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.
BDI Marketing announces new wave of energy drinks
CARMEL, Ind. BDI Marketing announced the release of a new series of products, including its new 357 Super Magnum Energy Shot, Xtreme Energy Rush and Top Gun sexual stimulant pills in a new 2-oz. liquid shot.
BDI’s 357 Super Magnum Energy Shot provides consumers with enough caffeine to stimulate and fuel the body to perform at unparralled levels throughout the entire day but without the fat, sugar, carbohydrates or calories, the company said.
In celebration of the 10th anniversary of the introduction of its popular Top Gun sexual stimulant pills, BDI is now offering the product in new two-ounce liquid shots, available in Cherry Passion flavors. The pill is aimed to provide consumers with enhanced libido and increased energy and endurance.
Xtreme Energy Rush is packed with three-times the strength of a single cup of coffee; a triple strength punch that provides the body with a shot of long lasting energy.
The new products join BDI’s ever-growing family of incredibly popular liquid, gum and capsule Mini Thin energy products to provide consumers with a delicious option to high-sugar energy drinks.
Ross Valley Pharmacy develops medication management, diabetes counseling initiatives
LARKSPUR, Calif. Ross Valley Pharmacy, an independent, locally owned pharmacy in Marin County, Calif., on Monday announced the availability of personalized medication management and diabetes counseling programs.
The MM program is designed to help local residents understand and reduce risk and side effects associated with taking multiple prescription and nonprescription drugs, supplements and vitamins.
Ross Valley Pharmacy’s counseling programs offer consumers the ability to create a profile that captures key information such as prescription and non-prescription drugs, vitamins, supplements, blood glucose levels, medical conditions, symptoms, height, weight and food by entering information on a customized version of TheCarrot.com’s popular, easy-to-use online platform. Once consumers, their family or caregivers enter the requested information, Ross Valley Pharmacy will assess the medication and/or diabetes profile and will schedule a one-on-one counseling session to educate and provide guidance on how to improve health outcomes. Patients with diabetes will be scheduled to see a Certified Diabetes Educator who evaluates blood glucose levels, medications and diet, the independent pharmacy stated.
“Many people often leave their doctor’s office not understanding why or how they should take prescribed medications,” stated Paul Lofholm, president of Ross Valley Pharmacy. “They look to a pharmacist to fill in communication gaps, but unfortunately, a pharmacist often doesn’t have all the information needed to provide comprehensive patient counseling. For example, at least 25% of medications consumed are over-the-counter drugs … these drugs, alone or when combined with other medications, vitamins and supplements, can produce harmful side effects. Our goals are to evaluate the aggregate effects of all the drugs an individual takes, educate consumers to better manage their health and arm them with the knowledge they need to ask their physicians the right questions.”
Examples of commonly unrecognized medication problems/issues include:
- The decongestant pseudoephedrine can raise blood pressure;
- There is an increased risk of liver damage when taking acetaminophen with Vicodin or Percocet;
- Combining non-prescription Prilosec with such similar prescription stomach acid reducers as Aciphex or Protonix limits absorption of other medications and can lead to anemia;
- Anti-depressants can trigger poor balance and falls;
- People with epilepsy need to eat proteins because seizure-controlling drugs must bind to protein to work effectively;
- Beta blockers, used to control blood pressure, can lower blood sugar;
- Grapefruit juice slows the body’s ability to metabolize cholesterol-lowering Lipitor, leading to elevated blood levels of the drug; and
- Calcium supplements halve the effectiveness of thyroid medications.