FDA to debate pediatric APAP dosing during mid-week advisory committee meeting
WASHINGTON — The Food and Drug Administration is convening its Nonprescription Drugs Advisory Committee Tuesday and Wednesday to debate mandating weight-based dosing for pediatric medicines containing acetaminophen on the Drug Facts label, as well as the potential expansion of dosing instructions to incorporate children under the age of 2 years old, according to material posted online by the FDA on Friday.
“[The Consumer Healthcare Products Association] supports inclusion of dosing information for children less than 2 years of age on labels of [over-the-counter] single-ingredient acetaminophen products intended for children, and the amendment of the OTC Internal Analgesics Monograph to reflect this labeling,” the association stated as part of a “Briefing Book” submitted for the meeting. “Further, our members also support dosing based on weight as the preferred method for dosing children.”
The Consumer Healthcare Products Association earlier this month announced that the industry would voluntarily homogenize liquid APAP concentrations for children in an effort to reduce medication errors. Beginning mid-2011 and continuing through early 2012, CHPA members will discontinue manufacturing concentrated infant drops and convert these products to the same concentration used today for children’s (ages 2 to 11 years) acetaminophen products (160mg/5mL), the CHPA noted in its pre-meeting minutes. The industry initiative is consistent with guidance from three advisory committees to FDA in 2009 that voted 36-1 in favor of standardizing acetaminophen liquid products to one concentration. In addition, the new products will be packaged with flow restrictors to make it difficult to ingest large amounts of liquid in the event of an accidental unsupervised ingestion. Dosing devices for infants will be calibrated oral syringes and for older children, calibrated dosing cups will be used.
That 2009 advisory committee meeting found that errors involving acetaminophen use in children are commonly caused by parents’ confusion about how much to dose, though CHPA cited research finding only 5% of all APAP-related overdosing in children were due to parent error; the vast majority of overdosing cases resulted from accidental ingestion.
APAP is the most commonly used children’s medicine for relieving pain and reducing fever, according to the CHPA. Estimates suggested that in any given week, approximately 12% of children up to age 11 years have taken acetaminophen. The peak of acetaminophen use is among children ages 6 months to 23 months of age, according to the association’s meeting materials.
FDA warns consumers of counterfeit ExtenZe
SILVER SPRING, Md. — The Food and Drug Administration on Friday warned consumers about a counterfeit product represented as "ExtenZe," which is the name of an authentic dietary supplement for male sexual enhancement.
The counterfeit product looks similar to the actual product, but either contains tadalafil, or a combination of tadalafil and sildenafil, all active ingredients in FDA-approved prescription medicines for erectile dysfunction.
"This incident is an example of a growing trend of products marketed as dietary supplements or conventional foods with hidden drugs and chemicals," said Ilisa Bernstein, deputy director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. "These types of products are typically promoted for sexual enhancement, weight loss, and body building, and are often represented as being ‘all natural.’ Consumers should exercise caution before purchasing products promoted for these uses."
The counterfeit product has the following lot numbers on the packages: LOT 1110075 and LOT F050899.
“Consumers who have an ExtenZe product should check the lot numbers on the package to make sure they do not have a counterfeit product,” the FDA said. “Consumers who think they might have the counterfeit product should stop taking the product and contact their healthcare professional if they are experiencing any negative side effects.”
Joe Montana tapped for Joint Juice partnership
SAN FRANCISCO — Joint Juice earlier in the week announced a partnership with National Football League Pro Football Hall of Fame quarterback Joe Montana on the Joint Juice challenge.
To kick off the partnership, Joint Juice and Montana launched a contest: “Do What You Love with Joe Montana.” Americans who share their joint health success stories will be entered to win an all-expenses-paid trip to spend an afternoon doing their favorite activity with the legendary football star, as well as $5,000 in cash.
“Joe is the perfect embodiment of what Joint Juice stands for: staying active at any age,” stated David Ritterbush, Joint Juice CEO. “As a company whose products were originally developed to help athletes, we’re thrilled to join efforts with a football legend.”