First responders helped by inhaled corticosteroids
Prophylactic use of inhaled corticosteroids reduced respiratory symptoms and improved quality of life for emergency responders working at the World Trade Center in New York on Sept. 11, 2001, according to a report given at CHEST 2007, the international scientific assembly of the American College of Chest Physicians.
The report was given by David Prezant, MD, FCCP, from Montefiore Medical Center in the Bronx, NY, who has been monitoring first responder respiratory status. He said a group of 156 firefighters who responded to Ground Zero began taking inhaled budisonide (AstraZeneca's Rhinocort® and Pulmicort®) two weeks after the attack. They experienced fewer respiratory symptoms and improved quality of life within four to six weeks of treatment compared with other workers who did not take the inhaled steroids, he said.
Some 3,000 firefighters originally enrolled in the study, but only 156 completed a minimum of four weeks of budesonide treatment.
Prezant told Reuters Health the subjects had a significant amount of fear over taking the drug, with many of the firefighters confusing it with anabolic steroids. Another significant number said they had not experienced symptom relief and stopped using their inhalers after a few days.
Those who completed the recommended amount of treatment showed "some clinical and statistically significant changes in symptoms and without any side effects," according to Prezant. He said forced vital capacity improved over 18 months, while the forced expiratory volume in one second declined in the first two years among those who did not take budesonide.
"The important thing to remember is that with any kind of disaster like that, there are going to be a lot of respiratory irritants and particulate matter," Prezant said.
He said prophylactic inhaled corticosteroids may be useful for those fighting wildfires and other emergency responders with prolonged exposure to particulate matter, but warned that patients need to be informed about the need for taking at least four weeks of treatment and need to be taught about adverse effects. Informed consent is necessary, he said, because this is an off-label use of the medications.
FDA expands age range for Menactra use
FDA has expanded the approved age range for Sanofi-Pasteur's bacterial meningitis vaccine Menactra® to include children ages 2-10 years. Menactra was first approved January 2005 for people 11-55 years old. The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices recommends meningococcal vaccination for children ages 2-10 who are at increased risk of developing meningococcal disease, such as those who have had their spleen removed or whose spleen is not functioning; those with a terminal complement component deficiency; and those who expect to travel outside the United States where the disease is common. Until now, the only vaccine available in the United States for use in children age 2-10 was Sanofi-Pasteur's Menomune™.
Menactra's effectiveness was measured in clinical trials with people ages 2- 55 years. It was shown to produce an immune response one month after vaccination. Its safety was evaluated in eight clinical studies that included a total of 10,057 participants who received Menactra and 5,266 participants who received Menomune.
The most common adverse events reported in the studies were pain at the injection site and irritability. Diarrhea, drowsiness, and lack of appetite also were common.
While not observed in the clinical trials, Guillain-Barré syndrome was noted as a possible but unproven risk in some adolescents following immunization with Menactra, occurring in an estimated one in one million vaccine recipients. FDA said that as a precaution, people who have previously been diagnosed with Guillain-Barré syndrome should not be given Menactra.
Change in Humate-P storage approved
FDA has approved a change in storage conditions for CSL Behring's Humate-P, a treatment for bleeding in certain patients with hemophilia A or von Willebrand disease. The treatment can now be safely stored for up to two years at 77° F. Previously, it required refrigerator-level temperatures for that length of storage.
Humate-P is manufactured from human plasma obtained from screened and tested U.S. donors.
Reported adverse reactions include allergic reactions such as hives, rash, chest tightness, swelling, and shock.