HEALTH

NAD recommends halt of Claritin ‘RediTabs’ broadcast ads

BY Michael Johnsen

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.”

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FDA to require NSAID manufacturers to revise labeling

BY Michael Johnsen

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.

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CDC updates proposed treatment course for swine flu

BY Michael Johnsen

ATLANTA The Centers for Disease Control and Prevention on Tuesday updated its proposed treatment course for any patient expected of having been exposed to the swine flu.

Either Tamiflu (oseltamivir) or Relenza (zanamivir) are recommended for up to 10 days after the last known exposure to a confirmed case of swine influenza A (H1N1) virus infection.

For pre-exposure protection, antivirals should be given during the potential exposure period and continued for 10 days after the last known exposure to a confirmed case of swine influenza A (H1N1) virus infection.

Antiviral used as a preventitive (pre-exposure or post-exposure) with either oseltamivir or zanamivir is recommended for the following individuals:

  • Household close contacts who are at high-risk for complications of influenza (e.g., persons with certain chronic medical conditions, persons 65 or older, children younger than 5 years old and pregnant women) of a confirmed, probable or suspected case;
  • School children who are at high-risk for complications of influenza (children with certain chronic medical conditions) who had close contact (face-to-face) with a confirmed, probable or suspected case;
  • Travelers to Mexico who are at high-risk for complications of influenza (e.g., persons with certain chronic medical conditions, persons 65 or older, children younger than 5 years old and pregnant women);
  • Healthcare workers or public health workers who were not using appropriate personal protective equipment during close contact with an ill confirmed, probable or suspect case of swine influenza A (H1N1) virus infection during the case’s infectious period.

Pre-exposure antiviral used as a preventatitive with either oseltamivir or zanamivir can be considered for the following:

  • Any health care worker who is at high-risk for complications of influenza (e.g., persons with certain chronic medical conditions, persons 65 or older, children younger than 5 years old and pregnant women) who is working in an area of the healthcare facility that contains patients with confirmed swine influenza A (H1N1) cases, or who is caring for patients with any acute feverish respiratory illness;
  • Non-high risk persons who are travelers to Mexico, first responders or border workers who are working in areas with confirmed cases of swine influenza A (H1N1) virus infection.

Children under one year of age are at high risk for complications from seasonal human influenza virus infections. The characteristics of human infections with swine H1N1 viruses are still being studied, and it is not known whether infants are at higher risk for complications associated with swine H1N1 infection compared to older children and adults. Limited safety data on the use of oseltamivir (or zanamivir) are available from children less than one year of age, and oseltamivir is not licensed for use in children less than 1 year of age. Available data come from use of oseltamivir for treatment of seasonal influenza. These data suggest that severe adverse events are rare, and the Infectious Diseases Society of America recently noted, with regard to use of oseltamivir in children young than one-year-old with seasonal influenza, that “…limited retrospective data on the safety and efficacy of oseltamivir in this young age group have not demonstrated age-specific drug-attributable toxicities to date.”

Because infants typically have high rates of morbidity and mortality from influenza, infants with swine influenza A (H1N1) influenza infections may benefit from treatment using oseltamivir.

Healthcare providers should be aware of the lack of data on safety and dosing when considering oseltamivir use in a seriously ill young infant with confirmed swine H1N1 influenza or who has been exposed to a confirmed swine H1N1 case, and carefully monitor infants for adverse events when oseltamivir is used.

Oseltamivir and zanamivir are “Pregnancy Category C” medications, indicating that no clinical studies have been conducted to assess the safety of these medications for pregnant women. Because of the unknown effects of influenza antiviral drugs on pregnant women and their fetuses, oseltamivir or zanamivir should be used during pregnancy only if the potential benefit justifies the potential risk to the embryo or fetus; the manufacturers’ package inserts should be consulted. However, no adverse effects have been reported among women who received oseltamivir or zanamivir during pregnancy or among infants born to women who have received oseltamivir or zanamivir, Pregnancy should not be considered a contraindication to oseltamivir or zanamivir use. Because zanamivir is an inhaled medication and has less systemic absorption, some experts prefer zanamivir over oseltamivir for use in pregnant women when feasible.

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