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

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 injection of onabotulinumtoxinA (Botox – Allergan) for prevention of headaches in adult patients with chronic migraine (≥15 headache days/month for ≥3 months). It is the first drug approved for treatment of this indication. Botox is also FDA-approved for treatment of upper limb spasticity, axillary hyperhidrosis, cervical dystonia, blepharospasm and strabismus, and for cosmetic reduction of wrinkles.

An oral solution (Vituz – Hawthorne) containing two old drugs, the centrally-acting opioid hydrocodone bitartrate and the first-generation H1-antihistamine chlorpheniramine maleate, has been approved by the FDA for relief of cough and [other] symptoms associated with upper respiratory allergies or a common cold in adults. Several extended-release products containing hydrocodone and chlorpheniramine are available as capsules and suspensions and have been used for years for similar indications. Vituz is classified as a schedule III controlled substance, but the FDA has asked the DEA...

The FDA has approved sebelipase alfa (Kanuma – Alexion), a recombinant form of lysosomal acid lipase (LAL), for enzyme replacement therapy in patients with LAL deficiency. Sebelipase alfa is the first drug to be approved in the US for treatment of LAL deficiency, a rare autosomal recessive storage disease.

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.

Cefmetazole sodium (Zefazone - Upjohn), a second-generation parenteral cephalosporin, was recently marketed in the USA for intravenous (IV) treatment of various infections caused by susceptible organisms. Like cefotetan (Cefotan), cefamandole (Mandol), cefoperazone (Cefobid), and moxalactam (Moxam), cefmetazole contains a methylthiotetrazole group that has been associated with prothrombin deficiency.

Felodipine (Plendil - Merck), an extended-release preparation of a dihydropyridine calcium-channel blocker was recently marketed in the USA for oral treatment of hypertension. An immediate-release formulation is available in some other countries.

Systemic allergic reactions to insect stings can include generalized urticaria, bronchospasm, laryngeal edema, hypotension and death. About 1% to 3% of adults in the USA have had a systemic allergic reaction to an insect sting (RE Reisman, Med Clin North Am, 76:883, 1992; UR M ller, Monogr Allergy, 31:131, 1993).

An intranasal formulation of the corticosteroid budesonide (Rhinocort Nasal Inhaler - Astra) was recently approved by the US Food and Drug Administration for treatment of seasonal or perennial allergic rhinitis in adults and children and nonallergic perennial rhinitis in adults. Budesonide has been available in Canada and Europe for several years for inhalation treatment of both allergic rhinitis and asthma.