Cold medicines for infants pulled amid safety concerns
CVS, Walgreens, Rite-Aid and other drugstores Thursday stopped selling over-the-counter cough and cold medications for children under age 2 after manufacturers asked them to pull the products because of safety concerns.
The products are not tainted or defective, and drug makers said there was nothing wrong with the medications when used as directed. But they issued the request amid mounting pressure from physicians, public health advocates and others concerned about deaths of young children linked to overdosing.
The withdrawn drugs involve “infant” formulations of cold and cough medications sold under the Dimetapp, Little Colds, PediaCare, Robitussin, Triaminic and Tylenol labels.
The withdrawal came a week before a committee of the Food and Drug Administration was set to review the safety and effectiveness of cold and cough medicine in children. A recent FDA report found that the agency had received 54 reports of deaths associated with decongestants and 69 deaths linked to antihistamines from 1969 to 2006 in children, most younger than 2.
Bob Graul, owner of the Rancho Santa Fe Healthmart pharmacy in San Diego County, said he was alerted by a fax from Johnson & Johnson’s McNeil Consumer Healthcare about 4 p.m. Thursday and wasted no time in heeding the notice.
“I’m in the process now of going through and seeing what to pull,” Graul said.
The renewed scrutiny of the drugs was prompted in part by concerns raised by public health officials and pediatricians in Baltimore nearly a year ago, after the deaths of four children under age 4 linked to overdoses of the medications in that city.
“This is a good step -- not enough, but it’s a good step,” Joshua Sharfstein, a pediatrician and Baltimore Health Commissioner, said of the voluntary removal from store shelves.
He said the FDA must prevent the manufacturers involved in the voluntary withdrawal from changing their minds and ensure that no other drug makers attempt to market such medications. “The FDA should make a clear statement,” Sharfstein said.
The FDA said it had not asked for the withdrawal but applauded it as “an important step in protecting these infants’ health.”
Joel Schiffenbauer, a research physician in the FDA’s nonprescription drug office, said that despite the manufacturers’ action the agency would go ahead with its meeting next week to assess “issues related to the efficacy, safety and labeling” of over-the-counter cold and cough medications.
Schiffenbauer said the FDA was looking at its previous approval of the drugs for children based on extrapolated data from studies on adults as well as whether dosage instructions should be based on weight rather than just age.
Diane Murphy, a pediatrician in the FDA’s Office of Pediatric Therapeutics, said there definitely was a problem with parents misunderstanding directions and not following them. But she also said the science about dosing had changed over the last 10 years.
“We have learned a lot about dosing, and it’s telling us we don’t know as much as we thought we did,” Murphy said. “We need to look at the safety and efficacy of these products.”
Los Angeles parents Laura and Bradford Smith said they had given their daughters, ages 1 and 4, Dimetapp Decongestant Infant Drops. But they said they were not concerned and would continue using the product unless their doctor told them otherwise.
“You can overdose on anything,” Bradford Smith said. “It’s up to the parents to be responsible with medicine.”
The Consumer Healthcare Products Assn., the industry group that announced the withdrawal, said the medications were not dangerous and took care to distinguish the withdrawal from a recall, which implies a product defect.
“These medicines are safe and effective when used as directed, and most parents are using them appropriately,” association President Linda A. Suydam said in a statement. But she added: “There have been rare patterns of misuse leading to overdose recently identified, particularly in infants, and safety is our top priority.”
Others, though, said there was no evidence that the drugs were safe or effective for infants or young children -- a conclusion the Baltimore group has petitioned the FDA to reach.
Concerns about pediatric cold remedies have swirled for years. In a 2001 article, the journal Pediatrics reported that although “they may alleviate some symptoms in adolescents and adults, many studies have demonstrated that [over-the-counter] cough and cold preparations did not achieve such claims in the younger pediatric population.”
A Centers for Disease Control and Prevention report this year found that 1,500 children had been treated in U.S. emergency rooms in 2004 and 2005 for “adverse effects” linked to the medications, and three babies died.
