FDA advisory committee to discuss curbing DXM abuse
BETHESDA, Md. The Food and Drug Administration on Tuesday announced through the Federal Register that a Sept. 14 meeting will be held with its drug safety and risk management advisory committee to ascertain the abuse potential of the cough-cold ingredient dextromethorphan as part of the over-the-counter cough suppressant’s benefit/risk ratio.
The Department of Health and Human Services received a request from the Drug Enforcement Administration for a scientific and medical evaluation and scheduling recommendation for dextromethorphan in response to the increased incidence of abuse, especially among adolescents, the FDA reported.
It is not a fresh issue — the Consumer Healthcare Products Association has been raising awareness among parents around the potential of OTC and prescription-drug abuse among teens for several years. In addition, most if not all pharmacy retailers voluntarily require an age verification that a purchaser of DXM products be at least 18 years old at the point of sale.
According to survey data released in March by the Partnership for a Drug-Free America and MetLife Foundation, there was no significant increase in the abuse of over-the-counter cough medicines containing dextromethorphan. The 21st annual Partnership/MetLife Foundation Attitude Tracking Survey found that while lifetime abuse rates among teens for OTC cough medicines have remained relatively flat over the past few years, 12% of teens still report having abused an OTC cough medicine to get high at least once in their lives.
CHPA has been engaged in a long-term, comprehensive initiative to end this type of abuse with partners including the Partnership for a Drug-Free America, the Community Anti-Drug Coalitions of America, and D.A.R.E. America, and more recently, the National Association of School Nurses.
“While these medicines [containing dextromethorphan] are safe and effective when used as directed, they can be dangerous when abused in extreme amounts, especially when combined with alcohol, illicit drugs or certain prescription drugs,” stated Linda Suydam, CHPA president. “The makers of OTC medicines have been aggressive in their efforts to prevent cough medicine abuse among teens.”
NASN and CHPA last month announced the launch of “Home to Homeroom,” an educational program that teams parents with the medical expert in their teen’s school — the school nurse — to help prevent and address teen medicine abuse.
Novo Nordisk launches online contest for insulin pen users
PRINCETON, N.J. Novo Nordisk is asking diabetics to show off how they flex — their insulin pens.
In an effort to change the way people think about taking insulin, Novo Nordisk has launched an online photo contest, “Where Have You Flexed,” for patients who use Levemir FlexPen, NovoLog FlexPen and NovoLog Mix 70/30 FlexPen. Patients can visit WhereHaveYouFlexed.com to submit photos they have taken in unique locations with their FlexPen.
“’Where Have You Flexed’ is an exciting way for people using the FlexPen to show first-hand how they can conveniently take their insulin on-the-go,” said Camille Lee, VP diabetes marketing for Novo Nordisk. “Through the interactive voting function on the site, we look forward to seeing which entries have the biggest impact within the diabetes community and hope that people still taking insulin with a vial and syringe will be inspired to talk to their doctor about FlexPen.”
Also on the WhereHaveYouFlexed.com site, viewers can watch video with stories from Firestone Indy Lights racecar driver Charlie Kimball, who uses the Levemir FlexPen to help manage his diabetes. The grand prize winner of the Where Have You Flexed contest (determined by a panel of judges and consumer votes) will receive a trip for two to the Firestone Indy Lights championship in Miami on Oct. 2 to see Kimball race, or an elliptical trainer exercise machine delivered to their home. Second and third place winners will receive exercise equipment for their home, while anyone who registers to vote on the site will be entered in a random drawing to win one of five iPod touch portable music players.
“As a professional racing driver, I get to ‘flex’ all over the country — including on the racetrack,” said Kimball, who drives the No. 26 Levemir FlexPen car and is the only licensed racer with Type 1 diabetes in the history of the Indy Racing League. “I’m looking forward to seeing the photos of where other patients with diabetes use their FlexPen and sharing videos of my experiences on the road.”
McNeil Consumer Healthcare recalls lots of infants’, children’s OTC medicines
FORT WASHINGTON, Pa. McNeil Consumer Healthcare on Friday voluntarily recalled all lots that have not yet expired of certain over-the-counter children’s and infants’ liquid products in consultation with the Food and Drug Administration.
McNeil Consumer initiated the recall because some of these products may not meet required quality standards, though no adverse medical events have been reported, the company stated. “However, as a precautionary measure, parents and caregivers should not administer these products to their children.”
Some of the products included in the recall may contain a higher concentration of active ingredient than is specified; others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles.
“While the potential for serious medical events is remote, the company advises consumers who have purchased these recalled products to discontinue use,” McNeil stated.
The company is conducting a comprehensive quality assessment across its manufacturing operations and has identified corrective actions that will be implemented before new manufacturing is initiated at the plant where the recalled products were made.
For a full list of products recalled, visit http://www.mcneilproductrecall.com/page.jhtml?id=/include/new_recall.inc