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FDA Warns Consumers Not to Use Body Building Products Marketed as Containing Steroids or Steroid-Like Substances
Agency issues Warning Letter to American Cellular Laboratories for marketing and distributing potentially harmful steroid-containing products
The U.S. Food and Drug Administration today issued a Public Health Advisory (PHA) warning consumers to stop using body building products that are represented as containing steroids or steroid-like substances. Many of these products are marketed as dietary supplements.
The agency also issued a Warning Letter to American Cellular Laboratories Inc. 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,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “The FDA is taking enforcement action today to protect the public.”
The products listed in the Warning Letter to American Cellular Laboratories Inc., 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.
Consumers taking body building supplements that claim to contain steroids or steroid-like substances should stop taking them immediately. Consumers should also consult a health care professional if they suspect they are experiencing problems associated with the products. Health care professionals and consumers are encouraged to report adverse events that may be related to the use of these types of products to the FDA's MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.
they contradict themselves... Without studying each case and see exactly what that person was taking/medical history/family history.. You can't blame just one thing..
That like that kid that died while on steroids.. which they blamed.. only to find out he was on any number of things that were more likely to be the cause of his death.. But yet you don't hear about them as they are Pharm made..
The drug manufactures just want you on all their drugs.. take this one because of this and you get this side effect, so they make another drug to counter that side, but give you yet another side.. all of which could send you into cardiac arrest.. But since they have lobbyist, it's OK..
Look at any depression medicine and you'll side that two of the side effects are "severe depression" yes you read that right.. even worse depression than you already have.. and death by suicide.. Giving any child a depression med is a crap shoot.. and yet another case was blamed on steroids and yet, the patient was young and on depression meds.. But do we hear about those.. Hell no.. You have to ask yourself as to why???
If bug drug companies made these products, you can damn site believe that we wouldn't be seeing this shit happen.. Especially id the guys in congress want a job after they serve in the house or senate. Check it out where these people work afterwards
Drug companies want you on their drugs and keep you on them, they don't want to male you healthy.. Think about it.. if they cure all diseases and made pills that made you better.. Then you wouldn't need them and they all would go bankrupt.. It's in their best interest to keep you sick..
sorry for the rant.. But soon there will come a time when we all wake up and realize that our government is self serving and you are not for whom they are serving.. It's a get what i can before the shit hits the fan..
Time for a tea party
Agency issues Warning Letter to American Cellular Laboratories for marketing and distributing potentially harmful steroid-containing products
The U.S. Food and Drug Administration today issued a Public Health Advisory (PHA) warning consumers to stop using body building products that are represented as containing steroids or steroid-like substances. Many of these products are marketed as dietary supplements.
The agency also issued a Warning Letter to American Cellular Laboratories Inc. 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,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “The FDA is taking enforcement action today to protect the public.”
The products listed in the Warning Letter to American Cellular Laboratories Inc., 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.
Consumers taking body building supplements that claim to contain steroids or steroid-like substances should stop taking them immediately. Consumers should also consult a health care professional if they suspect they are experiencing problems associated with the products. Health care professionals and consumers are encouraged to report adverse events that may be related to the use of these types of products to the FDA's MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.
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.
they contradict themselves... Without studying each case and see exactly what that person was taking/medical history/family history.. You can't blame just one thing..
That like that kid that died while on steroids.. which they blamed.. only to find out he was on any number of things that were more likely to be the cause of his death.. But yet you don't hear about them as they are Pharm made..
The drug manufactures just want you on all their drugs.. take this one because of this and you get this side effect, so they make another drug to counter that side, but give you yet another side.. all of which could send you into cardiac arrest.. But since they have lobbyist, it's OK..
Look at any depression medicine and you'll side that two of the side effects are "severe depression" yes you read that right.. even worse depression than you already have.. and death by suicide.. Giving any child a depression med is a crap shoot.. and yet another case was blamed on steroids and yet, the patient was young and on depression meds.. But do we hear about those.. Hell no.. You have to ask yourself as to why???
If bug drug companies made these products, you can damn site believe that we wouldn't be seeing this shit happen.. Especially id the guys in congress want a job after they serve in the house or senate. Check it out where these people work afterwards
Drug companies want you on their drugs and keep you on them, they don't want to male you healthy.. Think about it.. if they cure all diseases and made pills that made you better.. Then you wouldn't need them and they all would go bankrupt.. It's in their best interest to keep you sick..
sorry for the rant.. But soon there will come a time when we all wake up and realize that our government is self serving and you are not for whom they are serving.. It's a get what i can before the shit hits the fan..
Time for a tea party
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