Acetaminophen Liver Failure

Research has shown that hundreds of Americans each year experience acute liver failure as a result of taking acetaminophen — widely known under the brand name Tylenol — and about 100 people die annually from overdosing on the painkiller, either intentionally or unintentionally.

Although researchers have found that the drug is safe if taken at recommended levels, its prevalence in a variety of pain relievers, fever reducers and cough medicines as a somewhat hidden ingredient means patients don’t realize they are taking several drugs that all contain acetaminophen.

History of  Acetaminophen Liver Failure

In the late 1990s, research began to show that acetaminophen was a major cause of acute liver failure in the United States, with up to half of the cases due to accidental overdose. Responding to these concerns, FDA took a number of steps to reduce the incidence of liver injury related to acetaminophen.

In 1998, FDA finalized a regulation that required all OTC acetaminophen products to include an alcohol warning in labeling.

The warning stated: Acetaminophen. ‘‘Alcohol Warning’’: ‘‘If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.’’

In 2002, FDA convened an Advisory Committee meeting to discuss unintentional liver toxicity related to the use of OTC acetaminophen.7 The Advisory Committee recommended a specific liver toxicity warning and distinctive labeling on OTC packages so that products containing acetaminophen could be more easily identified. FDA and manufacturers were also advised to educate consumers and health professionals about the risk of liver injury from acetaminophen.

In early 2004, FDA launched a public education campaign to help consumers use acetaminophen more safely. By most standards, the campaign would be considered small, due to budgetary constraints. It was also limited by reluctance on the part of some commercial outlets to provide a venue for FDA’s message about acetaminophen toxicity as the product was sold or promoted in those outlets. Nonetheless, FDA has continued to expand efforts to improve public education about acetaminophen overdosing and liver injury and has recently updated the acetaminophen information on FDA’s Web site.

In 2004, FDA sent letters to every state board of pharmacy asking them to consider requiring labeling on the immediate container of Rx products containing acetaminophen that: (1) uses the term acetaminophen, not APAP, (2) instructs patients to avoid concurrent use of other acetaminophen containing drugs, (3) instructs patients not to exceed the maximum daily recommended acetaminophen dose, and (4) instructs patients to avoid drinking alcohol during prescription use.8 FDA was informed by the National Association of Boards of Pharmacy that, as of February 2008, no states had implemented regulations related to the request.

In December 2006, FDA issued proposed regulations for OTC labeling for acetaminophen containing products to require inclusion of new safety information and that the container and outer carton identify acetaminophen when it is an ingredient.9 The final version of the regulation is currently under review.

In 2007, the Director of FDA’s Center for Drug Evaluation and Research (CDER) convened a multidisciplinary working group in CDER to continue to evaluate the issues associated with acetaminophen-related liver injury and consider additional steps FDA could take to decrease the number of cases of acetaminophen-related liver injury. The working group considered detailed reviews of the issues from the Office of Nonprescription Products, the Office of Surveillance and Epidemiology and the Division of Anesthesia and Analgesic and Rheumatology Drug Products as part of its deliberations.

Source: FDA 2009 Meeting Materials web page

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Childrens Cold Medicine Recall
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Acetaminophen /Tylenol - Black Box Warning Recommended by the FDA

The FDA has recommends that the a black box warning is added to the labels of prescription pain and cold products that contain acetaminophen wich is widely known under the brand name Tylenol.

The FDA states that there is a signifigant health problem of liver injury related to the use of acetaminophen in both over-the-counter (OTC) and prescription (RX) products.

Because acetaminophen is important for the use of treating pain and fever they do not want to remove it from the market.

Acetaminophen containing products are used extensively making the absolute number of liver injury cases a public health concern.

Acetaminophen is the active ingredient in Tylenol.
It is also found in many other over-the-counter medications you can buy at the drug store and in prescription drugs your doctor prescribes:
Common names include:

• Actifed
• Alka-Seltzer Plus
• Benadryl, Butalbital
• Co-Gesic
• Contac
• Darvocet
• Excedrin
• Fioricet
• Lortab
• Midrin
• Norco
• Percocet
• Robitussin
• Sedapap
• Sinutab
• Sudafed
• TheraFlu
• Unisom With Pain
• Vick’s Nyquil
• Vick’s DayQuil
• Vicodin,
• Wygesic
• Zydone

Acetaminophen in overdose can seriously damage the liver. If the damage is severe, a liver transplant may be necessary in order to save a life.

