Depo-Testosterone treats men with low testosterone (“Low-T”), and patients only need doses every two to four weeks. But Low T medications are linked to an increased risk of cardiovascular problems. Doctors are sounding the warning and affected men are filing legal claims.
Depo-Testosterone is an injectable hormone (androgen) replacement used to treat men diagnosed with low testosterone (Low T), and Pfizer’s unit Pharmacia & Upjohn Co. currently markets the medication.
The Food and Drug Administration (FDA) originally approved this drug in 1979 to treat men whose bodies do not make enough testosterone naturally. This is what most doctors prescribe the medication for, but patients sometimes use it to enhance muscle growth and athletic performance – medically unapproved uses.
While lack of testosterone can be dangerous for men, having too much can also be deadly. The dangers of androgen therapy drugs include cardiovascular problems such as heart attack and stroke, and studies also point to an increased risk of prostate cancer.
Depo-Testosterone (testosterone cypionate) is one of the older drugs of its kind on the market, and it continues to sell quietly and make money for Pfizer. In recent years it enjoyed a resurgence in popularity.
The latest Low T craze, fueled by multi-million dollar ad campaigns launched by major drug companies, pushed the testosterone market to around $2 billion in annual sales. Prescriptions for these drugs increased, and concerned doctors now warn that many men may simply be using the drug to regain lost youth promised to men in pharmaceutical commercials.
Low T drug use once was rare, but now about 1 in 25 men in their 60s takes a testosterone drug.
Consumer advocates and some doctors are calling for the FDA to order drugs companies to add warning labels to these drugs. In September, an agency panel of experts voted for more heart safety studies and stricter guidelines for use on labels.
Meanwhile, a number of men – or their survivor – filed legal claims that accused drug companies of pushing the drugs on them by advertising unproven benefits and failing to warn of the risks. Pfizer and Pharmacia & Upjohn Co. face lawsuits in state and federal courts for Depo-Testosterone.
What Is Depo-Testosterone and How Does It Work?
Unlike AndroGel, the most popular testosterone drug on the market, Depo-Testosterone is not a topical gel. Instead, it is a liquid and is designed for injection into the muscle. The active ingredient, testosterone cypionate, is a white or creamy white powder mixed in with other ingredients to make a solution. The drug is available in two strengths, 100 mg and 200 mg.
Each bottle contains:
- Testosterone cypionate (active ingredient)
- Benzyl benzoate (a chigger, tick and mosquito repellent and fixative used in perfume)
- Cotton seed oil
- Benzyl alcohol (preservative)
Testosterone cypionate dissolved in oil gets injected into the muscle and stays in the body for several days. A patient injects a dose every two to four weeks. Hormones then bind to receptors in the body. The body then expels about 90 percent of the testosterone through urine and feces.
Depo-Testosterone is specifically indicated for use only in men with testicular failure that they were born with or because of a disease, such as prostate cancer. Unfortunately, many Low T clinics provide testosterone to men who are simply getting older and naturally producing less testosterone.
Heart Attacks, Other Side Effects
One of the most deadly and concerning side effects linked to Depo-Testosterone is an increased risk of cardiovascular problems like heart attacks and strokes. No testosterone drugs carry warnings for heart problems, and the FDA ordered more studies before ruling on adding labels.
Millions of American men may be at risk of heart attacks and strokes without even knowing.
There are already a handful of studies that link the drugs to heart attacks, and consumer advocates petitioned the FDA to add warnings. Dr. Sidney Wolfe of Public Citizen’s Health Research Group told Drugwatch, “A majority of the people [who use testosterone] should not be getting it. They’re not getting any benefit, and they’re getting the risk of a doubling of heart attack in the first three months after starting to use it.”
According to Wolfe’s article, published in the British Medical Journal (BMJ), as many as 1 in 100 men may be at risk. “That’s not some rare risk,” Wolfe said, estimating that more than two million men use injectable hormones like Depo-Testosterone.
Some other side effects caused by this drug include:
- Hypercalcemia (elevated levels of calcium that can cause bone, kidney and brain problems)
- Liver tumors and hepatitis
- Prostate cancer, tumors
- Blood clots in legs and lungs
- Congestive heart failure
- Development of male breasts (gynecomastia)
- Male pattern baldness
- Stomach problems
- Pain and inflammation at injection site
The drug’s label warns against the using it for enhancing athletic performance because of the possible side effects. An ingredient in the solution, benzyl alcohol is also linked to breathing problems in premature infants.
Men Suffer Heart Attacks, File Lawsuits against Pfizer
Several manufacturers of testosterone drugs are facing lawsuits in court filed by men who suffered heart attacks, blood clots and strokes. Pfizer and Pharmacia & Upjohn Co. are no exception.
In September 2014, Alvaro Roman Gutierrez took his case to court after using Depo-Testosterone and suffering heart problems he blames on the drug. He accuses Pfizer of “disease mongering” by downplaying the risks of the drug and exaggerating its benefits.
“As a direct and proximate result of the plaintiff’s use of Depo Testosterone, also known as Testosterone Cypionate, and plaintiff’s reliance on defendants’ representations regarding the character and quality of the products and defendants’ failure to comply with federal requirements, plaintiff suffered serious physical injury, harm, damages and economic loss and will continue to suffer such harm, damages and economic loss in the future,” Gutierrez says in his complaint.
The complaint also says the drugmaker had a duty to warn the public and did not. Pfizer denies any wrongdoing and stands by its drug.
“We do not believe that the cases against Pfizer have merit, and we intend to defend these cases vigorously in court,” Pfizer spokesman Steven Danehy said in a statement.
Pfizer is accustomed to fighting hormone drug lawsuits. In 2012, it paid $896 million to women who said their breast cancer was caused by the drug. Some doctors warn that testosterone might follow the same path estrogen therapy.