Tylenol side effects include severe liver damage and and in some cases, even death. Our law firm is now working with some of the more experienced Tylenol lawyers, who can file a Tylenol lawsuit on your behalf. And, there are no fees unless you receive settlement or award. Feel free to call us toll-free anytime or submit an online contact to receive a free legal consultation.
Tylenol (acetaminophen) is used to treat pain as well as reduce fevers. It is believed that the active ingredient raises the body’s pain threshold while releasing excess heat from the body. Tylenol first hit the market in 1955 and the drug was approved for over the counter sales in 1959. By 1976, it was the number one selling over the counter painkiller. Read the history of Tylenol. Today, it is currently available in more than 200 varieties and in 2005 patients used more than 28 billion doses of the drug (i). Many people do not appreciate the true risks of this medicine because it has been on the market so long and it is so widely used. The truth is that this drug has caused serious liver complications. Every year acetaminophen overdose causes 56,000 injuries, 2,500 hospitalizations, and almost 450 deaths (ii).
Tylenol Side Effects
Whenever someone takes medicine there is always the possibility that they will suffer a adverse event. In most cases, these complications are minor and do not cause permanent damage. However, acetaminophen has been associated with a number of complications including liver damage. If you have suffered a serious injury after taking this drug, then you may want talk to an experienced personal injury attorney. Tylenol side effects include:
- Swelling of the mouth and face
- Hives and rash
- Liver damage including liver failure and liver cancer
Tylenol Liver Damage
Liver failure and liver cancer can occur when the organ becomes blocked or overburdened by too much acetaminophen. This type of damage can be very severe and even cause death. Excess amounts of acetaminophen often occur because of an accidental overdose. Overdoses are surprisingly common because many people are not of the maximum dosage in a day or do not realize that the active ingredient acetaminophen is often combined with other drugs. People may not realize they are consuming doses of this drug when they take Excedrin, Nyquil, Sudafed, Theraflu, or Vicks. Additionally, the risk of suffering liver damage increases when a person consumes alcohol or caffeine. Early signs of liver damage include:
- Loss of appetite
- Dark urine
FDA Warnings and Tylenol Medical Studies
Although Tylenol has been on the market for many years, the FDA has recently made a number of changes in the drug’s labeling and prescribing information. In April 2009, the Agency required all over the counter manufacturers of pain relievers to warn about internal bleeding and liver damage. The Agency determined that people often take more acetaminophen than recommended and they also drink alcohol, which increases the risk of liver problems (iii). In January 2011, the FDA limited the dosage of acetaminophen in prescription drugs to 325 mg per dose. The Agency also added a boxed warning to “highlight potential for severe liver failure.” The changes were based upon medical studies which found that “acetaminophen was the leading cause of acute liver failure in the United States” (iv).
In addition to the changes instituted by the FDA, medical studies have indicated that more stringent warnings are needed on the labels of Tylenol products. In October 2012, Dr. Serper from Northwestern University presented her findings on acetaminophen drugs. Her study revealed that 45% of patients did not realize their that different products contained acetaminophen. Dr. Serper believes that “healthcare providers should clearly state the active ingredients in the medication.” Unfortunately, drug manufacturers do not put uniform labels on their products and even abbreviate the active ingredients differently as well as using different measurements such as grams versus milligrams. View her medical study here. A 2013 clinical trial from Harvard found that prolonged use of the drug was associated with an increased risk of renal cancer (v).
Possible Link Between Tylenol and SJS
In addition to liver problems, some have alleged that Tylenol can cause Stevens Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN). One case study reported the story of a 40-year-old woman who suffered both of these hypersensitivity reactions after taking acetaminophen for a fever. She suffered an SJS rash as well as a high grade fever. Extreme fevers are a trademark of these conditions that make the patient feel like they are burning from the inside out. She was successfully treated but the authors of the study reminded that this ingredient “can be potentially life threatening.” See the case study.
In recent years, product recalls have diminished Tylenol’s brand power and negatively affected both McNeil Pharmaceuticals and Johnson & Johnson. This product has been pulled from the market a number of times throughout its history but in recent years the frequency of recalls has been disconcerting. Between 2009 and 2012, McNeil issued at least 26 Tylenol recalls (vi). These were issued for various reasons including pesticide, wood, metal, and bacteria contamination as well as overdosed and underdosed medicines. Additionally, the presence of a musty smell has plagued many batches of the product. Many of these defective batches came from the company’s Fort Washington and Puerto Rico plants.
In March 2011, the FDA even took over three Tylenol manufacturing plants for repeatedly failing to comply with federal standards. This “consent decree” requires the plants to come into compliance with regulations quickly. McNeil must retain an independent expert to inspect the plants and ensure that adequate manufacturing processes are in place. Violations of the decree could lead to fines of $15,000 per day with an additional $15,000 for each violation of the law, totaling up to $10 million annually. Read the article. This substantial number of recalls caused investors to file a derivative lawsuit claiming the company concealed its quality control failures. In July 2013, Johnson & Johnson settled these claims for $22.9 million (vii).
Patients who have suffered serious injuries like liver failure and SJS have talked to Tylenol lawyers and are now filing lawsuits. In April 2012, one such suit was filed by a family whose 3-month-old son, Markus Cherry, died three days after being given Concentrated Tylenol Infant Drops. Lab tests showed that the medicine had been contaminated with a dangerous bacteria. The suit alleges that Johnson & Johnson issued a “stealth recall” rather than a formal, public recall. Read the article here. More recently, on April 1, 2013, liver failure lawsuits were consolidated in a single action called “In Re: Tylenol (Acetaminophen) Marketing, Sales Practices and Products Liability Litigation - MDL 2436.” Now more than 125 legal actions have been filed and it is being alleged that the drug “caused liver damage, including liver failure, even when taken as directed.” See the Tylenol MDL website.
Have You Suffered a Serious Tylenol Injury?
If you or a loved has suffered liver damage or any other serious reaction to this drug, then you should get legal advice from an attorney. Our legal staff is ready to answer your questions. And, we are currently working with experienced bad drug lawyers, who are filing Tylenol lawsuits and there is no legal fee unless you receive a settlement or award.
- (i) FDA Advisory Committee, May 2009.
- (ii) Pharmacoepidemiol Drug Safety, June 2006.
- (iii) FDA News Release, April 28, 2009.
- (iv) FDA Drug Safety Communication, January 13, 2011.
- (v) International Journal of Cancer, January 24, 2013.
- (vi) The Sacramento Bee, June 15, 2012.
- (vii) Chicago Tribune, July 17, 2013.