Tylenol Side Effects
Life-threatening Tylenol side effects remain a serious public health problem, even as Tylenol lawsuits increase in number. The Sanders Firm is committed to helping victims of these side effects obtain compensation for their injuries. Our veteran product liability attorneys offer free, no-obligation consultations to those harmed by Tylenol use. We can explain your legal options, give you an honest assessment as to the strength of your case, and help you and your family decide what to do next at this critical and trying time.
Tylenol liver damage
Acetaminophen is the active ingredient in Tylenol. The painkiller has been sold in the U.S. since the 1950s. It has been the most widely-used over-the-counter drug in the country since the mid-2000s. The Tylenol brand accounts for almost half of annual acetaminophen sales, according to McNeil Consumer Healthcare, the Johnson & Johnson division that manufactures and markets the drug. Generic forms of the drug are also widely available.
Acetaminophen is an ingredient in many over-the-counter medications such as allergy pills, cold and flu treatments, and cough syrups. Many prescription medications contain acetaminophen, such as Vicodin, Percocet, and other powerful narcotics. The combination of Tylenol and codeine, frequently used in prescription cough syrup, has been the most widely prescribed drug containing acetaminophen since 1997.
Tylenol relieves pain and reduces fever effectively and safely in most cases. However, its use can lead to severe liver damage, liver failure and other life-threatening complications. The FDA advises that adults take no more than 4 grams of acetaminophen per day – eight extra-strength tablets. But taking just 2 more tablets each day can result in deadly side effects.
As many as one in four Americans regularly take more than recommended dosages of pain relievers such as Tylenol. Sometimes people assume that the medication is safe because it is available without a prescription. In other instances patients inadvertently take multiple medications that contain Tylenol. For example, those suffering from flu may take Tylenol to relieve headache and fever, and also use cough syrup containing Tylenol – without realizing that they are exceeding the recommended daily dose.
Accidental acetaminophen overdoses can be especially dangerous. In the early stages, overdose patients may feel feverish and achy and suffer stomach discomfort. These are often the same symptoms of the cold or flu that caused the Tylenol use in the first place. By the time more serious side effects appear, it may be too late to avoid profound liver damage or liver failure.
Alcohol use increases the risk of liver damage from acetaminophen use. A 1986 study found that heavy alcohol users suffered severe liver toxicity after taking “apparently moderate doses” of acetaminophen. Those who drink more limited quantities are also at risk.
In 1993, the FDA ordered Tylenol labels to include a warning about the risks of liver damage by mixing acetaminophen and alcohol use. The agency called the scientific evidence of dangerous side effects “unusually strong and well-supported.”
Overdoses of acetaminophen cause up to 78,000 emergency room visits every year, according to federal data. Roughly 33,000 Americans are hospitalized as a result.
Acetaminophen is the leading cause of acute liver failure in the United States. One study found that, between 2004 and 2008, at least 555 patients on liver transplant waiting lists suffered from acetaminophen-related complications. Of these, 255 died before they could undergo surgery. Noting “important limitations” on the available data, the study’s authors estimated that the actual numbers of acetaminophen-related effects were significantly higher.
According to federal poison control center statistics, acetaminophen is connected with twice as many deaths as any other over-the-counter pain reliever. Between 2001 and 2010, over 1,500 people died as a result of accidental Tylenol overdoses.
Tylenol side effects in infants and children
Infants and young children may be especially vulnerable to side effects from Tylenol use. After 14 weeks, a developing fetus can be affected by maternal acetaminophen use, and even small overdoses can cause fetal death absent emergency treatment.
A 2013 Norwegian study looked at children exposed to prenatal paracetamol (as acetaminophen is known in Europe) for over 27 days. The researchers concluded that “children exposed to long-term use of paracetamol during pregnancy had substantially adverse developmental outcomes at 3 years of age.” Prenatal ibuprofen exposure, on the other hand, had no such side effects.
Over 10,000 under the age of 5 are admitted to emergency rooms every year due to Tylenol overdoses. Many of the cases involve unsupervised ingestion, resulting in severe liver damage and other side effects. In other situations, older children are mistakenly given highly-concentrated acetaminophen products intended for infants, causing serious complications.
Tylenol has also been the object of a number of recalls over the years. In 2009, many Tylenol products were recalled because of contamination with a chemical that caused nausea and vomiting. Between 2008 and 2010, the FDA found that tens of certain Tylenol products had been contaminated with metal shavings during the manufacturing process.
