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Acetaminophen and Liver Injury: Q & A for Consumers

On June 29 and 30, 2009, FDA held an advisory committee meeting in Adelphi, Md., about how to address the problem of liver injury related to the use of acetaminophen in both over-the-counter (OTC) and prescription products. For more information about the meeting, visit the Advisory Committee Web page.

Acetaminophen is the generic name of a drug found in many common brand name OTC products such as Tylenol, as well as prescription products such as Vicodin and Percocet. Acetaminophen is an important drug, and its effectiveness in relieving pain and fever is widely known. This drug is generally considered safe when used according to the directions on its labeling. But taking more than the recommended amount can cause liver damage, ranging from abnormalities in liver function blood tests, to acute liver failure, and even death.

Q: What is acetaminophen?

A: Acetaminophen (pronounced: a∙seet·aminofen), is an active ingredient found in many OTC and prescription medicines to help relieve pain and reduce fever.

It is also found in combination with other active ingredients, called combination medicines, which treat conditions such as:

Medicines containing acetaminophen are available in many forms, including drops, syrups, capsules, and pills.

Many people call OTC acetaminophen by a brand name, Tylenol. Others may know Percocet or Vicodin, which are prescription brand names that contain acetaminophen and other active ingredients to help relieve pain.

You might see acetaminophen abbreviated as “APAP” on prescription medicines.

In other countries, acetaminophen may have a different name. For example, acetaminophen is known as paracetamol in the United Kingdom.

Q. Are there risks from taking too much acetaminophen?

A: Yes, acetaminophen can cause serious liver damage if you take too much. It is very important to follow your doctor’s directions and the directions on the medicine label.

You may not notice the signs and symptoms of liver damage right away because they take time to appear. Or, you may mistake early symptoms of liver damage (for example, loss of appetite, nausea, and vomiting) for something else, like the flu. Liver damage can develop into liver failure or death over several days.

Acetaminophen is generally safe when taken as directed. To lower your risk of liver damage make sure you do the following:

Q: How can I tell which medicines contain acetaminophen?

A: Medicines have ingredients listed on their labels. On OTC medicines, check the “Drug Facts” label under the section called Active Ingredients. If your medicine contains acetaminophen, it will be listed in this section. On prescription medicine containers, the label will say “acetaminophen” or “APAP.”

Q: When should I talk to a doctor before taking acetaminophen?

A: Talk to your doctor before taking acetaminophen if you

Under these conditions, taking acetaminophen puts you at greater risk of getting liver damage, even when taking acetaminophen at the recommended dose.

If you take the blood thinner warfarin, you should also talk to your doctor before taking acetaminophen because taking warfarin and acetaminophen together may raise your risk of bleeding.

Q: How can I safely take acetaminophen?

A: Follow this advice to take acetaminophen safely:

Q: How can I safely give acetaminophen to my child?

A: You can safely give acetaminophen to infants, children, and teenagers if you

If a dose for your child’s weight or age is not listed on the label, or you can’t tell how much to give, ask your pharmacist or doctor what to do.

Prevent medicine accidents:

Q: What should I do if the pain or fever doesn’t get better after taking acetaminophen as directed?

A: Take the medicine only as directed. Don’t take more. If the medicine doesn’t help you feel better, talk to your doctor, nurse, or pharmacist.

Q: What should I do if I took too much acetaminophen? What should I do if I gave too much acetaminophen to my child?

A: Don’t wait! Call 9-1-1 or Poison Control at 1-800-222-1222 right away to find out what to do. The signs or symptoms of liver damage may not be noticeable for hours or even days after taking acetaminophen. By the time you notice changes, the liver damage may be severe and could lead to death.

Q: Where can I get more information on acetaminophen?


Don’t Overdo It with Acetaminophen (video) 



This article appears on , which features the latest on all FDA-regulated products.

Date Posted: June 24, 2009

Tylenol recall: Serious side effects investigated

The FDA is also investigating reports of several hundred serious side effects -- or "adverse events" -- and seven deaths since May 1, ...

The Committee on Oversight and Government Reform is scheduled to hold a hearing next week as part of an investigation into the pharmaceutical giant's recall of Children's Tylenol and other over-the-counter drugs for infants and children. The committee has asked CEO William Weldon to testify and also wants to hear from Food and Drug Administration Commissioner Margaret Hamburg. Weldon has already said hewill not testify as he recovers from back surgery.

Perfect Recall

Johnson & Johnson has survived recalls before, of course, most notably the 1982 fiasco when seven people in the Chicago area died after taking Extra Strength Tylenol capsules that had been laced with potassium cyanide. In that disaster, the company's reputation came out ahead, with its strong response -- in which it recalled 31 million bottles worth more than $100 million -- turning the incident into a textbook public-relations coup.

