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The fact that a U.S. Food and Drug Administration advisory panel and federal regulators have taken aim at over-the-counter (OTC) acetaminophen products is not just the stuff of recent headlines. We found newspaper articles dating back over twenty years in which scientists urged stronger warning labels on every bottle of acetaminophen, based on evidence that countless Americans unwittingly took toxic doses that harmed their livers.
In fact, in 1977, the FDA's advisers recommended explicit warnings not to exceed the dose or take acetaminophen for more than 10 days "because severe liver damage may occur." Back then, the FDA never followed that advice although they pledged to quickly consider its advisers' recommendations.
The slow pendulum has swung and now the agency is going out of its way to educate the public after official studies found that many people consume more than the recommended dose of these pain relievers in the mistaken belief that taking more will prove more effective against pain without posing health risks. Consumers may also not know that acetaminophen is present in many over-the-counter products, including remedies for colds, headaches and fevers, making it possible to exceed the recommended acetaminophen dose, more recent reports have said.
Although best known by the Tylenol brand, acetaminophen is in hundreds of branded and generic products, from headache relievers to cold-and- cough remedies. While mostly sold without a prescription, it's also part of the chemical mix in prescription painkillers like Percocet and Vicodin.
So while an estimated 100+ million people a year take acetaminophen, and manufacturers insist that serious liver damage is very rare, government regulators have finally stepped up their fight to educate and warn consumers that swallowing a few extra pills in hopes of faster pain relief and falsely thinking that over-the-counter medications are safe enough to push the dose are a mistake and could result in unknowingly ingesting potentially toxic amounts.
That push and the results of a soon to be released study by Bioelectronics Corp. (OTC:BIEL) have set the table for an intriguing penny play in the coming days.
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The company made this year's 10 Stock BioMed Momentum Index, with investors riding the wave of excitement about the technology and pending FDA decisions, but the upcoming news flash will likely make shares of the micro-cap company run up once again. How much the stock may run up remains to be seen, but even without official news, speculators moved the stock up over 20% on Tuesday- and results from the medical study aren't even scheduled to be released for at least a few more days.
Company officials won't yet officially disclose what the study results will reveal, but there are strong hints in what was released as part of the pilot section of the study last month. That Institutional Review Board (IRB) supervised study is directed at comparing the effects of the company's ActiPatch® Therapy to acetaminophen in the form of Extra Strength Tylenol® for the treatment of delayed onset muscle soreness (DOMS).
Participants in the pilot section of the study were randomly assigned to one of three groups, 1) a control group, 2) a group that used ActiPatch, and 3) a group that was treated with over-the-counter strength acetaminophen. Each of the group's participants then evaluated their levels of muscle soreness and discomfort 48 hours after vigorous resistance training designed to induce delayed onset muscle soreness.
The results from the October section of this study seemed to be highly statistically significant with the ActiPatch® group scoring its average level of muscle soreness and discomfort at much lower levels compared to either the control group or the acetaminophen treatment group according to principal investigator Sheena Kong, M.D.
BioElectronics's wearable ActiPatch® delivers pulsed electromagnetic therapy to reduce pain and swelling and accellerate healing. The technology was recognized by the Wall Street Journal as one of the year's best innovations and the company was quick to jump on the "anti-acetaminophen" bandwagon with this study since the product appears to address the same medical needs as Tylenol® while maintaining its status as a 100% drug free product which not only which relieves pain, but is also proven to repair damaged cells and minimize swelling and bruising- all without drug interactions and side effects.
"For many years physicians, medical researchers and sports trainers attributed this type of muscle soreness to the build up of lactate in muscle tissues after exercise," said investigator Kong. "A significant body of research now shows delayed onset muscle soreness is mainly attributable to damage to the muscle cell membrane, which sets off an inflammatory response leading to the formation of metabolic waste products that act as a chemical stimulus to the nerve endings that directly cause the pain that is experienced after muscle over exertion. While additional research needs to be conducted on the actual mechanism, it appears ActiPatch® works to reduce this inflammatory response resulting in a reduction in the formation of metabolic waste products and therefore, what appears, based on these preliminary results, to be a significant reduction in levels of muscle pain and soreness."
If the results come back as positive as expected, I'd look for BioElectronics to push more headlines with the results and use the data to promote the brand as an alternative to acetaminophen more agressively than ever.
Disclosure: Long BIEL
