Two options are available for patients requiring treatment for arthritis who are at risk for ulcer disease: nonsteroidal anti-inflammatory drugs (NSAIDs) that are selective for cyclooxygenase-2 (COX-2) or the combination of a non-selective NSAID with a proton-pump inhibitor. A recent study of representative members from these therapeutic classes has offered findings that the two alternatives are statistically similar in their efficacy with respect to the prevention of recurrent ulcer bleeding.Celecoxib, a COX-2-selective NSAID, was given to 144 patients through random assignment. Another group of patients (N=143) were randomly assigned to receive a combination of diclofenac (a nonselective NSAID) plus omeprazole (a proton-pump inhibitor) during the 6-month trial.
An ingredient in dozens of cough syrups, which the FDA says is not dangerous,
never underwent the current drug approval process because it was introduced
before FDA efficacy guidelines were in place. The drug, extended-release
guaifenesin, is marketed as an expectorant by 66 companies in prescription
New indications: Leukotriene blocker approved for treatment of seasonal allergic rhinitis
Washington, DC-Representatives from the American Society of Health-System
Pharmacists and the American Medical Association met with the Health and
Human Services assistant secretary for health Eve Slater, MD, and FDA's
deputy commissioner Lester Crawford, DVM, PhD, in late January to discuss
drug shortages and ask for federal assistance in resolving the problem.
Studies presented at the Third European Stanley Foundation Conference on Bipolar Disorder in September in Freiburg, Germany, show two newer antipsychotics are each more effective than standard therapy for preventing mania relapse or reducing symptoms.
A phase III study presented at the 14th annual meeting of the Migraine Trust International Research Symposium (MTIRS) in September in London showed that topiramate (Topamax) significantly reduced migraine frequency at doses as low as 100 mg/d. The onset of efficacy was observed as early as the first month of treatment. Topiramate is already approved in the United States and worldwide as an
NME:Abused drug approved for cataplexy in tightly controlled program
New indication: For delaying relapse in long-term treatment of schizophrenia
New formulation: Once daily administration for continuous Tx of chronic moderate-to-severe pain
New indication: Long-term, twice-daily treatment of bronchospasm associated with COPD