Manipulation 5: Diabetes (All Conditions)

M5_DSC Diabetes_All conditions_final.docx

Data to Support Drug Product Communications as Used by the FDA

Manipulation 5: Diabetes (All Conditions)

OMB: 0910-0695

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  1. Text


FDA Drug Safety Communication


FDA approves label changes for diabetes DRUG D due to risk of serious psychiatric and nerve side effects


RISK RATING: High


Text

Legend

Low

The severity of the adverse event or risk is low or mild. Only some users will experience the adverse event described.

Moderate

The severity of the adverse event or risk is moderate. Only some users will experience the adverse event described.

High

The adverse event or risk is serious and potentially life-threatening or deadly. Only some users will experience the adverse event described.


Safety Announcement

[7-29-2013] The U.S. Food and Drug Administration (FDA) has strengthened and updated warnings regarding nerve and psychiatric side effects associated with DRUG D, used to treat diabetes. A boxed warning, the most serious kind of warning about these potential problems, has been added to the drug label. We have revised the patient Medication Guide dispensed with each prescription and wallet card to include this information and the possibility that the side effects may persist or become permanent.


Patients, caregivers, and health care professionals should watch for nerve and psychiatric side effects when using DRUG D. The nerve side effects can include dizziness, loss of balance, or ringing in the ears. These can occur at any time during drug use, and can last for months to years after the drug is stopped or can be permanent. The psychiatric side effects can include feeling anxious, mistrustful, depressed, or having hallucinations. Patients who develop nerve or psychiatric symptoms should contact their prescribing health care professional. Do not stop taking DRUG D before discussing symptoms with your health care professional.


We will continue to evaluate the safety of DRUG D and will communicate with the public again when additional information becomes available.



  1. FACE

FDA Drug Safety Communication


FDA approves label changes for diabetes DRUG D due to risk of serious psychiatric and nerve side effects


RISK RATING:


Face

Legend


The severity of the adverse event or risk is low or mild. Only some users will experience the adverse event described.


The severity of the adverse event or risk is moderate. Only some users will experience the adverse event described.


The adverse event or risk is serious and potentially life-threatening or deadly. Only some users will experience the adverse event described.


Safety Announcement

[7-29-2013] The U.S. Food and Drug Administration (FDA) has strengthened and updated warnings regarding nerve and psychiatric side effects associated with DRUG D, used to treat diabetes. A boxed warning, the most serious kind of warning about these potential problems, has been added to the drug label. We have revised the patient Medication Guide dispensed with each prescription and wallet card to include this information and the possibility that the side effects may persist or become permanent.


Patients, caregivers, and health care professionals should watch for nerve and psychiatric side effects when using DRUG D. The nerve side effects can include dizziness, loss of balance, or ringing in the ears. These can occur at any time during drug use, and can last for months to years after the drug is stopped or can be permanent. The psychiatric side effects can include feeling anxious, mistrustful, depressed, or having hallucinations. Patients who develop nerve or psychiatric symptoms should contact their prescribing health care professional. Do not stop taking DRUG D before discussing symptoms with your health care professional.


We will continue to evaluate the safety of DRUG D and will communicate with the public again when additional information becomes available.




  1. COLOR

FDA Drug Safety Communication


FDA approves label changes for diabetes DRUG D due to risk of serious psychiatric and nerve side effects



RISK RATING:



Color

Legend


The severity of the adverse event or risk is low or mild. Only some users will experience the adverse event described.


The severity of the adverse event or risk is moderate. Only some users will experience the adverse event described.


The adverse event or risk is serious and potentially life-threatening or deadly. Only some users will experience the adverse event described.


Safety Announcement

[7-29-2013] The U.S. Food and Drug Administration (FDA) has strengthened and updated warnings regarding nerve and psychiatric side effects associated with DRUG D, used to treat diabetes. A boxed warning, the most serious kind of warning about these potential problems, has been added to the drug label. We have revised the patient Medication Guide dispensed with each prescription and wallet card to include this information and the possibility that the side effects may persist or become permanent.


Patients, caregivers, and health care professionals should watch for nerve and psychiatric side effects when using DRUG D. The nerve side effects can include dizziness, loss of balance, or ringing in the ears. These can occur at any time during drug use, and can last for months to years after the drug is stopped or can be permanent. The psychiatric side effects can include feeling anxious, mistrustful, depressed, or having hallucinations. Patients who develop nerve or psychiatric symptoms should contact their prescribing health care professional. Do not stop taking DRUG D before discussing symptoms with your health care professional.


We will continue to evaluate the safety of DRUG D and will communicate with the public again when additional information becomes available.



  1. NUMBER


FDA Drug Safety Communication


FDA approves label changes for diabetes DRUG D due to risk of serious psychiatric and nerve side effects


RISK RATING: 3


#

Legend

1

The severity of the adverse event or risk is low or mild. Only some users will experience the adverse event described.

2

The severity of the adverse event or risk is moderate. Only some users will experience the adverse event described.

3

The adverse event or risk is serious and potentially life-threatening or deadly. Only some users will experience the adverse event described.


Safety Announcement

[7-29-2013] The U.S. Food and Drug Administration (FDA) has strengthened and updated warnings regarding nerve and psychiatric side effects associated with DRUG D, used to treat diabetes. A boxed warning, the most serious kind of warning about these potential problems, has been added to the drug label. We have revised the patient Medication Guide dispensed with each prescription and wallet card to include this information and the possibility that the side effects may persist or become permanent.


Patients, caregivers, and health care professionals should watch for nerve and psychiatric side effects when using DRUG D. The nerve side effects can include dizziness, loss of balance, or ringing in the ears. These can occur at any time during drug use, and can last for months to years after the drug is stopped or can be permanent. The psychiatric side effects can include feeling anxious, mistrustful, depressed, or having hallucinations. Patients who develop nerve or psychiatric symptoms should contact their prescribing health care professional. Do not stop taking DRUG D before discussing symptoms with your health care professional.


We will continue to evaluate the safety of DRUG D and will communicate with the public again when additional information becomes available.



  1. METER

FDA Drug Safety Communication


FDA approves label changes for diabetes DRUG D due to risk of serious psychiatric and nerve side effects

Shape1

RISK RATING:


Meter

Legend

Shape2

The severity of the adverse event or risk is low or mild. Only some users will experience the adverse event described.

Shape3

The severity of the adverse event or risk is moderate. Only some users will experience the adverse event described.

Shape4

The adverse event or risk is serious and potentially life-threatening or deadly. Only some users will experience the adverse event described.


Safety Announcement


[7-29-2013] The U.S. Food and Drug Administration (FDA) has strengthened and updated warnings regarding nerve and psychiatric side effects associated with DRUG D, used to treat diabetes. A boxed warning, the most serious kind of warning about these potential problems, has been added to the drug label. We have revised the patient Medication Guide dispensed with each prescription and wallet card to include this information and the possibility that the side effects may persist or become permanent.


Patients, caregivers, and health care professionals should watch for nerve and psychiatric side effects when using DRUG D. The nerve side effects can include dizziness, loss of balance, or ringing in the ears. These can occur at any time during drug use, and can last for months to years after the drug is stopped or can be permanent. The psychiatric side effects can include feeling anxious, mistrustful, depressed, or having hallucinations. Patients who develop nerve or psychiatric symptoms should contact their prescribing health care professional. Do not stop taking DRUG D before discussing symptoms with your health care professional.


We will continue to evaluate the safety of DRUG D and will communicate with the public again when additional information becomes available.



  1. SYMBOL


FDA Drug Safety Communication


FDA approves label changes for diabetes DRUG D due to risk of serious psychiatric and nerve side effects

Shape5

RISK RATING:


Symbol

Legend

Shape6

The severity of the adverse event or risk is low or mild. Only some users will experience the adverse event described.

Shape7 Shape8 Shape9

The severity of the adverse event or risk is moderate. Only some users will experience the adverse event described.

Shape10

The adverse event or risk is serious and potentially life-threatening or deadly. Only some users will experience the adverse event described.


Safety Announcement

[7-29-2013] The U.S. Food and Drug Administration (FDA) has strengthened and updated warnings regarding nerve and psychiatric side effects associated with DRUG D, used to treat diabetes. A boxed warning, the most serious kind of warning about these potential problems, has been added to the drug label. We have revised the patient Medication Guide dispensed with each prescription and wallet card to include this information and the possibility that the side effects may persist or become permanent.


Patients, caregivers, and health care professionals should watch for nerve and psychiatric side effects when using DRUG D. The nerve side effects can include dizziness, loss of balance, or ringing in the ears. These can occur at any time during drug use, and can last for months to years after the drug is stopped or can be permanent. The psychiatric side effects can include feeling anxious, mistrustful, depressed, or having hallucinations. Patients who develop nerve or psychiatric symptoms should contact their prescribing health care professional. Do not stop taking DRUG D before discussing symptoms with your health care professional.


We will continue to evaluate the safety of DRUG D and will communicate with the public again when additional information becomes available.



  1. CONTROL


FDA Drug Safety Communication


FDA approves label changes for diabetes DRUG D due to risk of serious psychiatric and nerve side effects


Safety Announcement

[7-29-2013] The U.S. Food and Drug Administration (FDA) has strengthened and updated warnings regarding nerve and psychiatric side effects associated with DRUG D, used to treat diabetes. A boxed warning, the most serious kind of warning about these potential problems, has been added to the drug label. We have revised the patient Medication Guide dispensed with each prescription and wallet card to include this information and the possibility that the side effects may persist or become permanent.


Patients, caregivers, and health care professionals should watch for nerve and psychiatric side effects when using DRUG D. The nerve side effects can include dizziness, loss of balance, or ringing in the ears. These can occur at any time during drug use, and can last for months to years after the drug is stopped or can be permanent. The psychiatric side effects can include feeling anxious, mistrustful, depressed, or having hallucinations. Patients who develop nerve or psychiatric symptoms should contact their prescribing health care professional. Do not stop taking DRUG D before discussing symptoms with your health care professional.


We will continue to evaluate the safety of DRUG D and will communicate with the public again when additional information becomes available.


File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
AuthorWinthrop, Sally
File Modified0000-00-00
File Created2021-01-21

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