Gardasil approved for preventing genital warts in males

Oct 20, 2009 11:10 AM

The Food and Drug Administration has approved the Gardasil vaccine for preventing genital warts in boys and men, from ages 9 through 26. Gardasil was previously approved for the prevention of cervical cancer and genital warts in girls and women ages 9 through 26. Both cervical cancer and genital warts are caused by strains of human papillomavirus, the most common sexually transmitted infection in the U.S. About 2 out of every 1,000 American men develop genital warts each year.

The FDA said the new approval was based on a trial involving more than 4,000 boys and men, ages 16 to 26, that found Gardasil was nearly 90 percent effective in preventing genital warts caused by two types of HPV. Other studies that looked at the immune response in boys ages 9 through 15 indicated the vaccine would be just as effective in this younger age group.

The most common side effects of Gardasil include headache, fever, and reactions at the injection site, including pain, swelling and redness. The FDA said Merck, which manufactures Gardasil, is conducting additional studies to gather further information about the safety and effectiveness in boys and men.

—Steve Mitchell, associate editor, Consumer Reports Best Buy Drugs

For more about Gardasil, you can read our previous coverage, "HPV vaccine: Beyond the hype," and "Gardasil vaccine: Don’t let the headlines fool you."

Photo courtesy of the Centers for Disease Control and Prevention