Drugs and Devices

Drugs Today – May 2008

Guide to accompany Avandia prescriptions

Patients with type 2 diabetes mellitus taking rosiglitazone (Avandia) will now receive a safety guide along with the drug. The Food and Drug Administration (FDA) requires such guides for drugs considered to “pose a serious and significant public health concern.” The rosiglitazone guide tells patients that the drug can cause or worsen heart failure and that it can increase the risk of angina and myocardial infarction. Patients are told to call their physician immediately if they experience symptoms of heart failure. www.fda.gov/medwatch/safety/2008/safety08.htm#Avandia

Spiriva and Foradil: Patient teaching needed

The FDA has issued a public health advisory recommending that physicians, nurses, and pharmacists tell patients how to use the Spiriva HandiHaler and Foradil Aerolizer for asthma and chronic obstructive pulmonary disease. According to the FDA, many patients mistakenly swallow tiotropium bromide (Spiriva) and formoterol fumarate (Foradil) inhalation powder capsules, rather than using them in inhalers. Although ingestion is common, the FDA says few patients have experienced adverse effects. www.fda.gov/cder/drug/advisory/tiopropium_formoterol.htm

New indication for Aloxi

The FDA has approved palonosetron hydrochloride (Aloxi) injection to prevent postoperative nausea and vomiting for up to 24 hours after surgery. Available in the United States since 2003, it’s the only 5-hydroxytryptamine-3 receptor antagonist approved to prevent acute and delayed nausea and vomiting from moderately emetogenic chemotherapy and acute nausea and vomiting from highly emetogenic chemotherapy. http://media.prnewswire.com/en/jsp/latest.jsp;jsessionid=F71C8F4297F689B5CB6C4A79D5555A6A.tomcat2?resourceid=3678340&access=EH


Warning on Tamiflu

Roche Laboratories has revised the product label for oseltamivir phosphate (Tamiflu) to include a warning on possible neuropsychiatric effects. Postmarketing reports indicate that some flu patients who were receiving Tamiflu experienced delirium and abnormal behavior, leading to injury and even death. Most of the cases occurred in children and in Japan. www.fda.gov/medwatch/safety/2008/Tamiflu_DHCP.pdf

Bipolar-disorder drug now for kids

Aripiprazole (Abilify) can now be prescribed for children and adolescents who have acute manic and mixed episodes of bipolar I disorder, with or without psychotic features. During the study, the most common adverse reactions included somnolence, extrapyramidal disorder, fatigue, nausea, akathisia, blurred vision, salivary hypersecretion, and dizziness. The drug was already approved for acute and maintenance treatment of manic and mixed episodes associated with bipolar I disorder with or without psychotic features in adults. http://medheadlines.com/2008/03/03/abilify-now-available-for-younger-patients-with-bipolar-disorder/

New antidepressant

Desvenlafaxine (Pristiq) was recently approved to treat major depressive disorder in adults. Patients will take the new serotonin-norepinephrine reuptake inhibitor once daily. In trials, the most common adverse effects included nausea, dizziness, insomnia, hyperhidrosis, constipation, somnolence, decreased appetite, anxiety, and male sexual function disorders.

www.wyeth.com/news?nav=display&navTo=/wyeth_html/home/news/pressreleases/2008/1204331198948.htm

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