FDA PRESS RELEASE

On this page:

• Signs to Watch For
• FDA Actions
• Advice for Consumers

The Food and Drug Administration (FDA) announced on May 7, 2009, that it is requiring manufacturers of two prescription topical testosterone gel products, AndroGel 1% and Testim 1%, to include a boxed warning on the products’ labels.

The agency is requiring this action after receiving reports of bad side effects in children who were exposed to testosterone by accident through contact with another person being treated with these products (secondary exposure).

FDA approved the gels for use in men who either no longer produce the male sex hormone testosterone or produce it in very low amounts. Both products are applied once daily, to the shoulders or upper arms. Only AndroGel 1% is approved to apply to the abdomen.

Precautions in the current labels instruct users to wash their hands after using the product and to cover the treated skin with clothing. Despite these labeled precautions, as of Dec. 1, 2008, FDA has received reports of eight cases of secondary exposure to testosterone in children ranging in age from 9 months to 5 years. FDA continues to receive and review additional reports of secondary exposure.

In most of the cases, users of these products failed to follow the instructions for appropriate use, resulting in direct contact between the treated skin and the child.

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Signs to Watch For

Side effects reported in children include

• inappropriate enlargement of the external sexual organs (penis or clitoris)
• premature development of pubic hair
• advanced bone age
• increased self-stimulation
• aggressive behavior

In most cases, the signs and symptoms lessened when the child was no longer exposed to the product. However, in a few cases, enlarged sexual organs did not fully return to the child’s age-appropriate size and bone age remained greater than the child’s chronological age.

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FDA Actions

FDA is requiring the manufacturers of these products to

• make product label changes that will provide additional information about the risk of secondary exposure and the steps that should be taken to reduce this risk
• develop a Medication Guide to be given to people each time they receive these products from a pharmacy
• carry out a plan to ensure that the benefits of these products continue to outweigh their potential risks

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Advice for Consumers

• Adults who use testosterone gels should wash their hands with soap and warm water each time they apply the gel.
• Adults should cover the area where they have applied the gel with clothing once the gel has dried.
• Adults should wash the area where they apply the gel thoroughly with soap and warm water prior to any situation where skin-to-skin contact with another person may occur.
• Children and women should avoid contact with areas of skin where men have applied the gel.
• Adults should note that using any similar, but unapproved, products from the marketplace—including the Internet—can result in the same serious side effects and should be avoided.
• Adults should contact their child’s health care professional if they see any signs of the child’s exposure to testosterone gels.
• Health care professionals and consumers may report serious side effects or product quality problems with the use of these gels to FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.
• Online: www.fda.gov/MedWatch/report.htm
• Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
• Fax: (800) FDA-0178
• Phone: (800) FDA-1088

AndroGel 1% is manufactured by Solvay Pharmaceuticals in Marietta, Ga. Testim 1% is made by Auxilium Pharmaceuticals in Malvern, Pa.

This article appears on FDA’s Consumer Health Information Web page (www.fda.gov/consumer), which features the latest updates on FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.

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For More Information

FDA Press Release
www.fda.gov/bbs/topics/NEWS/2009/NEW02011.html

FDA Drug Safety Initiative Fact Sheet
www.fda.gov/oc/factsheets/initiative.html

Drugs@FDA: Information on FDA-Approved Drugs
www.accessdata.fda.gov/scripts/cder/drugsatfda/

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Date Posted: May 8, 2009

©2012 An Inconvenient Woman. All Rights Reserved.

Suicide rates for preteens and teenagers increased sharply when the Food and Drug Administration slapped a “black box” warning on anti-depressants and doctors started writing fewer prescriptions for young people, according to federal data released Thursday.

The FDA’s warning, publicly debated in 2003 and enacted in 2004, highlighted a link between anti-depressant use by young people and suicidal thoughts and behavior. But now some experts are asking whether the message backfired.

In 2004, the number of 10- to 24-year-olds taking their own lives rose by 8 percent, the Centers for Disease Control and Prevention reported. Over the previous 14 years, suicide rates had fallen 28.5 percent in that age group.

