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FDA panel: No Rx for DXM cough remedies
September 16th, 2010
WASHINGTON – Pharmacies and makers of over-the-counter medicines got good news this week when a Food and Drug Administration advisory panel voted against requiring prescriptions for cough medicines containing dextromethorphan (DXM).
The panel, which gave its recommendation on Tuesday, had agreed to look at the possibility of making DXM a controlled substance after a Drug Enforcement Agency report cited a spike in the abuse of over-the-counter cough medicines formulated with DXM.
According to the DEA, nonmedical use of DXM, a common cough suppressant approved since 1958, accounted for an estimated 7,988 emergency room visits in 2008, up from 4,634 in 2004. The problem is particularly acute among adolescents between ages 12 and 20, according to the agency.
Prior to its meeting, the FDA advisory panel said it hoped to determine if placing more restrictions on DXM would curb the rise in abuse.
A decision to reclassify DXM would have meant that such cough remedies as Pfizer Inc.'s Robitussin, Procter & Gamble Co.'s Vicks NyQuil Cough, Reckitt Benckiser's Delsym and Johnson & Johnson’s Tylenol Cough would only be available with a doctor’s prescription.
The Consumer Healthcare Products Association (CHPA), the Washington-based trade group that represents OTC companies, vehemently opposed reclassifying DXM and said it was happy that the FDA panel had opted to continue making cough medicines formulated with the ingredient available over the counter.
"The FDA advisory committee decision not to recommend scheduling OTC cough medicines containing dextromethorphan as a controlled substance reflects a sound balancing of the benefits of O-T-C medicines containing dextromethorphan," the group said in a statement.
Before the hearing, CHPA suggested that regulators and lawmakers find other ways to combat medication abuse. "There are more effective interventions to address cough medicine abuse in general, and dextromethorphan abuse in particular, that preserve the significant public health benefit of OTC access," the association said in a 78-page report submitted to the panel prior to its meeting.
The FDA usually follows advisory panel suggestions, but it is not bound by them. Congress still could move to limit sales to anyone under the age of 18.
Also addressing concerns about patient access was the National Association of Chain Drug Stores, which provided testimony at the meeting of the FDA's Drug Safety and Risk Management Committee.
Kevin Nicholson, vice president of regulatory affairs for NACDS, shared perspectives on the potential abuse of DXM and public health benefits and risks of the ingredient as a cough suppressant. "NACDS is committed to pursuing effective strategies to help prevent the abuse of both prescription and over-the-counter medications, and the devastating effects of such abuse on peoples’ lives and on society," he stated before the committee.
Nicholson conveyed that NACDS doesn't support the scheduling of DXM under the federal Controlled Substances Act because it would cause unnecessary increases in health care costs, including heavier administrative burdens for scheduling visits, conducting consultations and handling additional prescriptions.
"Dextromethorphan is consumers' No. 1 choice to treat cough. Depriving consumers of the option to self-medicate with dextromethorphan would have substantial public health consequences because cough and cold are extremely prevalent in the U.S. population, affecting the average adult two to four times per year."
NACDS also urged the committee to consider the approach set forth by Sen. Dick Durbin (D., Ill.) in the Dextromethorphan Abuse Reduction Act of 2009, which would prohibit the sale of DXM to minors.
"Dextromethorphan is the most common ingredient in over-the-counter cough medicines in the United States," Nicholson noted. "[The] abuse of dextromethorphan is concentrated primarily among teenagers, and this concentration makes possible a targeted and strategic approach to preventing abuse."
The association added that besides working on legislative remedies, it has also worked with the White House Office of National Drug Control Policy and the DEA to help raise awareness of medication abuse, especially among young people.
On the day of the FDA panel meeting, the Center for Medicine in the Public Interest (CMPI) released the results of a national teen substance abuse survey, which found that police officers and high-school teachers nationwide believe alcohol and marijuana are the most serious problem substances facing teenagers — not OTC medications.
The nonprofit research and educational group said that when asked which substances pose the greatest negative impact on teens, teachers and police overwhelmingly identified marijuana and alcohol, followed by methamphetamine and cocaine. What's more, no police offers and only 1% of high-school teachers cited cough and cold medicines as having the greatest negative impact on teens.
CMPI added that the survey also found that by a margin of two to one, police officers and high-school teachers support education efforts as a means to address abuse of OTC cough and cold medicines, rather than restricted accessibility to consumers.
"Americans expect to be able to buy cough medicines conveniently at the supermarket or their neighborhood corner store," commented CMPI vice president Robert Goldberg. "Overly restricting access to cough and cold products containing dextromethorphan will create more health problems than it will solve, especially during cold and flu seasons. We need to find common-sense solutions and invest more resources in education."