From Cleveland Plain Dealer, Staff and wire reports
As drug makers rushed to pull cold medicines for babies off the market across the nation Thursday, Dr. Haitham Haddad at Rainbow Babies & Children’s Hospital in Cleveland echoed a rising chorus of concerns about the safety of such medicines.
“Cold medicine doesn’t work on children under the age of 2,” Haddad said. “By giving cold medicine you’re asking for side effects.”
One serious side effect: The children could stop breathing, Haddad said.
“We don’t know what’s the right doses for the first years of life, and the concern is that if it doesn’t work, the parent will tend to give more of it and more frequently.”
The drug maker’s move Thursday represented a pre-emptive strike by the over-the-counter drug industry – a week before government advisers were to debate the medicines’ fate. But it doesn’t end concern about the safety of these remedies for youngsters.
Thursday’s withdrawal includes medicines aimed at children under age 2, after the Food and Drug Administration and other health groups reported deaths linked to the remedies in recent years, primarily from unintentional overdoses.
Haddad, a pediatrician and attending physician at Rainbow’s emergency room, said it is routine for the hospital to see young children who have overdosed on the medicine. The kids, more often than not, are very sleepy. Sometimes the child must be kept at the hospital and watched, he said.
“The huge concern is giving it during the first six months of age,” Haddad said. “That’s when it could be really lethal.”
Nationally, there are also questions about whether children under 6 should ever take these nonprescription drugs.
Baltimore city officials filed a petition with the FDA – joined by the American Academy of Pediatrics and prominent pediatricians – arguing that oral cough and cold medicines don’t work in children so young.
The challenge, said Dr. Joshua Sharfstein, Baltimore’s health commissioner and a pediatrician, will be to persuade parents to try old-fashioned methods, like suctioning out infants’ noses or using salt-water nose drops.
The Consumer Healthcare Products Association announced Thursday that manufacturers were voluntarily ending sales of over-the-counter oral cough and cold products aimed at infants. The list includes infant drops sold under the leading brand names Dimetapp, Pediacare, Robitussin, Triaminic, Little Colds, and versions of Tylenol that contain cough and cold ingredients.
CVS Caremark Corp. added that it would also end sales of CVS-brand equivalents.
The FDA is bringing its scientific advisers together next Thursday and Friday to debate the issues, but its own preliminary review concluded that very young children shouldn’t take some of these commonly used medicines. And while the FDA’s main focus is on children under 6, it also will ask if there’s evidence that these drugs work in children up to age 12.
FDA praised the drug makers’ withdrawals Thursday as important for protecting babies.
For other youngsters, parents should understand that cold remedies treat only symptoms, they don’t make viruses go away any faster, stressed FDA pediatrician Dr. Dianne Murphy.
Plain Dealer Sarah Jane Tribble and the Associated Press contributed to this story.
