FDA Warns About Supplements Marketed to Treat Impotence
The U.S. Food and Drug Administration is warning consumers not to buy or use products marketed as dietary supplements to treat erectile dysfunction because they could reduce blood pressure to dangerous levels in some men.
The products, produced in China, are marketed for the treatment of erectile dysfunction and for sexual enhancement. Although they're marketed as dietary supplements, they don't qualify as supplements because they contain "undeclared" active ingredients of FDA-approved prescription drugs for erectile dysfunction. That makes the products illegal because they lack FDA approval, the agency said in a statement released Friday evening.
The products are marketed as Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, Lady Shangai, Shangai Regular and Shangai Chaojimengnan products, the FDA said.
The agency said it performed chemical testing that showed that Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X and Lady Shangai contain sildenafil, the active ingredient in Viagra, an FDA-approved drug for impotence. Shangai Regular, also marketed as Shangai Chaojimengnan, contains an unapproved substance with a chemical structure akin to sildenafil that may cause similar side effects and drug interactions.
These undeclared ingredients could interact with nitrates found in some prescription drugs -- such as nitroglycerin -- and can lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Erectile dysfunction is a common problem in men with these medical conditions.
"Products like these put consumers at considerable risk because they contain undeclared active ingredients in FDA-approved drugs that require a prescription to obtain," said Dr. Janet Woodcock, the agency's deputy commissioner for scientific and medical programs, and acting director of the Center for Drug Evaluation and Research. "An unsuspecting consumer with underlying medical issues may buy and take these products without knowing that they can cause serious drug interactions."
The products are packaged and distributed by Shangai Distributor Inc. of Coamo, Puerto Rico, the FDA said.
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Here's to a Happy and Healthy New Ear -- and Nose and Throat
The American Academy of Otolaryngology-Head and Neck Surgery is offering some tips to protect the health of your ears, nose and throat in the new year.
"Ear, nose, and throat health problems are some of the most common ailments that Americans face," Dr. Jeffrey Spiegel, associate professor of otolaryngology-head and neck surgery at the Boston University School of Medicine, said in a prepared statement. "From colds and the flu in the winter to allergies in the spring, a few simple tips can help people enjoy a more productive, healthful 2008."
More than 37 million American adults suffer from the common respiratory condition sinusitis, and 45 million children and adults struggle with recurring seasonal and perennial allergies. Each season can bring a variety of ear, nose, and throat problems, the academy said.
The otolaryngologists -- doctors trained to treat conditions of the ear, nose, and throat -- recommend following these tips:
- Track your symptoms. Each winter, many people assume they're only suffering from a one-time bout with a cold or flu when they develop symptoms like a stuffy nose or watery eyes. But, they may have a chronic condition like sinusitis or allergies that can be easily controlled with proper treatment. If you suffer from the same symptoms time after time, or they occur at the same time every year, see an otolaryngologist for a diagnosis.
- Enjoy leisure time, but be aware. During the summer and fall, kids are at their most active. After a day at the pool, check with your kids to make sure they aren't suffering from symptoms of swimmer's ear. It's easy for water to get trapped in the ear canal after a swim or even a bath.
- Turn the volume down. Most people are exposed to noise 365 days a year, but they can help their hearing health by turning down the volume when they listen to music, watch TV, or use their cell phones. More than 20 million Americans have suffered permanent damage to their hearing from too much loud noise.
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Milk Considered Source of Food Poisoning That Killed 2 in Mass.
Massachusetts health officials have warned consumers not to drink milk produced by a local dairy, saying it was probably the source of a bacterial illness that killed two men and sickened two others, the Associated Press reported.
Whittier Farms has suspended operations and distribution, said Dr. Alfred DeMaria, the state director of communicable disease control, the AP reported. The news service said calls to Whittier Farms seeking comment were not immediately returned on Thursday.
The state Department of Public Health issued the warning Thursday after identifying four cases of listeriosis. Two of the victims, a 78-year-old man and a 75-year-old man, died in June and October, the AP said.