McNeil Consumer Healthcare, the subsidiary that makes Tylenol products, had posted seven recall notices between September and March. But McNeil's April 30 recall soon emerged as one the public wouldn't easily brush aside. It seems that much will be forgiven until children are put at risk.

The company voluntary recalled 43 over-the-counter medicines, including liquid versions of Tylenol, Motrin, Zyrtec and Benadryl, because of "manufacturing deficiencies which may affect quality, purity or potency," according to the FDA. 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.

The result? Some samples of the recalled infants' Tylenol contained as much as 24% more of the active ingredient than described on the label, according to a letter -- uncovered by The Wall Street Journal-- that McNeil sent to health-care providers. A pediatrics professor, however, told the Journal that "children would have to take the higher concentrations over a long period of time in order to be harmed," not only over a day or two.

'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 shor tapology on the company blog-- as well as other apologies in media interviews-- insufficient.


Johnson & Johnson slow to act on problem drugs, FDA says

An agency official tells the House oversight committee that it had urged the company to improve practices well before the recall of children's Tylenol and other medications.

May 28, 2010|By Andrew Zajac

Reporting from Washington — — Tribune Washington Bureau

The Food and Drug Administration, alarmed by quality-control problems with children's Tylenol and other Johnson & Johnson medications, prodded senior company officials last February to improve manufacturing and react faster to consumer complaints, a senior agency official told a congressional panel Thursday. 

But promised improvements didn't come quickly enough, and it was not until April 30 that the company — under FDA pressure — announced the largest recall of pediatric over-the-counter medicine in history.

Johnson & Johnson is under investigation by FDA's criminal division to determine whether any of its missteps warrant prosecution, Joshua Sharfstein, the FDA's principal deputy commissioner, told the House Oversight and Government Reform Committee.

Sharfstein characterized Johnson & Johnson's corporate culture as slow to respond and not always open about its actions.

In addition to last month's recall, the company pulled 8 million bottles of children's medications off the market in September 2009 because of a quality-control issue, and several million bottles of medications because of complaints of a musty odor that some consumers said made them sick.

Johnson & Johnson was required to notify the FDA of the consumer complaints within three days, Sharfstein said, but it waited a year to do so.

"What was troubling was there was a pattern of FDA finding out about things late," he said.

Colleen Goggins, chairwoman of Johnson & Johnson's consumer division, apologized "to the mothers and fathers and caregivers for the concern and inconvenience" caused by the April recall, which covered more than 40 compounds for infants and children — including Benadryl, Motrin and Zyrtec in addition to Tylenol.

In one previously undisclosed case, Johnson & Johnson learned in 2008 of a possible problem with its Motrin pain reliever but, instead of recalling it, hired a contractor who sent people out to buy up the product without revealing what they were doing.

Buyers were instructed to "simply 'act' like a regular customer…. THERE MUST BE NO MENTION OF THIS BEING A RECALL," according to an instruction sheet obtained by House investigators.

Some lawmakers dubbed it "a phantom recall."

Goggins told the House Committee On Oversight and Government Reform that she did not know what instructions the buyers were given, but said, "I don't believe there was any intent mislead or hide."

FDA found bacteria in lots for recalled Tylenol, cold medicines

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.

FDA inspectors visited the plant in mid-April and wrapped up their inspection Friday. J&J issued its "voluntary" recall later that night.

PRODUCTS RECALLED: List of cold medicines

MORE INFORMATION: Read the FDA press release

Among other problems, FDA inspectors said the company did not have laboratory facilities to test drug ingredients and failed to follow up on customer complaints.

J&J did not investigate more than 46 complaints received in the last year about "black or dark specks" found in Tylenol products, according to the FDA's report.

In a statement Tuesday, J&J called the problems discovered by the FDA "unacceptable to us, and not indicative of how McNeil Consumer Healthcare intends to operate." The company said production at the Fort Washington plant won't resume until corrective measures have been put in place.

The FDA reiterated that serious medical problems with the products are unlikely, but advised consumers to stop using the medicine as a precaution. Parents are instructed to use generic alternatives to the Tylenol products.

J&J's McNeil Consumer Healthcare unit has said some of the recalled medicines may have a higher concentration of the active ingredient than listed on the bottle. Others may contain particles, while still others may contain inactive ingredients that do not meet testing requirements.

Friday's sweeping recall, which involved products sold in the U.S. and 11 other countries, is the latest quality issue to taint J&J's over-the-counter medicine franchise. In January, the company recalled a line of adult Tylenol pain relievers due to complaints of a moldy smell associated with wooden pallets used to transport the drugs.

FDA leadership told reporters Tuesday that they first met with J&J in February to discuss manufacturing problems identified in a warning letter about another J&J plant. The agency decided to step up inspections of the company's facilities based on those problems.

"That warning letter brought us to point where we thought it was necessary to sit down with management and discuss our concerns," Autor said.

Copyright 2010 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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