Accordning to Research, hundreds of people each year are diagnosed with acute liver failure as a result of taking acetaminophen and about 100 people die annually from overdosing on the painkiller, either intentionally or unintentionally.

Although researchers have found that the drug is safe if taken at recommended levels, its prevalence in a variety of pain relievers, fever reducers and cough medicines as a somewhat hidden ingredient means patients don’t realize they are taking several drugs that all contain acetaminophen.

Related:

Acetaminophen Side Effects
Acetaminophen liver injury
Class Action Lawyers
Airborne Warning
Hydroxycut Lawsuit

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Defective IVC Filters:
The two defective products are:

• Bard Peripheral Vascular Recovery (Recovery TM)
• G2 Filter (G2TM).

Why are they considered defective?
The IVC filters are said to have caused severe injuries and side effects including:

• Filter Movement
• Fracture of the Filter
• Lung and Heart Puncture
• A few cases resulting in death

Reports by the FDA and Bard indicate that Bard IVC filters higher incidents of these injuries than any other IVC filters.

The action is an early indication that the Obama administration is likely to take far more aggressive enforcement actions againstdrug companies than the Bush administration did.

The Food and Drug Administration received 130 reports from consumers and doctors of people losing their sense of smell after using one of the Zicam nasal products, which include Zicam Cold Remedy and Zicam Cold Remedy Swabs. The reports date to 1999, when Matrixx Initiatives of Scottsdale, Ariz., first introduced the products.

In 2006, Matrixx paid $12 million to settle 340 lawsuits from Zicam users who claimed that the product destroyed their sense of smell, a condition known as anosmia. Hundreds more such suits have since been filed.

Although the F.D.A. took no action during the Bush administration, Dr. Margaret A. Hamburg, who was named the agency commissioner by President Obama, said the incidence of anosmia associated with Zicam “strikes us as a fairly large problem.”

The agency issued its consumer alert even though Matrixx refused to recall its products, a highly unusual event. In a news release, Matrixx said it had suspended shipments of Zicam and would reimburse customers who wanted a refund.

“Matrixx Initiatives stands behind the science of its products and its belief that there is no causal link between its intranasal gel products and anosmia,” the release said. “For this reason, Matrixx Initiatives believes that the F.D.A. action is unwarranted and will seek a meeting with the F.D.A. to review the company’s product safety data.”

Matrixx had $101 million in sales last year, of which $40 million came from Zicam products. Because Matrixx has called Zicam a homeopathic product, the company was not required to seek agency approval before selling it.

The F.D.A. does not have the power to order product recalls but must rely on manufacturers to do so voluntarily. Bills now moving through Congress would give the agency that power. Bush administration appointees said the F.D.A. did not need mandatory recall authority because companies always withdrew unsafe products when asked.

But the government sometimes negotiated for days or weeks before companies agreed to recalls, leading many more consumers to be put at risk. And the Zicam case demonstrates that aggressive enforcement action can lead to disagreements.

An F.D.A. warning letter sent to Matrixx on Tuesday states that Zicam Cold Remedy intranasal products “may pose a serious risk to consumers who use them” and are “misbranded.” Such language would normally describe a recall alert. The products have no proven benefits.

Matrixx has received more than 800 reports of Zicam users losing their sense of smell but did not provide those reports to the F.D.A., said Deborah M. Autor, director of compliance in the agency’s drug center. The law requires producers of approved drugs to forward to the F.D.A. all reports of product-related injuries, but Ms. Autor declined to say whether this reporting requirement applied to Matrixx.

“This disabling loss of one of the five senses may be long lasting or even permanent in some people,” Ms. Autor said. “People without the sense of smell may not be able to detect dangers such as gas leaks or smoke. They could lose much of the pleasure of eating, adversely impacting the quality of life.”

Dr. Charles E. Lee, a compliance officer in the agency’s drug center, said zinc could be toxic to nerve receptors in the nose. In the 1930s, intranasal zinc was tested as a polio preventative, and some patients suffered anosmia, Dr. Lee said.

The Consumer Product Safety Commission and Blair LLC, based in Warren, Pa., on Thursday said they were issuing the second recall notice in two months after receiving reports of six deaths due to the robes catching on fire. In five of the six cases, the victims were women who were cooking at the time; three of the victims were in their 80s. The recall applied to 162,000 robes.

