Failure to approve Claritin OTC for chronic idiopathic urticaria would perpetuate off-label use of non-prescription drugs to treat hives, Schering-Plough told FDA's Nonprescription Drugs Advisory Committee at a meeting in Bethesda, Md. April 22.

OTC Claritin likely would be used by some acute hives sufferers despite label statements limiting the drug's use to chronic, recurring hives of an unknown source, Schering Senior VP-Scientific & Regulatory Affairs John Clayton, PhD, conceded.

However, "we know that this is occurring today with sedating antihistamines OTC without benefit of any labeling to instruct the consumer how to properly use the product or when to see the physician," Clayton maintained.

Based on Claritin's extensive, non-Rx use for hives in foreign markets and "the current significant use of prescription Claritin for CIU in the U.S., we believe it would be inappropriate to switch Claritin OTC without labeling for this indication. Otherwise, we will continue to facilitate off-label use of OTC antihistamines for urticaria," the Schering exec said.

NDAC member Hari Sachs, MD, a Rockville, Md.-based clinician, questioned whether it would be more appropriate to expand the urticaria indication for OTC Claritin to include hives in general, or to merely switch the drug OTC for allergic rhinitis "and educate the affected [CIU] patients who are seeing their doctors anyway that it would be permissible to take something that's already OTC for their condition."

However, Dermatologic & Ophthalmologic Drugs Advisory Committee member Lloyd King, MD/PhD, Vanderbilt University, suggested the latter approach would essentially encourage physicians to promote off-label use of the non-sedating antihistamine.

"I don't think the FDA would want to be in that position," said King, who joined NDAC in its deliberations.

The committee voted unanimously (16-0) that CIU "could be" a disease process appropriate for OTC treatment by second-generation antihistamines and that data support switching Claritin for the indication.

Nevertheless, 15 members of the committee, which also included three representatives from the Pulmonary-Allergy Drugs Advisory Committee, voted in favor of expanding the CIU indication for the class of second-generation antihistamines to include such conditions as urticaria and hives.

NDAC member Frank Davidoff, MD, editor emeritus for the Annals of Internal Medicine, said the indication "possibly" could be broadened.

The committee's vote in favor of expanding the urticaria indication for the drug class stemmed, in part, from label comprehension data indicating acute hives sufferers are unable to correctly de-select a product indicated solely for CIU.

In addition, Schering presented survey data showing that consumers frequently turn to OTC remedies for treating hives, even though no over-the-counter drugs are approved for such an indication.

According to an Internet-based survey commissioned by Schering, 48% of 359 physicians interviewed recommend OTC products for treatment of CIU.

OTC antihistamines, such as Pfizer Consumer Healthcare's Benadryl , are recommended by 43% of doctors, while 18% of physicians recommend use of OTC topical creams or lotions, according to the survey, which was conducted last November.

A separate Internet-based survey of consumer habits and practices found that 43% of previously diagnosed CIU sufferers use an OTC to treat hives when they recur, while 52% use a prescribed medication already on hand.

Prior to physician diagnosis of their condition, 62% of consumers said they took an OTC antihistamine such as Benadryl or Schering's Chlor-Trimeton for their hives, according to the study, which surveyed a total of 388 CIU sufferers in October and November.

"The availability of an OTC, non-sedating, H1 antihistamine in CIU would represent a significant benefit to the patient or consumer in two ways," said Schering consultant Eugene Monroe, MD, Medical College of Wisconsin.

"It would provide better safety than exists with the current OTC antihistamines, and it would create an opportunity for better care through labeling and patient education," Monroe told the committee.

FDA Dermatologic & Dental Drugs Division Director Jonathan Wilkin, MD, echoed these points.

"I think this is an opportunity, if this goes OTC and it goes OTC for hives...to put some things in labeling...for some conditions that might be confused with or associated with hives and actually it could be better than" the current situation, in which consumers use OTCs without the benefit of educational messages in labeling, the FDAer said.

NDAC member Alastair Wood, MD, Vanderbilt University, suggested studying patients who are currently using OTC antihistamines to "see what conditions they're treating."

Similarly, FDA Division of OTC Drug Products Director Charles Ganley, MD, said "it would be interesting to understand" why consumers currently use OTC antihistamines for urticaria. "Consumers can be influenced by various information resources. The Internet is a prime example," he asserted.

"The other thing that we don't really have an understanding of is how these products are marketed. One example would be the brand names," Ganley maintained. "There are many brand names out there that include the term allergy. How do consumers interpret that? Do they extrapolate that to a lot of different diseases?"

Clayton said Schering is committed to supporting OTC Claritin with a consumer information program "to better educate CIU sufferers as to proper care for their disease."

Although specific details have not been finalized, Clayton said the education program would address both allergic rhinitis and CIU and "focus on...helping the consumer understand if Claritin is the appropriate drug for their situation, advising when to consult their physician or seek medical care, and when emergency care is appropriate."

"There are a number of platforms that we expect to utilize in this program, including Internet-based information, toll-free telephone, print and continuing education for health professionals," he said.

Claritin OTC Approval For CIU Would Reduce Off-Label Drug Use – Schering

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