drdĒv
04-08-2007, 10:55 PM
April 8, 2007
If dextromethorphan, a common ingredient in cough medications, came before the Food and Drug Administration today, it probably wouldn't be approved for over-the-counter sales.
It is one of several ingredients in cough medications approved for sale during a point in history when federal regulators required little or no safety testing for drugs sold over the counter. Dextromethorphan was approved by the FDA in 1958.
Brian Malone, director of pharmaceutical services at Winthrop-University Hospital in Mineola, describes it as the somewhat less potent cousin of a few well-known narcotic-grade drugs, even though dextromethorphan is not a narcotic.
"It's a cough suppressant that is chemically derived from the opioid class of medications," Malone said. "The opioids include morphine and codeine."
"Like codeine, this drug acts on the central nervous system to relieve ... coughing. What you don't get is the sedative effect like codeine. But when you take it in quantities larger than prescribed, you can get a euphoria effect -- and you can also get respiratory suppression," Malone said.
It is the respiratory suppression that causes abusers of cough and cold remedies to pass out when too little oxygen reaches the brain.
The Consumer Healthcare Products Association, a trade group of companies that market over-the-counter medications, has launched a campaign in conjunction with the Community Anti-Drug Coalitions of America citing rising dextromethorphan abuse and ways of preventing it. The industry group maintains that cough and cold medications are safe and effective when used according to the label.
But some experts worry that even the label instructions are a concern.
The FDA last month launched a review of over-the-counter children's cough and cold medications that contain the drug after the release in January of a startling report from the Centers for Disease Control and Prevention. The CDC found that misuse of the medications by well-intentioned parents resulted in three deaths and more than 1,500 adverse reactions requiring treatment in emergency rooms. All of the affected children were under age 2.
FDA spokeswoman Kimberly Rawlings said public comment is being accepted on the fate of children's cough remedies as part of the agency's review. Top pediatricians nationwide signed a petition last month insisting that the FDA revisit the drugs' safety, and some medical experts believe the FDA may respond by requiring the medications be kept behind pharmacy counters nationwide.
Consumer watchdog Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said dextromethorphan is a useless chemical additive that provides no therapeutic benefit.
"If dextromethorphan came on the market today, it wouldn't get approved," Wolfe said in a telephone interview. Dextromethorphan is one of many medications that he and his colleagues have targeted in their book and online publication, "Worst Pills, Best Pills."
Wolfe, a longtime critic of the FDA, added that dextromethorphan was last reviewed by the agency in the early 1970s, when FDA officials found it to be effective.
Since then, Wolfe said, studies have found several problems with the drug -- not to mention its capacity for abuse.
If dextromethorphan, a common ingredient in cough medications, came before the Food and Drug Administration today, it probably wouldn't be approved for over-the-counter sales.
It is one of several ingredients in cough medications approved for sale during a point in history when federal regulators required little or no safety testing for drugs sold over the counter. Dextromethorphan was approved by the FDA in 1958.
Brian Malone, director of pharmaceutical services at Winthrop-University Hospital in Mineola, describes it as the somewhat less potent cousin of a few well-known narcotic-grade drugs, even though dextromethorphan is not a narcotic.
"It's a cough suppressant that is chemically derived from the opioid class of medications," Malone said. "The opioids include morphine and codeine."
"Like codeine, this drug acts on the central nervous system to relieve ... coughing. What you don't get is the sedative effect like codeine. But when you take it in quantities larger than prescribed, you can get a euphoria effect -- and you can also get respiratory suppression," Malone said.
It is the respiratory suppression that causes abusers of cough and cold remedies to pass out when too little oxygen reaches the brain.
The Consumer Healthcare Products Association, a trade group of companies that market over-the-counter medications, has launched a campaign in conjunction with the Community Anti-Drug Coalitions of America citing rising dextromethorphan abuse and ways of preventing it. The industry group maintains that cough and cold medications are safe and effective when used according to the label.
But some experts worry that even the label instructions are a concern.
The FDA last month launched a review of over-the-counter children's cough and cold medications that contain the drug after the release in January of a startling report from the Centers for Disease Control and Prevention. The CDC found that misuse of the medications by well-intentioned parents resulted in three deaths and more than 1,500 adverse reactions requiring treatment in emergency rooms. All of the affected children were under age 2.
FDA spokeswoman Kimberly Rawlings said public comment is being accepted on the fate of children's cough remedies as part of the agency's review. Top pediatricians nationwide signed a petition last month insisting that the FDA revisit the drugs' safety, and some medical experts believe the FDA may respond by requiring the medications be kept behind pharmacy counters nationwide.
Consumer watchdog Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said dextromethorphan is a useless chemical additive that provides no therapeutic benefit.
"If dextromethorphan came on the market today, it wouldn't get approved," Wolfe said in a telephone interview. Dextromethorphan is one of many medications that he and his colleagues have targeted in their book and online publication, "Worst Pills, Best Pills."
Wolfe, a longtime critic of the FDA, added that dextromethorphan was last reviewed by the agency in the early 1970s, when FDA officials found it to be effective.
Since then, Wolfe said, studies have found several problems with the drug -- not to mention its capacity for abuse.