“CPSC urges all consumers to report any incidents or injuries involving consumer products, even after a recall has been announced,” said acting CPSC Chairman Thomas Moore. “Contact the CPSC so that we may help prevent tragic deaths or injuries like those that might be related to the Blair robes.”
CPSC and Blair initially announced their voluntary recall in April, citing three reports of the robes catching on fire, including one report of second-degree burns.

The robes, made in Pakistan, have the following item numbers: 3093111, 3093112, 3093113, 3093114, 3093115, and 3093116. They are a one-piece garment made of plush sculpted chenille, a shaped stand collar, and horizontal chenille front and back yolks and cuffs. The robes have a full-button front with seven matching button closures.

The robes were sold in Blair catalogs and on the company Web site, as well as Blair stores in Warren, Pa., Grove City, Pa., and Wilmington, Del., from January 2003 through March 2009. Consumers may return the robe to Blair and receive a refund or a $50 gift card by contacting the company at (877) 392-7095 between 9 a.m. and 9 p.m. ET Monday through Saturday, via the firm’s Web site at Blair.com/recall, or by e-mail at blairproductrecall(at)blair.com.

According to the FDA Propylthiouracil (PTU) can cause serious liver injury, including liver failure and death.

PTU is used to manage hyperthyroidism associated with Grave’s disease. It is also used to decrease symptoms of hyperthyroidism in preparation for surgically removing the thyroid gland or before inactivating the thyroid gland with radioactive iodine therapy

Reports to FDA’s Adverse Event Reporting System (AERS) suggest there is an increased risk of hepatotoxicity with PTU when compared with methimazole (MMI).

The FDA has identified 32 AERS cases (22 adult and 10 paediatric) of serious liver injury associated with PTU use. Of the adult cases, 12 deaths and 5 liver transplants occurred. Among the paediatric patients, 1 case resulted in death and 6 in liver transplants.

In contrast, for MMI only 5 AERS cases of serious liver injury were identified. All five cases were in adult patients and 3 resulted in death.

Although both PTU and MMI are indicated for the treatment of hyperthyroidism due to Graves’ disease, healthcare professionals should carefully consider which drug to initiate in a patient recently diagnosed with Graves’ disease. PTU may also be used when it is not advisable to remove the thyroid gland.

Physicians should closely monitor patients on PTU therapy for symptoms and signs of liver injury, especially during the first 6 months after initiation of therapy (fatigue, weakness, vague abdominal pain, loss of appetite, itching, easy bruising or yellowing of the eyes or skin).

In general, PTU is considered second-line drug therapy except in patients who are allergic to or intolerant of methimazole. Rare cases of embryopathy, including aplasia cutis, have been reported with use of MMI during pregnancy, while no such cases have been reported with PTU use. Thus, PTU may be more appropriate for patients with Graves’ disease who are in their first trimester of pregnancy.

Agranulocytosis is potentially the most serious side effect of Propylthiouracil therapy. Patients should be instructed to report any symptoms of agranulocytosis, such as fever or sore throat. Leukopenia, thrombocytopenia, and aplastic anemia (pancytopenia) may also occur. The drug should be discontinued in the presence of agranulocytosis, aplastic anemia (pancytopenia), ANCA-positive vasculitis, hepatitis, interstitial pneumonitis, fever, or exfoliative dermatitis. The patient’s bone marrow function should be monitored. Propylthiouracil can cause fetal harm when administered to a pregnant woman.

Because the drug readily crosses placental membranes and can induce goiter and even cretinism in the developing fetus, it is important that a sufficient, but not excessive, dose be given. In many pregnant women, the thyroid dysfunction diminishes as the pregnancy proceeds; consequently a reduction of dosage may be possible. In some instances, Propylthiouracil can be withdrawn 2 or 3 weeks before delivery.

On April 18, 2009, the FDA held a public workshop with the American Thyroid Association (ATA) to discuss PTU-related hepatotoxicity. The FDA is continuing to monitor these serious reported adverse events and working to make changes to the PTU prescribing information, particularly for use in paediatric patients. Also, the ATA plans to update its treatment guidelines for Graves’ disease in the upcoming months.

