Prescription Testosterone, Other Steroid Drugs Product Labels Get New Warning From FDA
The U.S. Food and Drug Administration, or the FDA, is issuing a new warning for prescription testosterone drugs about the risk and abuse associated with its intake, the FDA announced on Tuesday.
The recent warning comes as an addition to the series of steps that the administration has taken in order to control product prescriptions of drugs, this time targeting testosterone drugs, the usage of which has experienced a continuous uptrend in the past ten years, especially among middle-aged men.
Drugmakers were told by the FDA to clarify that the products are approved exclusively for males with specific medical conditions, adding that the drugs may push the risk of stroke and heart attack forward.
Apart from heart attacks and strokes, abnormal dosage of the said drugs has been linked to liver-related problems, depression, infertility in men and acquired hostility and aggression, the FDA said. Additionally, people who halt the intake of the drugs they abuse are subject to serious withdrawal symptoms, which include fatigue, loss of appetite, diminished libido, irritability and insomnia.
The FDA said that the new warning will bring possible risks of abuse to the attention of prescribers, alongside "serious adverse outcomes, especially those related to heart and mental health." As an example, athletes and bodybuilders have been known to take dosage of the said prescription drugs that eclipse the prescribed dosage itself. The new warning may also help health professionals or prescribers measure a patient's blood testosterone levels should they harbor suspicion of abuse from the user.
Testosterone is an anabolic steroid with eligible usage by adults and adolescents, including bodybuilders and athletes. To date, testosterone treatment is already a $2 billion industry, with millions of men being prescribed gels, pills or injections. Testosterone drugs are legally prescribed for delayed puberty and muscle loss-causing diseases such as AIDS or cancer. Beyond that is a very gray area.
"[S]ome athletes and bodybuilders abuse these drugs to boost performance or improve their physical appearance," says the National Institute on Drug Abuse.
In the last decade, prescription of drugs that treat low testosterone has experienced a steady uptick, accounted for by men whose testosterone levels naturally drop with age. Between 2009 and 2013, the FDA has recorded a 75 percent increase for men who are prescribed low testosterone drugs. Further research by consumer rights advocacy group Public Citizen suggests that nearly 25 percent of those men failed to have a blood test to actually determine if their testosterone level was low in the first place.