Clarithromycin (Biaxin - Abbott) and azithromycin (Zithromax - Pfizer), two macrolide antibiotics chemically related to erythromycin, have been approved by the US Food and Drug Administration for treatment of respiratory, skin, and skin structure infections. Azithromycin has also been approved for treatment of nongonococcal urethritis and cervicitis caused by Chlamydia trachomatis.

More antibiotics are prescribed for treatment of acute otitis media (AOM) than for any other infection in young children. Children with AOM typically present with otalgia, fever, and bulging and erythema of the tympanic membrane.

The FDA has approved a new indication for prevention of anal cancer and anal intraepithelial neoplasia in both sexes for the human papillomavirus (HPV) vaccine Gardasil (Merck). This vaccine is already FDA-approved for prevention of cervical cancer and genital warts in females 9-26 years old and for prevention of genital warts in males 9-26 years old. HPV types 6 and 11 cause about 90% of genital warts. Types 16 and 18 cause more than 70% of cervical cancer and about 80% of anal cancer.1 Gardasil is highly effective in preventing infection with HPV types 6, 11, 16 and 18 in both males and...

The FDA recently announced labeling changes for the combination antiviral products Viekira Pak (ombitasvir/paritaprevir/ritonavir with dasabuvir)1 and Technivie (ombitasvir/paritaprevir/ritonavir)2 warning of a risk of serious, potentially fatal liver injury.3 Viekira Pak, approved in December 2014 for treatment of hepatitis C virus (HCV) genotype 1 infection, including patients with compensated cirrhosis, and Technivie, approved in July 2015 for treatment of HCV genotype 4 infection without cirrhosis, have been identified as "possible" or "probable" causes in 26 postmarketing cases of hepatic...

The drugs of choice for treatment of fungal infections are listed in the table that begins on page 62. Some of the indications and dosages recommended here have not been approved by the FDA. More detailed guidelines for some of these infections are available online from the Infectious Diseases Society of America (www.idsociety.org).

The FDA recently announced that it will require the labeling of all direct-acting antiviral drugs used for treatment of hepatitis C virus (HCV) infection to include a boxed warning about a risk of hepatitis B virus (HBV) reactivation associated with their use.1Twenty-four cases of HBV reactivation occurring during treatment with direct-acting antiviral drugs for HCV were identified from the FDA Adverse Event Reporting System and the medical literature.2-5 Before starting direct-acting antiviral treatment for HCV, some of these patients were hepatitis B surface antigen (HbsAG) positive and...

Penciclovir 1% cream (Denavir - SmithKline Beecham) has been approved by the US Food and Drug Administration (FDA) for treatment of recurrent orolabial herpes simplex virus (HSV) infections in adults. Acyclovir (Zovirax) is also available in a topical formulation for treatment of herpes simplex infections, but is approved by the FDA only for use in immunocompromised patients. Oral drugs approved for treatment of some herpes simplex infections, but not recurrent orolabial infections, include acyclovir, valacyclovir (Valtrex) and famciclovir (Famvir), which is rapidly hydrolyzed to...

The FDA has approved Descovy (Gilead), a fixed-dose combination of the nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) emtricitabine (FTC) and tenofovir alafenamide (TAF) for use with other antiretroviral agents for treatment of HIV-1 infection. A combination of emtricitabine and tenofovir disoproxil fumarate (FTC/TDF; Truvada) has been available since 2004 for the same indication. Emtricitabine and TAF are also available in combination with the non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine as Odefsey and with the integrase strand transfer...

Cefprozil (Cefzil - Bristol-Myers Squibb), a new oral second-generation cephalosporin, was recently released in the USA for treatment of pharyngitis, bronchitis, otitis media, and skin and skin-structure infections.

Cefuroxime axetil (Ceftin - Glaxo), an oral form of the second-generation parenteral cephalosporin cefuroxime (Zinacef), was recently marketed in the USA. Previously available oral cephalosporins are the first-generation drugs cephalexin (Keflex; and others), cephradine (Anspor; and others) and cefadroxil (Duricef; and others), and the second-generation cefaclor (Ceclor); second-generation cephalosporins have more activity against gram-negative bacteria.