A NEW ORAL CONTRACEPTIVE ELIMINATES MENSTRUAL PERIODS
* Lybrel has been approved as the first contraceptive for continuous use.
* Lybrel does not stimulate scheduled menstrual periods.
* Breakthrough bleeding and spotting are common upon initial use.
Lybrel (a combination of levonorgestrel and ethinyl estradiol) is a unique oral contraceptive in that it is designed for continuous use, without the interruptions in therapy for scheduled menstrual periods that other oral contraceptive regimens have. The product prevents pregnancy in the same way that standard oral contraceptives do, but each pack of Lybrel contains 28 active pills. Although women taking Lybrel do not have regular menstrual periods, "unscheduled" bleeding or spotting is common for up to one year after initiating therapy.
In the yearlong clinical trials, 67% of subjects had breakthrough bleeding or spotting for four or more days during use of the second pill pack. Thirty-one percent had bleeding or spotting for four or more days during use of the 13th pill pack. The frequency of the unscheduled bleeding or spotting that can occur with Lybrel appears to decrease with continued use for a full year, but it caused some patients to discontinue treatment; in one clinical trial 18% stopped treatment partly for that reason. The adverse effects of Lybrel are comparable to those of other oral contraceptives, as are the contraindications, warnings, and precautions that apply to its use.
Lybrel was tested on 2,400 women who took the drug for one year during clinical trials. There are no long-term data on the effects of not having a menstrual period for longer than a year. This includes effects on fertility and risk of thromboembolism.
Although pregnancy is unlikely when Lybrel is taken as directed, the absence of menstrual periods may make it difficult to determine if conception has occurred. A pregnancy test should be performed and a health care professional contacted if conception is suspected because of either nonadherence to the regimen (the risk of pregnancy increases with each pill not taken) or symptoms of pregnancy (nausea, vomiting, unusual tenderness of the breasts). (Contraceptive effectiveness may also be diminished by certain antibiotics, anticonvulsants, and anti-HIV protease inhibitors.) Treatment with Lybrel should be initiated within 24 hours of the beginning of the menstrual period to minimize the risk of unintended pregnancy without the use of a "backup" means of contraception. Pills should be taken at the same time every day and the regimen should be stopped only if the patient is discontinuing therapy (not because of nausea, spotting, or unscheduled bleeding, and never between pill packs, for example). Nurses should instruct patients taking Lybrel to always have an extra pill pack on hand to avoid running out of pills.
U.S. Food and Drug Administration. FDA news: FDA approves contraceptive for continuous use. 2007 May 22. http://www.fda.gov/bbs/topics/news/2007/new01637.html Wyeth Pharmaceuticals. Lybrel (90 mcg levonorgestrel and 20 mcg ethinyl estradiol) tablets.http://www.fda.gov/cder/foi/label/2007/021864lbl.pdf.
A NEW TOPICAL ANTIBIOTIC FOR IMPETIGO
* Retapamulin ointment is a new antibiotic that is effective against impetigo, a bacterial skin infection most common in children.
* It has been found to be as effective as cephalexin.
The Food and Drug Administration recently approved retapamulin ointment (Altabax) for the topical treatment of impetigo, a staphylococcal or streptococcal skin infection. Retapamulin ointment can be used on patients of a wide range of ages, from nine-month-old children (on as much as 2% of total body surface area) to adults (on as much as 100 cm2 total area). The approval of retapamulin ointment was granted because of its effectiveness in treating impetigo, as demonstrated in comparison with a placebo. Retapamulin ointment was also tested against a standard oral antibiotic treatment, cephalexin (Keflex and others), and was found to be as effective. The adverse effects profiles of the two drugs are different--retapamulin ointment has been noted to cause irritation at the application site in a small number of patients, while cephalexin has been noted, rarely, to cause diarrhea--but both generally are tolerated well. Nurses should instruct patients or their parents to apply a thin layer of the ointment to the affected area twice daily for five days; a sterile, dry dressing can be placed over the area, if desired.
