Saturday, September 04, 2010
 
 
FDA Press

FDA seeks court order against Michigan dairy
The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against Scenic View Dairy of Hamilton, Mich., its president, and three of its managers alleging that they sold dairy cows for human consumption that contained illegal drug residues in edible tissues.

FDA launches new organizational performance management system
The U.S. Food and Drug Administration today launched an innovative performance management system designed to advance the President’s commitment to transparency, public participation, and collaboration in the work of government.

FDA Warns Consumers to Avoid TimeOut Capsules
The U.S. Food and Drug Administration is warning consumers not to take TimeOut Capsules because it contains an active drug ingredient that can dangerously lower blood pressure. The product is marketed as a dietary supplement for sexual enhancement.

FDA releases guidance on federal menu labeling requirements
The U.S. Food and Drug Administration today released two documents that outline steps to help chain restaurants comply with new federal nutrition labeling requirements.

FDA Warns of Possible Dangers from Portable Foot-Tanning Device
The U.S. Food and Drug Administration is warning consumers about the risk of ultraviolet radiation overdose with the Tootsie Tanner portable foot tanning device.

Study: Presence of murine leukemia virus found in CFS Patients, others
Researchers have found murine leukemia viruses (MLV) in blood samples collected from patients diagnosed with chronic fatigue syndrome (CFS) and some healthy blood donors, according to a study published online today by the scientific journal Proceedings of the National Academy of Sciences (PNAS).

Urgent Nationwide Egg Recall
The current recall of eggs in their shells, or “shell eggs,” is part of an ongoing and intensive investigation by local, state, and federal officials into the cause of recent cases of Salmonella Enteritidis.

Urgent Nationwide Frozen Mamey Fruit Products Recall
An investigation by the CDC and state partners showed an epidemiologic link between an ongoing outbreak of Salmonella Typhi and frozen mamey fruit products sold under the La Nuestra brand by Montalvan Sales Inc. Ontario, Calif, and under the Goya brand by Goya Foods Inc. Secaucus, New Jersey.

U.S. Marshals seize food from rodent-infested Ga. warehouse
U.S. Marshals, acting under a court order sought by the U.S. Food and Drug Administration, today seized packaged food products from a rodent-infested warehouse in Athens, Ga. A variety of products, including crackers, cookies and potato chips, were intended for sale to jails and prisons throughout the southeastern United States.

FDA Proposes Withdrawal of Low Blood Pressure Drug
The U.S. Food and Drug Administration today proposed to withdraw approval of the drug midodrine hydrochloride, used to treat the low blood pressure condition orthostatic hypotension, because required post-approval studies that verify the clinical benefit of the drug have not been done.

FDA approves ella™ tablets for prescription emergency contraception
The U.S. Food and Drug Administration today approved ella™ (ulipristal acetate) tablets for emergency contraception. The prescription-only product prevents pregnancy when taken orally within 120 hours (five days) after a contraceptive failure or unprotected intercourse. It is not intended for routine use as a contraceptive.

FDA: Aseptic Meningitis Risk with Use of Seizure Drug Lamictal
The U.S. Food and Drug Administration today warned that the drug Lamictal (lamotrigine), approved to treat seizures and bipolar disorder, can cause aseptic meningitis, an inflammation of the protective membranes (meninges) that cover the brain and spinal cord not caused by bacterial infection.

FDA: Salmonella risk from frozen rodents fed to reptiles
The U.S. Food and Drug Administration is warning U.S. and international customers who may have purchased frozen mice, rats and chicks from Biggers and Callaham LLC, dba/MiceDirect.com, that these products, which are used as food for reptiles, have the potential to be contaminated with Salmonella.

FDA Seeks Injunction Against Colorado Manufacturer of Cultured Cell Product
The U.S. Food and Drug Administration is seeking an injunction in federal court against Regenerative Sciences LLC, of Broomfield, Colo., citing violations of current good manufacturing practice (cGMP) that cause its cultured cell product to be adulterated. The product is also misbranded due to the lack of adequate directions for use and the failure to bear the “Rx only” symbol.

FDA Issues Assessments of the 510(k) Program and Use of Science in Decision-Making
The U.S. Food and Drug Administration today issued two comprehensive evaluations containing recommendations that address three key objectives of the agency’s public health mission as it relates to medical devices – foster device innovation, create a more predictable regulatory environment, and enhance device safety.

Statement by Margaret A. Hamburg, Commissioner of Food and Drugs on the Reopening of Florida State Waters to Commercial Fishing
We are pleased to be able to support the state of Florida as it reopens state waters off Pensacola to commercial fishing. Through close coordination with our state and federal partners, we are confident all appropriate steps have been taken to ensure that seafood harvested from the waters being opened today is safe and that Gulf seafood lovers everywhere can be confident eating and enjoying the fish that will be coming out of this area.

Statement by Margaret A. Hamburg, Commissioner of Food and Drugs, on the Reopening of Some Mississippi State Waters to Commercial Fishing
We are pleased to be able to support the state of Mississippi as it reopens state waters in the Mississippi Sound, from the mainland to the barrier islands, to commercial fishing. Through close coordination with our state and federal partners, we are confident all appropriate steps have been taken to ensure that seafood harvested from the waters being opened today is safe and that Gulf seafood lovers everywhere can be confident eating and enjoying the fish and shrimp that will be coming out of this area.”

