1. Dear Drugs-Forum readers: We are a small non-profit that runs one of the most read drug information & addiction help websites in the world. We serve over 4 million readers per month, and have costs like all popular websites: servers, hosting, licenses and software. To protect our independence we do not run ads. We take no government funds. We run on donations which average $25. If everyone reading this would donate $5 then this fund raiser would be done in an hour. If Drugs-Forum is useful to you, take one minute to keep it online another year by donating whatever you can today. Donations are currently not sufficient to pay our bills and keep the site up. Your help is most welcome. Thank you.

FDA looks to curb abuse of cough medicine

  1. Balzafire
    WASHINGTON – Federal health regulators are weighing restrictions on Robitussin, NyQuil and other cough suppressants to curb cases of abuse that send thousands of people to the hospital each year.

    The Food and Drug Administration on Tuesday posted its review of dextromethorphan, an ingredient found in more than 100 over-the-counter medications that is sometimes abused for its euphoric effects. The practice, dubbed "robotripping," involves taking more than 25 times the recommended dose of a cold medicine and is mainly associated with teenagers.

    At high doses the drug causes increased blood pressure, heart rate and fever. Abusers can also suffer side effects from other ingredients mixed in cough medicines, such as acetaminophen, which can cause liver damage.

    "Because of the drug's perceived safety, ease of availability, and desired psychoactive effects, it is sought after by those seeking to alter their mental state," states the FDA review.

    According to the FDA, inappropriate use of the ingredient was linked to nearly 8,000 emergency room visits in 2008. That was up more than 70 percent from reports in 2004.

    An FDA analysis concluded that dextromethorphan is abused less often than the popular painkiller codeine but more often than pseudophedrine, a cold medicine ingredient that can be processed into methamphetamine.

    The FDA has agreed to reconsider how it regulates the drug at the behest of the Drug Enforcement Agency, which has raised concerns about increasing abuse among adolescents.

    On Sept. 14, the FDA will ask a panel of outside experts whether dextromethorphan should be available only as a prescription. The agency is not required to follow the group's advice, though it often does.

    Mandating a prescription for the drug would deal a major blow to over-the-counter drug makers, which use the drug in dozens of combination cold medicines. Popular brands containing dextromethorphan include Wyeth's Dimetapp, Bayer's Alka Seltzer Flu Plus and Procter & Gamble's Vicks cough medicines. The drug is available in pills, gel caps, liquids and other forms.

    Most industry observers don't expect the FDA to mandate a prescription on those products due to the enormous workload it would create for doctors and pharmacists.

    One alternative could involve placing the drugs behind the counter, though the FDA's review did not discuss specific proposals.

    The over-the-counter medicine industry supports prohibiting sales of the medicines to people under age 18. Such age restrictions require legal changes, and the industry's trade association has lobbied on the issue at the state and federal levels.

    A spokeswoman for the Consumer Healthcare Products Association said the group has been working since 2003 to reduce abuse through educational campaigns targeting parents, teenagers and school nurses.

    "It's really about trying to take this multifaceted approach to inform parents that while these medicines are safe and effective, they are also vulnerable to abuse," said spokeswoman Elizabeth Funderbunk. The group represents Pfizer, Johnson & Johnson and most other over-the-counter drug companies.

    AP Business Writer


  1. Terrapinzflyer
    Other news reports have indicated that the FDAs move on this was in fact the result of pressure from the DEA, where Dextromethorphan*has been on the Drugs & Chemicals of Concern" list for quite sometime.
  2. Phungushead
    Panel Says No to Reclassifying Cough Syrup Ingredient

    ADELPHI, Md. -- An FDA advisory panel voted 15 to 9 on Tuesday against recommending that dextromethorphan -- the active ingredient in many common cough medicines -- be classified as a controlled substance.

    The Drug Safety and Risk Managment Committee decided that doing so would make hundreds of over-the-counter cough suppressants -- including Robitussin, NyQuil, Dimetapp, and Vicks -- too difficult to access. The vote came despite growing concern that adolescents are taking large doses of the medications to get high.

