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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.


In clinical trials of over 2,000 people, nebivolol demonstrated significant reductions in sitting diastolic and systolic blood pressure in a general hypertensive population that included 26% black, 54% male, 19% elderly, and 8% patients with diabetes.


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.


No increased heart problems with Nexium, Prilosec

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.

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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.


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 FDA notes that the fentanyl patch is only indicated for use in patients with persistent, moderate-to-severe chronic pain, who have been taking a regular, daily, 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.


Suicidal behavior associated with epilepsy medications

An FDA analysis suggests that 11 drugs used to treat epilepsy as well as psychiatric disorders and other conditions are linked with approximately twice the risk of suicidal behavior or ideation compared with patients receiving placebo. The increased risk was observed as early as 1 week after starting the antiepileptic drug and continued through 24 weeks. The relative risk for suicide was higher in patients with epilepsy compared with patients who took the medications for psychiatric and other conditions.


Healthcare practitioners should closely monitor all patients currently taking or starting any antiepileptic drug for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression, the FDA states. Drugs studied in the analysis include the following (some are available in generic form):


* carbamazepine (Carbatrol, Equetro, Tegretol, Tegretol XR)


* felbamate (Felbatol)


* gabapentin (Neurontin)


* lamotrigine (Lamictal)


* levetiracetam (Keppra)


* oxcarbazepine (Trileptal)


* pregabalin (Lyrica)


* tiagabine (Gabitril)


* topiramate (Topamax)


* valproate (Depakote, Depakote ER, Depakene, Depacon)


* zonisamide (Zonegran)



Although the analysis included only the 11 drugs listed, the FDA expects that the increased risk of suicide is shared by all antiepileptic drugs and that the class labeling will be applied broadly.


New Tekturna HCT tablet approved

The FDA has approved Novartis's aliskiren-hydrochlorothiazide (HCTZ) combination tablet, Tekturna HCT, for the second-line treatment of hypertension. The once-daily tablet is approved for patients not controlled by either drug alone, but should not be used before other medications have been tried first.


Tekturna HCT may be given with other antihypertensive medications in combination with medications for other conditions such as high cholesterol or diabetes. It can also be taken with or without food.


According to Novartis, Tekturna is the only medication to directly target renin. Tekturna HCT is available in four tablet strengths containing aliskiren-HCTZ: 150 mg/12.5mg, 150 mg/25 mg, 300 mg/12.5 mg, and 300 mg/25 mg. The most common side effects experienced by patients taking the new combination medication included dizziness, flulike symptoms, diarrhea, cough, and tiredness.


Liquid Leukine withdrawn from market

The FDA and Bayer have notified healthcare professionals that the current liquid formulation of the growth factor Leukine was removed from the market because of an upward trend in spontaneous reports of adverse reactions, including syncope, that are temporarily correlated with a change in the formulation of liquid Leukine to include edetate disodium (EDTA). The upward trend in adverse reaction reporting rates has not been observed with the use of lyophilized Leukine, the FDA notes.


Healthcare professionals are instructed to immediately stop using the liquid Leukine formulation and return unused vials to the manufacturer. Bayer will establish a special access program for the currently marketed lyophilized Leukine 250 mcg vial, which does not contain EDTA. The program is designed to prioritize the supply of lyophilized Leukine for oncologists and hematologists who prescribe Leukine.


FDA acts against compounded menopause drugs

The FDA sent warning letters to seven pharmacy operations concerning claims they made about the safety and effectiveness of their bioidentical hormone replacement therapy (BHRT) products. According to the FDA, these claims are unsupported by medical evidence and are considered false and misleading by the agency.


The BHRT drugs sold by these pharmacies contain estrogen, progesterone, and estriol; and the pharmacies claim that they are superior to FDA-approved menopausal hormone therapy (HT) drugs and can prevent or treat serious diseases. The agency is concerned that unfounded claims like these mislead women and healthcare professionals. "Compounded drugs are not reviewed by the FDA for safety and effectiveness, and the FDA encourages patients to use FDA-approved drugs whenever possible," the agency's statement notes. The FDA has never approved any drug product containing estriol, and the safety and effectiveness of estriol is unknown.

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The warning letters state that the pharmacy operations violate federal law by making false and misleading claims about their HT drugs. The agency's action does not target pharmacists who practice traditional pharmacy compounding and who do not make false or misleading claims about compounded products.