NAD recommends halt of Claritin ‘RediTabs’ broadcast ads
NEW YORK The National Advertising Division of the Council of Better Business Bureaus on Monday recommended that Schering-Plough, maker of the over-the-counter allergy medication Claritin “RediTabs,” discontinue broadcast advertising that features high-speed raceway images.
NAD, the advertising industry’s self-regulatory forum, examined broadcast advertising for the product following a challenge by McNeil Consumer Healthcare, the maker of competing OTC allergy medications Benadryl and Zyrtec.
NAD considered whether the race car imagery and narration in the commercial imply that Claritin RediTabs OTC provides the fastest relief of allergy symptoms.
The challenged advertising features NASCAR racecars running a track as Carl Edwards, a well-known NASCAR driver, appears and explains that “speed is important” to him and that when his allergies hit, he uses Claritin RediTabs, “the fastest dissolving allergy medicine.” A statement that “Speed of dissolution does not imply speed of relief” appears simultaneously on the screen.
Following its review of the evidence, including a consumer perception survey provided by the challenger, NAD determined one reasonable takeaway from the commercial is that RediTabs provides very fast or instantaneous relief of allergy symptoms in comparison to competing allergy medicines. Further, NAD determined that the disclosure “Speed of dissolution does not imply speed of relief” contradicted, rather than limited, the main message of very fast or instantaneous allergy relief.
NAD recommended that the commercial be permanently discontinued and that future advertising avoid imagery and claims that imply that Claritin RediTabs provide very fast or instantaneous allergy relief.
Schering-Plough, in its advertiser’s statement, said it that while the company did not intend to convey a claim of instant relief, it “greatly respects NAD and the NAD process and will take this decision into account in crafting its future advertisements.”
FDA to require NSAID manufacturers to revise labeling
ROCKVILLE, Md. The Food and Drug Administration issued a final rule Tuesday that requires manufacturers of over-the-counter pain relievers and fever reducers to revise their labeling to include warnings about potential safety risks, such as internal bleeding and liver damage, associated with the use of these drugs.
Products covered by the FDA action include acetaminophen, and a class of drugs known as the nonsteroidal anti-inflammatory drugs. NSAIDs include aspirin, ibuprofen, naproxen and ketoprofen.
The revised labeling applies to all OTC pain relievers and fever reducers, including those that contain one of these ingredients in combination with such other ingredients, as cold medicines containing pain relievers or fever reducers.
“Acetaminophen and NSAIDs are commonly used drugs for both children and adults because they are effective in reducing fevers and relieving minor aches and pain, such as headaches and muscle aches, “ stated Charles Ganley, director of FDA’s Office of Nonprescription Drugs in the Center for Drug Evaluation and Research. “However, the risks associated with their use need to be clearly identified on the label so that consumers taking these drugs are fully aware of the potential harm they can cause. It is important that they know how to take these medications safely to reduce their risk.”
Under the final rule, manufacturers must ensure that the active ingredients of these drugs are prominently displayed on the drug labels on both the packages and bottles. The labeling also must warn of the risks of stomach bleeding for NSAIDs and severe liver damage for acetaminophen.
The new rule requires all manufacturers to relabel their products by April 28, 2010.
However, many analgesic manufacturers are already in compliance with the new labeling rules, Barbara Kochanowski, VP regulatory affairs for the Consumer Healthcare Products Association, stated Tuesday.
“CHPA member companies voluntarily have begun implementing many of the label changes included in the final rule that will publish April 29, 2009, well ahead of the April 28, 2010, implementation deadline,” she said. “These label changes are designed to provide consumers with a greater understanding of some of the risks that could be associated with the misuse of these medications.”
An FDA Advisory Committee meeting will convene on June 29 and 30 to discuss further steps the FDA could take to reduce the risk of liver damage associated with acetaminophen overdoses.
World Health Organization announces flu pandemic alert change
GENEVA The current situation regarding the outbreak of swine influenza A(H1N1) is evolving rapidly, the World Health Organization stated in a press release Monday.
“As of 27 April, the United States government has reported 40 laboratory confirmed human cases of swine influenza A(H1N1), with no deaths. Mexico has reported 26 confirmed human cases of infection with the same virus, including seven deaths. Canada has reported six cases, with no deaths, while Spain has reported one case, with no deaths,” WHO stated.
In responose, WHO Director-General Margaret Chan has raised the level of influenza pandemic alert from the current phase 3 to phase 4. The change to a higher phase of pandemic alert indicates that the likelihood of a pandemic has increased, but not that a pandemic is inevitable.
In Phase 3, an animal or human-animal influenza reassortant virus has caused sporadic cases or small clusters of disease in people, but has not resulted in human-to-human transmission sufficient to sustain community-level outbreaks. Limited human-to-human transmission may occur under some circumstances, for example, when there is close contact between an infected person and an unprotected caregiver. However, limited transmission under such restricted circumstances does not indicate that the virus has gained the level of transmissibility among humans necessary to cause a pandemic.
Phase 4 is characterized by verified human-to-human transmission of an animal or human-animal influenza reassortant virus able to cause “community-level outbreaks.” The ability to cause sustained disease outbreaks in a community marks a significant upwards shift in the risk for a pandemic. Phase 4 indicates a significant increase in risk of a pandemic but does not necessarily mean that a pandemic is a forgone conclusion.
Phase 5 indicates an imminent pandemic and phase 6 signifies an actual pandemic.