FDA Reviews Liver Injuries Possibly Tied to Weight-Loss Drug
The U.S. Food and Drug Administration said Monday that it has begun a review of "adverse event reports" of liver injury in people taking the weight loss drug orlistat. The prescription version of the drug is marketed as Xenical; the over-the-counter version is known as Alli.
The FDA said it had received 32 reports of serious liver injury in patients taking orlistat between 1999 and 2008. Twenty-seven of the cases required hospitalization and six resulted in liver failure. Thirty of the "adverse events" happened outside the United States.
The most commonly reported side effects were jaundice (yellowing of the skin or whites of the eyes), weakness, and stomach pain, the agency said in a news release.
The FDA said it was reviewing additional data from orlistat manufacturers on suspected cases of liver injury. The FDA's analysis of this data is ongoing, and no definite link between liver injury and orlistat has been found, the agency said.
Consumers taking Xenical should continue to take it as prescribed, and those using over-the-counter Alli should continue to use the product as directed, the FDA said.
Consumers who have used orlistat should consult a health-care professional if they experience symptoms possibly linked to the development of liver injury, particularly weakness or fatigue, fever, jaundice, or brown urine. Other symptoms can include abdominal pain, nausea, vomiting, light-colored stools, itching, or loss of appetite, the FDA said.
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Speed Up Swine Flu Vaccine Distribution: Panel
A presidential panel has recommended that the U.S. government speed up availability of the H1N1 swine flu vaccine, develop a better system for tracking the virus and appoint a White House staff member to coordinate the nationwide response, the Washington Post reported.
The President's Council of Advisors on Science and Technology (PCAST) issued an 86-page report Monday that also recommended developing communications strategies before the resurgence of the H1N1 flu, which is expected to be stronger and more widespread this fall and winter.
The council also said the Obama administration should clarify how antiviral drugs can best be used to combat the pandemic, according to the Post report.
"Influenza brings many challenges, and agencies across the government will need to make many key decisions in the face of uncertainty about when and how the virus will play out," Eric Lander of the Broad Institute, council co-chair, said in a statement. "As we did in the spring, we can hope for the best. But we must prepare for the worst."
The World Health Organization in June declared a flu pandemic after the H1N1 virus emerged in Mexico and quickly spread to the United States and other countries around the world.
The U.S. government plans to purchase at least 159 doses of vaccine, but the initial doses aren't expected until mid-October.
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Worldwide Cost of New Cancers $305 Billion: Study
The world will see 12.9 million new cancer cases this year, with an estimated cost of $305 billion, according to a report presented Monday at the Livestrong Global Cancer Summit in Dublin, Ireland.
Cancer will continue increasing, jumping to 16.8 million new cases in 2020, according to The Economist Intelligence Unit, based in New York.
Anticipating a treatment expenditure gap of $217 billion in 2009 alone, experts called for greater cancer-control efforts worldwide, the Irish Times reported.
The report did not say how much each country needs to fill the gap, but the biggest void is seen in developing countries, where cancer is increasing but treatment is limited if even available, it said.
The report was commissioned by Livestrong, the Lance Armstrong Foundation, with support from the American Cancer Society. The estimate was based on costs involving the 26 most common cancers and included medical expenditures, time spent by family members caring for a loved one and contributions by non-governmental agencies, the Irish Times said.
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To Fight HIV, U.S. May Urge Circumcision for Baby Boys: Report
In an effort to help control the spread of the AIDS-causing HIV virus, U.S. health officials are weighing whether to promote routine circumcision for all baby boys born in the country.
The topic is sure to be controversial, even though proposed recommendations from the U.S. Centers for Disease Control and Prevention aren't expected until the end of the year, The New York Times reported.
Also under consideration is whether the surgery should be recommended for heterosexual men whose sexual practices make them risky candidates for infection. But health officials already know that such a recommendation would probably not have a significant impact in the United States because the surgery doesn't seem to protect those men at greatest risk in the country -- gay men, the newspaper said.
Studies in African countries hit hard by AIDS have shown that men who were circumcised reduced their chances of infection by 50 percent. But the African trials focused on heterosexual men at risk of HIV infection from infected female partners, the Times said.
For the time being, U.S. health officials seem to be focusing on recommendations for newborns -- a strategy that would take years to pay health-care dividends. Critics of circumcision say it subjects baby boys to medically unnecessary surgery without their consent, the newspaper said.
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