Flumazenil (Mazicon - Roche), a benzodiazepine receptor antagonist, has been approved by the US Food and Drug Administration to reverse the sedative effects of benzodiazepines after anesthesia, sedation for brief surgical or diagnostic procedures, or after benzodiazepine overdosage. The drug does not antagonize opioids, non-benzodiazepine sedatives, or anesthetic drugs.

The FDA has approved Vivlodex (Iroko), a low-dose formulation of the nonsteroidal anti-inflammatory drug meloxicam (Mobic, and generics), for management of osteoarthritis pain. According to the manufacturer, the new formulation aligns with stronger FDA warnings about the cardiovascular risks of NSAIDs and the recommendation to use the lowest possible doses of these drugs.

Pregabalin (Lyrica - Pfizer), a structural analog of gamma-aminobutyric acid (GABA) similar to gabapentin (Neurontin - Pfizer, and others), which recently became available generically, has been approved by the FDA for treatment of neuropathic pain associated with postherpetic neuralgia (PHN) and diabetic peripheral neuropathy (DPN), and for adjunctive treatment of partial onset seizures in adults with epilepsy.

The FDA has approved tramadol hydrochloride extended-release (Ryzolt – Purdue) for treatment of moderate to moderately severe chronic pain in adults. Tramadol is already available in another extended-release formulation (Ultram ER) and in immediate-release tablets alone (Ultram, and others) and combined with acetaminophen (Ultracet, and others).

The FDA has approved use of dinutuximab (Unituxin [yoo ni tux' in] – United Therapeutics) in combination with interleukin-2 (IL-2), granulocyte-macrophage colony-stimulating factor (GM-CSF), and isotretinoin for treatment of children with high-risk neuroblastoma who previously responded to first-line therapies. Dinutuximab is a monoclonal antibody that binds to GD2, a glycolipid that is overexpressed on the surface of neuroblastoma cells.1Dinutuximab received a priority review and orphan drug designation. Approval was based on the results of an open-label trial in 226 patients with high-risk...

The FDA has approved a new tablet formulation of immediate-release (IR) oxycodone (Oxecta – King) for management of acute and chronic moderate to severe pain.Oxecta uses a tamper-resistant technology designed to deter oxycodone abuse by injection or nasal snorting. Dissolving the crushed tablet in water or alcohol converts it into a viscous gel mixture, making it difficult to inject. Crushing the tablet and inhaling it through the nose causes burning and irritation. Whether the new formulation will actually prevent abuse of the drug has not been established. Oxecta is classified as a...

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.

Healthcare providers are often asked if drugs can be used past their expiration date. Because of legal restrictions and liability concerns, manufacturers do not sanction such use and usually do not comment on the safety or effectiveness of their products beyond the date on the label. Since our last article on this subject, more data have become available.

Ropinirole (Requip - GlaxoSmithKline), a dopamine agonist already available for treatment of Parkinson's disease, is now the first drug approved by the FDA for treatment of moderate to severe restless legs syndrome (RLS).

The FDA has approved pegvisomant (Somavert Pfizer), a growth hormone receptor antagonist, for parenteral treatment of acromegaly in patients who are not candidates for or have had an inadequate response to surgery or other treatment. This review describes the disease of acromegaly and its standard treatment options. Also included are sections on the mechanism of action, pharmacokinetics, adverse effects, drug interactions, and the dosage and cost of pegvisomant. Results of clinical studies are discussed. The conclusion provides an overall assessment of the prospects for this new drug.