Testosterone Drug Risks Subject of FDA Advisory Committee Hearing

Amid increasing concerns over the side effects of testosterone drugs, the FDA has asked two of its advisory committees to evaluate the potential health risks and issue recommendations about what regulatory actions may be necessary.

A joint meeting of the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee has been scheduled for September 17.

The FDA advisory committees have been asked to make recommendations about the potential cardiovascular risks with AndroGel, Testim and other popular “Low T” drugs. The outside experts will also discus what factors should be considered when deciding whether men need to use testosterone replacement therapy (TRT).

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While the committees do not have any regulatory authority, their recommendations tend to significantly influence the FDA’s final actions, and the agency generally only asks the committees to review a subject when it is preparing to take action to address concerns.

The hearing announcement came days after the Canadian drug regulators, Health Canada, announced they had completed their own review and found strong links between testosterone drugs and heart problems. The Canadian safety review determined that some cardiovascular problems disappeared after patients stopped using testosterone products and reappeared when they began using them again; typically considered strong evidence of a causal link.

The FDA launched its own investigation into the testosterone drug risks in January 2014, following several studies that suggested men may using the Low T treatments may face an increased risk of heart attacks, strokes and sudden death.

In November 2013, a study published in the Journal of the American Medical Association (JAMA) found that testosterone drug use was linked to heart injuries among men with pre-existing conditions.

That research was followed by a larger study published in the medical journal PLOSOne in January 2014, which involved a review of data on more than 55,000 men who received an initial prescription for testosterone and compared them to men who received a first prescription for an erectile dysfunction drug. The study found that low T treatments may double the risk of heart attack for younger men with pre-existing heart disease, and for men over the age of 65, regardless of their prior heart conditions.

Testosterone Black Box Warning Rejected by FDA

Earlier this year, the consumer watchdog group Public Citizen petitioned the FDA to add a black box warning to all testosterone products, which would alert users that studies show that the side effects of testosterone can increase the risk of cardiovascular problems. However, on July 16 the FDA sent Public Citizen a letter rejecting the petition (PDF), indicating that there is insufficient evidence at this time. The FDA said it would render a determination when its own review was complete.

In a letter responding to the FDA’s rejection (PDF), Public Citizen drew attention to what it sees as the absurdity of the agency’s stance given the evidence put forward by Canadian health officials.

Public Citizen’s founder and senior advisor of its health research group, Dr. Sydney wolf said there were only two possibilities, either “Canadian men are more sensitive to the cardiovascular risks of testosterone than American men, thus justifying new warnings in that country, but none, at this time, in the U.S.” or “the FDA is more sensitive to pressure from doctors dispensing more than 7 million prescriptions of testosterone in the past year and from the companies selling billions of dollars of testosterone products during the past year than Canadian regulators.”

Testosterone Blood Clot Warnings

On June 19, the FDA announced that it was requiring new venous thrombosis label warnings on testosterone drugs warning that they could increase the risk of blood clots.

Side effects of testosterone therapy were already known to increase the risk of blood clots due to a problem called polycythemia, an abnormal increase in red blood cells. However, the FDA now reports that it has found reports of blood clots above and beyond those linked to polycythemia. The new label warning changes the existing blood clot warning from one linking the problem to polycythemia, to a more generalized VTE warning.

Venous thromboembolism are blood clots that occur in the veins. They can lead to painful clots in the legs, known as deep vein thrombosis (DVT), or they can break off and flow to the heart and lungs, resulting in a pulmonary embolism, which can sometimes be deadly.

The FDA warning notes that these blood clots appear to be a different problem than those that may be causing testosterone users to suffer heart attacks and strokes.

Questions About Testosterone Blood Tests

Use of testosterone drugs has increased dramatically over the past decade, amid aggressive marketing that encourages men to seek prescription treatment for “Low T” if they are experiencing a number of symptoms common among men as they age, such as weight gain, reduced energy levels, diminished sex drive and loss of muscle strength.

Direct-to-consumer advertisements for testosterone drugs have suggested that men can find out whether they may need the medications through “a simple blood test.” However, a number of researchers and experts have challenged those claims and raised questions about the effectiveness of testosterone blood tests.

According to a study published in the medical journal Urology in February, there are a number of problems with low testosterone blood test diagnoses. Researchers found that the blood tests alone are not a good gauge for whether a man is actually suffering from low testosterone, suggesting that inconsistencies in testing methods and difficulty interpreting the results of blood tests may lead to a high rate of inaccuracy.

In some cases, blood tests conducted on the same man on the same day showed testosterone levels varying by as much as 30% between labs. The researchers have found that a number of factors can alter the levels of testosterone temporarily, even whether a man’s favorite sports team won a game the night before could affect the blood tests’ results.

Some critics have described the low testosterone drug marketing as “disease mongering”, encouraging men to seek prescription treatments for the natural effects of decreasing testosterone levels as all men age.

While TRT medications are only approved to treat testosterone deficiencies caused by a medical condition, such as hypogonadism, many prescriptions written in recent years are for “lifestyle reasons”.

Use of testosterone treatments has increased more than five times from 2000 to 2011, generating more than $1.9 billion in sales in 2012.

Testosterone Drug Lawsuits

The continuing FDA review of the safety of the drugs comes as a growing number of men throughout the United States are filing AndroGel lawsuitsTestim lawsuits, Axiron lawsuits, AndroGel lawsuits and other testosterone drug claims, alleging that the drug makers have withheld important safety information from consumers and the medical community.

Most of the complaints involve similar allegations that drug makers aggressively promoted testosterone gel treatments for use among men who had no real medical need. Plaintiffs indicate that use of testosterone drugs caused them to suffer a heart attack, stroke, deep vein thrombosis, pulmonary embolism or other serious injury, including many wrongful death lawsuits.

As the number of complaints filed in U.S. District Courts nationwide has continued to grow, the U.S. Judicial Panel on Multidistrict Litigation established coordinated pretrial proceedings for the cases last month, centralizing all testosterone litigation before U.S. District Judge U.S. District Judge Matthew Kennelly in the Northern District of Illinois.


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