To prevent overdoses, the Food and Drug Administration (FDA) has issued strict new limits on a common ingredient in prescription painkillers, The New York Times

reported Jan. 14.
 

The FDA has ruled that prescription painkillers may contain only 325 milligrams of acetaminophen -- about half of what many contain today.
 

Acetaminophen is a very popular ingredient in prescription pain medication and is also available over-the-counter in products such as Tylenol. Some patients increase their risk of overdose by supplementing prescription pain pills such as Percocet or Vicodin -- which contain narcotics combined with acetaminophen -- with an over-the-counter drug that contains acetaminophen, the agency said.
 

Overdoses, which can cause severe liver damage, kill over 400 people and hospitalize another 42,000 in the United States every year.
 

Drug-makers will have three years in which to adjust their formulas or take their products off the market. They will also have to add more explicit warnings about overdose risks to their packaging.

"F.D.A. is taking this action to make prescription combination pain medications containing acetaminophen safer for patients to use," said Dr. Sandra Kweder, deputy director of the FDA's Office of New Drugs.   
 

In 2009, an advisory panel recommended that the FDA outlaw acetaminophen as an ingredient in prescription painkillers. The FDA chose a more moderate course by limiting the allowable amount of acetaminophen in such pills.  
 

"We don't believe we're making these products less effective," Kweder said. "The amount of acetaminophen in these products has gradually crept up over the years."
 

The agency's ruling will affect a lot of patients and pills. Over 200 million prescriptions are written each year in America for painkillers that combine opioids like codeine, oxycodone, or hydrocodone with acetaminophen.
 

About half of acetaminophen overdoses are caused by prescription pills. Many overdoses are the result of over-the-counter medications. Once the FDA's new ruling takes effect, the acetaminophen content in some products, such as like Extra-Strength Tylenol, could exceed that found in prescription drugs.

The New York Times said that limiting acetaminophen in over-the-counter medications would be a "far more time-consuming and burdensome regulatory process" for the agency, and the FDA has not decided whether to act.
 

"We have not made a decision about what action or actions to take with regard to over-the-counter products," said Dr. Kweder. "We're continuing to consider our options along that line."

New York, NY -- The University of Michigan's Monitoring the Future study (MTF) -- the largest survey on teen drug abuse tracking over 46,000 8th, 10th and 12th graders -- found a huge falloff in teens' recalled exposure to drug abuse prevention messages over the past seven years. The new data from the MTF study have been released at a time when teens themselves report finding the drug-prevention messages to be effective.

Comparing 2003, the year in which kids and teens' recalled exposure to drug prevention messages from the White House Office of National Drug Control Policy (ONDCP)'s National Youth Anti-Drug Media Campaign (NYADMC) peaked, to today, the proportion of 8th graders that reported daily/or more often exposure dropped from 54 percent to 18 percent, a dramatic decrease of two-thirds among the youngest group surveyed.

Similar declines occurred among 10th graders (50 percent in 2003 to 17 percent in 2010) and 12th graders (32 percent to 10 percent). According to Lloyd Johnston, the principal investigator of the study, the rates of teens' recalled exposure of drug abuse prevention messages are lower in 2010 than they have been since his research team began tracking all three grades nearly two decades ago (view chart below).

"At a time when teen drug use is at relatively low levels, historically, and children are not learning as much through the news media about the health consequences of using many dangerous drugs, it is important that we get that information to them by other means - through prevention ads, in schools and through their families," said Johnston.

"If they don't get those messages, teens will come to view drug use as less dangerous than their predecessors did and that misconception will leave them vulnerable to having their own epidemics of drug abuse. In fact, we are already seeing these signs beginning to happen now for teen use of drugs like marijuana, Ecstasy and LSD."

Support for prevention programs like the state grants portion of the Safe and Drug-Free Schools and Communities Program, which was zeroed out in the 2011 budget, and the federal NYADMC, has dwindled significantly over the past decade. In fiscal year 2003, which marked the peak year for recalled exposure of drug abuse prevention messages among teens, federal support of the NYADMC was $145 million, compared to only $45 million for fiscal year 2010. The kinds of extracurricular activities -- programs in sports, civics and the arts -- that states and localities have funded to engage kids' positive energies and help prevent substance abuse continue to collapse under relentless budgetary pressure.

"Our prevention infrastructure is disappearing before our eyes and the result of all this is not fair, but it's undeniable: the additional burden is increasingly falling on the shoulders of parents and caregivers," said Steve Pasierb, President of The Partnership at Drugfree.org. "The slashing of funds and lack of support, coupled with the discussion of further cuts for effective prevention programs, are going to have a direct impact on the 35 million American families with children at risk of abusing drugs or alcohol."

Teens Seeing/Hearing Less Drug-Prevention Messages, But Find Them Effective

While recalled exposure among teens is down significantly, perceived effectiveness of the drug-prevention messages did not reflect the same dramatic drops and, for the most part, remained constant. Between 2003 and today, the proportion of 8th, 10th, 12th graders that agreed "the commercials made them, to a great extent, less favorable toward drugs" remained fairly stable. Among 8th graders, 42 percent in 2003 and 36 percent in 2010; among 10th graders, 26 percent in 2003 and 23 percent in 2010; and among 12th graders 22 percent in 2003 and 21 percent in 2010.

Similarly, the percentage of teens who agreed that drug-prevention messages made them less likely to use drugs in the future also remained stable, although they reported they are exposed to fewer messages.

"There is evidence of a correlation between decreased drug use among teens and their exposure to drug abuse prevention messages," said Pasierb. The alarming drops in the number of messages teens are seeing or hearing today is especially disturbing because the kids themselves report these messages are effective in keeping them from using drugs."

Increases in Teen Use of Illicit Drugs Correlate with Decreased Support for Anti-Drug Messages

The MTF survey also measures teen attitudes about drug and alcohol use, including perceived harmfulness and disapproval, factors that can predict future substance abuse. The perception among teens that regular marijuana use is harmful decreased among 10th and 12th graders, but declined the most among the youngest group of 8th graders. The study also confirmed a new uptick in teen Ecstasy use, especially, among 8th and 10th graders, following drastic declines of this drug of abuse over the past decade. As teen anti-drug attitudes erode and move in the wrong direction, increases in drug use are sure to follow.

"While we recognize the current constraints on the federal budget, we urge Congress to fund ONDCP's National Youth Media Campaign at the highest possible level and restore the funding cuts that have eroded the impact of this program and have most likely contributed to increases in teen drug abuse," said Pasierb. "We would welcome the opportunity to work with Congress and the Administration to increase the frequency with which teens receive anti-drug messages, while demanding full accountability for the program and its outcomes."

The National Youth Anti-Drug Media Campaign, administered by ONDCP, is aimed at reducing drug use among American teens. The Partnership at Drugfree.org assists in facilitating the creative development of the drug abuse prevention messages used by the NYADMC.

To learn more about how to help parents prevent, intervene in and find treatment for drug and alcohol use by their children, please visit drugfree.org.