Doctors Laud FDA Warning on Over-the-Counter Meds

By Delthia Ricks, Newsday, Melville, N.Y.

Aug. 20–The U.S. Food and Drug Administration’s warning against the use of over-the-counter cough and cold medications for children younger than 2 is being greeted with applause from medical experts who cite the drugs’ capacity to harm and even kill.

Federal drug regulators last week said the medications should be used by parents only under the guidance of a physician. The FDA is convening a panel of independent experts Oct. 18 to determine whether stronger restrictions are needed to protect children from over-the-counter cough suppressants and other common remedies.

Over-the-counter cough and cold medications have been medicine-cabinet staples for decades. Many contain ingredients that have been available since the era of Sputnik — and cars with fins. None of the older ingredients, how-ever, were ever rigorously tested in clinical trials. Compounds such as dextromethorphan and pseudoephedrine have eluded the scrutiny of modern safety testing because they were grandfathered into use, doctors say.

Even though a spotlight recently has been trained on the dangers of over-the-counter medications, some experts contend that countless infants probably were harmed for decades, but their injuries — and deaths — were not attributed to the drugs.

“No one has ever died of the common cold,” said Dr. Howard Sussman, an assistant professor of family medicine at Stony Brook University Medical Center. “Unfortunately there can be a grave outcome” for babies who’ve been improperly dosed with over-the-counter medications.

Ingredients that have not been studied or changed in a half-century worry Dr. Peter Dicpinigaitis, who heads the cough center at Montefiore Medical Center in the Bronx and who in June chaired the first American medical conference focusing on cough. He said parents can easily under-estimate the potency of over-the-counter drugs.

“Even though these drugs are sold over the counter they still have dangerous ingredients,” Dicpinigaitis said, referring to dextromethorphan and pseudoephedrine. “Dextromethorphan is a non-narcotic opioid in the codeine family, so even though it’s over-the-counter it potentially can cause sedation in a child.” Pseudoephedrine, he added, can have the opposite effect, causing the heart to race, which also can produce serious consequences.

A study of nonprescription drug misuse reported by the Centers of Disease Control and Prevention in January found that some infants had been given doses of nasal decongestants containing pseudoephedrine that were up to 14 times the amount recommended for children between 2 and 12 years old. High doses of pseudoephedrine can cause hypertension and stroke in babies — and older children.

Dextromethorphan has been the focus of debate because of its widespread abuse by teens and adults who consume cough and cold medications to get high. In May, Suffolk County lawmakers approved a landmark ban prohibiting the sale to minors of many nonprescription cough and cold medications that contain dextromethorphan, also known as DMX. Medical experts have said that large doses in teens and adults can lead to psychosis, brain damage and possibly death.

For babies, the question remains whether a tougher FDA policy is needed. “I think this comes down to a risk-benefit analysis on how useful and important it is that we give infants over-the-counter medications for what should be self-limiting illnesses, like the common cold,” Sussman said.

In March, FDA officials began studying problems associated with over-the-counter cough and cold remedies that had been improperly administered to infants, usually by well-meaning parents. The investigation resulted in last week’s advisory. The FDA probe grew out of the January report from the CDC found that three babies died and more than 1,500 were treated in emergency rooms nationwide after adverse reactions to the popular drugs.

“Manufacturers always say to consult your physician when dosing infants under 2 years old,” Sussman said. “That’s because little infants need to be dosed by weight rather than by the simple instructions on a package insert.”

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