Loratadine (Claritin) gets OTC status

Critics fear increase in sedating antihistamine use

As expected, the U.S. Food and Drug Administration (FDA) has given loratadine (Claritin) over-the-counter (OTC) status. Loratadine, the only nonsedating antihistamine available OTC, is approved for seasonal allergic rhinitis.

The FDA’s decision last November enables "many people to get less-sedating, effective relief for their allergy symptoms more quickly and at a lower cost," according to Mark B. McClellan, MD, PhD, commissioner of Food and Drugs. The price of OTC loratadine was expected to drop by as much as 76%, from as much as $3.80 a pill in its prescription form to about 92 cents and $1.17 a tablet OTC.

For a drug to be approved for OTC marketing, the FDA must determine that:

  • the drug in question treats a condition that consumers can diagnose and manage themselves;
  • the drug is sufficiently safe for use by consumers without direct prescriber supervision;
  • the drug’s label explains potential adverse effects and conditions of use with clear and understandable directions.

The FDA, according to loratadine manufacturer Schering-Plough, approved all five formulations of the Claritin brand at their original prescription strengths. These formulations include: Claritin Tablets, a once-daily formulation; Claritin RediTabs Tablets, a once-daily formulation in an orally disintegrating tablet; Claritin-D 24-Hour Extended Release Tablets, a once-daily formulation with a decongestant; Claritin-D 12-Hour Extended Release Tablets, a twice-daily formulation with a decongestant; and Claritin Syrup, a liquid formulation for use in children 2 years of age and older. The products were to be available by mid-December. Once loratadine OTC is available, all versions of the drug, either branded or generic, will only be sold over-the-counter. Schering-Plough’s patent for loratadine expired Dec. 19.

The company says it intends to support loratadine as an OTC product with an educational program focusing on allergies, allergy management, and potentially associated conditions, such as asthma. The program also will provide allergy sufferers with recommendations about when to remain in close communication with their treating physician.

In addition, Schering-Plough says it has received an "approvable" letter from the FDA for the use of loratadine as an OTC treatment for hives. The company must provide more information about the labeling for this indication before final approval can be given.

The implications of self-medication

Not everyone was pleased that the FDA gave loratadine OTC status. The National Consumers League in Washington, DC, expressed concern that once loratadine goes OTC, it is only matter of time before the FDA grants other non-sedating antihistamines (NSAs) the same status. (WellPoint Health Networks in Thousand Oaks, CA, had petitioned the FDA for OTC status for three leading prescription non-sedating antihistamines.)

"The consequence of this forced OTC shift, along with the other NSAs that WellPoint has petitioned on, would be to eliminate insurance coverage for the entire class of NSAs, reduce allergy patient contact with their physicians, and most likely encourage considerable numbers of allergy patients to choose cheaper, sedating antihistamines," maintains NCL president Linda Golodner, in a letter delivered to the FDA.

The American College of Allergy, Asthma, and Immunology (ACAAI) in Arlington, IL, says patients may be more likely to self-diagnose and self-medicate with the OTC loratadine. As a consequence, they may seek medical advice and care much later when their disease is more advanced and when they are at greater risk of comorbidities such as asthma and sinusitis. "Diagnosis and treatment of allergic diseases often require expert professional evaluation and advice," the ACAAI says in a statement.

Like the National Consumers League, the ACAAI also is concerned that increasing out-of-pocket costs for NSAs by either forcing patients to buy them OTC or to pay higher co-pays for the remaining prescription NSAs will result in some patients turning to less expensive antihistamines, which cause drowsiness.

For more information about popular prescription drugs going OTC, see the November 2002 issue of Drug Utilization Review.