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Whitehall-Robins urges consumers to continue to heed warning about Tylenol and alcohol; Company reaffirms veracity of Advil ad.

MADISON, N.J.--(HealthWire)--March 8, 1996--

The following is a statement by Whitehall-Robins:

Whitehall-Robins, maker of Advil, reaffirms that the information contained in the Advil television advertisement suggesting that consumers ask their doctors whether Advil (ibuprofen) may be a safer choice than Extra-Strength Tylenol (acetaminophen) for those people who generally drink three or more glasses of wine, beer, or mixed drinks a day is true and is not deceptive in any way. The advertisement is meant to alert consumers to the risk of liver damage for those people who regularly consume alcoholic beverages and take Extra-Strength Tylenol. We believe this issue continues to deserve attention, as the public health implications are extremely serious.

Nevertheless, Whitehall-Robins applauds ABC television network's decision to cease airing all commercials that make negative safety claims about competing analgesics. We are especially pleased that ABC has decided to stop airing several recent Tylenol advertisements that make false claims about the safety of Advil. Whitehall-Robins challenged the first of these advertisements earlier this year, and ABC and other networks agreed to withdraw the Tylenol commercial last month. As recently as Tuesday, Whitehall-Robins challenged two additional negative ads, sponsored by Tylenol, which ABC agreed yesterday to stop airing.

Whitehall-Robins has not put an alcohol warning on Advil because the scientific data do not support such a warning. Data presented at an FDA Advisory Committee meeting did not show an increased risk in gastrointestinal bleeding when ibuprofen is combined with alcohol. In contrast, the scientific literature contains a number of reports of acetaminophen-(Tylenol) induced liver damage in people who regularly drink alcohol. The mechanism by which acetaminophen damages the liver also has been clearly established.

The issue of liver toxicity and Tylenol first received broad public attention in October 1994 when a federal jury of the US District Court of the Eastern District of Virginia ordered McNeil, an affiliate of Johnson & Johnson and the maker of Tylenol, to pay more than $8.8 million in damages to Antonio Benedi after he suffered from liver failure that was brought upon by a toxic reaction to Extra-Strength Tylenol (acetaminophen). Johnson & Johnson, parent company of McNeil, appealed, but a three-judge panel resoundingly upheld the decision, noting,

"There was sufficient evidence to support the jury's finding

that McNeil negligently failed to warn consumers of the risk

associated with combining therapeutic doses of acetaminophen

with alcohol."

The court found further evidence that Johnson & Johnson withheld approximately 40 case reports from the FDA regarding the association of alcohol consumption and acetaminophen. The court also upheld the award of punitive damages, saying that,

"Benedi introduced sufficient evidence from which a reasonable

jury could find that McNeil acted with reckless indifference

to the health of consumers."

In fact, the court found

"evidence that McNeil instructed its sales representatives

to refrain from discussions with physicians about a scientific

article, which outlined the dangers associated with combining

acetaminophen with alcohol."

Advil, a nonprescription analgesic, has provided safe and effective pain relief to more than 156 million consumers since it received marketing clearance from the US Food and Drug Administration in 1984.

Advil has an excellent safety record. Safety data from controlled clinical trials confirm that Advil is well-tolerated in recommended doses. Both clinical and epidemiological studies have consistently shown that OTC doses of ibuprofen are not linked to an elevated risk of GI bleeding. Further, there is no clinical data to support an association between Advil and liver damage.

Whitehall-Robins Healthcare, a leader in the research and development, manufacturing and marketing of a broad range of consumer health care products, is committed to providing consumers with the information they need to make informed health decisions. Whitehall-Robins Healthcare products include analgesics, vitamin and mineral supplements, and cough/cold/allergy remedies.

CONTACT: Carol Dornbush





Sheila Marmion

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Publication:Business Wire
Date:Mar 8, 1996
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