Seniors' Flu Vaccine Approved by FDA
Fluzone High-Dose, a seasonal flu vaccine for people 65 and older, has been approved by the U.S. Food and Drug Administration, the agency said in a news release.
Seniors are at highest risk for complications of seasonal flu, including hospitalization and death. The Fluzone High-Dose vaccine, designed to prevent infection with influenza subtypes A and B, was given accelerated approval as a product designed to prevent serious or life-threatening disease. As part of the approval, manufacturer Sanofi Pasteur is required to "conduct further studies to verify that [the vaccine] will decrease seasonal influenza after vaccination," the FDA said.
Because of the vaccine's higher potency, mild side effects were reported more frequently compared with Sanofi's standard-strength Fluzone vaccine, the agency said. These included pain, injection-site redness and swelling, headache, muscle ache and fever.
People who are sensitive to egg products or who have had life-threatening reactions to prior flu shots shouldn't be vaccinated with Fluzone High-Dose, the FDA said.
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Teresa Heinz, Battling Cancer, Supports Regular Mammograms
Teresa Heinz, wife of the 2004 Democratic presidential nominee, Sen. John Kerry, is undergoing treatment for breast cancer and is urging younger women to continue getting regular mammograms despite recent federal guidelines recommending they get fewer of the cancer-detecting tests.
In an interview with the Associated Press, Heinz, 71, said the physical and emotional toll of the disease for women who need surgery and other follow-up treatment, such as chemotherapy, is far greater than the cost of mammography.
Her cancer was detected during an annual mammogram in late September, she said.
Heinz underwent lumpectomies in October and November, the first for what was thought to be a benign growth in her right breast, the second after the tumor was confirmed to be malignant.
She is advising other women to get tested in the wake of last month's controversial recommendation from the U.S. Preventive Services Task Force that women postpone the start of mammograms to age 50, rather than starting at 40, as has been customary.
The task force recommendations were criticized by many medical and women's organizations, and the government later backed down and said its policies "remain unchanged."
Heinz's treatment will include five days of targeted radiation starting next month, which could boost the odds of successful treatment to 95 percent, the AP said. She said she remains undecided about subsequent follow-up treatment.
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Texas Must Destroy 5 Million Blood Specimens From Babies
More than five million blood samples taken from babies without parental permission will be destroyed by Texas health authorities early next year following settlement of a lawsuit.
The blood specimens, stored indefinitely for scientific research, were the subject of a lawsuit filed by the Texas Civil Rights project on behalf of five plaintiffs, theAssociated Press reported.
The suit against the Texas Department of State Health Services and the Texas A&M University System argued that their failure to obtain parental consent violated constitutional protections against unlawful search and seizure. The parents feared their children's private health information would be misused.
About 5.3 million samples would be destroyed, said a state health services spokeswoman.
For decades, Texas has collected blood specimens to screen for birth defects and diseases. Last May, the state placed some restrictions on the procedures, giving parents the right to refuse and instituting controls over the research that can use the specimens. The lawsuit involves the samples collected prior to the new law.
If parents agree, the health department can still use the blood samples for disease research, the AP said.
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No Proof of Vytorin Cancer Link: FDA
An extensive data review of the cholesterol drug Vytorin turned up no evidence that the drug causes cancer, federal drug regulators say.
Following up on concerns raised by a patient study last year, the Food and Drug Administration examined all of the data from that study and reviewed available information from two ongoing large studies, the Associated Press reported.
But whether Vytorin, which is made by Merck & Co., is linked to a higher risk of cancer or death from cancer cannot definitively be ruled out, the FDA said.
Vytorin combines two types of cholesterol pills, Zetia and Zocor.
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