Genetic Test for Carbamazepine-Induced Stevens-Johnson Syndrome Carbamazepine (Tegretol, Carbatrol, Equetro, and others), which is now used to treat not only epilepsy but also trigeminal neuralgia and manic episodes in patients with bipolar disorder,1 is a known cause of Stevens-Johnson syndrome (SJS). The incidence of carbamazepine-induced SJS in countries with mainly white populations is 1 to 6 per 10,000 new users of the drug, but Asian patients have a 10-fold higher incidence of this reaction. An association has been found between the human leukocyte antigen (HLA)-B*1502 allele and...

The FDA has issued an update (August 18, 2008; www.fda.gov) on occurrences of acute pancreatitis in patients with diabetes taking exenatide (Byetta – Amylin/Lilly). The latest update, which follows an FDA Alert in October 2007, reports 6 cases of hemorrhagic or necrotizing pancreatitis with 2 deaths in patients taking the drug. Whether pancreatitis occurs more often in patients taking exenatide than in patients with diabetes not taking exenatide is not clear.1Given by subcutaneous injection, exenatide is a synthetic peptide that stimulates release of insulin from pancreatic beta cells.2 It...

Benzyl Alcohol Lotion for Head Lice (Med Lett Drugs Ther 2009; 51:57) In Table 1, the price for lindane 1% shampoo should be $136.86 (not $3.00). When a Statin Fails (Med Lett Drugs Ther 2009; 51:58) The first sentence should read as follows: "The National Cholesterol Program recommends that LDL-C be lowered to less than 100 mg/dL (2.6 mmol/L) for patients at high risk...." Tapentadol (Nucynta) - A New Analgesic (Med Lett Drugs Ther 2009; 51:61) In table 1, the half-life for tapentadol should be 4 hours (not...

The FDA has approved the use of dalfampridine (4-aminopyridine; Ampyra – Acorda), a potassium channel blocker, to improve walking speed in patients with multiple sclerosis (MS). Walking speed is considered a reliable clinical measure of impairment in patients with MS.

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.

The FDA has approved a new extended-release formulation of the corticosteroid budesonide (Uceris – Santarus) for induction of remission in patients with mild to moderate ulcerative colitis.

The FDA has approved Zorvolex (Iroko), a low-dose oral formulation of the relatively COX-2 selective NSAID diclofenac, for treatment of mild-to-moderate acute pain in adults.

The FDA has approved another fixed combination of the antibiotic clindamycin phosphate and the oxidizing agent benzoyl peroxide (Onexton Gel 1.2%/3.75% – Valeant) for topical treatment of acne in patients ≥12 years old. Topical products containing the same drugs have been available for many years. Onexton Gel contains a new strength of benzoyl peroxide.

The FDA has approved lanadelumab-flyo (Takhzyro – Takeda), a subcutaneously-administered plasma kallikrein inhibitor, for prevention of hereditary angioedema (HAE) attacks in adults and children ≥12 years old. Lanadelumab is the third drug to be approved for this indication; the human plasmaderived C1 esterase inhibitors (C1INHs) Cinryze, which is administered IV, and Haegarda, which is given SC, have been available for years for HAE prophylaxis in patients ≥6 years old.

Xywav (Jazz), an oral solution that contains calcium, magnesium, potassium, and sodium oxybates, has been approved by the FDA for treatment of idiopathic hypersomnia in adults. It is the first drug to be approved in the US for this indication. Xywav was approved in 2020 for treatment of excessive daytime sleepiness or cataplexy in patients ≥7 years old with narcolepsy. It contains about 92% less sodium than sodium oxybate oral solution (Xyrem), which has been available in the US for years for use in patients ≥7 years old with narcolepsy.