The oral kinase inhibitors dabrafenib (Tafinlar – GSK) and trametinib (Mekinist – Novartis) have received accelerated approval by the FDA for use together for a fifth indication: treatment of unresectable or metastatic solid tumors with a BRAF V600E mutation in patients ≥6 years old who have progressed following prior treatment and have no satisfactory alternative treatment options. The combination is not approved for treatment of colorectal cancer because of known intrinsic resistance to BRAF inhibition and dabrafenib is not approved for use in patients with wild-type BRAF...

Dronedarone (Multaq – Sanofi), an analog of amiodarone, was approved by the FDA in 2009 for oral treatment of paroxysmal or persistent (non-permanent) atrial fibrillation or atrial flutter. Amiodarone (Cordarone, and others) is more effective for this indication, but its use is often limited by its adverse effects, including thyroid and pulmonary toxicity.

View the Comparison Table: Some FDA-Approved Drugs for Weight Management

The FDA has approved the oral tyrosine kinase inhibitor cabozantinib (Cabometyx – Exelixis) for treatment of patients with advanced renal cell carcinoma previously treated with antiangiogenic therapy. Cabozantinib was first approved in 2012 as Cometriq for treatment of progressive, metastatic medullary thyroid cancer.Anti-VEGF antibodies, tyrosine kinase inhibitors, and mTOR kinase inhibitors have become the standard of care for treatment of unresectable or metastatic renal cell cancer.1FDA approval was based on the results of a randomized open-label trial (METEOR) comparing cabozantinib to...

Since 2008, because of safety concerns, the FDA has mandated that long-term cardiovascular outcomes trials be conducted for all new drugs for type 2 diabetes. Reductions in the incidence of macrovascular complications in these trials with some sodium-glucose co-transporter 2 (SGLT2) inhibitors and glucagon-like peptide 1 (GLP-1) receptor agonists in patients at risk for cardiovascular disease (see Table 1) have led to new recommendations.

The media recently reported that the FDA has threatened to withdraw Synthroid from the market, alarming many physicians and patients.

The FDA has approved a higher-dose injectable formulation of the long-acting glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide (Ozempic) for treatment of type 2 diabetes in adults. A single SC injection of the new 8 mg/3 mL formulation delivers 2 mg of semaglutide.

The thionamides propylthiouracil and methimazole are both used to treat hyperthyroidism.1 Propylthiouracil causes severe hepatic toxicity or hepatic failure in about 0.1% of adults and children.2,3 It is the third leading cause of liver transplants due to drug toxicity (acetaminophen and isoniazid are the first two). Methimazole may cause less serious hepatic toxicity; reversible cholestatic jaundice has been reported. There is generally no good reason to continue to use propylthiouracil, with 2 possible exceptions. First, propylthiouracil may be preferred for treatment of life-threatening...

The injectable glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide (Wegovy), which was approved by the FDA in 2021 for chronic weight management in adults, has now been approved for chronic weight management in children ≥12 years old with an initial BMI in the ≥95th percentile for age and sex.Semaglutide is also available as Ozempic and Rybelsus for treatment of type 2 diabetes in adults.

The injectable glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide (Wegovy) has been approved by the FDA to reduce the risk of major adverse cardiovascular events (MACE) in adults with established cardiovascular disease (CVD) and either obesity or overweight. Semaglutide is the first drug to be approved for cardiovascular risk reduction in this population. It is also approved in a lower-dose injectable formulation as Ozempic and in an oral formulation as Rybelsus (see Table 1).