Drugs and Devices

Drugs Today – February 2008

FDA advisory committee seeks stronger warnings for asthma drugs in children
The pediatric advisory committee of the Food and Drug Administration (FDA) has requested stronger warnings for Serevent (salmeterol) and Advair (salmeterol/fluticasone) to reflect these products’ risks in children. Both are inhaled long-acting beta2-agonists (LABAs) used to treat asthma. Between March 2006 and April 2007, five deaths and other serious adverse drug events were reported in children younger than age 16 who’d used these drugs. The FDA plans to conduct a new safety review of Servent and Advair, as well as Foradil (formoterol).
www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4325b_03_05_Salmeterol%20Adverse%20Event%20Review.pdf
Nexavar approved for inoperable liver cancer
The FDA has approved Nexavar (sorafenib) for use in treating inoperable hepatocellular carcinoma. (The drug was approved in 2005 for treatment of advanced renal cell carcinoma.) In a randomized clinical trial, patients with inoperable hepatocellular carcinoma who received the drug survived 2.8 months longer than those who hadn’t received it. The FDA describes Nexavar as “an important new treatment option for patients who are fighting this very difficult form of cancer.” A kinase inhibitor, the drug interferes with molecules involved in tumor cell signaling, angiogenesis, and cell death.
www.fda.gov/bbs/topics/NEWS/2007/NEW01748.html
FDA warns of desmopressin dangers
The FDA has requested that manufacturers update prescribing information for desmopressin to include new information about severe hyponatremia and seizures. The agency has received 61 postmarketing reports of hyponatremia-related seizures, including two deaths. Children receiving intranasal forms for primary nocturnal enuresis (PNE) are especially vulnerable to severe hyponatremia and seizures; thus, these forms are no longer indicated to treat PNE and shouldn’t be used in patients with hyponatremia or a history of it. The FDA also advises clinicians to interrupt PNE therapy with desmopressin tablets during acute illnesses that may lead to fluid or electrolyte imbalance.
www.fda.gov/cder/drug/InfoSheets/HCP/desmopressinHCP.htm
Smoking-cessation drug gets stronger warning
Pfizer has updated the label of Chantix (varenicline), its smoking-cessation drug, to include a warning that patients who take it should be observed for serious neuropsychiatric symptoms, including behavior changes, agitation, depressed mood, and suicidal ideation and behavior. The label change is based on postmarketing reports and was made after consultation with the FDA. Pfizer noted that although a causal relationship between the drug and these symptoms hasn’t been established, a link can’t be ruled out.
www.pfizer.com/news/press_releases/pfizer_press_releases.jsp
FDA approves nonprescription Zyrtec
The FDA has approved oral forms of Zyrtec (cetirizine HCl) for nonprescription use in treating symptoms of hay fever or other respiratory allergies in adults and children ages 2 and older, as well as to relieve itching caused by hives in adults and children ages 6 and older. Pfizer will market two distinct Zyrtec products for each dosage form—one that gives directions for use in treating hay fever and allergy symptoms, and another that gives directions for use in relieving hives.
The FDA also has approved nonprescription Zyrtec-D, which contains both cetirizine and pseudoephedrine, for relief of hay fever and other allergy symptoms (but not for relief of itching due to hives). Zyrtec-D sales are subject to the Combat Methamphetamine Epidemic Act, which restricts the sale of products containing pseudo­ephedrine.
www.fda.gov/bbs/topics/NEWS/2007/NEW01750.html
Myfortic delayed-release tablets linked to higher risk of pregnancy loss and congenital malformations
The pregnancy risk category for Myfortic (mycophenolic acid) has been changed to D (positive evidence of fetal risk) based on postmarketing data. An immunosuppressant, Myfortic is given with cyclosporine and corticosteroids to prevent organ rejection in patients receiving allogeneic kidney transplants. A patient who plans to become pregnant shouldn’t use the drug unless she can’t be treated with other immunosuppressants. Healthcare professionals should inform females of childbearing potential about the drug’s risks during pregnancy and require that they receive contraceptive counseling and use effective contraception during therapy.
www.fda.gov/medwatch/safety/2007/safety07.htm#Myfortic
Three common drugs cause more than a third of drug-related ED visits by elderly
Warfarin, insulin, and digoxin trigger more than one-third of emergency department (ED) visits made by elderly Americans for adverse drug events (ADEs), based on 2004 and 2005 surveys. According to the study’s lead author, the main problem with these drugs is the difficulty in determining the correct dosage. He believes even small improvements in their use may reduce the burden  of serious ADEs among older Americans.
www.annals.org/cgi/content/full/147/11/755
Erythropoiesis-stimulating agents get stronger warnings
The FDA has approved revised boxed warnings and other safety-related labeling changes for erythropoiesis-stimulating agents (ESAs), used to treat certain types of anemia. The new statements address the risks that Aranesp, Epogen, and Procrit pose to patients with cancer or chronic renal failure. They include a statement that ESAs don’t improve anemia symptoms, fatigue, or quality of life in cancer patients.
The new boxed warning clarifies that in cancer patients, ESAs should be used only to treat anemia resulting from chemotherapy (and not other causes), and should be discontinued once the chemotherapy course ends. For patients with chronic renal failure, the warning states that ESAs should be used to maintain hemoglobin between 10 and 12 g/dL; higher levels increase the risk of death and serious cardiovascular reactions.
www.fda.gov/bbs/topics/NEWS/2007/NEW01740.html

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