FDA Rounds

Internal Medicine World Report, April 2006, Volume 0, Issue 0

First Drug Patch for Depression

The first skin patch treatment for major depression, transdermal selegiline (Emsam; Bristol-Myers Squibb/Somer?set), has been approved. The patch is applied once a day and delivers selegiline, a mono?amine oxidase inhibitor (MAOI), into the bloodstream. At its lowest strength, selegiline can be used without the dietary restrictions required with oral MAOI antidepressants. The new agent will be available in 3 strengths that deliver 6, 9, or 12 mg of selegiline per 24 hours. The patch is a 3-layer matrix containing a backing, an adhesive drug layer, and a release liner that is placed against the skin. The only common side effect reported is a mild skin reaction (www.bms.com).

New Treatment for Candidemia

An antifungal medicine of the echinocandins class, IV anidulafungin (Eraxis; Pfizer), has been approved to treat candidemia, a potentially life-threatening bloodstream infection. The agent was also approved for 2 other infections caused by the Candida fungus—peritonitis and intra-abdominal abscesses—as well as for esophageal candidiasis. For Candida infections, including candidemia, a single 200-mg loading dose on day 1 should be followed by 100 mg daily; for esophageal candidiasis, a single 100-mg loading dose on day 1 is followed by 50 mg daily. The most common side effects are reduced serum potassium, increased alanine aminotransferase and gamma-glutamyl-transferase levels, diarrhea, and headache (www.eraxisrx.com).

First Immediate-Release PPI

An immediate-release oral formulation of the proton pump inhibitor (PPI) omeprazole and sodium bicarbonate (Zegerid; Santarus)—40/1100 mg and 20/1100 mg—has been approved for the treatment of heartburn and other gastroesophageal reflux symptoms; short-term treatment (4-8 weeks) of endoscopy-diagnosed erosive esophagitis or active benign gastric ulcers; short-term treatment of active duodenal ulcer; and the maintenance of the healing of erosive esophagitis. The recommended adult dosage is 20 mg/day taken on an empty stomach 1 hour before a meal. Adverse events include headache, diarrhea, and abdominal pain (www.santarus.com).

A 24-Day Oral Contraceptive Approved

A new monophasic oral contraceptive, which combines 20 ?g of ethinyl estradiol with 3 mg of the progestin dro?spir?enone (YAZ; Berlex), has received FDA approval. The 24-day, active regimen causes less hormonal fluctuations than traditional oral contraceptives that provide 21 days of active pills. YAZ is expected to be available shortly in the United States by prescription only. It should not be used in patients with conditions that predispose to hyperkalemia (www.berlex.com).

Imaging System Detects Cervical Precancer

A new imaging system that identifies sites on the cervix that may contain precancerous cells has been approved. The LUMA Cervical Imaging System (Medi?Spectra) is intended for use along with colposcopy. It works by analyzing how different areas of the cervix respond to light, assigning a score to small cervical areas, and producing a color map that helps physicians decide optimal biopsy sites (www.medispectra.com).

New Colonoscopy Bowel Prep

Sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP (OsmoPrep Tablets; Salix) have been approved for colon cleansing before a colonoscopy procedure in adults aged Ž18 years (www.salix.com).

New Indications

• Cetuximab (Erbitux; Bristol-Myers Squibb) received a new indication in combination with radiation therapy for the treatment of nonoperable squamous- cell carcinoma of the head and neck. It was also approved as monotherapy for head and neck cancers that have metastasized despite standard chemotherapy. The recommended initial loading dose of cetuximab in combination with radiation therapy is 400 mg/m2 administered as a 120-minute IV infusion 1 week before beginning radiation therapy, followed by a weekly maintenance dose of 250 mg/m2 infused over 60 minutes for the duration of the radiation therapy (www.bms.com).

• The selective B-cell therapy rituximab (Rituxan; Genentech/Biogen) received a new indication for use in combination with methotrexate (Trexall) to reduce the signs and symptoms of moderately to severely active rheumatoid arthritis in adults who have had an inadequate response to Ž1 tumor necrosis factor antagonist therapy. Rituximab is given as two 1000-mg IV infusions separated by 2 weeks, along with methotrexate. Adminis?tration of the steroid methylprednisolone (Depo-Medrol), 100 mg IV, is recommended 30 minutes before each infusion (www.gene.com).

• Approval has been granted to broaden the indication for fluocinonide (Vanos; Medicis), a class 1 corticosteroid, to include primary therapy for all inflammatory and pruritic skin conditions (eg, eczema, poison ivy) in patients aged Ž12 years who have responded to corticosteroids (www.medicis.com).

• Docetaxel (Taxotere; Sanofi-Aventis) has been approved in combination with cisplatin (Platinol-AQ) and 5-fluorouracil (Adrucil) for the treatment of patients with advanced stomach cancer, including cancer of the gastroesophageal junction, who have not already been treated with chemotherapy for advanced disease (www.taxotere.com).

• A new regimen of every-3-week dosing has been approved for darbepoetin alfa (Aranesp; Amgen) for the treatment of chemotherapy-induced anemia in patients with nonmyeloid malignancies. The updated labeling adds a recommended starting dose of 500 ?g once every 3 weeks to the recommended starting dose of 2.25 ?g/kg once weekly (www.amgen.com).

FDA Warnings

• The FDA and Actelion, the manufacturer of bosentan (Tracleer), which is indicated for the treatment of pulmonary arterial hypertension, have notified physicians of changes to the prescribing information based on case reports of hepatotoxicity. The revised label describing the duration of therapy, the need to adhere to recommended dosage adjustments, and monitoring guidelines can be found at www.fda.gov/medwatch/safety/2006/safety06.htm#Tracleer.

• Bristol-Myers Squibb, the manufacturer of gatifloxacin (Tequin), has notified the FDA about proposed changes to the prescribing information, including an up?date of the existing warning on hypoglycemia and hyperglycemia, and a contraindication for use in patients with diabetes. Additions include a listing of risk factors for low/high blood glucose while taking gatifloxacin, including advancing age, renal insufficiency, and concomitant use of glucose-altering medications. The specific wording is pending FDA ?review and approval (www.fda.gov/medwatch/safety/2006/safety06.htm#Tequin).