Some readers have objected to our recommendation (Med Lett Drugs Ther 2013; 55:55) that postmenopausal women with an intact uterus who take the oral estrogen agonist/antagonist ospemifene (Osphena) to reduce the severity of dyspareunia should also take a progestin.1 Ospemifene has agonistic effects on the endometrium, and the Osphena package insert says: "Generally, when a product with estrogen agonistic effects on the endometrium is prescribed for a postmenopausal woman with a uterus, a progestin should be considered to reduce the risk of endometrial cancer."Endometrial hyperplasia has been...

Terazosin (Hytrin - Abbott), a postsynaptic alpha 1 -adrenoreceptor blocker previ-ously available for treatment of hypertension (Medical Letter, 29:113, 1987), has now been approved by the US Food and Drug Administration (FDA) for treatment of benign prostatic hyperplasia (BPH). Although not previously approved by the FDA, terazosin and other alpha-blockers such as prazosin (Minipress, and others) or doxazosin (Car-dura) have been used for this indication for many years.

Clonidine, an Alpha2-selective adrenergic agonist marketed in the USA only for treatment of hypertension, has also been used in recent years to treat children with attention-deficit/hyperactivity disorder (ADHD).

In 2007, an FDA advisory committee asked that placebo-controlled, dose-ranging trials be conducted to establish the efficacy of the oral decongestant phenylephrine (Sudafed PE, and others), which is sold over the counter (OTC) as a single agent and in combination with other drugs for treatment of cold and allergy symptoms. Phenylephrine replaced pseudoephedrine (Sudafed, and others) in many OTC formulations when access to pseudoephedrine-containing products was restricted in an effort to reduce their use in the synthesis of methamphetamine.CLINICAL STUDIES — In a randomized, open-label,...

In our recent article on Lipid-Lowering Drugs,1 we said that statins can reduce the risk of first cardiovascular events and death (primary prevention) in patients at high risk for atherosclerotic cardiovascular disease (CVD) and significantly reduce the incidence of cardiovascular events in patients at lower risk for CVD. Now the United States Preventive Services Task Force (USPSTF) has issued new recommendations on the appropriate use of statins for primary prevention of CVD.2The USPSTF states that clinicians should periodically screen all persons 40-75 years old for cardiovascular risk...

The FDA has approved the use of the phosphodiesterase-5 (PDE-5) inhibitor tadalafil (Cialis – Lilly) for treatment of signs and symptoms of benign prostatic hyperplasia (BPH) in men with or without erectile dysfunction. Tadalafil is approved for use under another brand name (Adcirca) for treatment of pulmonary arterial hypertension. The other PDE-5 inhibitors available in the US for treatment of erectile dysfunction (sildenafil [Viagra]; vardenafil [Levitra]) have also been reported to be effective for treatment of BPH signs and symptoms, but have not been approved for this...

The FDA has approved Lomaira (KVK Tech), an 8-mg tablet formulation of phentermine that can be taken up to three times daily before meals, as an adjunct to lifestyle modifications for weight loss. It is only approved for short-term use (a few weeks) in adults with a body mass index (BMI) ≥30 kg/m2, or with a BMI ≥27 kg/m2 in addition to a weight-related comorbidity such as hypertension, dyslipidemia, or diabetes. Phentermine has been available alone and in combination with topiramate for years.1Lomaira was approved by the FDA under an abbreviated new drug application (ANDA) and is...

Many fermented foods contain tyramine as a byproduct formed by the bacterial breakdown of the amino acid tyrosine; it can also be formed by para-hydroxylation of phenylethylamine or dehydroxylation of DOPA and dopamine. Tyramine and some other amines found in food can cause hypertensive reactions in patients taking monoamine oxidase (MAO)inhibitors.

The FDA has approved Simbrinza (Alcon), an ophthalmic combination of the carbonic anhydrase inhibitor brinzolamide and the selective alpha₂-adrenergic receptor agonist brimonidine, for reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Simbrinza is the first product to combine drugs from these 2 classes.

The FDA has approved fostamatinib disodium hexahydrate (Tavalisse – Rigel), the first spleen tyrosine kinase (SYK) inhibitor, for oral treatment of thrombocytopenia in adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.