News Briefs
FDA: Manufacturers must use electronic drug labels
The FDA has begun requiring drug manufacturers to submit prescription drug label information to the agency in a new electronic format. This electronic format will allow health care providers and the general public to more easily access the product information found in the FDA-approved package inserts for all approved medicines in the United States, the FDA says.
Under the new regulations, drug manufacturers are now required to submit to FDA prescribing and product information in a structured product labeling (SPL) format that uses standardized medical terminology. Using embedded computer tags, the prescribing and product information in the SPL format can be electronically managed, allowing a user to search for specific information. These tags can instruct computers to read specific sections of a drug label including product names, indications, dosage and administration, warnings, description of drug product, active and inactive ingredients, and how the drug is supplied.
The new electronic product labels will be the key element and primary source of medication information for "DailyMed" — a new interagency on-line health information clearinghouse that will provide up-to-date medication information free to consumers, health care providers, and health care information providers. This information can be accessed through the National Library of Medicine at http://dailymed.nlm.nih.gov.
Updated product labels will be posted on the site within one business day of an approval action by FDA or submission to FDA of a product label change that does not require prior approval. Within one year, product labels for most approved prescription medications will be posted on Daily-Med.
In the future, this new product information will also be provided through [email protected], an Internet resource designed to give one-stop access for information about all FDA-regulated products.
Sales, marketing stopped for pemoline products
The FDA has concluded that the overall risk of liver toxicity from pemoline (Cylert) and generic pemoline products outweighs the benefits of this drug. In May 2005, Abbott chose to stop sales and marketing of Cylert in the United States. All generic companies have also agreed to stop sales and marketing of this product.
Pemoline, a central nervous system stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), is considered second-line therapy for ADHD because of its association with life-threatening hepatic failure. Health care professionals who prescribe Cylert, or any of its generics, should transition their patients to an alternative therapy.
Cylert will remain available through pharmacies and wholesalers until supplies are exhausted. No additional product will be available.
For more information, see www.fda.gov/medwatch/safety/2005/safety05.htm#Cylert.
Hepatic injury linked to duloxetine hydrochloride
Eli Lilly and the FDA have notified health care professionals of revisions to the Precautions/ Hepatotoxicity section of the prescribing information for duloxetine hydrochloride (Cymbalta), indicated for treatment of major depressive disorder and diabetic peripheral neuropathic pain.
Postmarketing reports of hepatic injury (including hepatitis and cholestatic jaundice) suggest that patients with pre-existing liver disease who take duloxetine may have an increased risk for further liver damage. The new labeling extends the precaution against using duloxetine in patients with substantial alcohol use to include those patients with chronic liver disease. It is recommended that duloxetine not be administered to patients with any hepatic insufficiency.
For more information, see www.fda.gov/medwatch/safety/2005/safety05.htm#Cymbalta.
Warning added to ibritumomab tiuxetan label
Biogen Idec and the FDA have notified health care professionals of revisions to the Boxed Warnings, Warnings, and Adverse Reactions sections of the Prescribing Information to describe severe cutaneous or mucocutaneous reactions, some with fatal outcome, that have been reported in association with the ibritumomab tiuxetan (Zevalin) therapeutic regimen in the post-marketing experience.
Patients experiencing a severe cutaneous or mucocutaneous reaction should not receive any further components of the ibritumomab tiuxetan therapeutic regimen and should seek prompt medical evaluation.
For more information, see www.fda.gov/medwatch/safety/2005/safety05.htm#Zevalin.
The FDA has begun requiring drug manufacturers to submit prescription drug label information to the agency in a new electronic format.Subscribe Now for Access
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