Month: August 2010

Shire PLC has pulled its drug ProAmatine from the U.S. market after regulators threatened to withdraw approval. In a letter posted online August 16, the Food and Drug Administration said Shire had failed to do follow-up research. The FDA approved ProAmatine in 1996 to treat very low blood pressure. It based that decision on early research, but told Shire to do more studies to prove long-term benefits. Shire never submitted them. The FDA letter this week offered to discuss the matter at a hearing. Instead, Shire announced that it would remove the drug by the end of September, the Associated Press (AP) said. The FDA has the power to remove drugs when follow-up studies are not done. However, it has never done so. Shire’s decision does not completely remove the drug from the market. It is also sold as a generic drug, known as midodrine.

Tai chi may improve pain and other symptoms of fibromyalgia, a small study suggests. Fibromyalgia symptoms include fatigue, body pain and tenderness in joints and muscles. They also vary from person to person. The cause is unknown. The study included 66 fibromyalgia patients. They were randomly assigned to one of two programs. One group did tai chi, a program of slow movements, meditation, deep breathing and relaxation. The other group received wellness education and did stretching exercises. Sessions occurred twice a week for 12 weeks. By the end, symptoms had improved for people who did tai chi. In questionnaires, they reported less pain. They also said they had better mood, sleep, exercise capacity and quality of life. There was little change for the other group. Improvements remained 12 weeks after the program ended. The New England Journal of Medicine published the study.

Doctors should routinely ask younger women about how much alcohol they drink, a Canadian group says. The advice comes from the Society of Obstetricians and Gynaecologists of Canada. It’s part of a new set of guidelines. The purpose is to help prevent fetal alcohol spectrum disorder in children. It’s unclear how much risk is linked to drinking small amounts, the group’s president told Canadian Press. But the guidelines urge a cautious course. They say women should be advised not to drink if they are or might become pregnant. About 3% of Canadian babies are born with fetal alcohol spectrum disorder, an expert told Canadian Press. The risk of this disorder is 40% for children of heavy drinkers, the expert said. The Journal of Obstetrics and Gynaecology published the guidelines August 12.

Poultry is the leading cause of U.S. food poisoning outbreaks, health officials report. The Centers for Disease Control and Prevention (CDC) did the report, based on numbers from 2007. The Associated Press wrote about it August 12. Poultry caused 17% of the U.S. outbreaks, the CDC said. Beef accounted for 16% and leafy vegetables 14%. The CDC counted more than 21,000 food poisoning-borne illnesses in 2007. They were part of about 1,100 outbreaks. But most cases aren’t reported. The CDC estimates there are 87 million U.S. cases of food poisoning each year. Bacteria cause about half of them, the CDC said. Viruses cause 40% of the cases. Mushroom toxin or other chemicals cause 7% and parasites about 1%.

U.S. inspectors say that shrimp and fish from parts of the Gulf of Mexico have been tested extensively and found safe to eat. More tests are being done on oyster and crab catches. That was the word from the Food and Drug Administration (FDA) August 16 as shrimp season began. A spill that began in April dumped nearly 5 million barrels of oil into the Gulf. In areas cleared for fishing, levels of oil-related chemicals in fish and shrimp are about the same as those found in non-Gulf waters, the FDA said. Fish and shrimp break down and remove these chemicals from their bodies faster than oysters and crabs do, experts told the Associated Press. The FDA said there’s also no reason to fear the chemicals put into the water to break up the oil from the recent spill. The FDA does not believe that these chemicals build up in seafood. The agency is still working on a test for them.

The worst form of staph infection is declining in U.S. hospitals, new research suggests. The study looked at infections caused by methicillin-resistant Staphylococcus aureus (MRSA) bacteria. They resist most antibiotics. That makes them very hard to treat. MRSA is mainly a skin infection. But the study focused on invasive cases. They are the most dangerous cases because they can spread throughout the body. The study looked at data from 9 metropolitan areas. Invasive cases dropped 16% between 2005 and 2008. Researchers said the drop reflects better germ-control efforts by hospitals. Many hospitals also test people for MRSA when they are admitted. The drop did not apply to all MRSA cases. Skin infections did not fall. The study appeared in the Journal of the American Medical Association. The Associated Press wrote about it August 11.

Some people get tiny filters implanted in a vein to keep blood clots in the legs from reaching the lungs. But the U.S. Food and Drug Administration (FDA) is warning that the filters can move or break. The FDA said it had received more than 900 reports of these problems since 2005. Problems occur mainly when the filters are left in for a long time. Pieces can break off, travel through the bloodstream, and punch holes in organs, the FDA said. The Associated Press (AP) wrote about the FDA warning August 9. The journal Archives of Internal Medicine published a report about the same problem. The study focused on 80 patients at one hospital. All received filters made by C.R. Bard Inc. About 16% of the filters broke and drifted away. The break rate was 25% among people who had an older model. The older filters had been implanted an average of 4 years, twice as long as the newer filters.