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 tablet is approved for patients not controlled by either drug alone, but should not be used before other medications have been tried.
Tekturna HCT may be given with other antihypertensives 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, flu-like symptoms, diarrhea, cough, and tiredness.
FDA Acts Against 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; 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.
The warning letters state that the pharmacy operations violate federal law by making false and misleading claims about their HT drugs.
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):
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.
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)