United States Seeks Permanent Injunction Against New York Food Processor
The U.S. Department of Justice, in an action initiated by the U.S. Food and Drug Administration, is seeking a permanent injunction against NY Gourmet Salads, Inc., a processor of ready-to-eat deli salads, seafood salads, and cream cheeses in Brooklyn, N.Y., and Leonard F. Spada, the company's president. (HR)

FDA Warns Consumers of Serious Harm from Drinking Miracle Mineral Solution (MMS)
The U.S. Food and Drug Administration is warning consumers not to take Miracle Mineral Solution, an oral liquid also known as “Miracle Mineral Supplement” or “MMS.” The product, when used as directed, produces an industrial bleach that can cause serious harm to health.

FDA Approves Vaccines for the 2010-2011 Influenza Season
The U.S. Food and Drug Administration announced today that it has approved vaccines for the 2010-2011 influenza season in the United States.
WebMD Health News

Hormone in Hair May Reveal Heart Risk
High levels of cortisol in the hair shaft may increase the risk of heart attack, a study shows.

SAM-e May Boost Effects of Antidepressants
SAM-e plus prescription antidepressants may spell relief for hard-to-treat depression, according to a new study.

Osteoporosis Drugs May Be Linked to Cancer Risk
The long-term use of oral bisphosphonate osteoporosis drugs such as Actonel, Boniva, and Fosamax may be associated with a doubling in esophageal cancer risk, but the risk to individual users remains small, researchers say.

Men With Insomnia May Have Higher Risk of Death
Men with insomnia have a fourfold higher death rate than those who sleep at least 6 hours a night, a 14-year study finds. It's not yet clear whether women with insomnia also die sooner.

Is Your Kitchen as Clean as a Restaurant's?
An online quiz rates your hygiene practices with a letter grade -- and gives you the information you need to keep your food safe from bacteria.

Prescription Drug Use on the Rise in U.S.
Prescription drug use in the U.S. has been rising steadily in the past decade and the trend shows no signs of slowing, the CDC says in a new report.

Teen Pot Smoking Won't Lead to Other Drugs as Adults
New research finds little support for the hypothesis that marijuana is a "gateway" drug leading to the use of harder drugs in adulthood.

Weight Loss Pill Meridia Ups Heart Attack, Stroke
People who take Abbott's weight-loss pill Meridia have a higher risk of non-fatal heart attack and stroke, a study sponsored by the drug's maker finds.

Physically Unprepared Skiers Face Heart Risk
Many people fail to rev up their exercise regimen before they leave for a ski vacation -- and the sudden burst of activity on the slopes puts them at risk for heart attack, researchers say.

New Anticlotting Drugs in the Works
The drugs apixaban and Xarelto are effective at preventing deadly blood clots, new studies show.

Sex Not on Most New Moms’ Minds
A research review finds that new moms have little sex drive in the first months after delivery.

Michael Douglas and Throat Cancer FAQ
In the wake of actor Michael Douglas's announcement that he has stage IV throat cancer, WebMD answers frequently asked questions about the disease.

Bad News About Youth Boosts Elders' Esteem
People over 50 get a self-esteem boost when they read negative news about young adults, a study shows.

Coffee May Combat High Blood Pressure
Older people with high blood pressure who drink one to two cups of coffee a day have more elastic blood vessels than those who drink less or more, Greek researchers report.

Timing of Delivery May Affect Cerebral Palsy Risk
Babies delivered at 37 or 38 weeks -- or at 42 weeks or later -- are at increased risk for cerebral palsy compared to those born at 40 weeks, a study shows.

Breast Cancer Gene Test, Preventive Surgery Save Women's Lives
Women who carry the BRCA1 or BRCA2 cancer genes cut their death risk by getting preventive surgery to remove their ovaries and fallopian tubes. Mastectomy further reduces their cancer risk.

Low Vitamin D Linked to Heart Failure Deaths
Low vitamin D levels are associated with a higher risk of death and hospitalization in people with heart failure, researchers report.

Selenium May Protect Against Bladder Cancer
Adding more selenium to your diet may reduce your risk of bladder cancer.

Seasonal Pattern Is Seen in MS Patients
Brain lesions associated with increased multiple sclerosis activity appear in patients more often between the months of March and August, a new study shows.

Pill Cuts Risk of Death in Heart Failure Patients
A pill that slows the heart rate substantially cut the risk of death and hospital stays for patients with severe heart failure, a study of more than 6,500 patients shows. The drug is called Procoralan.

Marathons Safe for Older Runners' Hearts
When it comes to your heart heath, don't let age alone make you reluctant to run a marathon. So say researchers who found that amateur runners over age 50 -- and as old as 72 -- experienced some temporary heart changes, but no lasting damage after the 26.2-mile run.

Blood Clot Risk From Stents Seen in African-Americans
African-Americans may be at an increased risk for developing life-threatening blood clots after receiving drug-coated stents that are meant to keep their arteries open, new research shows.

C-Section Rates Are High and Getting Higher
Cesarean section deliveries are at an all-time high in the U.S. and are expected to keep rising, and new government-funded research may help explain the trend.

Sports-Related Concussions on the Rise in Kids
The number of children treated in hospital ERs for concussions they got while playing on sports teams has doubled in just a decade, a new study shows.

First Genetic Link Found for Common Migraine
Scientists have identified the first-ever genetic risk factor for common migraines.
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