Heart Problems Not Exacerbated by Drugs
After a comprehensive scientific review, the FDA has determined that omeprazole (Prilosec) and esomeprazole (Nexium) are not likely to be associated with an increased risk of heart problems after long-term use. Healthcare providers are advised to continue to prescribe, and patients to continue to use these products according to their labeling.
A 14-year study of omeprazole in Europe analyzed patients with severe gastroesophageal reflux disease (GERD). The second study, which is still ongoing, compares 266 patients with severe GERD being treated with esomeprazole to 288 patients having surgery. The study, also conducted in Europe, has 5 years of follow-up data on patients.
According to the FDA, both studies collected safety data, but did not specify how heart problems were defined or verified, making it difficult to evaluate the safety of either drug. The agency notes, however, that an additional 14 studies of omeprazole do not suggest an increased risk of heart problems related to the drug.
Ointment for External Genital, Perianal Warts
Sinecatechins (Veregen) ointment, 15%, indicated for the topical treatment of external genital and condylomata acuminata (perianal warts) in immunocompetent patients 18 years of age and older, is now available. Sinecatechin is the first new prescription treatment for external genital warts in 10 years, according to the manufacturer.
The medication is the first botanical drug approved for prescription use in the United States. The active ingredient is sinecatechin, a proprietary mixture of eight catechins, the primary phenols found in green tea leaves. The health benefits associated with catechins are attributed in part to their antioxidant properties.
Clinical trials show that the medication is effective in clearing both baseline and newly emerging external genital and perianal warts, with complete clearance in 53.6% of patients studied who received the drug versus 35.3% of those receiving placebo. The medication also demonstrated low recurrence rates during these trials.
Most adverse reactions reported during these trials were mild to moderate skin and application site reactions. No systemic side effects were reported.
New Beta-Blocker Approved for Hypertension
Forest Laboratories and Mylan announced the approval of nebivolol (Bystolic), a new beta-blocker for the once-daily treatment of hypertension. Nebivolol can be used alone or in combination with other hypertension treatments.
At doses less than or equal to 10 mg/day, the medication is a selective beta 1-blocker and has the added pharmacologic properties of producing vasodilation and reducing total peripheral resistance.
Nebivolol was well tolerated in clinical trials, with a low incidence of side effects traditionally associated with beta-blockers. Headache, fatigue, and dizziness were the most commonly reported side effects. Nebivolol should not be combined with other beta-blockers. Refer to product labeling for detailed prescribing information.
FDA Updates Alert on Fentanyl Patch
The FDA has issued an update that highlights important information on appropriate prescribing, dose selection, and safe use of the fentanyl transdermal system. Overdoses have occurred when the fentanyl patch was used to treat pain in opioid-naive patients and when opioid-tolerant patients have applied more patches than prescribed, changed the patch too often, or exposed the patch to a heat source.
The fentanyl patch is only indicated for use in patients with moderate-to-severe chronic pain, who have been taking around-the-clock opioid pain medicine for more than a week, and are considered to be opioid-tolerant.
The directions for prescribing and using this product must be followed exactly to prevent death or other serious side effects from fentanyl overdose.