Pending Investigation Halts Norplant Shipments
By William T. Elliott, MD, FACP
Wyeth-ayerst has suspended all shipments of its contraceptive Norplant pending investigation into possible shelf-life stability problems. Several samples from lots that carry an expiration date of 2004 tested at the "lower end of the release rate specification for shelf life stability." The company says they are opting for a cautious approach while they perform more testing and recommend barrier methods of birth control for patients that have had Norplant implanted with a 2004 expiration date.
HIV Study
A study presented to the 13th International AIDS Conference in July has prompted the CDC to caution physicians that nonoxynol-9 is not an effective means of HIV prevention. The COL-1492 trial presented at the conference in South Africa suggested that the spermacide/microbicide commonly found in contraceptive jelly actually led to a higher HIV infection rate. The study, which was performed on commercial sex workers, showed a 50% higher rate of HIV infection rate with nonoxynol-9 than placebo gel (MMWR Morb Mortal Wkly Rep. CDC Surveill Summ 2000;49:717-718).
Women’s Care
The FDA has approved a new cream to slow the growth of unwanted facial hair in women. Eflornithine cream (Vaniqa) will be marketed by Bristol-Myers Squibb and the Gillette Company. The drug, which was initially investigated as an antineoplastic and antiparasitic agent, inhibits ornithine decarboxylase in the hair follicles. This enzyme is believed to be necessary for hair growth. Use of the cream twice a day for two months results in decreased facial hair in more than half of women in clinical trials.
Pediatrics
More than 80% of children with acute otitis media will improve within one week without antibiotics, according to data provided by the Agency for Healthcare Research and Quality (AHRQ). This compares to a 93% improvement in children treated with antibiotics. The data were culled from studies performed over the last 35 years. Their data also suggest that amoxicillin provides similar outcomes to more expensive antibiotics such as azithromycin, clarithromycin, or newer cephalosporins. AHRQ suggests that a few days of watchful waiting are worthwhile, with treatment only for those children whose symptoms do not improve. They also suggest that this more conservative approach may help avoid antibiotic resistance. The study can be found on the AHRQ website at www.ahrq.gov.
Flu Vaccine
With a looming shortage of flu vaccine this winter, the National Institute of Health is pulling all the stops, including testing the efficacy of half doses in healthy adults. The double-blind study will involve 840 adults at several sites across the country. Antibody production will be tested 21 days after injections with either full dose or half doses of the trivalent influenza vaccine. Results should be available this fall. If half doses were effective in healthy adults, this would potentially stretch the limited vaccine to allow full doses for high-risk patients. The vaccine shortage is due to lower than expected growth of the A/Panama virus, one of three components of this year’s vaccine.
Inhaled Steroids
Moderate doses of inhaled steroids result in a decrease in linear growth velocity in asthmatic children, according to a recent meta-analysis. The study combined the findings of five studies of beclomethasone and fluticasone. Beclomethasone at 328-400 µg/d resulted in a decrease in linear growth velocity of 1.51 cm/y while fluticasone resulted in decrease of 0.43 cm/y. It is unknown if these agents affect final adult height (Pediatrics 2000;106:e8). In a separate study, French researchers have shown that albuterol delivered via a metered dose inhaler (MDI) with a spacer is equivalent to delivery via a nebulizer in young children. The study, which was performed in a hospital emergency department, suggests that MDIs could become standard therapy because of ease of use in children and reduced cost of administration (Pediatrics 2000;106:311-317).
Cholesterol
Although cholesterol levels have not been linked to risk of stroke, lowering cholesterol with statins seems to reduce the risk of stroke, particularly in patients who have coronary artery disease (CAD). This finding was confirmed in a recently published arm of the "Long-Term Intervention with Pravastatin in Ischaemic Disease" study. More than 9000 patients with CAD were followed for six years. Risk of nonhemorrhagic strokes was 4.4% in the placebo group and 3.4% in the treatment group. There was no reduction seen in hemorrhagic strokes (N Engl J Med 2000;343:317-326).
GI
Recently approved for treatment of irritable bowel syndrome (IBS), Glaxo Wellcome’s alosetron (Lotronex) is already the subject of a "Dear Doctor" letter and a warning from the FDA. Alosetron was approved for women with IBS who have diarrhea as a predominant symptom. The concern centers on reports of severe constipation and ischemic colitis associated with use of the drug. The FDA is also requiring the company to attach a "Lotronex Medication Guide" to every bottle of the drug, which describes the signs and symptoms of severe constipation and ischemic colitis in layman’s terms. Public advocacy groups such as Public Citizen Health Research Group have been calling for the drug’s withdrawal from the market, a step the FDA feels is premature, but the Agency cautions physicians that the drug should never be initiated in women who are already constipated. Novartis’ IBS drug tegaserod (Zelmac) will be marketed soon for the same indication.
Cardiology
Newer thrombolytics for the treatment of acute myocardial infarction are capable of being administered in a single bolus rather than a constant infusion. New research from Canada suggests, however, that a rapid bolus of a thrombolytic drug increases the risk of intracranial hemorrhage. The meta-analysis of seven clinical trials found an increased risk whether comparing the same agent given in bolus vs. constant infusion or different agents, one given via bolus and the other via constant infusion. They conclude that the method of administration of a thrombolytic drug determines the risk of hemorrhagic stroke more than the drug itself (Lancet 2000;356:449-454).
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