FDA is taking action to curb inappropriate prescribing of Glaxo Wellcome's Relenza and Roche's Tamiflu.

The agency issued a public health advisory to health care professionals Jan. 12 "to remind prescribers of important and therapeutic considerations when treating patients with influenza-like symptoms," an FDA "Talk Paper" about the advisory noted.

Noting the existence of two older flu therapies, amantadine (Endo's Symmetrel and generics) and Forest's Flumadine (rimantadine), the health advisory states that "the recent approval and current promotion of two additional drugs with activity against influenza A and B, zanamivir (Relenza) and oseltamivir (Tamiflu), has increased interest in the role of specific antiviral drugs for this disease."

"Vaccination remains the primary method of preventing and controlling influenza," the letter states. Labeling for Tamiflu and Relenza emphasizes that the product is not a substitute for flu vaccination, and FDA urged the inclusion of this message in direct-to-consumer ads when the products were approved (¹ Also see "Tamiflu DTC Ads Should Encourage Flu Vaccination, FDA's Jolson Suggests" - Pink Sheet, 1 November, 1999.).

The advisory notes that FDA has become aware of inappropriate prescribing when bacterial infections are the cause of flu-like symptoms.

The agency has received several reports of patients with serious bacterial infections who initially had influenza-like symptoms and who had progression of bacterial infection during treatment with antiviral drugs alone, FDA said. "Always consider the possibility of primary or concomitant bacterial infection when making treatment decisions for patients with suspected influenza," the letter advises.

FDA also recommended that physicians "use special caution if prescribing Relenza to patients with underlying asthma or chronic obstructive pulmonary disease." There have been several reports of deterioration of respiratory function following inhalation of Relenza in patients with underlying asthma or COPD, the advisory added.

As promotional efforts and sales for the flu products have grown, DTC advertising for Relenza and Tamiflu has received increased FDA scrutiny.

FDA recently cited a Relenza television advertisement for misrepresenting the product's efficacy. "The overall presentation in the advertisement is misleading because it suggests that Relenza is more effective than has been demonstrated by substantial evidence," FDA said in a Nov. 23 letter to Glaxo.

The TV ad featured an actor portraying "influenza," who is banished from a woman's home after Relenza treatment. The ad concludes with the slogan: "If your doctor says its influenza, ask about Relenza."

Relenza labeling states that trial results "suggested up to one day of shortening of median time to improvement, not elimination, in major symptoms of influenza in patients receiving Relenza," the letter says.

The 60-second ad was discontinued Nov. 23. After being revised, it was re-launched Dec. 4. In the new version of the ad, instead of the flu being escorted to the door, it is found in the kitchen, mocking the sick woman's husband for preparing her chicken soup. "Soup?" the flu laughs, "Yeah, that'll do the trick."

Roche has also engaged in chicken soup-themed promotion for Tamiflu. As part of a consumer education program developed by the Diamond Group, actresses dressed as "grandmothers" distribute chicken soup packets to people on the streets of flu-prone areas. Consumers also receive a "Facts About the Flu" brochure, which describes the benefits of Tamiflu and notes its superiority to grandma's chicken soup.

In another Diamond Group effort, an actor "lives" inside a plexiglass cube designed as a studio apartment. The "man in the cube" is driven on the back of a truck through busy city streets, promoting the message that he is the only person in the city safe from influenza. Both campaigns, which have launched in Jacksonville, Chicago and New York, will be conducted throughout the flu season in the top 74 flu markets, as estimated by Roche.

While both Roche and Glaxo have unbranded educational campaigns that highlight the importance of flu vaccination, branded ads for Tamiflu and Relenza do not mention the flu shot.

Roche's unbranded campaign includes a written statement that "these prescription flu pills are not a substitute for the flu shot." In addition, the firm is collaborating with the National Women's Health Resource Center and the American Pharmaceutical Association to distribute educational information about influenza vaccination and treatment.

Glaxo is running national radio public service announcements and working with the American Lung Association on a three-year educational campaign that emphasizes the importance of flu vaccines as well as treatments available.

FDA approved Glaxo's inhaled flu treatment in July and Roche's Tamiflu capsules in October, making 1999-2000 flu season the companies' and wholesalers' first experience distributing the product under heightened demand.

Some pharmacies are experiencing short-term shortages of the products and are sometimes asking patients to return in one to two days to have their prescriptions filled. Both products should be taken within the first two days of the start of symptoms.

While there is no nationwide supply problem for Relenza, wide-spread flu activity has caused temporary shortages in a few areas due to consumer demand, Glaxo said. The company explained that it has had to overnight the product through wholesalers to areas where demand was greater than expected. Roche said it has a 24-hour turn around time for Tamiflu distribution.

Several wholesalers, including Bergen Brunswig, Bindley Western, Cardinal, McKesson and Neuman have had difficulty maintaining adequate supplies of reserve product or have experienced temporary shortages.

Bergen's computer system is designed to anticipate seasonal demand, the company said. Nevertheless, Bergen's Dallas, Tex. facility servicing Oklahoma, Arkansas, Louisiana and Texas said that, as of Jan. 11, it was unable to service 102 orders for Tamiflu.

After sales of about 1,400 pieces for the month of December, the Dallas facility saw sales of well over 2,000 pieces for the first 10 days of January. Over 3,000 additional pieces were on order.

As of Jan. 12, wholesaler Neuman had no Tamiflu in stock and was waiting for a shipment from the company. They had sold 9,000 pieces since October. Neuman had sold 5,600 pieces of Relenza, depleting its supply of the product to 2,400 units.

Bindley Western's Orange, Conn. facility servicing New York, New Jersey and Connecticut, was out of stock of Relenza for the first 10 days of January despite requests for the product, the wholesaler said. A 1,100-piece shipment was expected Jan. 11.

Relenza had 244,000 total scripts written from product launch in mid-October through the end of December. The company estimated that an additional 56,000 scripts were written in the first two weeks of January.

In the U.K., where Relenza is not recommended for general use, Glaxo also reported an increase in scripts in January. Rxs for Dec. 1-24 totaled 3,000. Glaxo estimated that an additional 5,000-7,000 scripts have been written through Jan. 4 in the U.K.

In the U.S., Roche launched its branded ad promotion for Tamiflu Jan. 6. The campaign, entitled "Trapped," builds on the unbranded television and print promotion that started running Nov. 15.

A 45-second TV ad depicts a woman suffering from the flu. "The world doesn't stop for the Flu. But you do - coughing, chills, fever and body aches can make you miserable for days on end," the commercial says. "But thanks to a new prescription pill, you can start to feel better," the ad states, using the slogan, "Tamiflu - helping you get through the flu."

A "direct response" 60-second version of the ad offers an educational brochure. "Now that the flu has hit, if you feel fluish, see your doctor early," the ad says. "And to learn to recognize flu symptoms send for this free brochure and learn more about Tamiflu."

The print ad depicts a cartoon of a person sprawled out on a bed and reads, "Introducing the pill that can stand up to the flu." The print ads will appear in Time and Life magazines, as well as in local newspapers.

Local radio ads will run in areas reporting high flu activity, as determined through Roche's Flu Surveillance System. "Now that the flu is here, it's important you know about a new prescription pill called Tamiflu....Tamiflu goes right to the very cause of the flu attacking the flu virus itself so you can start to feel better," the radio ad states, referring listeners to the print ad.

New York-based Young & Rubicam Advertising created the Tamiflu consumer advertising campaign. Young & Rubicam's Sudler & Hennessey division is creating the professional ad campaign.

FDA Counterdetailing Influenza Treatments Relenza and Tamiflu

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