Firms Consult FDA, Add “Do Not Use” For Under 4 To Pediatric Cold Products

Over-the-counter pediatric cough/cold products relabeled "do not use" for children under 4 will reach shelves in the next few weeks in a voluntary program manufacturers coordinated with FDA.

The labeling changes announced Oct. 7 were in the works months ahead of FDA's Oct. 2 public hearing on the safety and efficacy of cough/cold products for children, according to the Consumer Healthcare Products Association. However, the voluntary program was not mentioned at the meeting.

FDA conducted the hearing to gather input from parents, health care practitioners, drug manufacturers and other stakeholders about ingredients covered in the OTC cough, cold, allergy, bronchodilator and anti-asthmatic drug products monograph, which the agency is preparing to amend (¹ (Also see "Calls For Cough/Cold Collaboration As FDA Inches Toward Rulemaking" - Pink Sheet, 6 Oct, 2008.), p. 3).

The relabeling also includes adding a warning that products "containing certain antihistamines" listed in the monograph, such as diphenhydramine and brompheniramine, should not be used to sedate children.

CHPA members, in consultation with FDA, decided months ago to add the "under 4" advisory to labels based on "a significant break" between age groups shown in adverse event report data from the Centers for Disease Control, the trade group says.

The association emphasized that the medicines are safe and effective when used properly, but noted that the under-4 warning is intended to limit dosing errors and accidental ingestion, the most common causes of adverse events with these products.

"Adverse events related to the use of these medicines are very rare and are predominantly caused by accidental ingestion and improper dosing, particularly in 2- to 3-year-olds," CHPA Communications Director Elizabeth Funderburk noted.

In an Oct. 7 media conference call, CDER Director Janet Woodcock concurred. The cutoff is determined by "where we think the highest risk is" based on AER data, Woodcock said.

While the new labeling is "inconsistent" with the current monograph, FDA will not object to the change "which reflects a more restrictive use of the drugs in children," the agency said in an Oct. 8 statement.

Manufacturers will not withdraw products with existing labeling from stores as they introduce amended labeling, CHPA says. FDA "indicated it does not believe this labeling change warrants the removal of products ... during this time of transition," according to the trade group.

The agency acknowledges that products with and without the under-4 warning will be on store shelves simultaneously. Consumers should follow the directions and warnings printed on labels on products they purchase, FDA says.

The relabeling affects these product lines: McNeil Consumer Healthcare's Tylenol and Pediacare , Novartis Consumer Health's Triaminic , Wyeth Consumer Healthcare's Dimetapp and Robitussin ,Procter & Gamble's NyQuil and Vicks and Reckitt Benckiser's Delsym and Mucinex . CHPA provides a list of products on its OTCsafety.org Web site.

CHPA also announced it is expanding its education program for parents and other caregivers about safe and appropriate use of cough/cold products.

The education program is aimed at preventing accidental ingestions and overdoses by explaining appropriate use, reminding parents to keep the medicines out of a child's reach and advising parents and caregivers to consult physicians or health care professionals if they have questions.

Same Products, Different Question

The timing of CHPA's announcement elicited questions from media representatives because the relabeling plan was not mentioned at FDA's public hearing four days earlier.

Woodcock and John Jenkins, director of the Office of New Drugs, said FDA deferred to CHPA on the timing of the announcement.

They also said the meeting and the labeling initiative served different purposes, stressing the hearing was held to gather information to facilitate the rulemaking process of revising the monograph.

The relabeling is "just a voluntary action on the part of the industry and in no way supersedes our plan to address the entire age range in the monograph," Jenkins said.

CHPA said the announcement was made to coincide with the relabeled products "showing up on store shelves in some regions." The questions discussed at the hearing and adding the under-4 warning on labels are "completely independent" from one another, the group maintained.

Cough/Cold Criticism Continues

Scrutiny of pediatric cough/cold products increased in 2007 after public health and pediatric experts petitioned FDA to remove products marketed for children under 6, saying that safety and efficacy data for that population do not exist.

Baltimore Health Commissioner Joshua Sharfstein, the lead author of the petition, said the under-4 warning is "a big step in the right direction."

Sharfstein noted the petitioners still recommend that parents not give the "unproven and potentially unsafe" medicines to children under 6.

Sen. Chris Dodd, D-Conn., chairman of the Health, Education, Labor and Pensions Subcommittee on Children and Families credits the industry for making the change, but in an Oct. 6 letter to Commissioner Andrew von Eschenbach he continues urging FDA to remove the products from the market.

Peter Lurie, deputy director of the health research group at Public Citizen, says it appears CHPA's announcement is aimed at "once again attempting to delay more definitive action by the FDA."

Moreover, the label change sends the message the medicines are safe and effective for children 4 and up, something he notes has yet to be confirmed, adds Lurie, who provided comments to FDA for the Oct. 2 meeting.

In an October 2007 meeting, members of FDA's Pediatric and Nonprescription Drugs advisory committees made clear the agency should take a closer look at the products. Prior to that meeting, OTC drug firms voluntarily withdrew cough/cold products for children under 2 due to concerns about potential misuse, but not about the safety of the ingredients (² (Also see "Infant Cold Products Pulled; Waxman Looks For More OTC Risks" - Pink Sheet, 15 Oct, 2007.), p. 6).

- Katie Stevenson ([email protected])