The FDA has approved the marketing of loratadine (Claritin - Schering), a second-generation H₁-antihistamine, without a prescription. The drug was also recently approved for OTC use as Alavert (Wyeth) and other generics are expected.

The fixed-dose combination of olanzapine and fluoxetine (Symbyax - Lilly) has been approved by the FDA for treatment of depressive episodes associated with bipolar disorder. Olanzapine alone (Zyprexa), which is mainly used as an antipsychotic (Medical Letter 2003; 45:102), is FDA-approved for treatment of acute manic episodes and for maintenance treatment of bipolar disorder. Fluoxetine alone (Prozac, and others), which is mainly used as an antidepressant (Medical Letter 2003; 45:93), has no specific approval for use in bipolar...

Medical Letter consultants have brought to our attention some confusion that has accompanied the release of Adacel, a combination of tetanus toxoid, diphtheria toxoid and acellular pertussis antigens (Tdap) recently approved for use as a booster in adolescents and adults 11-64 years old (Med Lett Drugs Ther 2006; 48:5). Another Tdap vaccine, Boostrix, is approved for use in adolescents 10-18 years old. Some adults have inadvertently been immunized with Daptacel or Infanrix (DTaP), which are intended for active immunization of infants and children 6 weeks to 6 years old. Such mix-ups were...

Paliperidone palmitate (Invega Sustenna – Ortho-McNeil Janssen) has been approved by the FDA as a once-monthly injection for acute and maintenance treatment of schizophrenia in adults. An extended-release oral formulation (Invega) has been available since 2006.1 Long-acting injections of antipsychotic drugs typically are used to treat patients who cannot adhere to an oral regimen.2,3 Paliperidone is the primary active metabolite of risperidone (Risperdal), which is also available as a long-acting (every 2 weeks) injection. It is unclear whether either risperidone or paliperidone is a better...

Veltin Gel (Stiefel), a fixed-dose combination of the antibiotic clindamycin phosphate 1.2% and the retinoid tretinoin 0.025%, has been approved by the FDA for topical treatment of acne vulgaris in patients ≥12 years old. Another product containing the same active ingredients (Ziana) has been on the market since 2006.

Alcaftadine (Lastacaft – Allergan), an ophthalmic H₁-antihistamine, has been approved by the FDA for prevention of itching associated with allergic conjunctivitis in patients > 2 years old.

Gabapentin enacarbil (Horizant – GlaxoSmithKline), a new extended-release (ER) tablet formulation of gabapentin, has been approved by the FDA for treatment of moderate-to-severe restless legs syndrome (RLS). The immediate-release (IR) formulation of gabapentin (Neurontin,and others), which is approved for treatment of epilepsy and postherpetic neuralgia, has been used for many years to treat RLS. Another ER tablet formulation of gabapentin (Gralise) has been approved by the FDA for treatment of postherpetic neuralgia.

The FDA has approved fidaxomicin (Dificid – Optimer), a new oral macrolide antibiotic, for treatment of Clostridium difficile-associated diarrhea in patients ≥18 years old. The incidence and severity of C. difficile infection (CDI) have increased in recent years with the emergence of an epidemic hypervirulent strain (NAP1/B1/027), possibly related to widespread use of fluoroquinolones.

Live-attenuated vaccines are generally contraindicated during pregnancy; inactivated vaccines can be given if indicated. A more detailed review of routine immunizations for adults will be available in the December issue of Treatment Guidelines from The Medical Letter.

Electronic cigarettes, also called e-cigarettes, are battery-operated nicotine-delivery devices that resemble tobacco cigarettes. They deliver vapor containing a mixture of nicotine and either propylene glycol or glycerol. E-cigarettes are widely available in retail stores and on the internet in labeled strengths ranging from zero to high levels of nicotine and in flavors such as tobacco, mint, coffee, cherry, bubblegum, and chocolate. They are advertised as a healthier alternative to smoking a tobacco cigarette and, although not FDA-approved, as a smoking cessation tool.