According to the U.S. Centers for Disease Control and Prevention, listeriosis is a serious infection caused by eating food contaminated with the bacterium Listeria monocytogenes. The disease affects primarily pregnant women, newborns, and adults with weakened immune systems. Symptoms can include fever, muscle aches, and sometimes gastrointestinal problems such as nausea or diarrhea. If infection spreads to the nervous system, symptoms such as headache, stiff neck, confusion, loss of balance, or convulsions can occur.
Some steps to take to avoid listeriosis, according to the CDC, include:
- Thoroughly cooking raw food from animal sources, such as beef, pork, or poultry;
- Thoroughly washing raw vegetables before eating;
- Avoiding unpasteurized milk or foods made from unpasteurized milk.
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U.S. Ruling Allows Insurance Cutbacks for Retirees Over 65
U.S. employers can cut or eliminate altogether health benefits for retired people over age 65, the Equal Opportunity Commission ruled Wednesday.
The agency's decision permits the creation of two classes of retirees -- people younger than 65 who are entitled to more comprehensive benefits, and people 65 and older who can be afforded limited health benefits from their former employers or none at all, The New York Times reported. At age 65, many retirees become eligible for Medicare.
Employer-sponsored health premiums have risen an average of 6.1 percent this year and a total of 78 percent since 2001, the newspaper reported, citing statistics from the Kaiser Family Foundation.
The commission said employers are not required by federal law to offer health benefits to either active or former employees. However, in issuing its edict, the commission noted, "The final rule is not intended to encourage employers to eliminate any retiree health benefits they may currently provide."
Nonetheless, the AARP and other organizations representing seniors condemned the decision. "This rule gives employers free rein to use age as a basis for reducing or eliminating health care benefits for retirees 65 and older, said AARP attorney Christopher Mackaronis, who said the ruling could affect as many as 10 million people.
In June, a U.S. Court of Appeals decision upheld the commission's right to establish this sort of exemption to the Age Discrimination in Employment Act of 1967. The AARP has asked the U.S. Supreme Court to review that decision, the Times said.
In related news, a federal judge on Wednesday struck down a portion of a San Francisco program that provided health care benefits to some 82,000 uninsured residents, the Associated Press reported.
Employers cannot be forced to subsidize the city government's plan, U.S. District Judge Jeffrey White ruled. "By mandating employee health benefit structures and administration, those requirements interfere with preserving employer autonomy over whether and how to provide employee health coverage, and ensuring uniform national regulation of such coverage," White's decision said.
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Avastin Improves Advanced Breast Cancer Survival: Study
Avastin (bevacizumab), a drug that inhibits the growth of blood vessels that supply tumors, slows the progression of metastatic breast cancer and prolongs survival, researchers wrote in the Dec. 27 issue of the New England Journal of Medicine.
Their study of 722 women with recurrent breast cancer found that women who took Avastin combined with standard chemotherapy had progression-free survival of 11.3 months, compared to 6 months on standard chemotherapy alone.
"This therapy is a one-two punch! You hit the tumor with the chemo and sabotage new blood vessel growth by restricting its oxygen supply with Avastin," Dr. Melody Cobleigh, a study co-author and director of the Coleman Foundation Comprehensive Breast Center at Rush University, said in a statement.
Avastin not only slowed the growth of tumors, it also doubled the remission rate -- the shrinkage of tumors by 50 percent or more, the statement said.
About 178,000 women will be diagnosed in the United States this year with breast cancer, and an estimated 40,000 will die from the disease, the American Cancer Society says.
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Diabetic Test Strips Recalled
Certain diabetic test strips used with Bayer's Contour TS Blood Glucose Meter are being recalled, because they may overstate how much blood sugar a user has by up to 17 percent, the U.S. Food and Drug Administration said.
An error in the strips' manufacturing process led to the recall, Bayer said. Affected strips have lot numbers beginning with WK, followed by the characters 7D, 7E, 7F, or 7G, then followed by a series of additional letters and numbers.
The strips were sold mostly by mail order in the United States and may also have been distributed in France, Austria, Turkey, Korea, and Mexico.
The recall affects only the strips and not the meters themselves. Other strips and meters produced by Bayer are unaffected.
For more information, go to www.bayerdiabetes.com, or call toll-free 800-348-8100.
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