What FDA officials are saying

• FDA officials are asking all manufactures to limit the strength of acetaminophen to 325 mg per tablet in their prescription combination product to reduce and prevent the risk of severe liver injury from acetaminophen (Tylenol)
• By limiting the maximum amount of acetaminophen to 325 mg per tablet, FDA believes that patient will less likely overdose on acetaminophen if they mistakenly take more than the recommended amount when using acetaminophen combination products.

As requested by the FDA, Abbott is stopping production and distribution of the current Vicodin formulation and asking all pharmacies to return the current formulations in a timely manner to prevent confusion and potential dispensing errors when the new formulations are introduced.

The new formulations of Vicodin from Abbott are available now at the pharmacy:

• VICODIN (hydrocodone bitartrate and acetaminophen tablets) 5 mg/300 mg
• VICODIN ES (hydrocodone bitartrate and acetaminophen tablets) 7.5 mg/300 mg
• VICODIN HP (hydrocodone bitartrate and acetaminophen tablets) 10 mg/300 mg

However, manufactures of generic Vicodin, Norco, Percocet such as Endo Pharmaceuticals, Watson Pharmaceuticals and UCB Pharma have not yet responded to the new FDA request to reduce the acetaminophen dose in their combination products.

Most private insurance plans and Medicare/Medicaid do not cover brand name Vicodin. Since a generic version of the new Vicodin formulation is not yet available, patients should contact their insurance provider for copay information. If prior authorization or brand name Vicodin is not covered, doctors should request authorization or a change in regimen to prevent delaying treatment.

It is always good practice for patients to be aware of what is in their medication, the dosage, the strength, indication (uses) as well as potential side effects. Patients should inform their health care providers immediately if they suspect that they have taken too much acetaminophen or have any concerns.

Why is there a new dosage of acetaminophen in Vicodin

Acetaminophen, one of the most commonly used medications in the United States for pain and fever, has been associated with cases of liver failure that resulted in liver transplant and even death. Liver injury caused by acetaminophen most often occur when patients exceed the recommended dose of 4000 mg/day. This may occur because they are unaware of the acetaminophen component in their combination products.

There are nearly 60,000 emergency room visits, 26,000 hospitalizations and 458 deaths related to acetaminophen associated overdose annually.

Three most common causes for acetaminophen overdose

• Exceeding the recommended dosage of 4000 mg/day of acetaminophen
• Taking more than one acetaminophen containing product at the same time
• Drinking alcohol while taking acetaminophen

How does acetaminophen cause liver injury

When acetaminophen is metabolizing in the body, small amounts of acetaminophen are converted to a toxic metabolite that binds to liver proteins to cause cellular injury. The extend of liver injury depends greatly on the amount of toxic metabolite and the ability of the liver to remove the metabolite before it binds to the liver protein.

What are the signs and symptoms of acetaminophen overdose

Nausea, vomiting, malaise (sick feeling), loss of skin color, sweating, abdominal pain, increased heart rate, low blood pressure, elevated liver enzymes, jaundice (yellowish skin), low blood glucose, failure of several organs

How can you avoid acetaminophen liver toxicity

• Do not exceed the acetaminophen total daily dose of 4000 mg/day.
• Take acetaminophen containing products only as prescribed by your doctors.
• Do not take more than one product that contains acetaminophen at any given time.
• Read all prescription and OTC (over-the-counter) instructions to ensure that you are not taking multiple acetaminophen containing products.
• Do not drink alcohol while taking acetaminophen-containing medications.
• Seek medical help immediately if you have taken more acetaminophen than directed or if you experience symptoms of acetaminophen toxicity.

List of Prescrition Medications that Contain Acetaminophen

List of Over the Counter Medications with Acetaminophen

Resources:

Get Relief Responsibly: by entering your medication in the search box, you find out instantly whether your medication contains acetaminophen.

Abbott Pharmaceutical (1-800255-5162): New Vicodin strength is now available on the market

Watson Pharmaceutical (1-951-493-5300): Manufacturer of Norco, Lortab, Lorcet are unable to comment on the FDA request on lowering the acetaminophen strength in combination tablets.

Endo Pharmaceutical (1-800-462-3636): Manufacturer of Percocet, Percodan, Opana, Opana ER, Endocet, Endodan, Oxymorphone, Zydone and generic morphine are anticipating on removing the current combination products and marketing new strength by January of 2014.

References:

Fontana, Robert J. "Acute Liver Failure including Acetaminophen Overdose."National Center for Biotechnology Information. U.S. National Library of Medicine, 01 July 2008. Web. 23 Oct. 2012.

Laboratories, Abbott. "VICODIN (hydrocodone Bitartrate and Acetaminophen Tablets, USP)."VICODIN (hydrocodone Bitartrate and Acetaminophen Tablets, USP). Abbott, n.d. Web. 23 Oct. 2012.

FDA Drug Safety Communication: Prescription Acetaminophen Products to Be Limited to 325 Mg Per Dosage Unit; Boxed Warning Will Highlight Potential for Severe Liver Failure. FDA U.S. Food and Drug Administration, 21 Jan. 2011. Web. 23 Oct. 2012.

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