Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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FDA Advisory Panel Urges Restrictions on Testosterone Use

FDA Advisory Panel Urges Restrictions on Testosterone Use | Pharmaguy's Insights Into Drug Industry News |

A combined US Food and Drug Administration (FDA) advisory panel has voted nearly unanimously to change the labeling for testosterone-replacement products, with the aim of tamping down on their current widespread use for "age-related"hypogonadism. The panel also indicated that large studies are needed to demonstrate both clinical benefit and safety of the products.

The votes of the joint Bone, Reproductive, and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee were 20 to 1 in favor of label changes.

The panel primarily addressed the second indication, currently worded as "Hypogonadotropic hypogonadism (congenital or acquired): Idiopathic gonadotropin or luteinizing-hormone–releasing (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation."

The "idiopathic" wording has led to the widespread use of testosterone products for men with relatively low testosterone levels related to aging as well as for men with signs and symptoms of "low T" but who in reality have either normal testosterone levels or, in many cases, do not even have testosterone levels tested.

"Benefit is unclear in men diagnosed with hypogonadism due to no apparent cause other than older age. Yet testosterone is being predominantly prescribed to men 40 to 64 years of age. This has prompted the FDA to question whether labeling accurately reflects the appropriate indicated population," Hylton V. Joffe, MD, director of the Division of Bone, Reproductive, and Urologic Products at the FDA, told the panel in his introductory remarks.

Pharma Guy's insight:

As I reported back in February this year, Public Citizen urged the FDA to immediately add a black box warning about the increased risks of heart attacks and other cardiovascular dangers to the product labels of all testosterone-containing drugs available in the U.S. (see "Public Citizen Petitions FDA to Add a Black Box Warning to Low-T Drug Labeling").

From FierceBiotech (18 Sep 2014):

An expert panel assembled by the FDA has taken a big step toward blunting the fast-growing market for low-testosterone drugs, raising a thorny issue not just for the companies that sell such remedies, but also for two biotechs trying to gain approvals for new ones.

In a case of extraordinarily bad timing, Clarus Therapeutics is being cast as the first test subject to face these heightened safety fears and suggested testing requirements. Later today the FDA's experts will consider the biotech's case for Rextoro, which is angling to become the first oral drug to hit the market and compete against a slate of gels that currently command a multibillion-dollar market. And while Clarus maintains that it has the data to back up its application, it will be forced to respond to an internal review that questioned missing data, raising the chances that the therapy was not as effective as billed.

"Only 31% and 14% of men continued taking T-gels six and twelve months, respectively, after commencing therapy, according to a peer-reviewed study of more than 15,000 men with T deficiency," stated the new Clarus IPO. "We believe these low adherence rates result from inconvenient application and safety concerns about T-gels. In addition, T-gels carry a "black box warning" because of their risk of unsafe transference of T to children."

But if the FDA experts get their way, the label placed on approved testosterone treatments will include some severe restrictions.

Even if the FDA adds new CV study requirements and tries to restrict the market for these drugs, though, there are plenty of marketing experts who believe that off-label use would continue to drive sales. Still, payers would be unlikely to cover any use that wasn't specifically included in the label. And a shrinking market would have a chilling effect on any other biotechs thinking of braving more vigilant regulators and payers. -- John Carroll

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Health Canada Issues Warning About Possible Cardiovascular Problems Associated with Testosterone Products - FDA Sits Idly By

Health Canada Issues Warning About Possible Cardiovascular Problems Associated with Testosterone Products - FDA Sits Idly By | Pharmaguy's Insights Into Drug Industry News |

Health Canada is advising patients and healthcare professionals of new safety information regarding testosterone hormone replacement products and a risk of serious and possibly life-threatening cardiovascular (heart and blood vessel) problems.

Testosterone hormone replacement products are used in men who are experiencing medical conditions because their body cannot make enough testosterone. In Canada, there are 12 testosterone replacement products, including brand-name products: Androderm, Andriol, Delatestryl, Androgel, Axiron, Depo-Testosterone, Testim, and their equivalent generics.

Health Canada has recently completed a safety review on testosterone replacement products. This review found a growing body of evidence (from published scientific literature and case reports received by Health Canada and foreign regulators) for serious and possible life-threatening heart and blood vessel problems such as heart attack, stroke, blood clot in the lungs or legs; and increased or irregular heart rate with the use of testosterone replacement products. 

Health Canada is working with manufacturers to update the Canadian product labels regarding this risk. The Department continues to collaborate with foreign regulators including the United States Food and Drug Administration and the European Medicines Agency regarding this safety concern. Health Canada will keep Canadians informed and take action, as appropriate, if any new safety information is identified.

Pharma Guy's insight:

At the exact same time that Health Canada issued its warning, FDA denied a petition by Public Citizen’s Health Research Group calling for a black-box warning about these same risks. FDA said it needs “further exploration of a possible safety signal” before issuing any warning about the risks of heart attacks and strokes. 


Sidney M Wolfe, MD, Founder and Senior Advisor, Public Citizen’s Health Research Group, issued a statement claiming that FDA's inaction vs. Canada Health's action on this health risk is an indication that the agency needs "new, more public health-oriented leadership" (read the statement here).

BTW, Public Citizen has a pretty good track record of identifying drug risks years in advance of those drugs being withdrawn for the market due to the risks it identified. Read more about that & listen to Wolfe's comments in this post:

Sydney Wolfe's 7-Year Drug Rule/Itch

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