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Letter to the FDA Protesting Aveed

March 6, 2014

Margaret A. Hamburg, M.D.

Commissioner Food and Drug Administration Department of Health and Human Services

WO 2200 10903 New Hampshire Avenue Silver Spring, MD 20993-0002

Dear Dr. Hamburg,

I am writing to strongly protest and urge that you reverse the FDA’s decision, announced by Endo this morning,[1] to approve a very long-acting injectable form of testosterone (Aveed), because it will likely greatly expand the use of testosterone, now found to increase the risk of heart attacks and other cardiovascular diseases. This evidence is reviewed in our February 25 petition to place a black box warning on all testosterone products and to delay the decision on approval of Aveed.[2]

At an April 18, 2013, FDA advisory committee meeting on approval of the drug, there was a vote on the safety of the Aveed on this question:

“Given the severe post-injection reactions that were reported with testosterone undecanoate, TU [testosterone undecanoate], in clinical studies and post-marketing experience, do you believe that TU is safe for the proposed indication?”

Although the FDA presentation at that meeting and the advisory committee discussion was devoid of the topic of heart attacks or cardiovascular risks other than post-injection reactions associated with testosterone, the vote was nine against the drug being “safe for the proposed indication” and nine in favor of its safety.[3] Summarizing the “no” votes, it was stated that “there was thought to be insufficient data to really be satisfied that indeed this medication is safe, and, in fact, the risks do outweigh the benefits, especially for the general population.”[4]

It is likely, if not certain, that the vote against safety would have been even greater had there been a presentation and discussion of the cardiovascular risks known at that time.

The current FDA position on the risks and heart attacks, as articulated in a January 31 statement is that: the agency “has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack, or death.”[5]

We have previously described this statement, despite accumulating evidence of cardiovascular risk, to be reckless. Now, this FDA recklessness in reinforced by the decision to approve Aveed, apparently related to the prescription drug user fee (PDUFA) decision deadline of February 28, a deadline we had urged you to cancel because of this accumulating evidence of cardiovascular risk.

In addition to urging you to reverse this unsafe and unreasonable decision, please provide, as quickly as possible, all FDA staff documents concerning the cardiovascular safety of testosterone products, including any documents discussing concerns about these risks in the context of the decision to approve Aveed.

Sincerely,

Sidney M. Wolfe MD
Founder, Senior Advisor
Health Research Group at Public Citizen
1600 20th St. NW
Washington, DC 20009
_______________________________
References

[1] http://online.wsj.com/article/PR-CO-20140306-906700.html

[2] http://www.citizen.org/documents/21841.pdf

[3] http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ReproductiveHealthDrugsAdvisoryCommittee/UCM358027.pdfPDF page 305

[4] Ibid, PDF page 316

[5] http://www.fda.gov/Drugs/DrugSafety/ucm383904.htm

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