December 13, 1999
ST. LOUIS, (MD Consult) - An article in the December 13/27 issue of Archives of Internal Medicine identifies numerous risk factors for the overuse and/or underuse of inhaled medications by adult patients with asthma.
Over 2 years, Dr. Gregory B. Diette and colleagues of Johns Hopkins School of Medicine and other institutions followed 6,612 patients with asthma (70% female, 82% white, mean age 44 years). Patients were characterized according to numerous demographic factors, the severity of their disease, and their use of inhaled beta-agonists and/or inhaled corticosteroids. The use of an inhaled beta-agonist > 8 times/day was defined as overuse, and the use of an inhaled corticosteroid for < 5 days/week, or < 5 times/day during the previous 4 weeks was defined as underuse.
The authors found that 16% of patients with moderate or severe asthma overused inhaled beta-agonists, while 64% underused inhaled corticosteroids. There were strong associations between the overuse of inhaled beta-agonists and the concomitant treatment with inhaled corticosteroids or anticholinergic agents, increased severity of asthma symptoms, problems in obtaining asthma medication, and male sex. There were strong associations between the underuse of inhaled corticosteroids and nonwhite race, age between 18 and 34 years, lower use of inhaled beta-agonists, lower severity of asthma symptoms, and not having a peak flow meter.
Furthermore, misuse rates differed according to the physician's specialty: Beta-agonist overuse was more common in patients treated by pulmonologists, while inhaled corticosteroid underuse was more common in patients treated by a generalist. The authors suggest that adults with asthma who have the above-mentioned characteristics might benefit from a close review of their disease management program to optimize their drug therapy.
Arch Intern Med 1999; 159:2697-2704
December 7, 1999
ST. LOUIS, (MD Consult) - In an updated policy statement, the American Academy of Pediatrics (AAP) recommends that all future use of poliovirus vaccine for routine childhood immunization against poliovirus infection should be in the injected (IPV) form.
In January of 1999, recognizing the potential, albeit minimal, risk of vaccine-associated paralytic poliomyelitis (VAPP), the AAP advocated that children in the United States receive IPV for the first two doses of the polio vaccine series in most circumstances. The previous AAP statement allowed either IPV or oral poliovirus vaccine (OPV), which is given as drops, for the following two doses. However, the new policy recognizes that "VAPP can not be totally eliminated until oral poliovirus vaccine no longer is given."
"Pediatricians need to move to an all IPV schedule in an expeditious manner," said Jon Abramson, MD, FAAP, chair of the AAP Committee on Infectious Diseases. Dr. Abramson went on to say that doctors can continue to use their current supply of OPV, as long as it is administered only as the third and fourth doses. "There has never been a case of VAPP reported when the first two doses are IPV, followed by two doses of OPV," said Dr. Abramson.
Other recommendations in the policy include that, effective in early 2000, IPV is routinely given for all children at 2, 4, 6 to 18 months, and again at 4 to 6 years of age. In addition, the policy indicates that the transition to the all-IPV schedule should be completed as soon as feasible and no later than the first six months of 2000. To effect this change as soon as possible, OPV supplies no longer should be purchased for routine use.
According to the policy, OPV - if available - should be used only in the following circumstances, unless otherwise contraindicated:
The statement also recommends that whenever OPV is administered, the risk of VAPP in recipients and the contacts of those recipients should be discussed with the parents or caregivers.
October 27, 1999
ST. LOUIS, (MD Consult) - Glaxo Wellcome Plc said on October 27, 1999 that it had decided to withdraw Raxar (grepafloxacin) from the market worldwide after the drug was linked to seven deaths.
Although its role has not been proved, Raxar (grepafloxacin), a fluoroquinolone antibiotic launched in December 1997, has been linked to a small number of severe cardiovascular events and seven deaths.
Raxar (grepafloxacin) is the second fluoroquinolone antibiotic to present with safety issues this year. Pfizer's antibiotic Trovan was recommended for limited use only after being linked with 152 cases of hepatic damage, including possible deaths.
October 27, 1999
ST. LOUIS, (MD Consult) - The Advisory Committee on Immunization Practices of the US Centers for Disease Control and Prevention (CDC) announced on October 22,1999 the withdrawal of its recommendation that infants at 2,4 and 6 months of age be vaccinated against rotavirus.
This act is based on the recent finding of a strong and significant causal relationship between the rotavirus vaccine and an increased risk of intussusception in the first two weeks after vaccination. On the same day, the Wyeth Lederle Vaccines unit of American Home Products Corp. said that it had voluntarily withdrawn its RotaShield rotavirus vaccine from the market and had requested an immediate return of all vaccine doses.
More than one hundred cases of intussusception were reported among infants who received the rotavirus vaccine. However, according to the CDC, healthy children who were vaccinated before July are not at increased risk of intussusception.
October 15, 1999
ST. LOUIS, (MD Consult) - On October 15, 1999, The Wyeth Lederle Vaccines unit of American Home Products voluntarily withdrew its RotaShield rotavirus vaccine from the market and requested an immediate return of all vaccine doses.
The action was taken by American Home Products in consultation with the Food and Drug Administration (FDA) following a recommendation from the Centers for Disease Control and Prevention (CDC) to postpone administration because of reports to the Vaccine Adverse Events Reporting System (VAERS) of a possible association between the use of RotaShield and the development of intussusception.
For more information, physicians may call 1-877-ROTA-KID (1-877-768-2543).
October 1, 1999
ST. LOUIS, (MD Consult) - In September 1999, the Food and Drug Administration recommended physicians take precautions to reduce the "potential" risk of acute renal failure when administering immune globulin intravenous (IGIV) products, especially the ones that contain sucrose.
More than a hundred adverse events of renal dysfunction or acute renal failure associated with IGIV products were reported to the FDA since the IGIV products were first introduced in 1981. 17 patients have died of acute renal failure.
Physicians are now advised by the FDA to ensure that patients are not volume depleted prior to an infusion of IGIV, not to exceed the recommended dose for IGIV, and to periodically monitor renal function and urine output of patients. Physicians should also instruct patients to report symptoms of decreased urine output, sudden weight gain, fluid retention, and/or shortness of breath.
Special attention should be paid to those patients at increased risk for developing acute renal failure, which includes patients with:
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