FDA Adds New Warnings to All Testosterone Product Labels

Testosterone and other AAS, which have a schedule III classification by the Controlled Substances Act, may be abused by adults and adolescents, including athletes and body builders.

“Abuse of testosterone, usually at doses higher than those typically prescribed and usually in conjunction with other AAS, is associated with serious safety risks affecting the heart, brain, liver, mental health, and endocrine system,” the FDA notes.

Reported serious adverse outcomes include myocardial infarction, heart failure, stroke, depression, hostility, aggression, liver toxicity, and male infertility. People abusing high doses of testosterone have also reported withdrawal symptoms, such as depression, fatigue, irritability, loss of appetite, decreased libido, and insomnia, the agency says.

Source: FDA Adds New Warnings to All Testosterone Product Labels

Source: Safety Alerts for Human Medical Products > Testosterone and Other Anabolic Androgenic Steroids (AAS): FDA Statement – Risks Associated With Abuse and Dependence

It is interesting you no longer see those Low-T commercials on television any more.  Really?  Just another clever marketing campaign to create a disease that doesn’t exist along with a convenient drug based solution.  What side effects?

Read this book.  Now.

Source: Bill Moyers Journal . Profile . Melody Petersen | PBS

CNS – Pfizer to Face Testosterone Claims

Source: CNS – Pfizer to Face Testosterone Claims After All

   The multi-district master complaint asserted 10 primary state law claims, including strict liability based on design defect and failure to warn, negligence, breach of implied and express warranty, fraud, consumer protection, and unjust enrichment.
The plaintiffs also allege non-tort claims for wrongful death, survival, loss of consortium, and punitive damages.

One of the books I’m reading is Powerful Medicines – The Benefits, Risks, and Costs of Prescription Drugs written by Jerry Avorn M.D.  Definitely a fun read in  the context of our culture’s addiction to the quick fix.  Whatever ails you there is a pill that promises to fix everything.  Dr. Avorn’s book is packed with information.  Simply stated, there are benefits and risks associated with any medication.  Ultimately it is the consumer’s responsibility to know and understand what those benefits and risks are with anything you put in your body.

It was clear to me from the beginning that the unsuspecting and too trustful public was going to be introduced to a new disease  Low-T.  The pharmaceutical strategy  was just another medicalization of a natural process.

More. Drugs. Please.

Testosterone Treatment and MI Risk

Filling a prescription for testosterone therapy was associated with a greater risk of having a nonfatal myocardial infarction (MI) in the next 3 months, a large observational study showed.

The risk after a prescription was filled was more than doubled in men 65 and older overall compared with that in the year before the prescription (rate ratio 2.19, 95% CI 1.27-3.77), according to Robert Hoover, MD, ScD, of the National Cancer Institute in Bethesda, Md., and colleagues.

The study was limited, however, by the observational design, the use of administrative data that lacked information on indications for treatment, and the inclusion of nonfatal MIs only.

via Study Feeds Concerns About MI Risk With Testosterone Tx.

Testosterone Treatment Tied to Worse Cardiac Outcomes

After adjustment for the presence of coronary artery disease, testosterone therapy was associated with a greater risk of all-cause mortality, myocardial infarction, and ischemic stroke 3 years after angiography (25.7% versus 19.9%; HR 1.29, 95% CI 1.04-1.58), according to P. Michael Ho, MD, PhD, of the Department of Veterans Affairs (VA) Eastern Colorado Health Care System in Denver, and colleagues.

via Testosterone Tx Tied to Worse Cardiac Outcomes.

How come the television commercials don’t tell you this information when they try to make you think you have a disease called Low T?

Annual prescriptions for testosterone increased more than five-fold from 2000 to 2011. In 2011, the total number of prescriptions numbered 5.3 million and make up a market of 1.6 billion, the authors wrote.

Never mind.