Article Content

New Antibiotic Available for Adults with RTIs

Telithromycin (Ketek), the first in a new class of antibiotics known as ketolides, is now approved for the treatment of respiratory tract infections (RTIs). The once-daily oral medication is indicated for treatment of acute exacerbation of chronic bronchitis, acute bacterial sinusitis, and mild to moderate community-acquired pneumonia, including infections caused by multidrug-resistant Streptococcus pneumoniae in patients 18 years of age or older.


Ketek works by selectively targeting respiratory pathogens without significantly affecting bacteria not normally involved in RTIs. According to Aventis, this mechanism of action may be an important factor in minimizing the development of antibiotic resistance.


In clinical trials, the most commonly reported side effects were nausea, headache, dizziness, vomiting, and diarrhea.


Atypical Antipsychotic Drug Warning

The Food and Drug Administration (FDA) has asked all manufacturers of atypical antipsychotic medications to add a warning statement to the products' labeling describing the risk of hyperglycemia and diabetes associated with their use. This class of medication includes aripiprazole (Abilify), clozapine (Clozaril), olanzapine (Zyprexa), quetiapine (Seroquel), risperidone (Risperdal), and ziprasidone (Geodon).


The warning advises that hyperglycemia has been extreme in some cases, and associated with ketoacidosis or hyperosmolar coma, or death. The relationship between atypical antipsychotic use and glucose abnormalities is complicated by the possibility of an increased risk of diabetes in patients with schizophrenia and the increasing incidence of diabetes in the general population, but studies suggest an increased risk of treatment-emergent hyperglycemia-related adverse events in patients using atypical antipsychotic drugs.


Patients with an established diagnosis of diabetes who start taking atypical antipsychotic drugs should be monitored regularly for worsening glucose control. Patients with risk factors for diabetes who are starting treatment with atypical antipsychotic medications should undergo fasting blood glucose testing at the beginning of treatment and periodically during treatment.


Aerosol Approved for Nasal Allergies

The Food and Drug Administration (FDA) approved Aventis's triamcinolone acetonide (Nasacort HFA) Nasal Aerosol for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis in children age 6 and older and adults.


Nasacort HFA is the first intranasal corticosteroid dry-aerosol formulation approved in the United States that contains hydrofluoroalkane (HFA) rather than chlorofluorocarbons (CFCs). Nasacort HFA replaces Nasacort Nasal Inhaler, which was taken off the market in July 2003 to comply with Environmental Protection Agency and FDA requirements designed to protect the ozone layer.


The most common side effects in clinical trials of Nasacort HFA were sneezing, headache, nasal irritation, and rhinitis.


COX-2 Inhibitor Approved for Migraine Treatment

Merck's rofecoxib (Vioxx) is now approved for the acute treatment of migraine attacks with or without aura in adults. It is the first and only COX-2 specific inhibitor approved for treating migraine pain and associated migraine symptoms. Vioxx is already approved for the management of moderate to severe dental pain, primary dysmenorrhea, postorthopedic surgical pain, and the treatment of chronic conditions of osteoarthritis and rheumatoid arthritis in adults.


According to clinical studies, one dose (25 mg or 50 mg) of Vioxx relieved migraine pain for most patients within 2 hours. Both doses also reduced the incidence of migraine symptoms including photophobia, phonophobia, and nausea.


The most common adverse events occurring in patients taking rofecoxib were dizziness, nausea, somnolence, and dyspepsia.