Thomson Delmar Learning Online PDR Resource Center  

Home   |    Contact Us   |    About Us    |    Press Releases     |    Site Map


Shop Product Catalog
Drug Updates

Bonus Monographs

RN Magazine Highlights

Related Products

Drug Links

  Pharmaceutical
  Companies


  Government
  Resources


  Miscellaneous
  News Groups


 



 
WHAT'S NEW IN DRUGS
from RN Magazine, June 2002

Staff Editor: Paul L. Cerrato
Reprinted by permission. RN Magazine is published by Medical Economics, a Thomson company.
Archives

2002
June
May
April
March
February
January


CDC Needs You To Help Stop Antibiotic-Resistant Bugs
Notching up its efforts against the threat of drug-resistant pathogens, the Centers for Disease Control and Prevention (CDC) launched a major educational campaign aimed at clinicians. Called “Prevent Antimicrobial Resistance,” the campaign provides clinicians with concrete action steps based on CDC guidelines and other research.

The first set of 12 action steps focuses on hospitalized adults and includes simple, memorizable directives such as “Get the catheters out” and “Know when to say ‘No’ to vanco(mycin).” Similar 12-step programs will be issued to guide the care of other subgroups of patients, such as those in the ED and those on dialysis. In each program, the steps will center around four common strategies—prevent infection, diagnose and treat infection effectively, use antimicrobial agents wisely, and prevent transmission of resistant pathogens. CDC training materials include slide programs, posters, and pocket reminder cards.

For more information, visit www.cdc.gov/drugresistance/healthcare or call (800) 311-3435. Centers for Disease Control and Prevention. “CDC promotes campaign to prevent antimicrobial resistance in healthcare settings.” 2002. www.cdc.gov/od/oc /media/pressrel/r020326.htm (5 Apr. 2002).

[TOP]


Preventing Febrile Neutropenia Can Be Done In Fewer Doses
A newly approved drug, pegfilgrastim (Neulasta), drastically reduces the number of injections required to ward off infections that often arise from chemotherapy-induced febrile neutropenia in cancer patients. In clinical studies, a single 6 mg injection of pegfilgrastim given SQ once per chemotherapy cycle provided protection from infection that was comparable to 11 daily injections of filgrastim (Neupogen). It reduced both the duration of severe neutropenia and the frequency of neutropenia with fever. Pegfilgrastim is derived from filgrastim; both agents promote the growth of neutrophils, which cytotoxic chemotherapy depletes. Pegfilgrastim is approved only for patients receiving myelosuppressive chemotherapy for nonmyeloid cancers. It shouldn’t be given during the period 14 days before to 24 hours after administration of chemotherapy. In studies, the most common adverse effect (26%) was mostly mild to moderate bone pain. Patients should be monitored for potential risk of adult respiratory distress syndrome, splenic rupture, and sickle-cell crisis.

Amgen. “FDA approves Amgen’s Neulasta for serious and frequent chemotherapy side effect.” 2002. www.neulasta.com/neulasta_press_release1.html (13 Mar. 2002).

[TOP]


Not Enough Cardiac Patients Are Put
On Aspirin Therapy

The use of aspirin as prophylaxis against cardiac events and death in patients with coronary artery disease (CAD) is still “disappointingly low,” according to a large retrospective study funded by the federal Agency for Healthcare Research and Quality. Not all the news was bad, however. Analyzing follow-up data on 25,000 patients who’d been referred to Duke University Medical Center for coronary angiography, the researchers found that aspirin use increased from 59% of patients in 1995 to 81% in 1999, the most recent year for which data was available. Still, these numbers meant that many patients were not taking aspirin regularly, despite its known benefits and an absence of contraindications to it. The researchers estimated, roughly, that the risk of death among patients who never took aspirin was 85% higher than among regular aspirin users.

Califf, R. M., DeLong, E. R., et al. (2002). Underuse of aspirin in a referral population with documented coronary artery disease. Am J Cardiol, 89(6), 653.

