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.
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
Omron Healthcare makes donation to American Society of Hypertension
BANNOCKBURN, Ill. A leading manufacturer and distributor of blood pressure monitors designed for home use announced a donation to the American Society of Hypertension’s awareness initiative.
Omron Healthcare said it donated more than $30,000 worth of its home blood pressure monitors and pedometers to ASH’s Hypertension Community Outreach Initiative, which was held last week, which featured complimentary blood pressure, glucose and cholesterol screenings in New York. The donation included 200 home blood pressure monitors and 300 pedometers, which were provided to screening participants so that they could easily track their health and fitness goals in their efforts to prevent or fight hypertension.
“Hypertension can lead to serious health problems like heart attacks and stroke. We were thrilled to be able to make a donation to the American Society of Hypertension, Inc. that is making a concerted effort to make people aware of these issues,” said Jim Li, executive director medical affairs, Omron Healthcare, Inc. “Regularly checking your blood pressure is important, and this was a great way for Omron to show our commitment to making it easier for consumers to do that with clinically proven accurate products at home.”