Drug Safety-related Labeling Changes (SrLC)

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Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

DUODOTE (NDA-021983)

(ATROPINE; PRALIDOXIME CHLORIDE)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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10/06/2017 (SUPPL-23)

Approved Drug Label (PDF)

5 Warnings and Precautions

PLR conversion. The following subsections have been created; please refer to label for complete information:

5.1 Cardiovascular Risks

5.2 Heat Injury

5.3 Acute Glaucoma

5.4 Urinary Retention

5.5 Pyloric Stenosis

5.6 Exacerbation of Chronic Lung Disease

6 Adverse Reactions

PLR conversion; the following listing is added:

The following serious adverse reactions are described elsewhere in the labeling:

Cardiovascular Risks
Heat Injury
Acute Glaucoma
Urinary Retention
Pyloric Stenosis

Exacerbation of Chronic Lung Disease

Additions and/or revisions underlined:

6.1 Atropine

Because DuoDote contains pralidoxime chloride, which may potentiate the effect of atropine, signs of atropinization may occur earlier than might be expected when atropine is used alone.

6.2 Pralidoxime Chloride

6.3 Injection Site

Muscle tightness and pain may occur at the injection site.

6.4 Inadvertent Injection

In cases where DuoDote is inadvertently administered to people who are not poisoned with nerve agent or organophosphorus insecticide, the following effects on their ability to function normally may occur …

7 Drug Interactions

PLR conversion; additions and/or revisions as below:

7.1 Succinylcholine and Mivacurium

Since pralidoxime in DuoDote reactivates cholinesterases and succinylcholine and mivacurium are metabolized by cholinesterases, patients with organophosphorus nerve agent or organophosphorus insecticide poisoning who have received DuoDote may exhibit accelerated reversal of the neuromuscular blocking effects of succinylcholine and mivacurium (relative to poisoned patients who have not received pralidoxime). Monitor for neuromuscular effects with concomitant administration.

8 Use in Specific Populations

8.1 Pregnancy

PLLR conversion; revised as below:

Risk Summary

Atropine readily crosses the placental barrier and enters fetal circulation. There are no adequate data on the developmental risk associated with the use of atropine, pralidoxime, or the combination in pregnant women. Adequate animal reproduction studies have not been conducted with atropine, pralidoxime, or the combination. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

8.2 Lactation

PLLR conversion; revised as below:

Risk Summary

Atropine has been reported to be excreted in human milk. It is not known whether pralidoxime is excreted in human milk. There are no data on the effects of atropine or pralidoxime on the breastfed infant or the effects of the drugs on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for DuoDote and any potential adverse effects on the breastfed infant from DuoDote or from the underlying maternal condition.

8.4 Pediatric Use

Newly added information:

Safety and effectiveness of atropine in DuoDote in patients weighing more than 41 kg (90 pounds) is supported by published literature. Safety and effectiveness of pralidoxime chloride in DuoDote in patients more than 41 kg (90 pounds) is supported by data from pharmacokinetic studies in adults and experience in the pediatric population. Adverse events seen in pediatric patients treated with atropine are similar to those that occur in adult patients, although central nervous system complaints are often seen earlier and at lower doses.

8.5 Geriatric Use

Newly added information:

Geriatric patients may be more susceptible to the effects of atropine

8.6 Renal Impairment

Newly added information:

Pralidoxime chloride can cause decreased renal function. Patients with severe renal impairment may require less frequent doses after the initial dose.

8.7 Hepatic Impairment

Newly added information:

Patients with severe hepatic impairment may require less frequent doses after the initial dose.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Newly added information:

Use by Healthcare Providers

DuoDote is intended for use by Healthcare Providers. See the illustrated Instruction Sheet for Healthcare Providers. Seek Definitive Medical Care

If feasible and appropriate, advise patients that DuoDote is an initial emergency treatment, that they need additional care at a healthcare facility.

Avoid Overheating

If feasible and appropriate, advise the patient to avoid a hot environment and excessive physical activity since DuoDote can inhibit sweating which can lead to overheating and heat injury.

Other

PLR conversion