[TOP]


Form Helps Patients Learn More
About Their Meds

Empowering patients is important not only for effective care but also for medication safety. To support those goals, the FDA offers a printer-friendly form with questions patients should ask their healthcare providers about their medications. Questions include: What’s this drug for? How and when should I use it? When should I see a difference? What other drugs, supplements, foods, or activities should I avoid? What are possible side effects? What do I do if one occurs? (Tip: With a little word-processing, you can adapt the form so there’s room for patients to write down the answers.) To print out the form for patients, simply point your browser to www.fda.gov/cder/consumerinfo /question_guide.htm.

U.S. Food and Drug Administration. “Be an active member of your health care team.” 2001. www.fda.gov/cder/consumerinfo/active_member.htm (23 Jan. 2001).

[TOP]


Warnings On Lactic Acidosis, Other Risks,
With HIV Drug

Bristol-Myers Squibb Company has issued a warning letter alerting clinicians to the risk of rare but potentially fatal lactic acidosis syndrome (LAS) or hyperlactatemia in HIV patients taking nucleoside analogues, including its drug stavudine (Zerit), in combination with other antiretrovirals. The company had received reports of rapidly worsening neuromuscular weakness resembling symptoms of Guillain-Barré syndrome (including respiratory failure) that, in some cases, resulted in death. According to the manufacturer, patients on stavudine should be monitored for—and taught to recognize and immediately report—early signs of these disorders, which include nausea, vomiting, abdominal pain, sudden unexplained weakness, tachypnea and dyspnea, or neurologic symptoms. If a patient develops these symptoms, particularly motor weakness, antiretroviral therapy should be stopped and the patient given a full evaluation immediately. Symptoms may continue or worsen even after antiretroviral therapy has been halted. In patients with confirmed LAS, permanent discontinuation of the drug should be considered.

U.S. Food and Drug Administration MedWatch. “Zerit (stavudine).” 2002. www.fda.gov/medwatch/SAFETY/2002/safety02.htm#zerit (11 Apr. 2002).

[TOP]


FDA Upgrades Steroid’s Rating For Pregnancy
The pregnancy rating for the inhaled corticosteroid budesonide (Pulmicort Turbuhaler)—a maintenance therapy in asthma—has been “upgraded” to Category B. In this case, that designation means that although adverse effects on the fetus were seen in animal studies, human studies haven’t found a risk to the fetus in the first trimester, and there’s no evidence of risk in later trimesters. All other inhaled steroids are Pregnancy Category C. (Briefly put, this classification means that animal studies either have not been done or have shown a risk to the fetus, and there are no adequate human studies during pregnancy.) The change for budesonide is based on the FDA’s review of data from three Swedish registries covering over 2,000 births. The rate of recorded congenital malformations in infants born to mothers who used inhaled budesonide during early pregnancy was similar to the rate seen in the general population. The drug’s labeling, however, cautions that the possibility of fetal harm can’t be ruled out. The inhaler should be used during pregnancy only if clearly needed, at the lowest effective dose, and with monitoring.

Astra-Zeneca. “FDA approves pregnancy rating label change for asthma medication.” 2002. www.astrazeneca-us.com/news/article.asp?file=2002010301.htm (23 Jan. 2002).


OTC Talk
Acetaminophen And Kids: Handle With Care

Tylenol and Panadol, two brands of acetaminophen, can be found in countless medicine cabinets across the country. Parents, in particular, rely on it when their children aren’t feeling well. But they may not always stop to think that, like any other drug, it should be used with caution. That’s especially true when you consider that toxicity can occur not only as the result of an accidental (or intentional) overdose, but from cumulative normal doses in some patients. Early side effects include nausea, vomiting, and malaise. Less commonly, toxicity may lead to severe, even fatal, liver damage. Children and adults with hepatic disease should avoid acetaminophen because of their increased risk for these effects. Guidelines from the American Academy of Pediatrics advise providers to give parents specific written instructions on the exact dose of acetaminophen required, based on the child’s weight and the formulation used (infant drops, liquid, “junior strength” tablets, suppositories, etc.). Remind parents not to give their child additional cough/cold products that may contain acetaminophen, as well. Finally, parents, not the child, should administer the acetaminophen dose, preferably with food.

Source: American Academy of Pediatrics Committee on Drugs. (2001). Acetaminophen toxicity in children. Pediatrics, 108(4), 1020.

THE AUTHOR

JAMES M. WOOTEN, a member of the RN editorial board, is an assistant professor of medicine at the University of Missouri School of Medicine, in Kansas City, Mo.