Navigation Links
FDA Orders Label Warning for Testosterone Gels
Date:5/7/2009

Men who use the medications must be sure none rubs off on children, agency says

THURSDAY, May 7 (HealthDay News) -- Children can experience troubling health effects if they come into contact with topical testosterone gels used by some American men, and the U.S. Food and Drug Administration on Thursday announced that two of these preparations would now carry boxed warnings to highlight the risk.

Accidental pediatric exposures to the gels can occur when the "consumer forgets to wash their hands or forgets to cover a treated area, and then has close contact with the child, or may have not waited for their skin to dry and then picks up a child," Dr. Dianne Murphy, the FDA's director of the Office of Pediatric Therapeutics within the Office of the Commissioner, said during a Thursday afternoon press conference.

Over time, these exposures can lead to premature and/or abnormal development of male characteristics in both boys and girls, the FDA said.

The two affected prescription medications are AndroGel 1%, made by Solvay Pharmaceuticals, and Testim 1%, made by Auxilium Pharmaceuticals. These are currently the only topical gel drugs approved by the FDA to address an insufficient or total lack of testosterone production among men.

Men typically rub the gels onto their upper arms or shoulders, according to the FDA.

According to the FDA, in 2007, pharmacies dispensed about 1.4 million prescriptions for the most popular medication, AndroGel, and about 370,000 prescriptions for Testim.

In addition to the new warning box, manufacturers will also have to develop a medication guide "to ensure that consumers who use these products are aware about the risk to children of secondary exposure," Murphy said.

The new requirements arose after a thorough review of eight cases, reported since December 2008, in which children -- ranging from as young as nine months to as old as five years -- experienced a range of adverse side effects as a result of coming into direct and repeated contact with the treated skin of an adult user of either gel.

This type of exposure triggered "inappropriate virilization" among the young patients, Murphy said, including the onset of premature male characteristics in boys and inappropriate male characteristics among girls. The effects included "inappropriate enlargement of the penis or clitoris, premature development of pubic hair, advanced bone age, increased libido, and aggressive behavior" among the eight cases analyzed, Murphy said.

In most cases, these side effects subsided after exposure ceased, the FDA said, but in certain instances, genitalia enlargement and bone age did not revert to normal. As well, some children had to undergo invasive diagnostic procedures, while in one of the eight cases, hospitalization and surgical intervention was required.

"In the cases we reviewed, the average duration of exposure was around six months to a year" before the children received medical attention, noted Dr. Mary Roberts, a medical officer in the division of metabolism and endocrinology within the FDA's Office of New Drugs, Center for Drug Evaluation and Research (CDER). "We can't tell you if it lasted for five minutes or five hours, but we do know the exposure did occur over a period of time."

Murphy and her colleagues hope the new labeling requirement will encourage consumers to more closely follow the approved protocol for the use of such gels. These include avoiding application of the drugs to parts of the body not indicated as appropriate; washing hands with soap and water after every application; and covering the application site with clothing once dry.

And they added that women should not use either gel, despite the fact the agency found that about 25,000 of the AndroGel prescriptions in 2007 were, in fact, dispensed to women.

More information

There's more on testosterone replacement therapy at the U.S. Food and Drug Administration.



SOURCES: May 7, 2009, press teleconference with: Dianne Murphy, director, Office of Pediatric Therapeutics, Office of the Commissioner, U.S. Food and Drug Administration; and Mary Roberts, M.D., medical officer, division of metabolism and endocrinology, Office of New Drugs, Center for Drug Evaluation and Research (CDER), FDA


'/>"/>
Copyright©2009 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. School-based overweight prevention program may cut risk of eating disorders among girls
2. Author Kris Carr to Sign Crazy Sexy Cancer Tips at Two Borders(R) Stores in California
3. UCLA receives $22.5 million to explore the fundamental biology of mental disorders
4. Oncologists are critical in managing psychiatric disorders in patients with advanced cancer
5. National Movement Disorders Interactive Experience Center Comes to Tampa Bay for First Time
6. Spectrum of Eating Disorders - from Anorexia to Obesity - are Cause for Rising Concern among K-12 Students and Educators
7. Black gay men, lesbians, have fewer mental disorders than whites, says Mailman School of PH study
8. Sleep Disorders: Waking Up to Reality
9. St. Davids Medical Center Implements New Robotic Technology to Treat Common Heart Rhythm Disorders
10. Antibody leads to repair of myelin sheath in lab study of multiple sclerosis and related disorders
11. National Energy Services Receives Repeat Orders From Golden Living and Cathedral Rock Skilled Nursing Facilities
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Orders Label Warning for Testosterone Gels
(Date:6/25/2016)... ... June 25, 2016 , ... ... issues and applications at AcademyHealth’s Annual Research Meeting June 26-28, 2016, at the ... several important health care topics including advance care planning, healthcare costs and patient ...
(Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand gesture ... said Christina Austin - CEO of Pixel Film Studios. , ProHand Cartoon’s package ... Final Cut Pro X . Simply select a ProHand generator and drag it ...
(Date:6/25/2016)... , ... June 25, 2016 , ... ... and non-athletes recover from injury. Recently, he has implemented orthobiologic procedures as a ... area —Johnson is one of the first doctors to perform the treatment. Orthobiologics ...
(Date:6/24/2016)... Angeles, CA (PRWEB) , ... June 24, 2016 , ... ... surgery procedures that most people are unfamiliar with. The article goes on to state ... procedures, but also many of these less common operations such as calf and cheek ...
(Date:6/24/2016)... ... ... was in a crisis. Her son James, eight, was out of control. Prone to extreme ... “When something upset him, he couldn’t control his emotions,” remembers Marcy. “If there was ... other children and say he was going to kill them. If we were driving ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... a startling report released today, National Safety Council research ... proven plan to eliminate prescription opioid overdoses. Prescription Nation ... tackling the worst drug crisis in recorded U.S. history, assigned a ... , New Mexico , Tennessee ... failing states, three – Michigan , ...
(Date:6/23/2016)... 23, 2016 Bracket , a leading clinical ... generation clinical outcomes platform, Bracket eCOA (SM) 6.0, at ... 26 – 30, 2016 in Philadelphia , ... Outcome Assessment product of its kind to fully integrate with ... Bracket eCOA 6.0 is a flexible platform for electronic clinical ...
(Date:6/23/2016)...  Guerbet announced today that it has been named ... . One of 12 suppliers to receive ... support of Premier members through exceptional local customer service ... to lower costs. ... outstanding customer service from Premier," says Massimo Carrara ...
Breaking Medicine Technology: