FDA MedWatch - Acetaminophen Prescription Products Limited to 325 mg Per Dosage Unit: Drug Safety Communication

[Guest guest]

Acetaminophen Prescription Products Limited to 325 mg Per Dosage Unit: Drug

Safety Communication

AUDIENCE: Pharmacy, Pain Management

ISSUE: FDA notified healthcare professionals that it has asked drug

manufacturers to limit the strength of acetaminophen in prescription drug

products, predominantly combinations of acetaminophen and opioids, to 325 mg per

tablet, capsule, or other dosage unit, making these products safer for patients.

This action will help to reduce the risk of severe liver injury and allergic

reactions associated with acetaminophen. A Boxed Warning highlighting the

potential for severe liver injury and a Warning highlighting the potential for

allergic reactions (swelling of the face, mouth, and throat, difficulty

breathing, itching, or rash) will be added to the label of all prescription drug

products that contain acetaminophen.

BACKGROUND: Acetaminophen, one of the most commonly used drugs in the United

States, is widely and effectively used in both prescription and over-the-counter

(OTC) products to reduce pain and fever. Examples of prescription products that

contain acetaminophen include hydrocodone with acetaminophen (Vicodin, Lortab),

and oxycodone with acetaminophen (Tylox, Percocet). OTC products containing

acetaminophen (e.g., Tylenol) are not affected by this action. Information about

the potential for liver injury is already required on the label for OTC products

containing acetaminophen. FDA is continuing to evaluate ways to reduce the risk

of acetaminophen related liver injury from OTC products. No drug shortages are

expected, because the 3-year implementation period should permit adequate time

for necessary reformulations.

RECOMMENDATION: Healthcare professionals were reminded to advise patients not to

exceed the acetaminophen maximum total daily dose (4 grams/day), and not to

drink alcohol while taking acetaminophen-containing medications.

Healthcare professionals were encouraged to inform patients that there is no

immediate danger to patients who take these combination pain medications, and

patients should continue to take them as directed by their health care provider.

The Drug Safety Communication provides additional information for healthcare

professionals, information for patients, a data summary and a list of all

affected products.

Read the MedWatch safety alert, including links to the FDA Drug Safety

Communication, Q & As, and Consumer Update, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedical\

Products/ucm239955.htm

Tell us how we are doing:

http://survey.foreseeresults.com/survey/display?cid=d509U9xg0gZVxkMRcoMsQg== & sid\

=link & cpp[date]=01_13_2011_1321 & cpp[type]=S

You are encouraged to report all serious adverse events and product quality

problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

Follow MedWatch on Twitter

This service is provided to you at no charge by U.S. Food & Drug Administration

(FDA).

U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring,

MD 20993 · 800-439-1420

[Guest guest]

Acetaminophen Prescription Products Limited to 325 mg Per Dosage Unit: Drug

Safety Communication

AUDIENCE: Pharmacy, Pain Management

ISSUE: FDA notified healthcare professionals that it has asked drug

manufacturers to limit the strength of acetaminophen in prescription drug

products, predominantly combinations of acetaminophen and opioids, to 325 mg per

tablet, capsule, or other dosage unit, making these products safer for patients.

This action will help to reduce the risk of severe liver injury and allergic

reactions associated with acetaminophen. A Boxed Warning highlighting the

potential for severe liver injury and a Warning highlighting the potential for

allergic reactions (swelling of the face, mouth, and throat, difficulty

breathing, itching, or rash) will be added to the label of all prescription drug

products that contain acetaminophen.

BACKGROUND: Acetaminophen, one of the most commonly used drugs in the United

States, is widely and effectively used in both prescription and over-the-counter

(OTC) products to reduce pain and fever. Examples of prescription products that

contain acetaminophen include hydrocodone with acetaminophen (Vicodin, Lortab),

and oxycodone with acetaminophen (Tylox, Percocet). OTC products containing

acetaminophen (e.g., Tylenol) are not affected by this action. Information about

the potential for liver injury is already required on the label for OTC products

containing acetaminophen. FDA is continuing to evaluate ways to reduce the risk

of acetaminophen related liver injury from OTC products. No drug shortages are

expected, because the 3-year implementation period should permit adequate time

for necessary reformulations.

RECOMMENDATION: Healthcare professionals were reminded to advise patients not to

exceed the acetaminophen maximum total daily dose (4 grams/day), and not to

drink alcohol while taking acetaminophen-containing medications.

Healthcare professionals were encouraged to inform patients that there is no

immediate danger to patients who take these combination pain medications, and

patients should continue to take them as directed by their health care provider.

The Drug Safety Communication provides additional information for healthcare

professionals, information for patients, a data summary and a list of all

affected products.

Read the MedWatch safety alert, including links to the FDA Drug Safety

Communication, Q & As, and Consumer Update, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedical\

Products/ucm239955.htm

Tell us how we are doing:

http://survey.foreseeresults.com/survey/display?cid=d509U9xg0gZVxkMRcoMsQg== & sid\

=link & cpp[date]=01_13_2011_1321 & cpp[type]=S

You are encouraged to report all serious adverse events and product quality

problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

Follow MedWatch on Twitter

This service is provided to you at no charge by U.S. Food & Drug Administration

(FDA).

