Cough and cold recommendations may impact other products

November 19, 2007

Two Food and Drug Administration advisory committees voted 13 to 9 to recommend that cough and cold over-the-counter medications not be used for children who are more than two and less than six years old.

Two Food & Drug Administration advisory committees, meeting jointly lastmonth, voted 13 to 9 to recommend that cough and cold over-the-counter medicationsnot be used for children who are more than two and less than six years old. Italso voted 21 to 1 to recommend that the products not be used in children undertwo. In contrast, the committees voted 15 to 7 against a statement that wouldhave opposed the medications' use for children over six and under 12.

Thepanel members did not say the medications are not effective in children, althoughthere was skepticism on that point among some of the members. They did state thatthey had not seen adequate studies to indicate that effectiveness.

The committeesasked that careful studies be done to prove the medications' efficacy in children.Those studies will probably take at least two to three years, said John Jenkins,M.D., director of the Office of New Drugs, in the FDA's Center for Drug Evaluationand Research.

Follow the leader

TheFDA usually follows the recommendations of its advisory panels. However, in apress conference following the meeting, Jenkins said officials "need to takeback and discuss internally within the agency all the advice and recommendationswe heard so that we can decide what our course of action will be."

Theagency must go through a formal rule-making process to change the drugs' labeling,which could take a year or much longer, but Jenkins said the FDA may get backto the public soon with interim recommendations.

The committees discussedextensively the issue of whether efficacy data should be extrapolated from adultsto children for these products and voted that extrapolation was not appropriatefor children under 12. Jenkins pointed out that the vote was "in contradistinctionto the advice that we received approximately 30 years ago for the original cough/coldpanel for the monograph process."

Jenkins noted that extrapolationfrom adults to children has been done for other medications. He said the agencywould have to think about whether the committees' advice is pertinent only tothe cough/cold arena or if it has broader implications.

Many of these coldproducts also have labeling statements for other indications. The FDA monographfor these medications is the same one for the bronchodilators and some allergyproducts, Jenkins stated. He also said the agency must decide what the implicationsare for hay fever and other types of allergic conditions.

Combinationforms

The committees also voted that these products should beallowed in combination forms if safety and efficacy of the separate ingredientsare demonstrated, for children over two and under 12. The FDA had asked the panelabout such combinations in light of concerns that caregivers may use several productsand not realize the same ingredient is in more than one.

In discussionson the FDA's list of questions—with many of the conversations held withouta specific vote—the committees also urged that safety improvements be madein labeling, dosing instructions, and dosing devices.
Some committee membersquestioned whether it is feasible to do studies large enough to identify relativelyrare adverse events for these products. On the other hand, Marie Griffin, M.D.,a Vanderbilt University School of Medicine professor, cited some large trialsthat have been done on other drugs and said, "It may be beyond the scopeof manufacturers to do this, but it may be in the interest of the public and thegovernment to support these kinds of trials for a very, very common conditionfor drugs that are used by half of the population."

In testimony priorto the committees' discussion, Winnie Landis, president of the American PharmacistsAssociation, told the panel, "Unfortunately, despite a recommendation froma physician or pharmacist not to use a cough or cold product in children undersix, parents do give such medication out of desperation to do something to addresstheir child's health needs. This is a patient safety issue that may be more commonthan we like to admit."

APhA also recommended that the FDA considerstandardizing dosing unit terminology to reduce confusion and called for the agencyto move against the same brand-name or brand-name line extensions being used forOTC products that actually have different active ingredients.

Of the 22voting members on the Nonprescription Drugs Advisory Committee and the PediatricAdvisory Committee, a majority was made up of professors of medicine and epidemiology.There were also experts in pharmacology and pharmacoepidemiology.

Informationabout the issues and the meeting can be found at