The FDA has approved ziconotide (Prialt - Elan) intrathecal infusion for management of severe chronic pain in patients who are intolerant of or refractory to other treatments. Ziconotide is a synthetic neuronal N-type calcium channel blocker. It is intended for use with a programmable implanted microinfusion device, but an external microinfusion device can be used temporarily.

The FDA has approved a new oral solution of the calcium channel blocker nimodipine (Nymalize – Arbor) to reduce the severity of neurological deficits associated with vasospasm after subarachnoid hemorrhage from a ruptured intracranial aneurysm. An older formulation of nimodipine has been available for such use for many years.1Since 1988, nimodipine has been available only in liquid-filled gel capsules (Nimotop, and generics) that a conscious patient could swallow intact. For unconscious patients, the package insert included instructions for use of a needle and syringe to aspirate the liquid...

The FDA has approved aliskiren/amlodipine/hydrochlorothiazide (Amturnide) for treatment of hypertension, with no restrictions except that it should not be used for initial therapy. A combination of the direct renin inhibitor aliskiren and the calcium channel blocker amlodipine (Tekamlo) was approved earlier for initial treatment.1Use of combination tablets is, of course, more convenient than taking the components separately, and as long as all the same doses are available and the cost is no greater, there is no reason not to use them.Aliskiren alone or in combination has not been shown to...

A reader commenting on our Treatment of Lyme Disease article (Med Lett Drugs Ther 2016; 58:57) objected to a footnote in the table advising against use of doxycycline in children <8 years old. This warning has been included in the labeling of all tetracyclines since 1970 when it was recognized, after decades of use, that these drugs caused permanent staining and enamel hypoplasia of developing teeth. The CDC recently stated that short courses of doxycycline, which was first marketed in the US in 1967 and has less affnity for calcium than other tetracyclines, have not been shown to cause...

Zafirlukast (za fir loo kast; Accolate - Zeneca), the first leukotriene receptor anta-gonist approved by the US Food and Drug Administration, is now being heavily promoted for oral maintenance treatment of chronic asthma in patients more than 12 years old. It is not recommended for treatment of acute asthma.

Older patients are especially susceptible to drug-induced cognitive impairment. They are more likely to be taking multiple drugs, to have higher blood levels of those drugs because of renal or hepatic dysfunction, and to have pre-existing cognitive problems that make it difficult to detect the role of drugs causing new symptoms or making old ones worse.

Ibandronate (Boniva - Roche/GSK), a new oral bisphosphonate, was recently approved by the FDA in a once-monthly formulation for prevention and treatment of postmenopausal osteoporosis. The drug was initially approved in 2003 as a daily tablet, but was not marketed. An intravenous formulation for use once every 3 months is under investigation.

Zoledronic acid (Reclast - Novartis) is the first bisphosphonate approved by the FDA for once-yearly intravenous (IV) treatment of osteoporosis in postmenopausal women. Reclast is also approved for treatment of Paget's disease. Another IV formulation of zoledronic acid (Zometa) is approved for treatment of hypercalcemia of malignancy, multiple myeloma and bone metastases from solid tumors.

The FDA, which recently approved subcutaneous (SC) administration of denosumab (Prolia – Amgen) for treatment of postmenopausal osteoporosis,1 has now approved the same drug with a different brand name (Xgeva – Amgen) and dosage for prevention of skeletal-related events (such as pathologic fracture, spinal cord compression or radiation to bone) in patients with bone metastases from solid tumors. Denosumab is a fully human anti-RANK ligand antibody that inhibits the formation, activation and survival of osteoclasts.2A prospective, randomized, double-blind trial in 1901 patients with bone...

A randomized, placebo-controlled trial evaluating the addition of the direct renin inhibitor aliskiren (Tekturna – Novartis) to an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) in 8606 patients with type 2 diabetes and renal impairment (ALTITUDE) was terminated prematurely by the manufacturer because the combined incidence of cardiovascular and renal events was higher in patients who received aliskiren than in those who received placebo.1Combining two different types of drugs that block the renin angiotensin system in patients at high-risk for...