Reports to FDA’s Adverse Event Reporting System (AERS) suggest there is an increased risk of hepatotoxicity with PTU when compared to methimazole (MMI). Although both PTU and MMI are indicated for the treatment of hyperthyroidism due to Graves’ disease, healthcare professionals should carefully consider which drug to initiate in a patient recently diagnosed with Graves’ disease. Physicians should closely monitor patients on PTU therapy for symptoms and signs of liver injury, especially during the first six months after initiation of therapy. PTU and MMI were approved in 1947 and 1950, respectively.

• Hydroxycut Regular Rapid Release Caplets
• Hydroxycut Caffeine-Free Rapid Release Caplets
• Hydroxycut Liquid Shots
• Hydroxycut Hardcore RTDs (Ready-to-Drink)
• Hydroxycut Max Aqua Shed
• Hydroxycut Hardcore Liquid Capsules
• Hydroxycut Max Liquid Capsules
• Hydroxycut Regular Drink Packets
• Hydroxycut Caffeine-Free Drink Packets
• Hydroxycut Hardcore Drink Packets (Ignition Stix)
• Hydroxycut Max Drink Packets
• Hydroxycut 24
• Hydroxycut Carb Control
• Hydroxycut Natural

Users of Hydroxycut should be aware of symptoms of possible liver damage from hydroxycut, including, jaundice, brown urine, nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching, and loss of appetite.

As millions of people in the United States attempt to lose weight for a plethora of reasons, many are turning to different products to help them do so. As a result, companies are beginning to research, develop and market these products as a way to accomplish the weight loss they desire in a fast and safe manner.

Unfortunately, some of these weight loss aids are proving to be dangerous, and that appears to be the case with one of the most popular product lines on the market - Hydroxycut products by Iovate Health Sciences, Inc. Below is a brief overview of the burgeoning issue with these products:

The Products

The products at issue are the line of Hydroxycut weight loss aids that are marketed to help consumers weight-loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss, all of which are meant to promote better health because of less weight. These products sold in huge numbers since hitting the market, and they are seen as cost-effective and efficient.

The Problems

The problems that have arisen in response to using them have been not only numerous, but serious in nature.

Specifically, these problems include:

• Seizures
• Cardiovascular disorders
• Rhabdomyolysis – A type of muscle damage that can lead to other serious health problems such as kidney failure.

Perhaps most serious is the trend that points towards different forms of liver damage. These different forms of damage include jaundice and elevated liver enzymes, which can lead to the immediate need for a liver transplant.

At this point, at least 23 reports of serious side effects developing as a result of using these products and one death has been reported. Given the small sample pool and the relatively short amount of time in which they have been generated, the US Food and Drug Administration (FDA) has decided to act now.

FDA’s Response

The FDA has recently issued a public warning to all consumers that they should immediately stop using any of these products until additional investigations can be completed regarding Hydroxycut weight loss products. This investigation centers on the ingredients present in the products and other factors included with their usage.

If you or someone you love has been harmed as a result of using Hydroxycut weight loss products, contact a defective drugs lawyer as soon as possible to schedule a free initial consultation.

Worldwide, 0.3% of patients have developed pre-tibial soft tissue swelling, which can mimic the
appearance of an infection between 2 and 36 weeks after implantation. The manufacturer is
currently investigating the cause of this problem.

Most cases resolved without intervention. A small number of cases needed local debridement and
removal of any remaining screw fragments, or replacement with an alternative screw or bone graft.
The manufacturer estimates that about 2,550 devices have been used in the UK since 2006.
The manufacturer is aware of seven reported cases of inflammation in the UK of which two
required implant revision.

The manufacturer wrote to chief executive officers of trusts, theatre managers, and surgeons who
were known to use CALAXO about this product recall in August 2007 (see MHRA website). This
notice is to facilitate the recall.

The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin, a drug product used to treat heart failure and abnormal heart rhythms. The drug has a narrow therapeutic index and the existence of higher than labeled dose may pose a risk of digoxin toxicity in patients with renal failure.

Digoxin toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, and bradycardia. Death can also result from excessive digoxin intake. A lower than labeled dose may pose a risk of lack of efficacy potentially resulting in cardiac instability.

Consumers with the recalled product should return these products to their pharmacy or place of purchase.

The U.S. Food and Drug Administration and the California Dept. of Public Health are investigating the matter. Thus far, several illnesses have been reported by consumers that may be associated with the pistachios, the FDA said.

The recalled nuts were shipped on or after Sept. 1, 2008 by Setton Pistachio of Terra Bella Inc.