The Food and Drug Administration has added information to statin labels regarding an effect on diabetes, noting reported increases in glycated hemoglobin and fasting serum glucose levels but adding that it believes that the cardiovascular benefits outweigh the risks.

In the 21st century, osteoporosis, a disease once considered an inevitable consequence of aging, is both diagnosable and treatable. Large, randomized, controlled trials have shown that bisphosphonate therapy for 3 to 4 years is effective in reducing the ...

Osteoporosis, a disease characterized by reduced bone mass and increased skeletal fragility, affects 10 million Americans; another 34 million are at risk for it. Bisphosphonates are widely prescribed for osteoporosis; more than 150 million prescriptions ...

U.S. patients continue to be exposed to underperforming and potentially hazardous medical devices after FDA approval. Most recently, Riata and Riata ST implantable cardioverter–defibrillator leads — currently implanted in more than 75,000 U.S. patients — were recalled.

Failures of implantable medical devices can carry substantial risk of serious injury, and effective systems for monitoring safety after marketing begins are essential. Several FDA initiatives have been launched to fill the gaps in the passive event-reporting system.

By law, dietary supplements whose ingredients were not sold in the United States before 1994 require demonstration of a “reasonable expectation of safety” — a currently unenforced requirement. Will the FDA's proposed new guidance in this area be adequate?

Of the 100,000-plus implantable cardioverter–defibrillators (ICDs) implanted in the United States annually, at least 25% are generator replacements required for depleted batteries. Should all those patients be receiving replacement ICDs?

Lipitor (atorvastatin) was the top-selling prescription drug in the United States in 2010, but its patent expired in June 2011, and the first generic version entered the market on November 30. What economic impact will the availability of generic atorvastatin have?

On December 7, Health and Human Services Secretary Kathleen Sebelius overruled an FDA decision to approve over-the-counter sales of Plan B One-Step. Although the drug can be used safely without medical supervision, it apparently poses unacceptable political risks.

On November 7, a federal judge in Washington, D.C., issued a preliminary injunction blocking some key provisions of the Family Smoking Prevention and Tobacco Control Act as unconstitutional restrictions on commercial speech. The battle may end up in the Supreme Court.

In July, the FDA approved Arcapta Neohaler (indacaterol maleate powder), a long-acting beta-agonist, at a daily dose of 75 μg for chronic obstructive pulmonary disease. Why was this dose selected, after the European Medicines Agency approved 150-μg and 300-μg doses?

Fifty years ago, a constellation of events transformed the way we think about drug safety. Key among them: the actions of Frances Kelsey at the FDA, who kept thalidomide off the U.S. market, sparing Americans an epidemic of limb-reduction birth defects.

An FDA advisory committee recently considered a new drug application for rivaroxaban for preventing stroke and systemic embolism in patients with nonvalvular atrial fibrillation, but there are important concerns about interpretation of the results of the key study.

The FDA approves many devices on the basis of similarity to precursors, possibly encouraging development of slightly improved, higher-cost devices. A modeling approach can illuminate interplay among efficacy and durability, patient characteristics, costs, and outcomes.