U.S. Food and Drug Administration. FDA news: FDA approves antibiotic ointment for children and adults. 2007 Apr 13. http://www.fda.gov/bbs/topics/news/2007/new01607.html GlaxoSmithKline. Prescribing information: Altabax (retapamulin ointment), 1%. 2007. http://www.fda.gov/cder/foi/label/2007/022055lbl.pdf; Parish LC, et al. J Am Acad Dermatol 2006;55(6):1003-13. [Context Link]
A TRANSDERMAL DRUG FOR PARKINSON DISEASE
* Rotigotine is the first transdermal dopamine agonist approved for treating the symptoms of early Parkinson disease.
* The patch is changed every 24 hours.
The Food and Drug Administration recently approved rotigotine (Neupro), which is unique as a pharmacologic treatment for Parkinson disease because it is a transdermal patch that is applied daily. The neurotransmitter dopamine is depleted in patients with Parkinson disease and, like other treatments for Parkinson disease, rotigotine is a dopamine agonist, meaning that it stimulates dopamine receptors. Rotigotine controls the four principal symptoms of Parkinson disease: tremor (trembling in the hands, arms, legs, jaw, and face), rigidity (stiffness of the limbs and trunk), bradykinesia (slowness of movement), and postural instability (impaired balance and coordination). The patch delivers the drug through the skin continuously for 24 hours.
The patch's adhesive layer contains the drug and several inactive ingredients, including sodium metabisulfite. Patients who are sensitive to sulfites might experience allergic responses, including symptoms of anaphylaxis, and the product labeling warns that rotigotine can cause asthma attacks that may be life threatening or less severe. Although sensitivity to sulfites in the general population is not believed to be prevalent, it is more common among people with asthma.
The label also warns that patients might fall asleep during normal activities of daily living (ADLs). Some rotigotine study participants felt that they had been alert just before they fell asleep while performing ADLs, such as driving. Patients with preexisting somnolence may be more likely to fall asleep while performing ADLs. This adverse effect occurred in some patients who had taken the drug for a year. In addition, 2% of study patients treated with rotigotine reported hallucinations, which were severe enough that one discontinued treatment. Rotigotine, like other dopamine agonists, may cause postural hypotension, especially during dose escalation. Reactions at the application site also occurred in study participants, as did generalized skin reactions, although at a lower rate. Fainting, nausea, vomiting, increased blood pressure and heart rate, and weight gain associated with fluid retention were also reported.
Nurses should assess patients for allergy to sulfites and for asthma. Patients should be advised to immediately remove the patch and contact the prescriber or seek emergency care if they experience difficulty in breathing or swallowing. Nurses should also assess patients for a history of somnolence and warn them and their families about the risk of falling asleep during ADLs and that activities such as driving and operating machinery and those involving heights should be undertaken with caution. If the patient experiences somnolence while taking rotigotine, she or he should not engage in those activities.
Nurses should also teach patients how to apply the rotigotine patch every 24 hours to clean, dry, intact skin on the abdomen, thigh, hip, flank, shoulder, or upper arm. The application site should be alternated from one side of the body to the other and from the upper to the lower body (from the right shoulder to the left thigh, for example); the same application site should not be used more frequently than once every 14 days. If the patch must be affixed to a site that is hairy, the site should be shaved three days beforehand. If the patch comes off, it should be replaced with a new one for the remainder of the day.
A used patch should be carefully removed to avoid skin irritation and folded in half before disposal so that it sticks to itself. Adhesive remaining at the application site can be removed with either mild soap and warm water or with baby or mineral oil, but never with alcohol or other solvents that can irritate the skin. Patients and caregivers should be instructed to wash their hands after handling the patch to avoid getting the drug in their eyes or on any objects. If a rash or skin irritation develops, patients should be instructed not to expose the area to direct sunlight before it has healed so changes in skin color do not occur.
U.S. Food and Drug Administration. FDA news: FDA approves Neupro patch for treatment of early Parkinson's disease. 2007 May 9. http://www.fda.gov/bbs/topics/news/2007/new01631.html Schwarz Pharma. Neupro (rotigotine transdermal system) continuous delivery for once-daily application.http://www.fda.gov/cder/foi/label/2007/021829lbl.pdf.
ANTIDIABETES DRUG MIGHT POSE CARDIOVASCULAR RISK
* New data indicate that rosiglitazone appears to increase the risk of ischemic cardiac events. Clinical trial results are being analyzed. No drug has been recommended for use in its place.
