The FDA issued a public health advisory on March 10, 2005 warning about a risk of cancer with topical formulations of tacrolimus (Protopic) and pimecrolimus (Elidel) used to treat eczema in adults and children more than 2 years old. Elidel has been heavily promoted to the general public on television. The warning was based on reports of dose-related cancer in animals and 29 reports of cancer (including 8 skin malignancies and 12 lymphomas) in adults and children treated with these immunosuppressive drugs. Cause and effect have not been established. When Protopic was first marketed, The Medical...

The FDA has approved marketing of Zegerid powder for oral suspension (Santarus), an immediate-release formulation of the proton-pump inhibitor (PPI) omeprazole (Prilosec, and others). All other oral PPIs are delayed-release, enteric-coated formulations designed to prevent degradation of the drug by gastric acid. Each 20- or 40-mg packet of Zegerid contains 1680 mg of sodium bicarbonate, which protects the drug from gastric acid degradation. A dose of Zegerid contains 460 mg of sodium, which may be excessive for some patients. Zegerid is the first oral PPI to be approved by the FDA for...

Inavolisib (Itovebi – Genentech), an oral kinase inhibitor, has been approved by the FDA for use in combination with palbociclib and fulvestrant for treatment of endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer. This is the first approval for Itovebi; palbociclib and fulvestrant have been available for years for treatment of HR-positive, HER2-negative breast cancer.

Management of intermittent claudication, the most common symptom of peripheral arterial disease (PAD), involves both risk factor modification and symptomatic treatment (WR Hiatt, N Engl J Med 2001; 344:1608; RM Schainfeld, J Am Board Fam Pract 2001; 14:443).

Health Canada, the Canadian equivalent of the FDA, recently issued a public advisory about postmarketing reports of myalgia, rhabdomyolysis, hepatitis, pancreatitis and thrombocytopenia associated with use of ezetimibe (Zetia in the US; Ezetrol in Canada). Ezetimibe is often added to a statin to increase LDL cholesterol lowering (Drugs for Lipids, Treat Guidel Med Lett 2005; 3:15). The advisory did not specify whether these patients were also taking a statin, but according to the Canadian manufacturer Merck Frosst/Schering (Merck/Schering-Plough in the US), some of the patients who developed...

On February 9, 2005, Health Canada suspended the marketing of Adderall XR (Shire), a mixture of amphetamine salts used to treat attention-deficit hyperactivity disorder (ADHD) (Med Lett Drugs Ther 1994; 36:109). The immediate-release form of Adderall was never marketed in Canada. The withdrawal was based on 20 reports internationally of sudden death in patients taking the drug. These deaths, 14 of them in children, were not linked to overdose or abuse. The FDA decided that the number of sudden deaths was no greater than expected among the large number of people taking the drug, but because 5...

Telithromycin (Ketek) is an oral erythromycin derivative FDA-approved for treatment of mild to moderate community-acquired pneumonia, exacerbations of chronic bronchitis and acute bacterial sinusitis (Med Lett Drugs Ther 2004; 46:66). It is generally considered an alternative antibiotic because of its cost, potential for adverse effects including visual disturbances, exacerbation of myasthenia gravis, hepatotoxicity and drug interactions. A recent report (Ann Intern Med 2006; 144:415) described serious hepatotoxicity probably related to telithromycin in three patients, including one who died...

In the CLINICAL STUDIES - Other Cancers paragraph (Med Lett Drugs Ther 2007; 49:35), the dosage in the first line should be 2.5 mg/kg, not 25 mg/kg.

The article in the July 14th issue contained an error in the last sentence of the last paragraph beginning on page 55. The instrument's reading is determined not by the degree of protrusion of the tympanic membrane, but rather by its mobility.