In other cases, the company used an ingredient that may have been tainted with dangerous bacteria. After the FDA issued its April 2010 report listing multiple violations, McNeil recalled 136 million bottles of pediatric and other Tylenol products, in what has been described as the largest recall in the history of pediatric medicine.
Later, the federal Justice Department began investigating the plant that had produced most of the recalled products. That factory was closed and the FDA was given authority to monitor production at other plants to ensure quality control.
In 2012, nearly 600,000 infant Tylenol bottles were recalled to prevent a defective dispenser from causing improper dosages.
In 1998, the FDA finalized a regulation requiring all over-the-counter acetaminophen products to include an alcohol warning in their labeling. The warning advised consumers who ingest 3 or more alcoholic drinks every day to ask their doctor whether they should take acetaminophen or other pain relievers/fever reducers.
In 2009, an FDA advisory committee recommended requiring that acetaminophen prescription drugs include a so-called “black box” warning about the risk of severe liver injury and liver failure. In January 2011, noting “continued reports of liver injury,” the agency adopted the recommendation and ordered the inclusion of the agency’s strongest warning for prescription drugs on all products containing acetaminophen. The agency also recommended that manufacturers limit the amount of acetaminophen to 325 mg. per tablet in order to minimize the risk of accidental overdose.
In January 2014, the agency announced its intention to withdraw approval of prescription drugs with more than 325 mg per pill that remain on the market. The agency noted that “[i]nadvertent overdose for prescription combination drugs containing acetaminophen accounts for nearly half of all cases of acetaminophen-related liver failure in the United States, some of which result in liver transplant or death.”
The FDA also advised of its intention to address over-the-counter Tylenol and other acetaminophen products in a separate rulemaking process.
Many victims of Tylenol liver damage or liver failure have sued Johnson & Johnson and its McNeil division, seeking compensation for their losses. In 2013, many of the Tylenol lawsuits were centralized before a single federal judge in Philadelphia. This Multi-District Litigation is designed to streamline pretrial handling of the lawsuits. Other cases remain in state courts around the country.
A few lawsuits have been resolved, including one $8.5 million verdict awarded to a man whose Tylenol use destroyed his liver, requiring him to undergo a liver transplant and a two-month hospitalization.
A personal injury attorney at The Sanders Firm can help
The Sanders Firm can help those who have suffered liver damage due to Tylenol use, and the families of those whose Tylenol use caused death.
Because our personal injury attorneys specialize in helping victims of dangerous drugs like Tylenol obtain compensation for their losses, our advice draws on decades of experience in these situations.
We know how devastating a serious injury or death can be to the entire family, in every aspect of life. That’s why we are dedicated to helping recover for losses when companies put profits ahead of people. We encourage you to contact us for a free, confidential, and no-obligation consultation about your case.
- FDA, “Acetaminophen Information,” http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm165107.htm
- FDA, Acetaminophen Overdose and Liver Injury — Background and Options for Reducing Injury http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/UCM164897.pdf
- Budnitz, Daniel, MD MPH CDR, USPHS, “Acetaminophen-related Emergency Department Visits: National Electronic Injury Surveillance System (NEISS), 2004-2007,” June 29, 2009 http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/drugsafetyandriskmanagementadvisorycommittee/ucm171579.pdf
- FDA News Release, “FDA limits acetaminophen in prescription combination products; requires liver toxicity warnings,” January 13, 2011, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm239894.htm
- McNeil-PPC, Inc., “Tylenol Product Warnings,” http://www.tylenol.com/products/tylenol-extra-strength-caplets
- FDA, “Over-the-counter drug products … Labeling Acetaminophen,” 21 CFR § 201.326(a)(1) (2009), http://www.gpo.gov/fdsys/pkg/CFR-2011-title21-vol4/pdf/CFR-2011-title21-vol4-sec201-326.pdf
- Brandlistuen, R.E., et al., “Prenatal paracetamol exposure and child neurodevelopment: a sibling-controlled cohort study,” October 24, 1013 http://ije.oxfordjournals.org/content/early/2013/10/24/ije.dyt183.short?rss=1
- ProPublica, “Use Only as Directed,” September 20, 2013, http://www.propublica.org/article/tylenol-mcneil-fda-use-only-as-directed
- Seef EH et al., “Acetaminophen hepatotoxicity in alcoholics. A therapeutic misadventure” March 1986, http://www.ncbi.nlm.nih.gov/pubmed/3511825