Action Against Marketing Unapproved Drugs
The FDA ordered several companies to stop marketing unapproved drugs containing quinine, citing serious safety concerns, including deaths, associated with quinine products. The agency is also cautioning consumers about off-label use of quinine to treat leg cramps.
While quinine is an approved treatment for malaria, it is also commonly prescribed to treat leg cramps. The agency notes that because malaria is life-threatening, the risks associated with its use are justified for malaria, but the FDA believes it should not be used to prevent or treat leg cramps.
One quinine product, Qualaquin (Mutual Pharmaceutical Company), is FDA-approved to treat certain types of malaria. Unlike the approved product, many unapproved quinine products are marketed without a caution against use of the product for treatment of leg cramps. Food and Drug Administration-approved labeling for quinine contains extensive warnings about potentially serious adverse events associated with quinine. The agency notes that since 1969, there have been 665 reports of adverse events with serious outcomes associated with quinine use, including 93 deaths.
Add-on Therapy for Type 2 Diabetes
The FDA approved exenatide (Byetta) injection as an add-on therapy to improve blood glucose control in people with type 2 diabetes who have not achieved adequate control on a thiazolidinedione (TZD).
Exenatide comes in a prefilled pen with a simple, fixed dosing for all patients that does not depend on the size of the meal or amount of exercise. Patients are started on 5 mcg twice daily for at least 30 days, but the dose may be increased to 10 mcg.
Exenatide improves blood glucose control by lowering both postmeal and fasting glucose levels, resulting in better long-term control. The medication controls blood glucose through several physiologic actions, including stimulation of insulin secretion only when blood glucose is high.
In a clinical trial of exenatide in combination with a TZD, 62% of patients who added exanatide to their existing medications had A1Cs of 7% or less, compared with 16% of patients on placebo. The patients taking the placebo also lost an average of 3.3 pounds over 16 weeks, compared with an average weight loss of 0.4 pounds in the other group. The most common side effect was nausea.
Celecoxib for Juvenile Rheumatoid Arthritis
Pfizer's celecoxib (Celebrex) has gained approval for an expanded indication: relief of the signs and symptoms of juvenile rheumatoid arthritis (JRA) in patients 2 years of age and older. The FDA approved the new indication based on the results of a 24-week study of celecoxib involving 242 patients between 2 and 17 years of age, which demonstrated its effectiveness in treating juvenile rheumatoid arthritis. The most commonly reported side effects were cough, cold, upper respiratory tract infection, abdominal pain, headache, fever, nausea, diarrhea, and vomiting.
According to the FDA, while there are other medications approved for JRA, they may have limited effectiveness or cause intolerable side effects in some children. Safety was not studied beyond 6 months. Postmarketing studies will be performed by Pfizer.
Proposed Changes to OTC Pain Med
The FDA has proposed to change the labeling regulations on nonprescription internal analgesic, antipyretic, and antirheumatic drug products (acetaminophen and nonsteroidal anti-inflammatory drugs [NSAIDs]) to include important safety information concerning the potential for stomach bleeding and liver damage, and when to consult a healthcare practitioner.
The following labeling changes are under consideration:
For products containing acetaminophen, new warnings highlighting the potential for liver toxicity.
For products containing an NSAID, a new warming stating the potential for stomach bleeding. The name of the NSAID ingredient and the term "NSAID" would also be displayed.