HEALTH

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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Dietary supplement industry bands together to challenge NDI reporting requirements

BY Michael Johnsen

WASHINGTON — Five trade associations representing the dietary supplement industry on Tuesday collectively called for an overhaul of the Food and Drug Administration’s draft guidance regarding new dietary ingredient reporting requirements.

"The [NDI] draft guidance issued by FDA in July, if implemented and enforced by FDA, would burden industry, placing unreasonable requirements on business, especially smaller firms, and create unreasonable barriers of entry for newer market entrants, without any related benefits for consumers," the trade associations stated. While the groups submitted separate comments to reflect their own membership priorities, the five associations stressed that FDA should focus on the common themes in their respective submissions. “We are all committed to seeing a substantial overhaul of the draft guidance and are united in our common belief that the document is overreaching and contravenes [the Dietary Supplement Health and Education Act]."

Common key issues include:

  • Requiring submission of a notification for virtually every product that contains an NDI from every manufacturer;

  • A shift in the burden of proof that an ingredient is not an NDI from the FDA to individual companies;

  • FDA’s claim that there are no authoritative lists of “grandfathered” ingredients that can be used to establish that a dietary ingredient is an Old Dietary Ingredient, which dismisses the relevance of “grandfathered” lists submitted by the trade associations in 1996-1998 for establishing that dietary ingredients are pre-DSHEA ingredients;

  • Redefining the meaning of the term ‘‘chemically altered’’ in such a way that significantly expands the category of ingredients that would constitute an NDI;

  • Stating that human synthesized constituents of botanical ingredients are different from those synthesized by the plant; and

  • Imposing a level of data necessary to demonstrate the safety of an NDI similar to what is required for food additives, a standard already rejected by Congress and the courts.

The trade associations include the American Herbal Products Association, the Consumer Healthcare Products Association, the Council for Responsible Nutrition, the Natural Products Association and the United Natural Products Alliance.


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