FDA Was Pressured By J&J Not to Address Tylenol Liver Damage Risk: Report

Documents recently described in the pending litigation over Tylenol suggest that Johnson & Johnson officials tried to leverage the FDA, Congress and even the White House through their lobbyists, in an attempt to prevent restrictions on Tylenol and other acetaminophen-based products, despite evidence that high doses may increase the risk of liver damage. 

The information was presented as part of a trial that began this week in the Superior Court of New Jersey, involving a liver damage lawsuit filed by Regina Jackson, who was hospitalized due to elevated liver enzymes after accidentally overdosing on Extra Strength Tylenol.

The case is one of more than 200 similar Tylenol liver damage lawsuits pending in various state and federal courts nationwide, which all allege that Johnson & Johnson provided false and misleading information about the risks associated with the pain reliever acetaminophen.

Tylenol is one of the most widely used painkiller medications in the United States, which is widely assumed to be safe by most consumers and has been used by millions of Americans. The acetaminophen contained as the active pharmaceutical ingredient in Tylenol has been identified in recent years as a leading cause for liver injury in the United States.

All of the complaints involved in the Tylenol litigation raise similar allegations that Johnson & Johnson knew or should have known for decades that side effects of Tylenol increase the risk of liver damage, yet failed to adequately warn consumers or the medical community.

A number of documents revealed during the discovery process in the Tylenol litigation indicate that Johnson & Johnson executives were alarmed that the FDA was considering restrictions on the use of Extra Strength Tylenol, due to its links to liver damage.

A recent story by the public interest journalism organization ProPublica highlights the drug maker’s attempts to avoid regulations that would restrict use of their popular brand-name pain killer, distributed by it’s McNeil Healthcare subsidiary..

One of the documents described in the report outlines how the company planned to keep the FDA from following the advice of its advisory committee, which recommended that Extra Strength Tylenol no longer be available over-the-counter.

“Here is how we are going to do it. We’re going to involve key opinion leaders, and we’re going to get them to help us influence the FDA to disregard what the advisors said,” according to a PowerPoint presentation.

The company lobbied Congress and even the White House in attempts to keep Extra Strength Tylenol on store shelves despite the FDA’s misgivings, according to information presented in the case.

The first FDA hearings on liver damage caused by acetaminophen began 38 years ago, but the agency still has not taken action to make regulations regarding the safe use of Tylenol, Jackson’s attorneys note.

Tylenol Liver Damage Concerns

In a consumer update issued by the FDA on May 28, 2014, the agency warned that there is no way of determining who may experience liver damage due to a Tylenol overdose. Additionally, many consumers accidentally overdose on its active ingredient, acetaminophen, because they do not realize that it is in numerous cold medications and pain relievers.

The FDA has indicated that acetaminophen may be responsible for more than 50,000 emergency room visits each year, including 25,000 hospitalizations and over 450 deaths annually. In recent years, efforts have been ramped up to bring the risk of acetaminophen overdose to the public’s attention and to reduce the amount of liver injury cases linked to the popular analgesic.

In 2011, Johnson & Johnson lowered the maximum recommended dosage on Tylenol and other acetaminophen-based products from 4,000 mg per day to 3,000 mg per day, after the FDA announced the new limits on acetaminophen levels in prescription painkillers like Vicodin and Percocet. However, the drug maker continues to maintain that Tylenol is a safe and effective, and few consumers realize the risk of liver damage that may be caused by taking more than two pills with each dose or failing to carefully monitor the frequency of doses.

Many of the complaints pending nationwide suggest that the FDA would never approve Tylenol as an over-the-counter medication if it were first introduced today.