Pharmacy & Therapeutics - October 2008 - (Page 571)

NEW DRUGS narcotic medication, fentanyl citrate buccal tablets (Fentora), unless the company finds better ways to inform patients and health care professionals about the drug’s risks. The FDA is not requesting additional safety or efficacy studies. The tablets are approved for breakthrough pain, consisting of brief but intense flare-ups in cancer patients who are already being treated with prescription opioids. Because life-threatening respirator y depression can occur at any dose in opioid-intolerant patients, Fentora is contraindicated for managing acute or postoperative pain. Fentora is part of the opioid class of prescription pain drugs, which can be addictive and are sometimes abused. The FDA approved Fentora in 2006 under strict guidelines. Since then, the drug has often been prescribed for off-label uses. Fentora is currently sold under an FDA safety alert for potential life-threatening risks. Cephalon has reported five patient deaths attributed to negative reactions or overdoses of fentanyl. The company had requested approval to market Fentora to treat breakthrough pain in patients with chronic lower back and nerve pain who were already taking prescription opioids. In May, 2008, an FDA panel of outside experts voted 17–3 against wider use of the drug, citing potential harm from misuse. In February 2008, the company had warned health care professionals to follow dosage instructions carefully and to prescribe Fentora only for patients already taking opioid pain medications around the clock. (Source: The Philadelphia Inquirer, September 16, 2008.) DRUG NEWS heart failure. The use of TNF-α blockers more than quadrupled the risk of death among patients using these drugs who had a history of heart failure. More than half of the patients had been taking the drugs for more than two years. Patients who used TNF-α blockers tended to have more severe rheumatoid arthritis. Among the patients using the drugs, 59 were admitted for heart failure during 1,680 person-years of TNF-α blocker use, compared with 227 admissions during 10,623 person-years of methotrexate use. Other researchers mention a lower risk, but those trials were conducted in younger patients, most of whom had no histor y of heart failure or significant cardiovascular comorbidities. In this study, almost 30% of patients with rheumatoid ar thritis without a histor y of heart failure had conditions suggestive of structural heart disease. (Source: Am Heart J 2008;156:336– 341.) Ranbaxy Laboratories plants in India to enter the U.S. However, drugs already in the U.S. are considered safe and will not be removed from pharmacy shelves. Ranbaxy was judged to have dem onstrated a lack of compliance with the FDA’s safety manufacturing standards. The import alert was not expected to cause any shortages, except perhaps for ganciclovir capsules (Cytovene), which are made solely by Ranbaxy. To avoid potential shortages, the FDA has exempted ganciclovir from the alert. The affected drugs are acyclovir, cefprozil, cefuroxime axetil, cephalexin, ciprofloxacin, clarithromycin, feno fibrate, fluconazole, fosinopril sodium, fosinopril sodium and hydrochloro thiazide, gabapentin, glimepiride, isotretinoin, lamivudine, nonprescription loratadine, metformin, nefazodone HCl, nitrofurantoin, nitrofurantoin and macrocrystalline, ofloxacin, pravastatin, ranitidine, simvastatin, terazosin HCl, valacyclovir HCl, and zidovudine. (Source: MedPage Today, September 16, 2008, www.medpagetoday.com.) TNF-α Blockers and Fungal Infections Manufacturers of adalimumab (Humira, Abbott), certolizumab (Cimzia, UCB), etanercept (Enbrel, Amgen, Wyeth), and infliximab (Remicade, Centocor) have been asked to strengthen warnings in the drugs’ prescribing information relating to the risk of opportunistic fungal infections. Some patients with invasive fungal infections have died. TNF-α blockers, which suppress the immune system, are approved to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and Crohn’s disease. Since the initial approval of the four agents, the prescribing information has mentioned the risk of serious infections, but health care professionals have been overlooking cases of histoplasmosis and other invasive fungal infections, leading Tumor Necrosis Factor-α Antagonists TNF-α Blockers and Heart Failure Tumor necrosis factor–alpha (TNF-α) antagonists can be beneficial for patients with rheumatoid ar thritis, but these drugs can also raise the risk of heart failure. Researchers at Brigham and Women’s Hospital and Harvard Medical School in Boston conducted a cohort study using data from 1,002 patients 65 years of age and older who were treated with TNF-α blockers and from 5,593 patients who received methotrexate. The study authors noted a 70% increase in the rate of hospitalization for heart failure among the patients using TNF-α blockers, compared with patients using methotrexate, whether or not there was a history of FDA Bans 30 Generic Drugs Made in India The FDA has announced that it would not permit 30 generic drugs made at two Vol. 33 No. 10 • October 2008 • P&T® 571 http://www.medpagetoday.com

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Pharmacy & Therapeutics - October 2008 Contents Editorial Medication Errors Prescription: Washington New Drugs/Drug News/ New Medical Devices Drug Forecast Medical Management of Parkinson’s Disease Why Is Health Care Regulation So Complex? The Next President’s Prescription for Action on Drugs Trends in Managing Multiple Sclerosis Product Profiler: Sancuso®

Pharmacy & Therapeutics - October 2008

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