The FDA has required changes in the labeling of all systemic fluoroquinolone antibiotics to strengthen warnings about the risk of severe hypoglycemia and mental health effects associated with their use.1An FDA review identified 67 cases of hypoglycemic coma associated with fluoroquinolone use, 22 of which resulted in death or disability. Most cases occurred in patients with risk factors such as diabetes (especially those taking a sulfonylurea), older age, or renal insufficiency.1 In observational studies in older adults and patients with diabetes, fluoroquinolones have been associated with...

The FDA has required a new warning in the labels of prescription and over-the-counter products containing nonsteroidal anti-inflammatory drugs (NSAIDs) advising against their use during pregnancy beginning at 20 weeks’ gestation because of a risk of renal dysfunction in the fetus that could lead to low amniotic fluid levels (oligohydramnios) and neonatal renal impairment. NSAID labels previously warned against use of the drugs beginning at 30 weeks' gestation because of a risk for premature closure of the ductus arteriosus and persistent neonatal pulmonary hypertension

Radicava ORS, an oral suspension formulation of the free radical scavenger edaravone (Mitsubishi Tanabe Pharma), has been approved by the FDA for treatment of amyotrophic lateral sclerosis (ALS). An IV formulation of edaravone (Radicava) has been available since 2017.

We reviewed brolucizumab (Beovu – Novartis) for treatment of neovascular (wet) age-related macular degeneration in our February 10 issue. On February 23, the American Society of Retina Specialists reported that 14 patients who received the drug have developed retinal vasculitis, a potentially vision-threatening complication.

In 1989, Photoplex (Allergan Herbert), a combination of the dibenzoyl methane avobenzone (Parsol 1789) and the aminobenzoic acid (PABA) ester padimate O, was the first 'broad spectrum' sunscreen to become available in the USA (Medical Letter, 31:59, 1989). Now, Shade UVAGuard (Schering-Plough), a similar product, has been approved by the US Food and Drug Administration; it also contains avobenzone, plus the benzophenone oxybenzone and octyl methoxycinnamate.

Glatiramer acetate (Copaxone - Teva Marion Partners), formerly known as copolymer-l, has been approved by the US Food and Drug Administration (FDA) for treatment of relapsing-remitting multiple sclerosis (MS). Interferon β-1b (Betaseron) and interferon β-1a (Avonex - Medical Letter, 38:63, 1996) were previously approved for this indication.

Extracts made from leaves of the ginkgo tree (Ginkgo biloba) are available in the uSA as deitary supplements, in France and Germany as licensed drugs and worldwide as herbal remedies for treatment of dementia and many other indications.

Once-a-week formulations of alendronate (Fosamax) in 35- and 70-mg tablets have now been approved by the FDA and are being heavily promoted for prevention and treatment of postmenopausal osteoporosis. A new formulation of risedronate (Actonel) for once-a-week use is under development and may be available next year.

A new once-daily formulation of gabapentin (Gralise – Depomed) has been approved by the FDA for treatment of postherpetic neuralgia (PHN). Immediate-release (IR) gabapentin (Neurontin, and others), which has been available in the US since 1994, is also approved for this indication, but is taken three times a day. Extended-release gabapentin enacarbil (Horizant) was recently approved by the FDA for treatment of restless legs syndrome.

Probiotics are live, nonpathogenic microorganisms (usually bacteria or yeasts) marketed as dietary supplements. They have not been approved by the FDA for any indication. Since our last article on this subject, some new data have become available.