FDA Rounds Dec 05

FDA Rounds [December]

First Oral Agent for Chronic Iron Overload

Deferasirox (Exjade; Novartis), a once-daily oral iron chelator, has received accelerated approval from the FDA for the treatment of chronic iron overload associated with multiple blood transfusions. Deferasirox is the first oral medication indicated for this use. Until now, treatment for iron overload has required daily infusions lasting 8 to 12 hours. Adverse events include nausea and abdominal pain (www.novartis.com).

New Spray Treatment for Plaque Psoriasis

Clobetasol propionate (Clobex; Galderma) .05% spray has been approved for the treatment of moderate-to-severe plaque psoriasis. Available in a 2 fluid oz bottle, this twice-daily administered product should be applied directly on the lesion(s), avoiding the surrounding skin. Adverse events include burning, pruritus, dryness, pain, hyperpigmentation around the resolving plaque, irritation, and atrophy (www.galderma.com).

Cancer Medications in the News

• The FDA has granted accelerated approval to the chemotherapeutic agent, nelarabine (Arranon; GlaxoSmithKline) for the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to, or has relapsed following treatment with, at least 2 chemotherapy regimens. Postmarketing evaluation to verify and describe the agent’s clinical benefit will be provided by a randomized, multicenter phase 3 trial. Side effects include fatigue, nausea, vomiting, and diarrhea (www.gsk.com).

• Tamoxifen oral liquid solution (Soltamox; Savient), 10-mg/5-mL, has been approved for adjuvant treatment of breast cancer following primary therapyand treatment ofmetastatic breast cancer, to reduce the risk of breast cancer in women with ductal carcinoma in situ, and to reduce breast cancer incidence in women at high risk of the disease. Adverse reactions include hot flashes and vaginal discharge (www.savient.com).

• Erlotinib (Tarceva; OSI, Genentech) has received new indication for use in combination with gemcitabine chemotherapy in the treatment of advanced pancreatic cancer in patients who have not yet received chemotherapy. Erlotinib is a once-daily oral tablet is already approved for treatment of non—small-cell lung cancer in patients whose disease had progressed after ³1 course of chemotherapy (www.osip.com or www.gene.com/gene/index.jsp).

New Stent System Receives Approval [picture—see email with link to image]

A new stent system (Xact Carotid Stent System, Abbott) was approved to be used as part of an embolic protection system for the treatment of patients at risk of stroke who are not candidates for surgery. The new stent, which is designed to treat occluded carotid arteries in patients with carotid artery disease, is self-expanding and has a closed-cell design that creates a tightly knit, yet flexible, mesh intended to help restore the inner diameter of a carotid artery, promote a smooth inner vessel surface, and potentially inhibit the release of emboli from a diseased vessel when it is treated, thus lessening the risk of stroke. It is designed to be used in combination with the fully retractable Emboshield filter, which is designed to capture emboli that can break off during a carotid stenting procedure (www.abbottvascular.com/carotidfb).

Albumin Solution in Flexible Container

Albumin (Human) 25% solution (Flexbumin; Baxter), the first preparation of human albumin to be packaged in a flexible container, has been approved. The agent is a sterile, nonpyogenic preparation of albumin in a single dosage form for IV administration. Baxter’s current albumin 25% solution (Buminate) is only available in glass bottles. The solution will be available in both 50-mL and 100-mL flexible containers(www.baxter.com).

FDA Issues New Warnings/Label Changes

• Estradiol transdermal birth control system. The FDA has added a warning to the label of the estradiol transdermal contraception system with norelgestromin/ethinyl(Ortho-McNeil) to alert physicians and patients that this product exposes women to higher levels of estrogen than most birth control pills. The new warning specifies that this form of contraception provides approximately 60% more estrogen than an oral birth control pill containing 35 mg of estrogen. Increased estrogen exposure may increase the risk of adverse events, including the development of blood clots (www.fda.gov/bbs/topics.news/2005/NEW01262.html).