In August, the FDA issued an advisory that “reports of serious adverse events associated with the use of these products appear to be the result of giving too much of these medicines to children.” The agency also advised parents against using the drugs in children under age 2 unless directed to do so by a physician.
The Consumer Healthcare Products Assn. said it and its member companies had recommended that the FDA strengthen the warning labels on all oral over-the-counter children’s cough and cold medicines to say “do not use” in children younger than 2. Currently, they advise consumers to “ask a doctor” before using.
Rep. Henry A. Waxman (D-Beverly Hills), chairman of the House Oversight and Government Reform Committee, asked the association in a letter last week why the companies continued to market the medicines for infants even after the industry association had recommended that they should not be given to children under 2.
Suydam said the companies elected to take the medications off the market out of an abundance of caution. The association said the voluntary market withdrawal affected only “infant” oral medicines, not those intended and labeled for children ages 2 and older.
The group also said it would launch a campaign to educate parents and healthcare providers about the safe use of over-the-counter medicines in children.
Pediatricians said they had been advising parents against using the drugs on children under 2 for some time.
“Our advice really changed about a year and a half ago when we read the first study that came out about these over-the-counter medications,” said Lori Krieger, a San Pedro pediatrician. “We began telling parents with children under the age of 2 that we were not indicating any over-the-counter medications besides Tylenol and Motrin.”
Krieger said it was easy for parents to overdose small children, either by giving too much of one drug or by giving more than one containing the same active ingredient.
Richard Pan, an associate professor of clinical pediatrics at UC Davis, said he recommended against using the medications for young children and “strongly discourages” their use on children not yet 1 year old.
“The side effects may be worse than the benefit,” he said.
Duaine R. Arvidson said he didn’t even keep the medications on the shelves of his Corona pharmacy because of concern that they would be misused.
“We stock children’s” medicine, Arvidson said. “We don’t stock infants’.”
Some drugstores, including Rite-Aid, said they would issue refunds if customers brought the medications back.
(BEGIN TEXT OF INFOBOX)
The cough and cold medicines that are being voluntarily removed from store shelves are:
* Dimetapp Decongestant Plus Cough Infant Drops
* Dimetapp Decongestant Infant Drops
* Little Colds Decongestant Plus Cough
* Little Colds Multi-Symptom Cold Formula
* PediaCare Infant Drops Decongestant
* PediaCare Infant Drops Decongestant & Cough
* PediaCare Infant Dropper Decongestant
* PediaCare Infant Dropper Long-Acting Cough
* PediaCare Infant Dropper Decongestant & Cough
* Robitussin Infant Cough DM Drops
* Triaminic Infant & Toddler Thin Strips Decongestant
* Triaminic Infant & Toddler Thin Strips Decongestant Plus Cough
* Tylenol Concentrated Infants’ Drops Plus Cold
* Tylenol Concentrated Infants’ Drops Plus Cold & Cough
Source: Consumer Healthcare Products Assn.
What to do if your child has a cold
The Food and Drug Administration says children under age 2 should not be given over-the-counter cold medications without a physician’s direction, but the American Academy of Pediatrics takes a more conservative approach. It says such products should be avoided in children younger than age 3. The group notes that there’s no cure for the common cold and that often the best a parent can do is to make the child comfortable. It recommends the following:
* Make sure the child gets extra rest and drinks more fluids
* For a stuffy nose, consider using a suction bulb, saline nose drops or a cool-mist vaporizer
* Ordinarily, there’s no reason to suppress a cough. Coughing is a protective mechanism that clears mucus from the lower part of the respiratory tract.
* If your child has a fever and is very uncomfortable, give him or her acetaminophen or ibuprofen. Ibuprofen can be used in children ages 6 months and older, but should never be given to children who are dehydrated or who are vomiting continuously. Follow the recommended dosage for the child’s age.
* If your baby is 3 months old or younger, call your pediatrician at the first sign of illness
Source: American Academy of Pediatrics