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In April 2007, FDA approved a new topical treatment for impetigo, a skin infection caused by bacteria. Altabax (retapamulin ointment) is for use by adults and children at least 9 months old and is available by prescription only. Retapamulin is a new molecular entity, which is an active substance that has never before been approved for marketing in any form in the United States.
Altabax was shown to be safe in 5 studies of approximately 2,000 adults and children over 9 months old. The most common side effect related to Altabax was irritation of the skin where the ointment was applied, which occurred in less than 2 percent of the people in the study. Altabax is meant for use twice daily for a 5-day period.
Impetigo is an infection of the skin's surface, usually caused by one of two bacteria: group A streptococcus or staphylococcus aureus. The bacteria enter breaks in the skin, such as scratches, that often go unnoticed.
The infection causes red bumps to form, usually on the face (particularly around the nose and mouth) and the legs, although these bumps may appear on other parts of the body. The red bumps fill with pus, then break open and form a honey-colored crust. Impetigo lesions are usually itchy, though not painful, and people who have impetigo do not have a fever or appear sick.
Anyone can get the infection, but it is most common in children between 2 and 6 years old, and tends to occur during the warmer months.
Impetigo is highly contagious. You should not scratch the infected skin areas. Scratching or touching the infected skin and then touching another part of the body can spread the infection to that area. Impetigo can also spread from one person to another. The hands are the most common source for the spread of impetigo.
Overuse of antibacterial drugs can cause drug-resistant bacteria to develop, and then the drugs aren't as effective. To keep Altabax, manufactured by GlaxoSmithKline, Research Triangle Park, N.C., and other antibacterial drugs effective, use the ointment only to treat or prevent infections that are known or strongly suspected to be caused by bacteria.
Date Posted: May 21, 2007
