Warnings Added to Two Antidepressants
GlaxoSmithKline and the Food and Drug Administration (FDA) have notified healthcare professionals about changes made to the prescribing instructions for the antidepressants bupropion (Wellbutrin) and paroxetine (Paxil). This final labeling follows an earlier public health advisory issued by the FDA that cautioned medical practitioners, patients, and families about the need to closely monitor all patients being treated with antidepressants. The final labeling alerts medical providers that patients with a major depressive disorder, both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior, whether or not they are taking antidepressant medications.
The warning recommends that patients taking antidepressants should be observed closely for worsening depression and suicidality, particularly at the beginning course of drug therapy or when dosing increases or decreases. The revisions to the warning and precautions labeling were made to Wellbutrin tablets, Wellbutrin SR (sustainedreleased tablets), Wellbutrin XL (extended-release tablets), Paxil tablets, and Paxil CR (controlled-release tablets). These products are not approved for use in the pediatric population, the company notes.
For further information, visit http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#wellbutrin and http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#paxil.
Estrogen Patch for Osteoporosis Prevention
Berlex has received FDA approval to market its low-dose estradiol transdermal system Menostar to prevent osteoporosis. The once-weekly, dimesized patch delivers 14 mcg of estrogen per day-half of the lowest currently available transdermal estrogen dose. According to Berlex, because the new estrogen patch delivers such a small dosage of plant-derived estrogen, it can be used in women with or without a uterus. In a 2-year clinical trial of Menostar, the new treatment did not increase the risk of endometrial hyperplasia among women with a uterus, and use of the patch does not require a concomitant progestin.
The clinical trial also demonstrated that Menostar increased lumbar spine bone mineral density (BMD) by 3% over baseline and 2.6% over placebo. Menostar increased hip BMD by 0.84% over baseline and 1.6% over placebo. The safety and tolerability of Menostar was comparable to placebo. The most frequently reported side effects were application site irritation, joint pain, and leukorrhea. Consult product labeling for prescribing details and precautions.
Traveler's Diarrhea Treatment Approved
Salix Pharmaceuticals has received FDA approval for rifaximin (Xifaxan) tablets for the treatment of traveler's diarrhea caused by noninvasive strains of Escherichia coli in patients 12 years of age and older. The new medication is the first non-systemic (less than 0.4% of the drug absorbed into the bloodstream), gastrointestinal selective oral antibiotic to receive FDA approval.
In clinical trials, rifaximin was effective in shortening the duration of diarrhea for the most common cause of this disease: noninvasive strains of E coli. According to the manufacturer, rifaximin's beneficial effect was achieved with minimal systemic absorption, unlike systemically absorbed anti-infective agents. This reduces the potential for the development of systemic antimicrobial resistance and drug-to-drug interactions.
In clinical trials, rifaximin was generally well tolerated. The most common side effects were flatulence, headache, abdominal pain, and rectal tenesmus. The new medication should not be used in patients with diarrhea complicated by fever, blood in the stool, or diarrhea due to pathogens other than E coli.