• Revised Rx information for telithromycin. The FDA has issued revisions to the prescribing information for the anti-infective agent telithromycin (Ketek; Aventis), including the “precautions” sections concerning the occurrence of syncope usually associated with vagal syndrome, and the addition of palpitations, pancreatitis, and syncope to postmarketing reports in the “Adverse Events” section (www.fda.gov.cder/whatsnew.htm).

• New averse reactions reported with ibritumomab tiuxetan. Additions to the “boxed warnings” and “adverse reactions” sections of the prescribing information for the antineoplastic agent ibritumomab tiuxetan (Zevalin; Biogen Idec) describe severe cutaneous or mucocutaneous reactions, some with fatal outcomes that have been reported, according to the FDA and the manufacturer (www.fda.gov/medwatch.safety/2005/safety05.htm#Zevalin).

FDA Bans Use of Antibiotics in Poultry

In an effort to stem the tide of antibiotic resistance, the FDA has recently prohibited the use of enrofloxacin (Baytril; Bayer)—an antibiotic nearly identical to the human antibiotic ciprofloxacin (Cipro)—from use in poultry. Both enrofloxacin and ciprofloxacin belong to the fluoroquinolone class of antibiotics. The FDA’s Center for Veterinary Medicine began proceedings to stop the use of the animal drug in poultry because of scientific data showing it caused emerging resistance to Campylobacter, a bacterium that causes foodborne illness.Bayer was until now the only remaining manufacturer of fluoroquinolones for use in poultry. Abbott Laboratories previously manufactured fluoroquinolones for poultry use, but voluntarily withdrew its product from the market in 2000, when the FDA indicated it intended to propose a ban on enrofloxacin. The ban affects only the use of enrofloxacin in poultry; other approved veterinary uses of the drug are not affected (www.fda.gov/bbs/topics/news/2005/new01212.html).

Serious Problems with Glucose Monitoring Systems Reported

• Potentially life-threatening, falsely elevated glucose readings have been reported in patients who have received parenteral products containing maltose, galactose, or oral xylose and who have subsequently been tested with glucose dehydrogenase pyrroloquinolinequinone-based glucose monitoring systems, according to the FDA. There have been reports of the inappropriate administration of insulin and consequent life-threatening and fatal hypoglycemia in response to erroneous test results obtained from patients receiving parenteral products containing maltose, xylose, or galactose. A preliminary listing of US products that may cause glucose test interference can be found at www.fda.gov/medwatch/safety/2005/safety05.htm#maltose.

• Blood glucose monitors manufactured by Abbott Diabetes Care, Alameda, Calif, have reportedly malfunctioned, according to the FDA. The meters can accidentally be switched from one unit of measurement to another, resulting in inaccurate blood glucose interpretation by the user. Patients in the United States should make sure that their meter reading is displayed as mg/dL, not mmol/L, the unit of measure used in Europe (www.fda.gov/medwatch/safety/2005/safety05/htm#glucose).

New Warnings for 3 Long-Acting Beta₂-Adrenergic Agonists

The FDA has requested the manufacturers of fluticasone propionate/salmeterol (Advair Diskus; GlaxoSmithKline), formoterol fumarate (Foradil Aerolizer; Schering), and salmeterol xinafoate (Serevent Diskus; GlaxoSmithKline) to update their product labels to include new warnings and a “medication guide” for patients to alert physicians and patients that these medications may increase the risks of severe asthmatic episodes and death when such episodes occur. All 3 agents contain long-acting beta₂-adrenergic agonists, which, even though they decrease the frequency of asthma episodes, may make the episodes more severe when they do occur (www.fda.gov/medwatch/safety/2005/safety05.htm#LABA).

Synthetic Polymer Injector Device Recalled

Boston Scientific has issued a voluntary recall for all Enteryx Procedure kits and Enteryx Single Pack Injectors because of reports of serious adverse events, including death, in patients treated with the product. The Enteryx Procedure was intended to treat patients with gastrointestinal reflux disease and involves injecting a synthetic polymer substance used as a bulking agent or the placement of a prosthesis for the purpose of improving the function of the gastroesophageal sphincter. Physicians should stop injecting Enteryx immediately and follow the manufacturer’s procedures for returning unused products, according to the FDA (www.fda.gov/cdrh/safety/101405-enteryx.html).