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Health Highlights: Aug. 1, 2007
August 1st, 2007

Here are some of the latest health and medical news developments, compiled by editors of HealthDay:

Tysabri Should be OK'd for Crohn's Patients: FDA Panel

The multiple sclerosis drug Tysabri should be approved to treat patients with Crohn's disease, a U.S. Food and Drug Administration advisory panel said Tuesday.

The 12-3 vote in favor of this use for the drug came during a joint meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, The Boston Globe reported. Two committee members abstained from the vote.

Crohn's is an inflammatory bowel disorder that affects about 600,000 people in the United States. The panel said that Tysabri helps ease the symptoms of the disease in patients who don't respond to steroids or immunosuppressants. Both MS and Crohn's are autoimmune diseases.

The advisory panel recommended that Tysabri be used only for Crohn's patients with moderate to severe symptoms, and that this use be subject to strict controls, The Globe reported. The FDA is not bound to follow the recommendations of advisory panels, but it usually does.

Six weeks ago, European regulators voted against the use of Tysabri to treat Crohn's patients, saying that clinical studies failed to show that the drug's risk outweighed its benefits.

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More Data Needed to Approve Menopause Drug: FDA

The U.S. Food and Drug Administration wants more evidence before it considers approving the nonhormonal drug Pristiq as a treatment for menopause symptoms, but that should not delay FDA approval of the drug as a depression treatment, according to officials with drugmaker Wyeth.

In mid-July, the FDA said it wanted more long-term data on Pristiq's effects on the heart and liver, after studies showed that a small number of women taking the drug for menopause symptoms experienced serious heart or liver complications, the Associated Press reported. The FDA told Wyeth to conduct a new clinical trial of one year or longer. Company officials said Tuesday they'll work closely with the FDA to hasten Pristiq's approval as the first nonhormonal treatment for menopause symptoms such as hot flashes, mood swings, and sleep problems.

Wyeth officials also said the FDA told them the additional safety data required before the company can apply to have the drug approved to treat menopause symptoms will not delay approval of Pristiq as a depression treatment, the AP reported.

That approval could come early next year, according to Wyeth executives.

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U.S. Considers New Alcohol Labeling Rule

A new regulation requiring all alcohol drink packaging to provide information about alcohol content, serving sizes and nutrition is being considered by the U.S. Treasury Department.

The proposal -- which was published Tuesday for public comment -- would require all alcohol product labels to state the drink's percent of alcohol by volume, along with a "serving facts" panel outlining the number of calories, carbohydrates, fat and protein in a standard serving size, the Associated Press reported.

If they choose, companies could also list the amount of pure (ethyl) alcohol per serving.

Under current law, labels on all wine and liquor with more than 14 percent alcohol by volume must list at least the alcohol content, the AP reported. But, with the exception of some states, that information is not required on the labeling of regular beer. However, labels on "light" beer must list caloric content and the percent of alcohol by volume.

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U.S. Chief Justice Roberts Leaves Hospital

U.S. Chief Justice John Roberts was released from a hospital on Tuesday, one day after suffering a seizure at his summer home on a Maine island, the Associated Press reported.

Roberts walked out of the Penobscot Bay Medical Center in Rockport, wearing a blue sport coat, open collar shirt and slacks. He waved to onlookers before getting into a sports utility vehicle, the news service said.

He plans to continue his summer vacation in Maine, Supreme Court spokeswoman Kathy Arberg said, adding that doctors found no cause for concern after evaluating Roberts.

The chief justice, 52, had been hospitalized overnight for observation after falling on a dock near his home, according to spokespersons for the U.S. Supreme Court and the Penobscot Bay Medical Center.

In a phone call with President Bush Tuesday morning, the AP reported, Roberts said he was doing well.

Roberts "sounded like he was in great spirits," White House press secretary Tony Snow said.

On Monday, a Supreme Court statement said the chief justice was "fully recovered" from the 2 p.m. seizure and had undergone "a thorough neurological evaluation, which revealed no cause for concern." He was kept overnight as "a precaution," The New York Times reported.

The newspaper noted that this was the second recorded seizure suffered by Roberts; the first occurred in 1993. This one was described as a benign idiopathic seizure, the newspaper reported, which means that the cause is unknown. A U.S. Supreme Court press release said the 1993 seizure was similar to the one that occurred Monday.

According to the AP, the court press release said Roberts "experienced minor scrapes" when he fell after the seizure.

Roberts was "conscious and alert" when he was taken off the boat from his island home at Port Clyde and put in an ambulance, St. George Fire Chief Tim Polky told the AP.

The wire service and the Times interviewed a number of medical experts who concluded that the diagnostic equipment at Penobscot Bay Medical Center was sufficient for initial testing, but that, after having gone through two seizures, the chief justice probably would need to be evaluated to determine whether further treatment was necessary.

Dr. David J. Langer, director of cerebrovascular neurosurgery at St. Luke's-Roosevelt, Beth Israel and Long Island College Hospital in New York, told the Times that if Roberts began taking medication to control future seizures, it could "have significant side effects."

And Dr. Edward Mkrdichian, a neurosurgeon at the Chicago Institute of Neurosurgery and Neuroresearch, told the AP that anyone who has had two unexplained seizures was at high risk for a third. Mkrdichian said he prescribes anti-seizure medications for those patients.

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FDA Program Aims to Improve Food Safety

A national program to strengthen state food safety programs was announced today by the U.S. Food and Drug Administration. Current state-to-state variations in regulations can lead to inconsistencies in food safety supervision, the agency said.

The new program is designed to introduce "more uniform, equivalent, and high quality regulatory programs by state agencies responsible for regulating facilities that manufacture, process, pack, or hold food under FDA's jurisdiction," said a news release from the FDA.

The Manufactured Food Regulatory Program Standards will be pilot-tested in New York, Oregon, and Missouri before Sept. 30, 2007.

"This risk-based program represents a significant step in further integrating our food safety system. We realize it will be several years before it's fully implemented, but we're confident this program will bring great benefits to the public health," Margaret Glavin, FDA's associate commissioner for regulatory affairs, said in a prepared statement.

The FDA regulates about 80 percent of the U.S. food supply for humans and animals. Meat, poultry and egg products are regulated by the Department of Agriculture.

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U.S. Blood Donor Pool Smaller Than Thought: Study

The number of people in the United States eligible to donate blood may be much smaller than previously thought, according to a study in the journal Transfusion that found that only 37 percent of the U.S. population is eligible to donate blood -- about 60 million fewer than previous estimates.

"The conventional method of calculating eligible donors indicates that there are approximately 177 million eligible donors in the U.S. population. This study indicates that only 111 million individuals in the U.S. are eligible to donate blood," Jeffrey McCullough, an expert in transfusion medicine and blood banking, said in a prepared statement.

Currently, age is used to determine eligibility for donating blood, according to a news release. The estimate in this study is based on a more stringent model that excludes people from donating blood due to factors such as age, disease exposure, high-risk behavior, and the presence of chronic diseases.

"As additional donor restrictions are implemented and the population ages, the country could lose more and more willing donors, which could pose an even greater threat to our national blood supply," Karen Shoos Lipton, chief executive officer of the American Association of Blood Banks, said in a prepared statement.

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