March 2006
New warnings, risks, or restrictions for three skin drugs
It's enough to make your skin crawl: The Food and Drug Administration has slapped two drugs with black-box warnings; research suggests that antibiotics for acne may increase the risk of upper-respiratory tract infections; and the FDA is trying to prevent birth defects through a stringent program restricting the use of the powerful acne drug isotretinoin (Accutane).
It's enough to make your skin crawl: The Food and Drug Administration has slapped two drugs with black-box warnings; research suggests that antibiotics for acne may increase the risk of upper-respiratory tract infections; and the FDA is trying to prevent birth defects through a stringent program restricting the use of the powerful acne drug isotretinoin (Accutane).
- Eczema drugs. The FDA has announced that the topical eczema drugs pimecrolimus (Elidel) and tacrolimus (Protopic) may increase the risk
of skin cancer and lymphoma, and must now carry a "black-box" warning, the most serious label alert. The new labeling also
cautions that the drugs should be used only if eczema has not responded to topical corticosteroids, the first-line treatment.
Pimecrolimus and tacrolimus suppress the immune system, so they should not be taken by people with weakened immunity or by pregnant or lactating women or children under age 2. People with Netherton's syndrome, a rare inherited skin disorder, should avoid the drugs, too. Other people should ask their doctor whether the risks outweigh the benefits for them. If you're about to take either drug, ask for the lowest effective dose, take it for a limited time only, and call your doctor if your symptoms worsen or persist or you experience side effects, such as infection or skin irritation. If you're already on one of those drugs, don't stop without first consulting your doctor. - Antibiotics for acne. People who use antibiotics for that purpose have a doubled risk of colds and other upper-respiratory-tract infections, a
study in the September 2005 Archives of Dermatology has found.
Researchers at the University of Pennsylvania retrospectively analyzed data on some 85,000 people who took antibiotics for acne and another 34,000 acne patients who didn't take those drugs. Regardless of whether the acne patients used oral or topical antibiotics, they developed roughly twice as many upper-respiratory infections as the other group did in one year. One possible explanation for the apparently increased risk: Antibiotics--even topical ones for some reason--may increase the infection-causing capacity of certain bacteria and viruses in the nose and mouth.
Other 2005 studies suggest that overuse of certain antibiotics can increase the chance of infection with a virulent, drug-resistant strain of Clostridium difficile bacteria, apparently because the drugs knock out protective intestinal bacteria.
Overuse of antibiotics can create drug-resistant bacteria. The infection studies add another possible reason to use these drugs only when necessary. For acne patients, that generally means when other topical treatments--such as salicylic acid (in Clearasil Clearstick, Oxy Night Watch, Stri-Dex), benzoyl peroxide (Brevoxyl, Desquam-X), sulfur-containing drugs (Klaron, Novacet, Sulfacet-R), or retinoin (Retin-A)--have failed. - Potent acne drug. People using isotretinoin (Accutane, Amnesteem, Claravis, Sotret) to treat acne or other skin disorders literally need to
get with the program--the iPLEDGE program.
Isotretinoin poses an extremely high risk of severe birth defects. The iPLEDGE program, which was implemented March 1, 2006, is the FDA's latest and most aggressive effort to help ensure that women won't get pregnant while taking the drug. The program involves a stringent set of requirements restricting the drug's use to authorized, registered patients, doctors, pharmacists, and drug wholesalers. Male users must register, too, because isotretinoin can have psychiatric side effects such as depression and suicidal thoughts.
Under iPLEDGE, all patients will receive no more than a one-month supply of isotretinoin and must visit their doctor monthly for a new prescription. Women with childbearing potential must first submit two negative, professional pregnancy tests, the second by a regulated laboratory. Every month during treatment they must take another laboratory pregnancy test and submit certain information to iPLEDGE by phone or Internet. In addition, they must use two types of effective birth control during treatment, as well as one month before and after, and they must not be breast-feeding. All iPLEDGE participants--including physicians, pharmacies, and drug wholesalers--agree to immediately report any isotretinoin use during pregnancy to both the FDA and the iPLEDGE registry.
To register with iPLEDGE, go to www.ipledgeprogram.com.
For more information, see our free report on the hidden dangers of common drugs. Also see our reports on how to get the best drugs for less and allergy drugs, available to subscribers.
