DRUG NEWS

SEVERE FOOD ALLERGIES Parents fear using ACCUTANE AND BIRTH DEFECTS EpiPen on their kids More restrictions announced for drug Many parents of children with se- Under a new FDA program, everyone prescribing, taking, selling, or dispensing the vere food allergies are reluctant to acne drug (Accutane) will be required to enroll in a national registry by use the EpiPen autoinjector to ad- the end of the year. The iPLEDGE program is intended to ensure that health care pro- fessionals and patients understand the drug’s serious risks—, severe minister epinephrine to their child. birth defects, depression, and suicidal thoughts—and take appropriate precautions, Of 165 parents responding to a writ- including avoiding . Notorious for causing birth defects, isotretinoin has ten survey, 45% said they’d feel un- long been under fire by the March of Dimes and other advocacy groups who want comfortable using the EpiPen in an it tightly controlled or taken off the market altogether. emergency. They cited three reasons: Beginning on December 31, all patients, prescribers, pharmacies, and whole- • lack of confidence in their ability salers involved in use, sale, or distribution of isotretinoin must join the registry, to recognize signs and symptoms of which requires that linked to isotretinoin be reported. The registry anaphylaxis opened in August to allow patients and health care professionals to become famil- • fear of hurting the child iar with its provisions before year’s end. For more information, go to http://www. • fear that they’d forget how to use ipledgeprogram.com or call 1-866-495-0654. the EpiPen correctly under pressure. Researchers say that parents’ feel- ings of competence and empower- 12 hours. The most common adverse safety may be enhanced by increas- ment were more closely associated reactions are nausea and vomiting. ing the use of beta-blockers in high- with confidence using the EpiPen Pregnant women shouldn’t take it, risk patients.” than knowledge of anaphylaxis and it may discolor teeth in young Two randomized studies are under symptoms or prior EpiPen use. They children. Dosage adjustments aren’t way to help determine whether beta- urge health care providers to educate required for patients with impaired blockers pose a risk to low-risk car- parents about the risk of anaphylaxis, renal function. diac patients. Until more evidence is train them to use the device, and in, changing treatment protocols for encourage them to “take ownership” PERIOPERATIVE CARE these patients isn’t recommended. of learning how to administer the Source: Perioperative beta-blocker therapy and mortality Hold the beta-blockers? after major noncardiac surgery, The New England Journal of medication in a life-threatening Medicine, PK Lindenauer, et al., July 28, 2005. emergency. New research questions the common Source: Parental use of EpiPen for children with food aller- practice of giving beta-blockers to pa- LOCAL ANALGESIA gies, The Journal of Allergy and Clinical Immunology, JS Kim, et al., July 2005. tients with cardiac conditions before Warming up and after surgery to prevent compli- BROAD-SPECTRUM ANTIBIOTIC cations. Although the drugs were to a heated patch No mercy for MRSA beneficial for cardiac patients with a Recently approved by the FDA, a high risk of complications, they may lidocaine-tetracaine patch (Synera) The FDA has approved tigecycline increase the risk of death for those has a built-in heating component (Tygacil), the first in a new class of with a low risk of complications. that enhances the medication’s anal- drugs called glycylcyclines. This Researchers analyzed the records gesic effect. The patch consists of a broad-spectrum antibiotic treats of 664,000 patients with cardiac- thin, uniform layer of emulsified complicated intra-abdominal infec- related problems who had major medication integrated with an tions and skin and skin structure noncardiac surgery in 2000 and oxygen-activated heating compo- infections in adults. It’s also effec- 2001. They used the Revised Cardiac nent. Applied to intact skin, the tive against methicillin-resistant Risk Index to determine the level of patch provides analgesia during Staphylococcus aureus (MRSA). risk for perioperative complications. venipuncture and superficial derma- Derived from the tetracycline fami- The researchers found that beta- tologic procedures such as shave ly, tigecycline can be used as mono- blockers were associated with a biopsies of skin lesions. Local skin therapy at the onset of treatment reduced risk of in-hospital death reactions, including erythema, before the causative pathogen has among high-risk, but not low-risk, blanching, and edema, are the most been identified. It’s given I.V. every patients, and concluded that “patient common adverse reactions.‹›

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