FDA warns consumers about body-building products that contain steroids, related substances
ROCKVILLE, Md. The Food and Drug Administration on Tuesday issued a Public Health Advisory warning consumers to stop using body-building products that are represented as containing steroids or steroid-like substances and oftentimes misbranded as dietary supplements.
The agency also issued a Warning Letter to American Cellular Laboratories for marketing and distributing body-building products containing synthetic steroid substances. Although these products are marketed as dietary supplements, they are not dietary supplements, but instead are unapproved and misbranded drugs.
The PHA notifies consumers and health care professionals that the FDA has received reports of serious adverse events associated with the use of body-building products that claim to contain steroids or steroid-like substances. Those adverse events include cases of serious liver injury, stroke, kidney failure and pulmonary embolism (artery blockage in the lung). The PHA also advises consumers to stop taking body building products from any manufacturer that claim to contain steroid-like substances or to enhance or diminish androgen-, estrogen-, or progestin-like effects in the body.
The FDA has received five adverse event reports, including serious liver injury, in men taking products marketed as dietary supplements by American Cellular Laboratories, including TREN-Xtreme and MASS Xtreme. Acute liver injury is generally known to be a possible side effect of using products that contain anabolic steroids. Some of the cases resulted in hospitalization, but there were no reports of death or acute liver failure.
“Products marketed for body-building and claiming to contain steroids or steroid-like substances are illegal and potentially quite dangerous,” stated FDA commissioner Margaret Hamburg. “The FDA is taking enforcement action today to protect the public.”
The products listed in the Warning Letter to American Cellular Laboratories, include “TREN-Xtreme,” “MASS Xtreme,” “ESTRO Xtreme,” “AH-89-Xtreme,” “HMG Xtreme,” “MMA-3 Xtreme,” “VNS-9 Xtreme,” and “TT-40-Xtreme,” and are sold on the Internet and in some stores. These products, which claim to contain steroid-like ingredients but in fact contain synthetic steroid substances, are unapproved new drugs because they are not generally recognized as safe and effective. In addition, the products are misbranded because the label is misleading and does not provide adequate directions for use.
Bayer Consumer Care launches virtual march against breast cancer
MORRISTOWN, N.J. Bayer Consumer Care last week announced an initiative encouraging women to join a virtual march against breast cancer as part of its One A Day Women’s Take A Stand Campaign.
Through the end of October, women will have the opportunity to show that they’re taking a stand against breast cancer by going to www.oneaday.com, and creating a customizable character in honor of someone special.
According to a recent Yankelovich survey, although a large majority of women know there are simple steps they can take to support breast health, few women are taking the necessary actions. As many as 80% of the women surveyed have been personally affected by breast cancer or know someone who has been.
The survey also found that 1-in-5 women who support breast health or breast cancer awareness causes wish they could do more, and 60% of women who have not supported breast cancer organizations and causes say they lack the time or money.
“Joining the Take A Stand virtual march provides a quick, easy and free way for women to help raise funds to support breast cancer awareness and research,” Bayer stated. “For each character created, the One A Day brand will make a donation to a breast cancer cause that will be determined by an online vote.”
The organizations to be included in that vote are: The Breast Cancer Research Foundation, the American Cancer Society and the National Breast Cancer Foundation.
“This program is part of our continued efforts to increase awareness about the importance of supporting breast health,” stated Barton Warner, VP marketing and new business for Bayer Consumer Care. “Last year One A Day Women’s woke women up about breast cancer through the One A Day Women’s Wake-Up Call program, and now it’s time women answer the call by taking a stand.”
CDC: H1N1 virus expected to make a large impact on upcoming cough-cold-flu season
ATLANTA The novel H1N1 virus is expected to make a big impact in the coming cough/cold/flu season, though just by how much is hard to determine, noted Anne Schuchat, director of the National Center For Immunization and Respiratory Diseases for the Centers for Disease Control and Prevention, during a press conference held Friday.
Based on the course of the novel H1N1 virus in the spring, between 6% and 8% of people in those communities that were affected came down with the novel flu, at a time when seasonal flu incidence is relatively zero. “In a longer winter season, attack rates would probably reach higher levels than that,” Schuchat said. “Maybe two or three times as high as that.” During seasonal influenza in the winter, as many as15% of people develop influenza-like illness.
Worse-case scenario models used as pre-pandemic planning tools have accounted for as many as 40% of Americans to be infected, or to be tasked with caring for an infected relative, this fall — which is expected to cause mass absenteeism across schools and work forces.
“Much of our framing has been focused on the very severe impact where 40% of the workforce might be absent because they’re sick or staying home to care for a sick person,” Schuchat said, but that isn’t the most likely scenario. “Right now we’re not expecting that high an absentee rate, but we are expecting challenges.”
As of Friday, there were 43,771 confirmed novel H1N1 cases, including 302 deaths. But that case count is a far cry from accurately measuring the number of cases, Schuchat warned, especially as the number of states actually testing for the novel H1N1 virus drops.
“We believe there have been well over a million cases of the new H1N1 virus so far in The United States,” Schuchat said. “And the patterns that we’re seeing right now are 20 states reporting widespread or regional influenza activity. … It’s very unusual for that kind of illness to be occurring at this time of the year. The Novel H1N1 viruses are making up 98% of all the subtyped viruses we have, subtype influenza A viruses, and we’re seeing them dominate here in the U.S.”
The CDC also updated its vaccination recommendations Friday. “At this point, 83% of the population is recommended to get an annual flu vaccine and we recommend it for anyone who wants to reduce their risk of flu,” Schuchat said. “Unfortunately, only about 40% of the U.S. population received the flu vaccine last year, so we’re really recommending an intensifying use of this vaccine because it does protect against illness and complications like hospitalization and severe outcomes.”
Schuchat also stressed that health care workers need to get vaccinated, especially this year. “We recommend them strongly to receive the seasonal flu vaccine,” Schuchat said. “And I’m expecting when H1N1 vaccine recommendations come out it’s very, very likely health care workers will be in that group that ought to get vaccines as well.” Presently, CDC is estimating that enough novel H1N1 vaccine, if approved, may be ready by mid-October to sustain a national vaccination program.