Cough Medicine Ingredient Faces FDA Review

The U.S. Food and Drug Administration’s (FDA) drug safety advisory committee is planning on looking into the “risks and benefits” of <"http://www.yourlawyer.com/practice_areas/defective_drugs">dextromethorphan (DXM or DM), a cough medication ingredient, said Dow Jones. The review is being undertaken in the midst of concerns about the increase cough suppressant product abuse among teens, said Dow Jones. The panel meeting is scheduled for September 14, according to the FDA’s Website.

DXM can be found in many over-the-counter (OTC) cough and cold remedies. While generally safe, ingestion of excessive amounts of DXM is extremely dangerous and may cause serious adverse reactions including brain damage, seizure, loss of consciousness, irregular heartbeat, and death.

DXM can be found in over 100 OTC medications such as some of Pfizer Inc.’s Robitussin, Novartis AG’s Triaminic, and Procter & Gamble Co.’s Nyquil, said Dow Jones. The FDA said the Drug Enforcement Administration (DEA) requested a “scientific and medical evaluation” for dextromethorphan, quoted Dow Jones.

A recent National Institute on Drug Abuse-funded survey found that there is a rise in teens reporting have used the medications for nonmedical reasons in 2009, said Dow Jones. Now, the DEA is looking into regulating DXM in similar ways to how other drugs are regulated, such as narcotics, said Dow Jones. And, while DXM is not considered a narcotic, it does have a significant abuse potential given that it can produce a high when taken at higher-than-recommended doses, explained Dow Jones. DXM abuse is referred to as “Robo-tripping” or “skittling,” said the DEA.

Teenagers are abusing OTC cold medicines at an alarming rate. In large doses, OTC cough syrups and cold pills can be used to induce hallucinations, out-of-body experiences, and other effects. Shockingly, about 3.1 million people between the ages of 12 to 25—five percent of that age group—have used these potentially dangerous drugs to get high, a 2006 U.S. government survey conducted by the Substance Abuse and Mental Health Services Administration (SAMHSA) found.

The DEA cited the rising popularity of cough syrup cocktails: Prescription, codeine-laced cold medicines mixed with soda or sports drinks sometimes called “Syrup,” “Purple Drank,” and “Lean.” The trend of this cocktail has since spread to more readily available OTC versions of cough suppressants to make more accessible cocktails.

DXM is a cough-suppressant found in medicine ranging from pain relief to psychological applications, and is found in over 140 OTC cough and cold medications. Pure dextromethorphan occurs as a powder made up of white crystals, but is generally administered via syrups, tablets, or lozenges. When taken at doses higher than are medically recommended, dextromethorphan acts as a dissociative, hallucinogenic drug and can cause disorientation, blurred vision, slurred speech, and vomiting.

A prior study conducted by the U.S. Centers for Disease Control and Prevention (CDC) found that 1500 children nationwide had been treated in emergency rooms for problems related to OTC cold medicines and that three died as a result of misused cold medications. The CDC findings caused the FDA to launch an investigation into the use of these drugs in children.

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