The FDA has approved the oral tyrosine kinase inhibitor ripretinib (Qinlock – Deciphera) for treatment of adults with advanced gastrointestinal stromal tumors (GISTs) who have previously received treatment with ≥3 kinase inhibitors, including imatinib (Gleevec, and generics).

The FDA has approved an intranasal formulation of the opioid antagonist nalmefene (Opvee – Indivior) for emergency treatment of known or suspected opioid overdose in persons ≥12 years old. Nalmefene, which is available by prescription, is the second opioid antagonist to become available as a nasal spray for this indication; the first was naloxone, which is now available for sale over the counter (Narcan, and generic). Other nasal spray formulations of naloxone and injectable formulations of nalmefene and naloxone are available by prescription (see Table 2).

The FDA has approved daxibotulinumtoxinA-lanm (Daxxify – Revance), an acetylcholine release inhibitor and neuromuscular blocking agent, for temporary improvement in the appearance of moderate to severe glabellar (frown) lines associated with corrugator and/or procerus muscle activity. Daxxify is the fifth botulinumtoxin type A product to be approved in the US for this indication (see Table 1). It is also approved for treatment of cervical dystonia in adults

Adenosine (Adenocard - Fujisawa), an endogenous purine nucleoside, was recently approved by the US Food and Drug Administration for intravenous treatment of paroxysmal supraventricular tachycardia, including Wolff-Parkinson-White (WPW) syndrome. Adenosine is not approved for and has not been effective in treating atrial flutter, atrial fibrillation, or ventricular tachycardias.

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).

Liraglutide (Victoza – Novo Nordisk), a glucagon-like peptide-1 (GLP-1) receptor agonist given by subcutaneous injection, has been approved by the FDA for treatment of patients with type 2 diabetes. It can be used alone or in addition to oral antidiabetic drugs such as metformin (Glucophage, and others) or glimepiride (Amaryl, and others). Liraglutide is not recommended for first-line therapy and is not approved for use with insulin.

The FDA has asked Impax Laboratories/Teva Pharmaceuticals to stop production and distribution of Budeprion XL 300 mg, a generic extended-release formulation of the antidepressant bupropion (Wellbutrin XL), because it has found that Budeprion XL 300 mg releases bupropion more rapidly than Wellbutrin XL 300 mg, the original brand name product. Patients switched from the brand name to the generic formulation have complained for years that the generic was less effective and caused more side effects than the original formulation. In 2007, ConsumerLab.com, an independent laboratory, conducted...

Our July 9, 2012 article (Med Lett Drugs Ther 2012; 54:55) on renal sympathetic denervation for multiple-drug resistant hypertension concluded that the catheter-based procedure (Symplicity Catheter System – Medtronic) can lower blood pressure in most patients with hypertension resistant to ≥3 antihypertensive drugs. That conclusion was based on the results of 2 studies. SYMPLICITY HTN-1 compared outcomes to baseline blood pressures. SYMPLICITY HTN-2 randomized patients to renal denervation or usual care.Medtronic has issued a press release (January 9, 2014) announcing that SYMPLICITY...

Several readers have raised questions about the statement in our recent article (Med Lett Drugs Ther 2012; 54:58) that long-acting insulins, like metformin and sulfonylureas, have been shown to decrease long-term cardiovascular risk. Our statement was based on the extension of the UKPDS (RR Holman et al, N Engl J Med 2008; 359:1577), which is the longest prospective trial of drug therapy in patients with type 2 diabetes. Shorter studies in older patients with long-standing diabetes did not find a reduction in cardiovascular risk with these and other drugs (The Action to Control Cardiovascular...

The FDA has amended its Emergency Use Authorization (EUA) for Paxlovid (Pfizer), the investigational oral antiviral drug nirmatrelvir copackaged with oral ritonavir, to allow for it to be prescribed by licensed pharmacists in certain situations. Paxlovid is authorized for oral treatment of mild to moderate COVID-19 in high-risk outpatients ≥12 years old who weigh at least 40 kg. NIH guidelines list it as the treatment of choice for COVID-19 in high-risk adult outpatients.