Tylenol Side Effects



Tylenol Liver damages -- February 2014

This April 2014, the first of two dozen pending cases involving plaintiffs who fell seriously ill or died from the same medication will be heard in a New Jersey court. And 120 more cases are headed for federal court in Philadelphia. They claim that McNeil-PPC Inc., the Fort Washington company that makes Tylenol, and others repeatedly concealed the serious health risks of the painkiller, also known as acetaminophen.

Acetaminophen is the number-one cause of acute liver failure in the United States. Overdoses send more than 78,000 people to the emergency room and result in about 33,000 hospitalizations a year. Studies suggest that several hundred people die from accidental acetaminophen toxicity each year.

Acetaminophen does not directly damage the liver. But in the chain of chemical changes as it is processed, a toxic compound is produced. Normally, the liver clears that compound quickly before any harm is done. Large doses and alcohol, however, increase the amount of the compound and the length of time it lingers.

"It doesn't make any sense," said Sidney Wolfe, senior advisor of the Public Citizen's Health Research Group, who served on an FDA drug safety group that urged for stronger warnings and lower doses. "Why bother having advisory committees who spend hundreds of hours researching these issues and then not do one of the most important things we recommend?"

Ninfa Redmond, a toxicologist who served on the FDA advisory panel in the 1970s, said  "we were fully aware of our capacity as advisors. We were not there to make laws. But we felt so strongly about the liver damage from acetaminophen that we said the warning should be obligatory."

It was the only time in the massive report reviewing scores of drugs, she said, that the group used such strong language.

 "In a democracy, when we present a report, it will take several months. The FDA has to send the 220-plus pages to companies, get replies, answer the comments and the comments of the comments. But that doesn't explain 32 years," she said. "I think the industry must have put up a big fight."



Tylenol Adverse Events

FDA investigates 775 'adverse events' from Tylenol recall - May ...

May 25, 2010 ... "We track all adverse events and thoroughly investigate all serious adverse cases that are reported and, in turn, report these to the FDA, ...


Daily Kos: FDA investigating raft of complaints about Tylenol ...

May 26, 2010 ... Now we know what the FDA is looking into--at least 775 customer complaints ..... A serious adverse event (SAE) is one that results in Death, ...


May 26, 2010 ... FDA Evaluating 775 Side

Effect Reports from Children's OTC Drugs ... track all adverse events and thoroughly investigate all serious adverse ...

GAO-01-775T Human Subjects Research: HHS Takes Steps to Strengthen ...
File Format: PDF/Adobe Acrobat - Quick View
GAO-01-775T adopted a separate set of human subjects protection ..... regarding reporting of serious adverse events that are different from FDA's ...
Searches related to 775 serious adverse events


The company voluntary recalled 43 Dilantin Cerebellar Atrophy Risks medicines, including liquid versions of Tylenol, Motrin, Zyrtec and Benadryl, because of "manufacturing deficiencies which may affect quality, purity or potency," according to the Those "manufacturing deficiencies" included myriad manufacturing process, control and procedure issues, such as inadequate laboratory facilities and untrained staff, as well as grime, dust, a hole in the ceiling, clutter and bacteria-contaminated raw ingredients in the Fort Washington, Penn., plant. One pharmaceutical professor described the conditions as "shocking,"CNN reported.

'Unacceptable' Results

Still, Johnson & Johnson itself called the manufacturing problems "unacceptable," apologized and promised to fix them. And after eight months and five recalls, the company earlier this month suspended production at the plant. Critics contend that with so many recalls, it's difficult to see how the company failed to discover the issues earlier. And the FDA, finally realizing that the problems could be more widespread, on Monday said it would expand its investigation of McNeil's drug-manufacturing practices "to determine whether similar problems exist throughout the company."

So far, Johnson & Johnson's reputation doesn't seem to be faring as well in this recall as it did in 1982. Some industry watchers have accused Weldon of being completely out of touch with consumers, while others found his short apology on the company blog-- as well as other apologies in media interviews-- insufficient.

By Matthew Perrone, Associated Press
WASHINGTON — Ingredients used by Johnson & Johnson (JNJ) in some of the 40 varieties of children's cold medicines recalled last Friday were contaminated with bacteria, according to a report by the Food and Drug Administration.

Agency officials said Tuesday none of the company's finished products tested positive for the contaminants, though such testing is not exhaustive.

"We think the risk to consumers at this point is remote," said Deborah Autor, director of FDA's drug compliance office, on a call with reporters.

The FDA report lists more than 20 manufacturing problems found at the McNeil Consumer Healthcare plant in Fort Washington, Pa., where the formulas were produced. The recalled products include children and infant formulations of Tylenol, Motrin, Zyrtec and Benadryl...