FDA Experts Recommend Banning Darvon
Darvon, a decades-old painkiller chiefly marketed as Darvocet, should be banned by the U.S. Food and Drug Administration, an expert panel advising the agency recommended Friday.
The advisory panel voted 14-12 to recommend withdrawing Darvon, first approved in 1957. Earlier Friday, the agency said it was reviewing the drug after critics charged it provided little relief and posed a risk for overdose and suicide, the Associated Press reported. The full FDA usually follows the recommendations of its expert panels, but isn't bound to do so.
Darvon, which includes a dose of acetaminophen, is among the top prescribed medications. More than 20 million prescriptions were written in 2007, the wire service said. Xanodyne Pharmaceuticals and Qualitest/Vintage Pharmaceuticals, two firms that market Darvocet, called the medication safe and effective when used as directed.
But critics complained that the government review was too long in coming. "[The drug] has unique risks and no unique advantages," Dr. Sidney Wolfe, a drug safety expert with the consumer group Public Citizen, told the AP. "It has been a big drug of abuse for quite a long time." Public Citizen first sought a ban on Darvon in the 1970s, and the United Kingdom banned its version in 2005, the AP said.
Besides an outright ban, the FDA's other options include requiring stiffer warnings, additional studies or education efforts to alert doctors and patients of potential misuses, the AP reported.
Octuplets' Mom has 6 Other Children, Family Says
The woman who gave birth to octuplets this week in Southern California already has six other young children at home, her family told the Associated Press on Friday.
On Thursday, Angela Suleman, the woman's mother, told The Los Angeles Times that her daughter took fertility treatments but did not expect to give birth to eight babies. She and the children's grandfather told the AP that the mother, who has requested her name be kept confidential, now has a total of 14 children, the wire service reported.
Meanwhile, the babies, who are expected to remain in the hospital for at least seven more weeks, are doing fine and are receiving nutrition and fluids intravenously, the AP said. The woman gave birth on Monday.
U.S. Senate Passes Children's Health Insurance Bill
A bill to provide health insurance to more than four million uninsured children in the United States was passed by the Senate in a 66 to 32 vote Thursday. It's expected that President Barack Obama will be quick to sign the bill, which advances the goal of providing insurance for all children and eventually all Americans, The New York Times reported.
Two weeks ago, the House passed a nearly identical bill, by a vote of 289 to 139.
Under the bill, states would be able to provide coverage for more than four million uninsured children by 2013, while continuing coverage for seven million children. The increased spending, estimated at more than $32 billion over four and a half years, would be offset by higher tobacco taxes.
The bill is "needed now more than ever," because tens of thousands of children are losing health insurance as their parents lose their jobs, Cindy Mann, executive director of the Center for Children and Families at Georgetown University, told The Times.
While Democrats support the expansion of the child health program, many Republicans say they're concerned it's part of a long-term campaign to replace private health insurance with government insurance.
New Blood Thinner Appears Closer to FDA Approval
A new blood thinner called prasugrel appears more effective than the current leading blood thinner Plavix, according to a U.S. Food and Drug Administration review that suggests the agency may be moving closer to approving the new drug.
Next week, an FDA panel of independent cardiology experts is scheduled to give their opinion about the benefits and risks of prasugrel, which was developed by Eli Lilly and Japanese drugmaker Daiichi Sankyo, the Associated Press reported.
Since prasugrel was submitted for approval last January, the FDA has twice put off making a decision due to concerns about its safety. While the drug reduces life-threatening heart problems, it increases the risk of internal bleeding. One study showed that for every 24 serious heart problems it prevented, prasugrel caused 10 bleeding side effects.
But the new FDA document, posted online, seems to indicate the agency believes the drug's lifesaving benefits clearly outweigh its risks, the AP reported. The agency will ask experts whether the bleeding side effects of prasugrel could be minimized by restricting its use in certain patients.