for Safe Cosmetics prompted Shanghai-based Nonggongshan Supermarkets Corp. to pull J&J's baby products from its 3,500 stores in China. The supermarket chain resumed sales of the products after they were cleared by government officials.
J&J denies the allegations by Campaign for Safe Cosmetics, a coalition of nonprofit organizations. The company says all its products are in compliance with safety laws in the countries were they're sold, the AP reported.
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