    The Drug Enforcement Agency (DEA) asked the FDA to revisit the issue of whether dextromethorphan has a high potential for abuse and should therefore be classified as as controlled substance. The DEA cannot add a drug to the schedule unless the FDA recommends it.

    The agency has convened panels on the same issue twice before, most recently in 1992. Since then, however, there has been an increasing number of reports of adolescents "robo-tripping" -- taking doses of cough medicine that are 10 to 20 times greater than the amount recommended for cough suppression.

    Such doses can result in a euphoric, hallucinogenic high, and "zombie-like walking," FDA reviewers said in briefing documents prepared before the Tuesday's hearing.

    A larger overdose can result in nausea, vomiting, drowsiness, dizziness, blurred vision, nystagmus, ataxia, shallow respiration, urinary retention, stupor, toxic psychosis, seizures, and coma.

    Dextromethorphan played a role in 8,000 emergency room visits in 2008 -- up 70% percent from 2004 -- according to the FDA staff. However, they noted, people who abuse dextromethorphan generally are abusing other drugs as well, so it's difficult to tease out which drug was responsible for the hospitalization.

    Of the five reported deaths in 2008 in which dextromethorphan played a role, the victims all had other drugs in their systems as well, an FDA reviewer said.

    Although the panel was concerned that some adolescents are using dextromethorphan to get high, the majority of members felt the abuse problem wasn't widespread enough -- especially compared with the abuse of other controlled substances such as oxycodone -- to warrant classifying the drug under the Controlled Substances Act.

    "I believe we should try and find the appropriate size patch for the problem we are trying to fix," said panelist Lawrence Carter, PhD, a professor at the University of Arkansas who specializes in addiction. "I think scheduling is a drastic move to fix a problem that is far from epidemic."

    The panel did express support for making it illegal for anyone under age 18 to purchase medication that contains dextromethorphan and limiting sales of bulk dextromethorphan. Doing so would require an act of Congress.

    The Consumer Products Healthcare Products Association also backs that plan.

    If the FDA doesn't follow the panel's advice -- an uncommon occurrence -- and makes dextromethorphan a scheduled drug, it would likely be placed in the least strict group -- Schedule V -- along with cough syrup with codeine. Placing a drug into Schedule V would allow dextromethorphan to remain an over-the-counter medication, but it would make it illegal for those under 18 to purchase it.

    Such a move would also require customers to sign a log when purchasing medication containing dextromethorphan and would require a pharmacist to sell the drug. That would mean common brands such as Robitussin, NyQuil, and Dimetapp would disappear from grocery store shelves.

    According to the Consumer Healthcare Products Association (HCPA), 18 states have laws requiring prescriptions for all controlled substances, regardless of which schedule they're in.

    Since dextromethorphan's approval in the 1950s, the FDA has evaluated the safety of the drug a number of times. In 1983, the agency concluded that with a " ... low order of toxicity, dextromethorphan is probably the safest antitussive presently available."

    In fact, dextromethorphan was specifically excluded from the Controlled Substances Act in 1970 because of the lack of abuse potential.

    Tuesday's panel, however, was in agreement that there is enough pharmacological and epidemiological data to show that dextromethorphan has abuse potential, and that the specific population most at risk for abuse are adolescents who are also using other drugs to get high.

    One panelist, Thomas Kosten, MD, a specialist in psychiatry and addictions at Baylor College of Medicine in Houston, called dextromethorphan a gateway drug to PCP.

    CHPA runs a national campaign to educate the public about the dangers of abusing cough medicine; however, the group stressed the importance of targeting the campaign to parents and to those likely to abuse cough medicine.

    "Today's 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 over-the-counter medicines containing dextromethorphan," said CHPA. "We do, however, recognize the need for continued education to keep any abuse levels low."

    September 14, 2010

  3. fuzelogic
    Sorta like the meth issue couple years ago...does mean swim will now have to get the cough syrup imported from Mexcio :)
To make a comment simply sign up and become a member!