Market Watch

New Warnings

• Topical testosterone products (e.g., Androgel and Testim) have received a boxed warning.14 This warning is due to multiple reports of adverse effects in children exposed to the drug via contact with a topical testosterone-treated person. There are current product label precautions; however, the FDA has received reports of secondary exposure to testosterone in children 5 years old or younger. Adverse events included inappropriate genitalia enlargement, premature pubic hair development, bone age advancement, increased libido, and aggressive behavior. The FDA has provided recommendations to minimize secondary exposure. TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City.

References

1. FDA statement on the voluntary withdrawal of Raptiva from the U.S. market. Food and Drug Administration Web site. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149561.htm Accessed July 2, 2009.
2. Withdrawal of Raptiva from U.S. market. The Medical News Web site. Available at: www.news-medical.net/news/48133.aspx. Accessed May 12, 2009.
3. Taro receives final FDA approval for carbamazepine extended-release tablets. Medicine News Today Web site. Available at: www.medicalnewstoday.com/articles/145217.php. Accessed May 12, 2009.
4. FDA OKs Mylan generic version of transplant drug. Forbes Web site. Available at: www.forbes.com/feeds/ap/2009/05/07/ap6392275.html. Accessed May 8, 2009.
5. Exocrine Pancreatic Insufficiency Drug Products. Federal Register Web site. Available at: www.fda.gov/ohrms/dockets/98fr/04-9652.htm. Accessed May 7, 2009.
6. Guidance for industry exocrine pancreatic insufficiency drug products—submitting NDAs. FDA Web site. Available at: www.fda.gov/ohrms/dockets/98fr/2003d-0206-gdl0001.pdf. Accessed May 7, 2009.
7. Phend C. FDA formally approves Creon pancrelipase. Medpage Today Web site. Available at: www.medpagetoday.com/ProductAlert/Prescriptions/14021. Accessed May 7, 2009.
8. FDA approves Exforge HCT—the only high blood pressure treatment to combine three medications in a single pill. Novartis Web site. Available at: www.novartis.com/newsroom/media-releases/en/2009/1310474.shtml. Accessed May 7, 2009.
9. Phend C. FDA approves triple-drug antihypertensive polypill. Medpage Today Web site. Available at: www.medpagetoday.com/ProductAlert/Prescriptions/14032. Accessed May 7, 2009.
10. Neergaard L. FDA backs drug that treats diabetes via the brain. Physorg.com Web site. Available at: www.physorg.com/news160843146.html. Last Accessed May 8, 2009.
11. FDA approves Cycloset. Drugs.com Web site. Available at: www.drugs.com/newdrugs/veroscience-announces-fda-approval-cycloset-type-2-diabetes-1344.html. Accessed May 8, 2009.
12. FDA approves monthly injectable drug for treating three types of immune-related arthritis. FDA Web site. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149569.htm. Accessed April 24, 2009.
13. FDA approves Fanapt to treat schizophrenia. FDA Web site. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149578.htm. Accessed May 7, 2009.
14. Testosterone gel safety concerns prompt FDA to require label changes, medication guide. FDA Web site. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149580.htm. Accessed May 12, 2009.