HEALTH

FDA advises against use of three adulterated drug products

BY Michael Johnsen

BETHESDA, Md. — The Food and Drug Administration on Thursday advised consumers not to purchase or use three separate sexual enhancement products that are being promoted as dietary supplements because they contain undeclared and unapproved prescription-only ingredients. 

The three products include Libido Sexual Enhancer, a product promoted and sold for sexual enhancement on various web sites, including www.vegasredpleasure.com; Rock-It Man, a product promoted and sold for sexual enhancement on www.shopinprivate.com and in some retail stores; and Stiff Days, a product also promoted and sold both online and in stores. 

FDA laboratory analyses of the three medicines confirmed that they contain ingredients such as sildenafil, the active ingredient in the FDA-approved prescription drug Viagra, used to treat Erectile Dysfunction. "This undeclared ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates," the agency advised. 

 

 

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Study: Lower levels of vitamin D linked to greater cancer risk in smokers

BY Michael Johnsen

WASHINGTON — Lower levels of vitamin D may predispose smokers to developing tobacco-related cancer, according to research published last week by Clinical Chemistry, the journal of the American Association of Clinical Chemistry. Consequently, study authors suggested that vitamin D blood tests and supplements have the potential to improve smokers’ health.

“Our analyses show that the association between lower concentrations of plasma vitamin D and higher risk of cancer may be driven by tobacco-related cancer as a group, which has not been shown before,” stated author Børge Nordestgaard. “This is important for future studies investigating the association between plasma vitamin D and risk of cancer.”

The data also indicate that tobacco smoke chemicals may influence vitamin D metabolism and function, while vitamin D may conversely modify the carcinogenicity of tobacco smoke chemicals, Nordestgaard noted. If further research confirms this, it would be consistent with previous studies demonstrating the anti-tumorigenic effects of vitamin D derivatives, as well as the correlation of vitamin D deficiency with favorable cancer-forming conditions and increased susceptibility to tobacco smoke carcinogens. Interestingly, though, low vitamin D levels were not connected with risk of other cancer types.

Cigarette smoking accounts for more U.S. deaths annually than HIV, illegal drugs, alcohol, motor vehicle injuries, suicides and murders combined. It is the primary causal factor for at least 30% of all cancer deaths, and can lead to multiple kinds of cancer, including bladder, cervical, esophageal, head and neck, kidney, liver, lung, pancreatic and stomach, as well as myeloid leukemia. According to the Centers for Disease Control and Prevention, the healthcare expenditures and productivity losses due to smoking cost the economy approximately $193 billion per year.


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Doctors, public health experts want more FDA regulation of energy drinks

BY Alaric DeArment

NEW YORK — A group of doctors and public health professors are hoping the Food and Drug Administration will place stronger regulations on energy drinks to protect children and adolescents from what they call the harmful effects of high caffeine consumption.

The group, which includes 18 doctors and public health experts from around the country, delivered the letter to FDA commissioner Margaret Hamburg Tuesday, citing research indicating that consuming energy drinks — which have a high caffeine content — is leading to emergency room visits and even deaths among children.

"Children and adolescents are particularly vulnerable to the serious health risks of these drinks," University of California Berkeley public health professor and signatory Patricia Crawford said. "They have no place in the diets of young people."

The letter noted that energy drinks are projected to reach $19.7 billion in sales this year and that, according to an FDA-commissioned study from 2010, 65% of the people consuming them are ages 13 years to 35 years, while according to recent reports, between 30% and 50% of adolescents and young adults consume energy drinks. At the same time, according to the Drug Abuse Warning NEtwork, emergency room visits related to energy drinks more than doubled between 2007 and 2011, from 10,068 to 20,783.

On Tuesday, the New York Times reported that Monster Beverage, the largest maker of energy drinks, plans to change the labeling on its Monster Energy drink and sell it as a beverage rather than a dietary supplement, as it has for a decade. The Times reported that the change would mean the company would no longer required to inform regulators about reports that may link its drinks to injuries and deaths. The company also plans to list Monster Energy’s caffeine content on the can. Another energy drink line, Rockstar Energy, underwent a similar change to its packaging.


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