Metallic, medicated patches could cause skin burns, FDA warns
ROCKVILLE, Md. People undergoing magnetic resonance imaging scans may suffer skin burns if they wear certain medicated patches, according to a warning issued by the Food and Drug Administration Thursday.
The warning includes branded, generic, prescription and OTC patches.
The FDA said warnings were absent from the labeling of some transdermal patches that contained aluminum or other metals in their non-adhesive backing. While not attracted to the MRI’s magnetic field, the metal can conduct electricity, which generates heat and can cause burns.
“The risk of using a metallic patch during an MRI has been well-established, but the FDA recently discovered that not all manufacturers include a safety warning with their patches,” FDA Center for Drug Evaluation and Research director Janet Woodcock said in a statement. “Because the metal in these patches may not be visible, and the product labeling may not disclose the presence of metal, patients should tell both their healthcare professional and their MRI facility that they wear a medicated adhesive patch.”
GAO suggests FDA improves dietary supplement industry protocol
WASHINGTON The U.S. Government Accountability Office on Monday suggested that the Food and Drug Administration take several measures to better regulate the dietary supplement industry.
The GAO issued a report advising the FDA to coordinate with stakeholder groups involved in consumer outreach to identify additional mechanisms — “such as the recent WebMD partnership” — for educating consumers about the safety, efficacy and labeling of dietary supplements; implement these mechanisms; and assess their effectiveness.
The GAO report also recommended that in order to enhance the FDA’s oversight of dietary supplements and foods with added dietary ingredients, and to improve the information available for identifying safety concerns [to meet its responsibility to protect the public health], the Secretary of the Department of Health and Human Services should direct the commissioner of FDA to request authority to require dietary supplement companies to identify themselves as a dietary supplement company as part of the existing registration requirements and update this information annually, which includes providing a list of all dietary supplement products they sell, a copy of the labels used on their products, and report all adverse events related to dietary supplements; not just serious adverse events as is currently required.
Furthermore, the GAO report suggested that the FDA issue guidance to clarify when an ingredient is considered a new dietary ingredient. This evidence, the report said, is needed to document the safety of new dietary ingredients and appropriate methods for establishing ingredient identity.
Overall, members of the Council for Responsible Nutrition welcomed the comments, suggesting that GAO’s latest commentary underscore the amount of FDA oversight the agency already exercises over the industry.
“We are [also] appreciative that the report refers to several of the regulatory improvements instituted — and fought for by responsible industry — including the issuance by FDA of Good Manufacturing Practice specific to dietary supplements and passage of a law mandating that serious adverse events are reported to FDA,” stated Steve Mister, president and CEO, CRN. “We disagree [however] with the logic behind the recommendation of submitting all adverse event reports, versus the important need to submit serious adverse event reports.
“The adverse event reporting law was carefully considered and supported by numerous stakeholders, including consumer groups, and there is no need to revise a law that only recently went into effect and appears to be working,” Mister added.
To date, the recent requirement of dietary supplement companies and suppliers of monographed over-the-counter medicines to submit serious adverse event reports has resulted in a 218.1% increase in the number of reports submitted from January through October 2008, as compared to the year-ago period. The FDA received 948 adverse event reports — 596 of which were mandatory reports submitted by industry — compared with 298 received over the same time period in 2007.
Retail sales increase for Home Diagnostics, Inc.
FORT LAUDERDALE, Fla. The continued nationwide launch of the new TRUEresult and TRUE2go blood glucose monitoring systems with Walgreens and Rite Aid helped Home Diagnostics, Inc. increase its retail channel sales by 14.6 percent for the year ended Dec. 31, HDI reported Tuesday.
Retail channel results also benefitted from the nationwide roll out of TRUEtrack into all Walmart pharmacy stores.
Total revenue for the fourth quarter was $29.5 million, an increase of 6.4%. For the full year, revenue grew by 6.9% to $123.6 million.