8 Opinion S KIN & ALLERGY N EWS • March 2005

U NDER M Y S KIN Computer Correspondence h, Monday tagord. He’s just canceling an appoint- way to communicate. No phone tag, no More credit card come-ons. Look at Amorning. ment ... what’s this? This Dirk sure needs trying to find a good time to call in a dif- that, they’re coming in bunches, 5 in a row, Time to check an editor. What kind of message is, ferent time zone, no interruptions in the 10 in a row, 50, same message. More mort- e-mails from “stethoscope mercy brunhilde huzzah buf- middle of patients. I installed a spam fil- gages, 10, 20, 50, REFINANCE NOW, RE- far-flung pa- falo carson allure?” ter, but it worked so well that I couldn’t FINANCE NOW, REFINANCE NOW. ... tients. Miran- Now what? Look, I’m a physician, so even e-mail myself from home. How Buy a Rolex, buy a Seiko, buy Vicodin, buy BY ALAN ROCKOFF, M.D. da, a music don’t expect me to believe you can change would I know if a patient tried to reach me Cialis. The e-mails are like locusts, I can’t major at the size of anything with a cream. Besides, and got his or her message blocked? kill them fast enough. ... I don’t want any Michigan, will size doesn’t matter. It does? She would? I Now what? Great, first they enlarge of those drugs! Nobody by that name remind me about her . Mur- never thought about it. ... More drugs for you, then they shrink you back down. Al- missed an appointment! I’m not going to ray’s mellowing on Minocin in Morocco. sale. Judging by TV ads and cyberpromo- ice in Wonderland had nothing on these update personal information for a bank I Goodness, that inbox has certainly filled tions, half the world has fungal toenails guys. A revolutionary new diet pill that never heard of! I’m not shrinking or en- up over the weekend. What’s this? Mort- and the other half has erectile dysfunction. makes you lose up to 30 pounds in 30 days larging anything! How am I supposed to gage rates are that low? Wouldn’t you Another patient confirming an ap- or less, automatically while you sleep? respond to marion allegiant asphalt tally- know it—we just refinanced! pointment. ... Thelma Fontenot? A Rolex Body wrap at home to lose 6-20 inches in ho torture confrontation? I refuse to an- Look, I’ve been preapproved for credit. for $9.95? I wonder if it’s genuine. 1 hour! Put lindane under that overnight, swer Verzieren Sie die Uhr mit einer We have enough credit cards already, OK, knock it off—I got the mortgage and the scabies mites won’t even find you Gravur und sie warden! They’re coming thanks. stuff already. And phentermine, too. I’m in the morning. faster and faster. ... I can’t see the screen Hmm, I knew they’re importing med- just going to delete this stuff. Mortgage, Gustavo Fontenot? Must be Thelma’s ... everything’s going black. OK, that’s it, ications from Canada and Mexico, but delete. Credit cards, delete. Viagra, cousin from Caracas. ... What? “Sehr I’m bailing out, I’m deleting the whole what kind of quality controls do they have delete. Latin gibberish, delete. This is geehrte Damen und Herren, die Weih- Outlook. Mayday! Mayday! SOS! Abort! in Bulgaria? Let’s see, they’re running a fun! Levitra, Cialis, Vicodin, delete, nachtszeit naht und haben wir sicherlich Abort! Control! Select All! Alt! DELETE, special on phentermine. Looks like a good delete, delete. Ha! Hold on a second. ... noch einen guten Tipp!” Hey, Gustavo, I’ll DELETE, DELETE. ... price. I wonder what phentermine is. What I think one of those messages I just delet- give you a guten Tipp in your guten Darn—I think I deleted Murray. else do they have ... narcotics, anxiolytics ed was the one I was waiting for from Mi- Keester! A monkeypox on all the ... never mind. Why no topical ? randa in Michigan. Great, how am I go- Fontenots. ... DR. ROCKOFF practices dermatology in Finally, an e-mail from a patient! Don’t ing to find it in the 3,000 messages in the Another canceled appointment? Hey, Brookline, Mass. To respond to this column, recognize the name, though. I think I’d re- deleted folder? fool me once—Paris Hilton is not a real write Dr. Rockoff at our editorial offices or member someone named Dirk Cen- It’s too bad. E-mail could be such a nice name! Video? What video? e-mail him at [email protected].

