Regulatory Focus™ > News Articles > Consumer Group Calls for New Warnings for Low-T Products, Delay of Endo's Aveed

Consumer Group Calls for New Warnings for Low-T Products, Delay of Endo's Aveed

Posted 26 February 2014 | By Alexander Gaffney, RAC

Less than a month after US regulators issued a preliminary warning about the cardiovascular risks associated with products intended to treat low testosterone levels in men, a prominent consumer advocacy group is calling on the US Food and Drug Administration (FDA) to add more serious warnings to the products.

Background

FDA's review of the products, commonly known as "low-T" drugs, was triggered by two separate studies.

The studies, in the Journal of the American Medical Association (JAMA) and in the journal Public Library of Science: Medicine (PLoS Medicine), both showed an elevated risk of cardiovascular events. The JAMA study suggested a 30% increase in risk of stroke, heart attack and death in those taking products intended to treat low-T, while the PLoS study showed that older men (ages 65 and older) exhibited a two-fold increase of heart attack and younger men with a history of heart disease had a two- to three-fold increased risk of the same.

Based on those studies, FDA said it would reassess the risks of testosterone treatment, but stopped short of asking physicians to alter their current prescribing habits.

The drugs are already subject to a number of serious safety warnings, including that accidental exposure to testosterone (such as by family members) may cause health problems. The drugs also contain warnings that patients should tell their doctors if they have prostate cancer, heart problems, kidney or liver problems or urinary problems.

Citizen Petition

While the public awaits the agency's final conclusions and recommendations, at least one group is using the reassessment as an opportunity to petition FDA for additional restrictions across the drug class.

In a Citizen Petition sent to FDA on 25 February 2014, the advocacy group Public Citizen called on the agency to add Black Box Warnings (also known as Boxed Warnings) to all testosterone products.

The warnings are highly visible and prominent warnings that alert consumers to the most serious risks associated with some products. Boxed warnings are typically reserved for increased risks of fatal or potentially fatal events, and generally inform the patient about ways to mitigate those risks through correct use of the product.

Public Citizen's petition cites the same evidence cited by FDA, but also notes the huge number of prescriptions filled for four testosterone products: Androgel, Axiron, Testim and Fortesta. More than five million prescriptions were filled in the US in 2013, the group said.

'Hyped-Up' Advertising

"Hyped-up" advertising campaigns for the drugs mean that "many men in the US prescribed testosterone do not meet the FDA-specified criteria of both low testosterone levels and an associated medical condition due to hypogonadism," the group added.

 Public Citizen's petition also calls attention to a discrepancy in safety data compiled about the drugs.

"Although 13 of these studies, funded by the drug industry, collectively showed no increased risk, the 14 studies not funded by the industry collectively showed a highly significant increased cardiovascular risk," Public Citizen observed-a "remarkable finding."

"Unless the FDA immediately begins to provide strong, adequate black-boxed warnings about the risks of heart attacks and other cardiovascular diseases, the continuing toll of heart attacks, many in people who are not even candidates for testosterone, will continue," Sidney Wolfe, senior advisor to Public Citizen's Health Research Group, said in a statement.

The petition goes on to request a Boxed Warning that reflects the risk of increased cardiovascular events on all testosterone products. FDA is also petitioned to send "Dear doctor" letters to all healthcare providers warning them in writing about the new risks.

Delay for Endo's Aveed?

The petition finally ends by asking FDA to delay its PDUFA date for Endo Pharmaceuticals' Aveed (testosterone undecanoate), currently set for 28 February 2014. Public Citizen said in light of the new risks, introducing a new product to the market could exacerbate harms by impacting additional patients.

 

Public Citizen Petition

Public Citizen Statement


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