GlaxoSmithKline, the manufacturer of rosiglitazone (Avandia, Avandamet, and Avandaryl), submitted new data to the Food and Drug Administration (FDA) from a metaanalysis of 42 clinical studies that indicate that the antidiabetes drug increases the risk of ischemic cardiovascular events. Rosiglitazone increases liver, muscle, and adipose tissues' sensitivity to the action of insulin and inhibits hepatic gluconeogenesis in patients with type 2 diabetes. Rosiglitazone's labeling has always warned that the drug can exacerbate or cause heart failure because it promotes fluid retention, and that a roughly twice-greater incidence of both angina and myocardial infarction is associated with its use, compared with placebo, in clinical trials. However, because the original trials were not designed to assess ischemic cardiac events, the data were inconclusive concerning direct risk. The new data submitted to the FDA were compiled from numerous clinical trials, none of which had been designed to specifically assess cardiovascular safety, either. As is common in metaanalyses, the studies had differing primary end points and compared rosiglitazone to a variety of antidiabetes therapies or to a placebo. In some studies rosiglitazone alone was compared with a combination of rosiglitazone and another antidiabetes drug. In all, 8,604 patients were treated with rosiglitazone and 5,633 with either another antidiabetes regimen or a placebo. Only four studies were longer than six months in duration. The pooled analysis submitted by GlaxoSmithKline indicates there is a 30% higher risk of myocardial ischemic events in patients treated with rosiglitazone.
Interpreting the data submitted by the manufacturer is complicated for two reasons. First, metaanalysis data are always difficult to interpret and subject to misinterpretation because of the studies' possible differences in design, sample, and follow-up. Second, other long-term clinical trials have not indicated that rosiglitazone increases the risk of ischemic cardiovascular events. In the safety alert the FDA issued to health care professionals on May 22, the agency stated that it was continuing to evaluate all data. Last month, in what is likely to be a controversial decision, an FDA panel voted to allow the drug to remain on the market. In addition, the manufacturer is not yet required to place a black box warning on the drug's labelling-a move called for by some on the panel. Nurses should carefully assess patients taking rosiglitazone for cardiovascular complications.
U.S. Food and Drug Administration. Information for healthcare professionals: rosiglitazone maleate (marketed as Avandia, Avandamet, and Avandaryl). 2007 May 22. http://www.fda.gov/cder/drug/infosheets/hcp/rosiglitazonehcp.htm.
On the Cover
In the cover photograph, taken on February 22, an eight-year-old girl with a postoperative recurrence of retinoblastoma is carried to a radiation treatment room after receiving anesthesia.
"It touched my heart to see the real emotional relationship between nurse and child," writes photographer and oncologist Rashid Un Nabi in an e-mail from Mohakhali, Dhaka, Bangladesh, where he is assistant professor in the department of radiation oncology at the National Institute of Cancer Research and Hospital. Retinoblastoma afflicts children worldwide but is most often seen in children in developing countries. "Day by day this humanity is lost throughout the whole world," Un Nabi says. "But this moment is really the best example of nurses at work." The child died recently from intracranial metastasis.
The cover photograph won second place in the 2007 "Faces of Caring: Nurses at Work" photography contest sponsored by AJN and the New York University (NYU) College of Nursing, with support from Johnson and Johnson's Campaign for Nursing's Future, the Beatrice Renfield Foundation, and the Jonas Center for Nursing Excellence. (Twenty-six photographs were selected for an exhibition mounted at NYU in May that is now touring the country. For information on booking the exhibition, call Amanda Geer at [646] 674-6609.)
In the photograph on this page, nurses are mixing a chemotherapeutic drug with IV fluid. Un Nabi writes, "I have seen the faces of sadness of the patients because they know they have cancer. I like the photograph because it is simple and clearly defines the job of nurses in their working conditions."
Un Nabi has studied in cities around the world, including Bangkok, Mumbai, and Manila. He has won 63 international photography awards, more than any other Bangladeshi photographer. About 700 of his prints are exhibited in 40 countries and have appeared in 50 international publications.-Alison Bulman, senior editorial coordinator