FDA looks to curb abuse of cough medicine

Aug 31, 2010 By MATTHEW PERRONE , AP Business Writer

(AP) -- 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 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, and fever. Abusers can also suffer side effects from other ingredients mixed in cough medicines, such as acetaminophen, which can cause .

"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 .

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.

Later this month 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 . 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.

Explore further: New treatment approved for rare form of hemophilia

not rated yet
add to favorites email to friend print save as pdf

Related Stories

FDA panel to vote on painkiller restrictions

Jun 30, 2009

(AP) -- Government experts are scheduled to vote on whether Nyquil and other combination cold medications should be pulled from the market to help curb deadly overdoses.

FDA weighs options to reduce painkiller overdoses

Jun 29, 2009

(AP) -- Tylenol, Excedrin, NyQuil. These household brands and others have come to symbolize safe, convenient relief from the aches and pains of everyday life. But this week the Food and Drug Administration ...

FDA panel: Lower maximum daily dose of Tylenol

Jun 30, 2009

(AP) -- Government experts called for sweeping safety restrictions Tuesday on the most widely used painkiller, including reducing the maximum dose of Tylenol and eliminating prescription drugs such as Vicodin ...

Recommended for you

WHO: Millions of Ebola vaccine doses ready in 2015

13 hours ago

The World Health Organization says millions of doses of two experimental Ebola vaccines could be ready for use in 2015 and five more experimental vaccines will start being tested in March.

Added benefit of vedolizumab is not proven

Oct 23, 2014

Vedolizumab (trade name Entyvio) has been approved since May 2014 for patients with moderately to severely active Crohn disease or ulcerative colitis. In an early benefit assessment pursuant to the Act on the Reform of the ...

Seaweed menace may yield new medicines

Oct 22, 2014

An invasive seaweed clogging up British coasts could be a blessing in disguise. University of Greenwich scientists have won a cash award to turn it into valuable compounds which can lead to new, life-saving drugs.

User comments : 0