Health Highlights: April 26, 2016
Letters Alerting Women About Dense Breast Tissue Often Tough to Understand: Study Gold Emblem Tea Recalled by CVS FDA Panel Votes Against Approval of Drug for Duchenne Muscular Dystrophy
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
Letters Alerting Women About Dense Breast Tissue Often Tough to Understand: Study
Many women find it difficult to understand letters informing them they have dense breast tissue, a new study says.
About 40 percent of women who undergo mammograms are found to have dense breast tissue, which both increases the risk of breast cancer and makes it more difficult to detect the cancer, The New York Times reported.
But researchers analyzed dense breast tissue notification letters sent to women in 23 states and found that a college degree was needed to understand the language in many of the letters.
The study was published as a letter in the Journal of the American Medical Association.
"Twenty percent of the population only reads at an eighth-grade level, and many more don't read at a much higher level than that," study author Nancy Kressin, a professor at Boston University School of Medicine and a senior researcher at the Veterans Affairs Boston Healthcare System, told The Times.
"For many women, these notifications are not going to be easy to read" and could even cause alarm, Kressin said. "We've talked to some women who received these letters, and their reaction was 'Oh my God, I have cancer.' "
Gold Emblem Tea Recalled by CVS
Potential salmonella contamination has led CVS Pharmacy to recall some cases of 1.4-ounce cartons of Gold Emblem Abound Organic Spiced Herbal Tea.
The recalled products have a best by date of 18 Mar 2018 and the UPC code 0 50428 541043. The tea was sold at CVS Pharmacy stores across the United States.
Some of the tea was sold before the recall was announced and the product was removed from CVS stores, but the company said it does not know of any cases of illness related to the tea.
Consumers who bought the tea should not use it and can return it to CVS for a refund. For more information, call CVS at 1-800-746-7287.
FDA Panel Votes Against Approval of Drug for Duchenne Muscular Dystrophy
The drug eteplirsen should not be approved for treatment of Duchenne muscular dystrophy, a U.S. Food and Drug Administration advisory panel said Monday.
There are no drugs to treat the disease. Patients, parents and doctors insist the drug prolongs the ability of boys with Duchenne's to walk long after they would normally be in wheelchairs, The New York Times reported.
However, the FDA's panel of outside experts said clinical trial data from drug maker Sarepta Therapeutics did not meet the agency's requirements for well controlled studies necessary for approval. The vote was 7-3, with three abstentions.
The study submitted by Sarepta included only 12 patients and did not have adequate placebo control, The Times reported.
The panel members were torn between patient testimony and FDA rules.
"Based on all I heard, the drug definitely works, but the question was framed differently," said Dr. Bruce Ovbiagele, chairman of neurology at the Medical University of South Carolina, who voted against approval, The Times reported.
The FDA's decision on whether to approve eteplirsen will be made by May 26. The agency does not have to follow the recommendations of its advisory panels.