Merck Fosamax broadcast reminder ads should be withdrawn due to their product-specific content, FDA's ad division told Merck in a July 16 letter.

A televised reminder ad for the osteoporosis therapy featuring a menopausal woman swimming "in its entirety makes a representation or suggestion about Fosamax," FDA declared, referring to the statements "I don't feel I have changed and I certainly don't want to change my life" and "Discover Fosamax."

A second unbranded Fosamax (alendronate) broadcast ad also was considered by FDA to be product specific. The ad's statement "there is a medication with the power to rebuild bones and reduce the risk of fractures" implies "only Fosamax as the drug with both of these particular effects," FDA said.

FDA also requested that Merck cease publication of a reminder print ad for its COX-2 pain reliever Vioxx (rofecoxib). The agency specifically took issue with an X-ray image of a hand with superimposed red markings at the joints. The image makes a "representation about the use of Vioxx," FDA charged. The ad ran July 7 in five Puerto Rican newspapers, Merck said.

Both the Fosamax broadcast and Vioxx print ads ran only in Puerto Rico, Merck said. Both campaigns were discontinued following receipt of the FDA letter.

Roche's Xenical (orlistat) computerized "re-shaping" program overstates effectiveness of the weight loss therapy, FDA's ad division said in a July 19 letter.

Roche's "Weight and See Computerized Reshaping Program," showcased at a June Endocrine Society meeting, "overstates the expected efficacy of Xenical... [and] also implies effects of Xenical that have not been demonstrated by substantial evidence," FDA said.

Print-outs of program results "make claims about the change in an individual's relative risk of coronary heart disease, type 2 diabetes and hypertension relative to the change seen in that person's body mass index."

The presentation "implies that taking Xenical will decrease a person's BMI while decreasing their risk of other clinical conditions," FDA found. The agency noted that not all patients will lose weight or see a decrease in BMI as a result of using Xenical, and therefore would not reduce their risk of heart disease, diabetes and hypertension.

FDA also charged that Roche sales representatives at the same meeting minimized the risks associated with Xenical. "When asked by a clinician if there were any risks associated with Xenical therapy, the rep indicated that there was little or nothing to worry about because once a patient's body adjusts to the medicine, usually within a couple of weeks, and once they comply with the recommended diet, the side effects will disappear," FDA reported.

"Although the frequency of reported side effects may have decreased during the second year" of Roche's studies, FDA acknowledged, "there is no evidence to support that this was due to patient's compliance to a 'recommended' diet or that a patient's body will adjust to the medicine within two weeks."

Schering-Plough received a July 15 FDA letter due to a "change in [the agency's] opinion" regarding the appropriate description of the target population for Rebetron (ribavirin and interferon alfa-2b) therapy.

Although Rebetron is indicated for patients with chronic hepatitis C with compensated liver disease, FDA in the past has allowed Schering to omit "chronic" and "compensated" from some descriptions of the appropriate population, Schering said.

According to Schering, after "routine monitoring," the agency determined that Schering should provide a "clearer and more detailed description" of the intended population, noting concerns that a broader indication could be inferred if the language was not more consise.

"Because these comments concerning the product's indication constitute a change in [the FDA ad division's] opinion, Schering will be provided with a reasonable period of time in order to make these revisions," FDA told the company.

Schering responded to the letter July 29 and ceased distribution of relevant materials, the company said.

Sigma-Tau's brief summary attached to print ads for its carnitine deficiency agent Carnitor (levocarnitine) also drew a July letter. Although a journal ad primarily contained claims about I.V. Carnitor, the brief summary was "for the tablets, oral solution and intravenous formulations" and contained "contradictory information such as 'not for parenteral use'" from tablet and oral solution labeling.

Merck Fosamax Reminder Ads Should Be Withdrawn - FDA Ad Division

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