Manufacturers of testosterone drugs taken by millions of men each year should conduct more tests on the cardiovascular safety of their products and limit indications for use. That was the recommendation of the U.S. Food and Drug Administration’s Bone, Reproductive and Urologic Drugs Advisory Committee, which last week re-examined the risks and benefits of testosterone replacement therapy.
The panel voted 20-1 that drugmakers like AbbVie, Pfizer and Eli Lilly & Co. need to revise product labels to include stricter language on what health conditions should be treated with the drugs.
Panel members also agreed that drug companies should conduct more safety studies to definitively rule out risk of cardiovascular problems.
Men who took the drugs and suffered heart attacks, strokes and blood clots already filed lawsuits against testosterone manufacturers after studies linked the medications to cardiovascular risks.
“There’s no way testosterone would be approved for the treatment of age-related Low T today by contemporary regulatory standards,” John Teerlink told The Associated Press. Teerlink, a heart specialist at the University of California San Francisco, served on the FDA panel.
The number of men taking drugs such as AndroGel, Testim and Depo-Testosterone – drugs previously only prescribed for serious medical conditions – ballooned over the past few years. Experts worry men may be using the drug as a lifestyle enhancer for normal symptoms of aging and testosterone decline commonly called Low T. The condition is characterized by symptoms such as fatigue, low libido and erectile dysfunction without having actual clinical need.
Some doctors feel rampant drug advertising played a role in building the Low T empire and little is known about the long term safety risk.
“The whole idea is to try to rein in the inappropriate advertising and use of these drugs,” Dr. Michael Domanski, panel member and director of heart failure research at Mount Sinai School of Medicine told The New York Times.
Drugmakers disagree, saying their products are being overused. However, they pledged to work with the agency.
“Testosterone replacement therapy is an important men’s health topic. AbbVie is committed to our patients and we will work with the FDA during its review,” Illinois-based AbbVie said in a statement.
No Evidence of Benefit
Sales of the drugs were fueled by the Low-T craze, and drugmakers poured millions of advertising dollars to direct ads at men, promising them renewed vitality. The marketing tactic worked.
“People are looking for the fountain of youth,” Dr. Aaron Katz, chairman of the Department of Urology at Winthrop-University Hospital in Mineola, N.Y., told the New York Times.
There was just one problem with the drugmakers’ promise. Little scientific evidence backs up claims that testosterone is the fountain of youth.
There is no data proving testosterone drugs are effective in treating symptoms men naturally experience as they age, the panel said in a report. They voted to revise labels to include clear language informing the public that these drugs are not clinically proven for these uses.
“I think the current labeling is vague and has been subject to misinterpretation,” said panelist Marjorie Shaw Phillips of Georgia Regents Medical Center.
Billion Dollar Drugs May Be Deadly
The prospect of narrowing the pool of patients that use Low T drugs by adding label changes doesn’t please pharmaceutical companies who make billions with the drugs.
AndroGel, the market leader, made over a billion in profit for AbbVie last year. Auxilium Pharmaceuticals made $271 million with Testim, according to Bloomberg News.
They also disagree with studies that show a possible increase in the risk of heart problems.
Eli Lilly said its assessment of the risk did not support a link to cardiovascular problems, but intended to cooperate. “However, based on feedback from the committees, Lilly will collaborate with the FDA to determine how to communicate cardiovascular risk to patients,” it said in an email statement to Bloomberg.
One study linked the drugs to a 30 percent increased risk of heart problems and death, and another showed the risk of heart attack doubled in the first 90 days after taking the drug.
The FDA is not required to follow the advice of the panel, but it usually does. Even with regulatory changes, it will be more difficult to police individual physicians’ prescribing habits, the panel said.
Meanwhile, Health Canada already evaluated the drugs and concluded they posed a heart risk.