The FDA has approved stiripentol (Diacomit – Biocodex) for treatment of seizures in patients ≥2 years old with Dravet syndrome who are also taking clobazam (Onfi). Stiripentol, which has been available in Europe, Canada, and Japan for many years, is the second drug to be approved in the US for this indication; cannabidiol oral solution (Epidiolex), a purified marijuana product, was the first.

Rozanolixizumab-noli (Rystiggo – UCB), a neonatal Fc receptor (FcRn) blocker, has been approved by the FDA for treatment of generalized myasthenia gravis in adults with anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibodies. It is the first drug to be approved for treatment of generalized myasthenia gravis in patients with anti-MuSK antibodies. Four other biologic drugs – the FcRn blocker efgartigimod alfa (Vyvgart; Vyvgart Hytrulo) and the complement inhibitors eculizumab (Soliris), ravulizumab (Ultomiris), and zilucoplan (Zilbrysq) – are...

The FDA has approved a new tablet formulation of immediate-release (IR) oxycodone (Oxecta – King) for management of acute and chronic moderate to severe pain.Oxecta uses a tamper-resistant technology designed to deter oxycodone abuse by injection or nasal snorting. Dissolving the crushed tablet in water or alcohol converts it into a viscous gel mixture, making it difficult to inject. Crushing the tablet and inhaling it through the nose causes burning and irritation. Whether the new formulation will actually prevent abuse of the drug has not been established. Oxecta is classified as a...

Some readers of our article on Antiviral Drugs for Seasonal Influenza have expressed concerns regarding our recommendation for use of the oral neuraminidase inhibitor oseltamivir (Tamiflu) to treat high-risk patients with confirmed or suspected influenza illness, citing the British Medical Journal and The Cochrane Collaboration, which have contended that there is no acceptable evidence that the drug prevents complications or hospitalizations and have questioned the completeness of the results of controlled trials conducted by the manufacturer (Roche).

Nafarelin acetate (Synarel - Syntex), a synthetic analog of gonadotropin-releasing hormone (GnRH), was recently approved by the US Food and Drug Administration for treatment of endometriosis. The drug is available only in a nasal spray formulation.

Tacrine hydrochloride (Cognex - Parke-Davis), an acridinamine derivative, will soon be available for treatment of cognitive deficits associated with Alzheimer's disease.

Venlafaxine hydrochloride (Effexor - Wyeth-Ayerst) was recently approved by the US Food and Drug Administration for treatment of depression. An aminomethyl-benzyl- cyclohexanol, it is chemically related to bupropion (Wellbutrin).

Tramadol hydrochloride (Ultram - Ortho-McNeil), a centrally-acting analgesic marketed in Germany since 1977, was recently approved by the US Food and Drug Administration for oral treatment of moderate to moderately severe pain. Despite some opioid activity, tramadol has not been scheduled as a controlled substance.

Zileuton (zye loo' ton; Zyflo - Abbott), an inhibitor of leukotriene synthesis, has been approved by the US Food and Drug Administration (FDA) for prophylaxis and maintenance treatment of chronic asthma in adults and children more than 12 years old. A related drug—zafirlukast (Accolate), a leukotriene receptor antagonist—was recently reviewed in the Medical Letter (vol. 38, page 111, December 20, 1996). Neither of these drugs is recommended for treatment of acute asthma.

The FDA has added a boxed warning to fluoroquinolone package inserts about tendon injuries that may occur as a result of their use. Tendinitis or tendon rupture may occur rarely with systemic use of any fluoroquinolone, either while the drug is being taken or for up to several months afterwards.Fluoroquinolone-related tendon injury is rare; estimates for its incidence in the general population range from 0.14% to 0.4%. The risk is higher for patients >60 years old and for those taking corticosteroids. For patients with organ transplants, the incidence may be as high as 15%.1 A case-control...