HEALTH

GoldToe Moretz to target drug channel with new line of compression socks

BY Michael Johnsen

NEWTON, N.C. — GoldToe Moretz last week announced the launch of a new SoleUtion socks line for men and women that provides enhanced comfort and overall foot and leg well-being. Dress and casual SoleUtion styles range in price points from $8 and $16, and currently are available online.

The company, however, is targeting a launch in the drug channel.
 
The SoleUtion line features mild, moderate and firm compression choices; crew and quarter profile choices; and non-­binding tops to help circulation.

“Gold Toe is an established brand with more than 80 years of heritage that consumers know and trust,” GoldToe Moretz VP marketing Trish McHale said. “[For] people looking for socks that address specific medical conditions, or people who just want socks that deliver enhanced functionality, choosing SoleUtion will be easy. There is a major opportunity for retailers with the SoleUtion program.”
 
GoldToe Moretz is a subsidiary of Gildan Activewear. The company is a supplier of branded and private label athletic, casual and dress socks, with distribution across retail channels in the United States.


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Despite bleeding risk, aspirin may be beneficial before cardiac surgery

BY Michael Johnsen

PHILADELPHIA — Aspirin taken within five days before cardiac surgery is associated with a significant decrease in the risk of major postoperative complications, including renal failure, an intensive care unit stay, and even early death (30-day mortality), according to findings from an observational cohort study by researchers at Thomas Jefferson University and the University of California Davis Medical Center that are set to appear in the journal Annals of Surgery.

The researchers acknowledged that bleeding remains a concern with preoperative aspirin therapy. However, they argued that in the current era of cardiac surgery, the potential for bleeding may be avoided by using a low dose of aspirin and/or giving antifibrinolytic therapy perioperatively.

“Therapies targeted to prevent or reduce major complications associated with cardiac surgery have been few and ineffective so far,” stated Jianzhong Sun, an anesthesiologist at Thomas Jefferson University and lead author of the study. “These complications are significant and costly both for the public health and the quality of patient life.”

The study team evaluated the impact of preoperative aspirin on major outcomes in adults (4,256 consecutive patients) who had cardiac surgery — mostly coronary artery bypass graft or valve surgery — at Thomas Jefferson University Hospital and UC Davis Medical Center between 2001 and 2009. Among 2,868 patients who met the inclusion criteria, 1,923 were taking aspirin (within about 81 to 325 mg daily) at least once within five days preceding their surgery versus 945 not taking aspirin (nonaspirin therapy).

The outcomes showed that preoperative aspirin therapy (versus non-aspirin) is associated with a significant decrease in the risk for 30-day mortality, and for the composite outcome of major adverse cardiocerebral events, postoperative renal failure, and the average time spent in the intensive care unit. Beneficial effects of preoperative aspirin use found in the current study “are in line with our previous findings and findings from early postoperative aspirin studies,” wrote Sun and colleagues in their paper.

“We know that aspirin can be lifesaving for patients who have experienced heart attacks,” stated Nilas Young, chief of cardiothoracic surgery at UC Davis and a study co-author. “Now we know that this simple intervention can do the same for patients who undergo certain coronary surgeries. This outcome could lead to new preoperative treatment standards in cardiac medicine.”

“Overall, the outcome benefits provided by preoperative aspirin therapy may override its possible risk of excess bleeding in patients undergoing cardiac surgery. Nonetheless, further studies are certainly needed to examine this potential side effect carefully,” Sun added.


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FDA seizes ephedrine ingredients

BY Michael Johnsen

SILVER SPRING, Md. — At the request of the Food and Drug Administration, U.S. marshals on Tuesday seized raw materials imported by Infinity Marketing Group containing ephedrine alkaloids, a large family of pharmacological compounds called sympathomimetics that have been banned by the FDA for use in dietary supplements since 2004.

The seizure took place in Rancho Dominguez, Calif. Through this action, FDA removed more than $70,000 worth of dietary supplement ingredients from the market.

"Working in close coordination with our federal colleagues in U.S. Customs and Border Protection, Immigration and Customs Enforcement and the Drug Enforcement Administration, the FDA helped identify and remove these potentially dangerous products from the marketplace," said Dara Corrigan, FDA associate commissioner for regulatory affairs. "We will continue to take enforcement action that prevents potentially harmful products from reaching consumers and endangering their health."

Ephedrine alkaloids are adrenaline-like stimulants that potentially can have dangerous effects on the heart. Prior to 2004, dietary supplements containing ephedrine alkaloids extensively had been promoted for aiding weight control and boosting sports performance and energy. But available data showed little evidence of the compound’s effectiveness except for modest, short-term weight loss without any clear health benefit, while confirming that the substance raised blood pressure and otherwise stressed the circulatory system. These effects were linked to significant adverse health outcomes, including heart attack, stroke and death.

FDA’s chemical analysis confirmed the presence of these alkaloids in the shipment, but the shipping drums carried no labels indicating that the material contained the banned ephedrine alkaloids.


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