The FDA recently advised health care professionals and consumers not to use a number of dietary supplements found to contain the phosphodiesterase-5 inhibitor sildenafil (Viagra) or an analog of the drug (www.fda.gov). Although the effects of sildenafil may be noticeable (in men), the presence of other, possibly more toxic adulterants in dietary supplements may be more difficult or impossible to detect.Other drugs previously found in dietary supplements have included lovastatin (Mevacor, and others), estrogen, alprazolam (Xanax, and others), indomethacin (Indocin, and others) and warfarin...

The Medical Letter was founded in 1959 by Arthur Kallet, an engineer, and Dr. Harold Aaron, an internist. In 1932, Kallet had written the book 100,000,000 Guinea Pigs, a best-seller that was partly responsible for the Food and Drug Act of 1938, which required for the first time that new drugs show proof of safety. He was the founding director of Consumers Union and started the publication of Consumer Reports. Dr. Aaron, who became the medical director of Consumer Reports, suggested to Kallet that doctors could use a similar publication to evaluate the new drugs that were coming on the market...

The FDA has approved ruxolitinib (Jakafi – Incyte), a janus-associated kinase (JAK) inhibitor, for treatment of myelofibrosis. Jakafi is the first JAK inhibitor to be approved for any indication and the only drug approved for treatment of myelofibrosis.

The FDA has approved Nuedexta (Avanir), a fixed-dose combination of the cough suppressant dextromethorphan hydrobromide and the antiarrhythmic quinidine sulfate, for oral treatment of pseudobulbar affect. The combination is the first treatment approved by the FDA for this indication. Studies to support the effectiveness of Nuedexta were performed in patients with underlying amyotrophic lateral sclerosis (ALS) or multiple sclerosis (MS); the drug has not been shown to be safe or effective in other types of emotional lability.

An unpublished 2-year randomized study (ENHANCE) on the effect of adding ezetimibe 10 mg to simvastatin 80 mg in 720 patients with heterozygous familial hypercholesterolemia has been in the news recently. About 80% of these patients had previously been treated with statins. The primary endpoint was the change in the intima-media thickness (IMT) of the carotid artery (baseline 0.68 and 0.69 mm); the IMT increased by 0.0111 mm with ezetimibe plus simvastatin and 0.0058 mm with simvastatin 80 mg alone (p=0.29). The ezetimibe- simvastatin combination lowered LDL-C by 58% compared to 41% lowering...

Dordaviprone (Modeyso – Jazz), an oral protease activator, has received accelerated approval from the FDA for treatment of diffuse midline gliomas harboring a H3 K27M mutation in patients ≥ year old who had disease progression following prior treatment. It is the first drug to be approved in the US for this indication.

Donepezil hydrochloride (Aricept - Eisai), a piperidine-based acetylcholinesterase inhibitor, is now being marketed for oral treatment of cognitive symptoms in patients with mild to moderate dementia due to Alzheimer's disease. Donepezil is the second drug approved for this indication; tacrine hydrochloride (Cognex), also an acetylcholinesterase inhibitor, has been available in the USA for four years (Medical Letter, 35:87, 1993).

Vimseltinib (Romvimza – Deciphera), an oral kinase inhibitor, has been approved by the FDA for treatment of symptomatic tenosynovial giant cell tumor in adults for whom surgical resection would cause worsening functional limitation or severe morbidity. The kinase inhibitor pexidartinib (Turalio) was approved for a similar indication in 2019.

Sitagliptin (Januvia) and metformin (Glucophage, and others) are now available in a single tablet (Janumet - Merck) for treatment of type 2 diabetes. The combination is approved by the FDA for use in patients not adequately controlled by sitagliptin or meformin alone or in those already taking both drugs. Metformin is also available in combination with the thiazolidinediones pioglitazone and rosiglitazone and with the sulfonylureas glipizide and glyburide.

View the Comparison Table: Triptans for Migraine