U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring,

MD 20993 · 800-439-1420

[Guest guest]

Acetaminophen Prescription Products Limited to 325 mg Per Dosage Unit: Drug

Safety Communication

AUDIENCE: Pharmacy, Pain Management

ISSUE: FDA notified healthcare professionals that it has asked drug

manufacturers to limit the strength of acetaminophen in prescription drug

products, predominantly combinations of acetaminophen and opioids, to 325 mg per

tablet, capsule, or other dosage unit, making these products safer for patients.

This action will help to reduce the risk of severe liver injury and allergic

reactions associated with acetaminophen. A Boxed Warning highlighting the

potential for severe liver injury and a Warning highlighting the potential for

allergic reactions (swelling of the face, mouth, and throat, difficulty

breathing, itching, or rash) will be added to the label of all prescription drug

products that contain acetaminophen.

BACKGROUND: Acetaminophen, one of the most commonly used drugs in the United

States, is widely and effectively used in both prescription and over-the-counter

(OTC) products to reduce pain and fever. Examples of prescription products that

contain acetaminophen include hydrocodone with acetaminophen (Vicodin, Lortab),

and oxycodone with acetaminophen (Tylox, Percocet). OTC products containing

acetaminophen (e.g., Tylenol) are not affected by this action. Information about

the potential for liver injury is already required on the label for OTC products

containing acetaminophen. FDA is continuing to evaluate ways to reduce the risk

of acetaminophen related liver injury from OTC products. No drug shortages are

expected, because the 3-year implementation period should permit adequate time

for necessary reformulations.

RECOMMENDATION: Healthcare professionals were reminded to advise patients not to

exceed the acetaminophen maximum total daily dose (4 grams/day), and not to

drink alcohol while taking acetaminophen-containing medications.

Healthcare professionals were encouraged to inform patients that there is no

immediate danger to patients who take these combination pain medications, and

patients should continue to take them as directed by their health care provider.

The Drug Safety Communication provides additional information for healthcare

professionals, information for patients, a data summary and a list of all

affected products.

Read the MedWatch safety alert, including links to the FDA Drug Safety

Communication, Q & As, and Consumer Update, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedical\

Products/ucm239955.htm

Tell us how we are doing:

http://survey.foreseeresults.com/survey/display?cid=d509U9xg0gZVxkMRcoMsQg== & sid\

=link & cpp[date]=01_13_2011_1321 & cpp[type]=S

You are encouraged to report all serious adverse events and product quality

problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

Follow MedWatch on Twitter

This service is provided to you at no charge by U.S. Food & Drug Administration

(FDA).

U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring,

MD 20993 · 800-439-1420

[Guest guest]

Acetaminophen Prescription Products Limited to 325 mg Per Dosage Unit: Drug

Safety Communication

AUDIENCE: Pharmacy, Pain Management

ISSUE: FDA notified healthcare professionals that it has asked drug

manufacturers to limit the strength of acetaminophen in prescription drug

products, predominantly combinations of acetaminophen and opioids, to 325 mg per

tablet, capsule, or other dosage unit, making these products safer for patients.

This action will help to reduce the risk of severe liver injury and allergic

reactions associated with acetaminophen. A Boxed Warning highlighting the

potential for severe liver injury and a Warning highlighting the potential for

allergic reactions (swelling of the face, mouth, and throat, difficulty

breathing, itching, or rash) will be added to the label of all prescription drug

products that contain acetaminophen.

BACKGROUND: Acetaminophen, one of the most commonly used drugs in the United

States, is widely and effectively used in both prescription and over-the-counter

(OTC) products to reduce pain and fever. Examples of prescription products that

contain acetaminophen include hydrocodone with acetaminophen (Vicodin, Lortab),

and oxycodone with acetaminophen (Tylox, Percocet). OTC products containing

acetaminophen (e.g., Tylenol) are not affected by this action. Information about

the potential for liver injury is already required on the label for OTC products

containing acetaminophen. FDA is continuing to evaluate ways to reduce the risk

of acetaminophen related liver injury from OTC products. No drug shortages are

expected, because the 3-year implementation period should permit adequate time

for necessary reformulations.

RECOMMENDATION: Healthcare professionals were reminded to advise patients not to

exceed the acetaminophen maximum total daily dose (4 grams/day), and not to

drink alcohol while taking acetaminophen-containing medications.

Healthcare professionals were encouraged to inform patients that there is no

immediate danger to patients who take these combination pain medications, and

patients should continue to take them as directed by their health care provider.

The Drug Safety Communication provides additional information for healthcare

professionals, information for patients, a data summary and a list of all

affected products.

Read the MedWatch safety alert, including links to the FDA Drug Safety

Communication, Q & As, and Consumer Update, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedical\

Products/ucm239955.htm

Tell us how we are doing:

http://survey.foreseeresults.com/survey/display?cid=d509U9xg0gZVxkMRcoMsQg== & sid\

=link & cpp[date]=01_13_2011_1321 & cpp[type]=S

You are encouraged to report all serious adverse events and product quality

problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

Follow MedWatch on Twitter

This service is provided to you at no charge by U.S. Food & Drug Administration

(FDA).

U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring,

MD 20993 · 800-439-1420