G UEST E DITORIAL

5. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic For Topical Use Only pants on a child being treated in the diaper area, as these garments may constitute The Quandary That Is Called the FDA DESCRIPTION: Cloderm Cream 0.1% contains the medium potency topical occlusive dressings. , pivalate, in a specially formulated water-washable emollient Laboratory Tests: The following tests may be helpful in evaluating the HPA axis cream base consisting of purified water, white petrolatum, mineral oil, stearyl alcohol, suppression: polyoxyl 40 stearate, carbomer 934P, edetate disodium, sodium hydroxide, with methylparaben and propylparaben as preservatives. Urinary free test n the wake of the Vioxx scandal, the order to expedite drug approval and get Chemically, clocortolone pivalate is 9-chloro-6␣-fluoro-11␤ , 21-dihydroxy-16␣ ACTH stimulation test methylpregna-1, 4-diene-3, 20-dione 21-pivalate. Its structure is as follows: Food and Drug Administration has new drugs to market faster. The phar- Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long-term animal studies have I not been performed to evaluate the carcinogenic potential or the effect on fertility of topical . suddenly become the whipping boy of maceutical industry convinced Congress Studies to determine mutagenicity with and have revealed both the press and Congress, a combi- that unless the drug approval process negative results. Pregnancy Category C: Corticosteroids are generally teratogenic in laboratory animals nation that is certainly hard to beat. A was not accelerated, thousands of pa- when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory feeding frenzy has erupted, with charges tients would die. Examples of this threat animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the coming from inside and outside the have so far been illusory. Industry also potential risk to the fetus. Drugs of this class should not be used extensively on pregnant CLINICAL PHARMACOLOGY: patients, in large amounts, or for prolonged periods of time. agency. convinced Congress that it cost them too Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions. Nursing Mothers: It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. I, too, have been critical of the FDA at much to bring products to market, many The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Systemically administered corticosteroids are secreted into breast milk in quantities not Various laboratory methods, including vasoconstrictor assays, are used to compare and likely to have deleterious effect on the infant. Nevertheless, caution should be exercised times and have expressed concern about of which were “me too” drugs. As a re- predict potencies and/or clinical efficacies of the topical corticosteroids. There is some when topical corticosteroids are administered to a nursing woman. evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man. Pediatric Use: Pediatric patients may demonstrate greater susceptibility to topical some of its premature decisions and lack sult of these initiatives, the approval of corticosteroid-induced HPA axis suppression and Cushing’s syndrome than mature Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids is patients because of a larger skin surface area body weight ratio. of postapproval surveillance new molecular entities in- determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. of drugs. Nevertheless, let’s creased from 30 in 1991 to Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or Manifestations of adrenal suppression in children include linear growth retardation, other disease processes in the skin increase percutaneous absorption. Occlusive delayed weight gain, low plasma cortisol levels, and absence of response to ACTH place some of the blame 53 in 1996. Now Congress, dressings substantially increase the percutaneous absorption of topical corticosteroids. stimulation. Manifestations of intracranial hypertension include bulging fontanelles, Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant headaches, and bilateral papilledema. dermatoses. (See DOSAGE AND ADMINISTRATION). where it should be placed; in its infinite wisdom, Administration of topical corticosteroids to children should be limited to the least amount Once absorbed through the skin, topical corticosteroids are handled through compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may there is enough to go charges that the FDA has pharmacokinetic pathways similar to systemically administered interfere with the growth and development of children. corticosteroids.Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the ADVERSE REACTIONS: The following local adverse reactions are reported infrequently around. The FDA, created been too hasty and superfi- kidneys. Some of the topical corticosteroids and their metabolites are also excreted into with topical corticosteroids, but may occur more frequently with the use of occlusive the bile. dressings. These reactions are listed in an approximate decreasing order of occurrence: in 1906 as part of the Pure cial with its drug approval INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the Burning inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Itching Food and Drug Act, has process. Irritation CONTRAINDICATIONS: Topical corticosteroids are contraindicated in those patients with Dryness gone through a number of As medical therapy has a history of hypersensitivity to any of the components of the preparation. Folliculitis Hypertrichosis PRECAUTIONS Acneiform eruptions iterations in response to changed in the last half cen- General: Systemic absorption of topical corticosteroids has produced reversible Hypopigmentation hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s Perioral dermatitis changes in the industry it is tury, so too has the role of syndrome, hyperglycemia, and glucosuria in some patients. Allergic contact dermatitis Conditions which augment systemic absorption include the application of the more Maceration of the skin intended to control and in the FDA in evaluating potent steroids, use over large surface areas, prolonged use, and the addition of Secondary infection BY SIDNEY occlusive dressings. Skin atrophy the human beings it is ex- drugs’ efficacy and safety. Striae GOLDSTEIN, M.D. Therefore, patients receiving a large dose of a potent topical applied to a large Miliaria surface area or under an occlusive dressing should be evaluated periodically for evidence pected to protect. In its near- Mid-20th century medical of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If OVERDOSAGE: Topically applied corticosteroids can be absorbed in sufficient amounts HPA axis suppression is noted, an attempt should be made to withdraw the drug, to to produce systemic effects (see PRECAUTIONS). ly 100 years of life, drugs therapy was focused on the reduce the frequency of application, or to substitute a less potent steroid. DOSAGE AND ADMINISTRATION: Apply Cloderm (clocortolone pivalate) Cream 0.1% Recovery of HPA axis function is generally prompt and complete upon discontinuation of sparingly to the affected areas three times a day and rub in gently. have become more complex, and Ameri- treatment of episodic short-term diseases the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring Occlusive dressings may be used for the management of psoriasis or recalcitrant supplemental systemic corticosteroids. conditions. cans have grown older. The acceleration like pneumonia. Safety and efficacy could Children may absorb proportionally larger amounts of topical corticosteroids and thus be If an infection develops, the use of occlusive dressings should be discontinued and more susceptible to systemic toxicity. (See PRECAUTIONS - Pediatric Use). appropriate anti-microbial therapy instituted. of technology and pharmacology that be measured in days or weeks. If irritation develops, topical corticosteroids should be discontinued and appropriate HOW SUPPLIED: Cloderm (clocortolone pivalate) Cream 0.1% is supplied in 15 gram, 45 therapy instituted. has occurred in the last half century has Major changes occurred in the 1970s gram and 90 gram tubes. In the presence of dermatological infections, the use of an appropriate antifungal or Store Cloderm Cream between 15° and 30° C (59° and 86° F). Avoid freezing antibacterial agent should be instituted. If a favorable response does not occur promptly, provided physicians and patients a breath- and 1980s that led to the consideration of the corticosteroid should be discontinued until the infection has been adequately Distributed by: controlled. taking array of medical options to pro- drugs for the long-term prevention and Information for the Patient: Patients using topical corticosteroids should receive the following information and instructions: long and improve the quality of life. At the treatment of chronic diseases that affect Healthpoint, Ltd. 1. This medication is to be used as directed by the physician. It is for external use only. San Antonio, Texas 78215 same time, many of these products have an increasingly aging population. Drugs Avoid contact with the eyes. 1-800-441-8227 2. Patients should be advised not to use this medication for any disorder other than Reorder No.0064-3100-15 (15g) the potential to adversely affect the safe- and devices to treat atherosclerotic car- for which it was prescribed. Reorder No.0064-3100-45 (45g) 3. The treated skin area should not be bandaged or otherwise covered or wrapped as Reorder No. 0064-3100-90 (90g) ty of those individuals who are the treat- diovascular disease, hypertension, and di- to be occlusive unless directed by the physician. 4. Patients should report any signs of local adverse reactions especially under occlusive ment targets. abetes mellitus were developed. Clinical 127825-0303 dressing. It was but a short 12 years ago that trials suggested that drugs should be tak- Congress pressured the FDA to get into en for a lifetime, and that could be a very bed with the pharmaceutical industry in Continued on following page