Although the numbers do not prove a connection between suicide and the drop in anti-depressant use, several experts suggested Thursday that the FDA re-evaluate its warnings on the medications in light of the new CDC report.

“It’s time for the agency’s warnings to be modified,” said Dr. David Schaffer, a leading expert on teen suicide and chief of child and adolescent psychiatry at Columbia University Medical Center in New York City.

Thomas Laughren, director of the FDA’s division of psychiatry products, acknowledged the suicide numbers are “clearly a dilemma for us” and “not what you would want to see,” but cautioned that firm conclusions should not be drawn from a one-year increase.

Girls show sharpest increase

The new numbers documented a particularly startling rise in the rate for girls, with suicides rising 41 percent among 10- to 19-year-olds. Suicides for boys in the age group climbed 8.5 percent.

Ileana Arias, director of the CDC’s Center for Injury Prevention and Control, called the report’s findings “sobering” and said she was troubled that the increase was concentrated almost entirely in preteens and teenagers. Rates were relatively flat for adults 20 to 24 years old.

In all, the agency’s numbers show that 4,599 people ages 10 to 24 committed suicide in 2004, 367 more deaths than the previous year.

The FDA was prompted to issue warnings about anti-depressants by two dozen studies showing that young people were twice as likely to consider killing themselves or start taking steps to do so after taking the drugs. None of the subjects in the studies committed suicide, and the risks were relatively small (4 percent versus 2 percent), but the agency decided it had to act.

In 2003 and 2004, the FDA issued public health advisories warning that anti-depressants appeared to increase suicidal thoughts and behavior among teens. Late in 2004, it ordered drugmakers to place a black box warning — the agency’s strongest signal of serious risk — on the medications’ labels.

The move contributed to a steep decline in anti-depressant prescriptions for teens, as pediatricians and family doctors re-evaluated their risks and benefits. Firms tracking drug use report declines of 25 percent or more since 2003.

On Wednesday, University of Illinois at Chicago psychiatry professor Robert Gibbons published a paper in the American Journal of Psychiatry that documented a close correlation between declining use of the anti-depressants known as SSRIs and rising suicide rates among young people up to age 19.

It concludes that if the FDA’s warnings had been correct, “we would have expected to see decreases in the suicide rate during the period of declining SSRI prescription rates.” Instead, “we saw an increase.”

The FDA’s black box warning has had a “horrible and unintended effect” and should be withdrawn, Gibbons said Thursday. The benefits of anti-depressants far exceed the risks, he said.

Hard questions raised

Many of the suicide numbers issued Thursday raised more questions than could be readily answered.

The CDC data show that 453 girls ages 10 to 19 killed themselves in 2004, up from 321 deaths the year before. The numbers for boys committing suicide were much larger, but the percentage increase was smaller: 1,530 suicides in 2004, compared with 1,410 with 2003.

Why did suicide rates rise so steeply among young girls? “Unfortunately, we don’t know that,” said Arias of the CDC. It could be a statistical fluke, because the actual numbers are relatively small. Or it could be that there are troubling changes in girls’ stress levels or ability to cope, she said.

The numbers also show that more young people are ending their lives by hanging or suffocating themselves, especially girls. CDC officials noted that the means to commit suicide this way tend to be readily available and that more adolescents are playing a dangerous “choking game,” a way of getting high by temporarily restricting oxygen flow.

But the game is more common among boys, making the significant rise in hangings and suffocations among girls harder to explain, officials suggested.

It’s also unclear whether the increase in teen suicides truly represents an emerging trend. “Until the CDC publishes data for 2005 we won’t really know,” Schaffer said.

He suggested more research is needed to understand the connection between teens’ growing misuse of prescription drugs and suicide. Changing patterns of alcohol use by teens also are important, insofar as two-thirds of suicides by older teens are linked to alcohol abuse.

Dr. Louis Kraus, chief of child and adolescent psychiatry at Rush University Medical Center, said the key point for anxious parents is this: “If your kid is troubled, get him to a child mental-health expert to be assessed, and make sure there’s good follow-up” if medication is prescribed.

Source: Chicago Tribune, Tribune staff reporter, Judith Graham

©2012 An Inconvenient Woman. All Rights Reserved.