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.

ATROPINE (AUTOINJECTOR) (NDA-212319)

(ATROPINE)

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

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07/09/2019 (SUPPL-2)

Approved Drug Label (PDF)

5 Warnings and Precautions

PLR conversion; the following subsections have been created:

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

5.7 Hypersensitivity

6 Adverse Reactions

PLR conversion; extensively changed. Please refer to label for complete information.

7 Drug Interactions

PLR conversion:

7.1 Pralidoxime: Information has stayed the same

Newly added information:

7.2 Barbiturates

Barbiturates are potentiated by the anticholinesterases; therefore, barbiturates should be used cautiously in the treatment of convulsions resulting from exposure to Atropine.

8 Use in Specific Populations

PLLR conversion; additions underlined:

8.1 Pregnancy

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 in pregnant women. Adequate animal reproduction studies have not been conducted with atropine.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown.

8.2 Lactation

Risk Summary

Atropine has been reported to be excreted in human milk. There are no data on the effects of atropine on the breastfed infant or the effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Atropine and any potential adverse effects on the breastfed infant from Atropine or from the underlying maternal condition.

8.4 Pediatric Use

Safety and effectiveness of the 2 mg Atropine autoinjector in pediatric patients weighing less than or equal to 41 kg (90 pounds) have not been established.

Safety and effectiveness of atropine in patients weighing more than 41 kg (90 pounds) are supported by published literature. Adverse reactions seen in pediatric patients are similar to those that occur in adult patients. However, central nervous system effects are often seen earlier, and pediatric patients may be more susceptible to the pharmacologic effects of atropine.

Although the 2 mg Atropine autoinjector is not approved for pediatric patients less than 41 kg, overheating (atropine fever) caused by suppression of sweat gland activity may be more pronounced in infants and small children. Extreme hyperthermia in a newborn has been reported with as little as 0.065 mg orally.

8.5 Geriatric Use

Geriatric patients may be more susceptible to the pharmacologic effects of atropine.

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

PATIENT COUNSELING INFORMATION

PLR Conversion; newly added section:

Advise the patient to read the FDA-approved patient labeling (Instructions for Use). Administration

Ensure that users understand the indications for and use of Atropine, including review of symptoms of poisoning and operation of the Atropine autoinjector.

Seek Definitive Medical Care

If feasible and appropriate, advise patients that Atropine 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 atropine can inhibit sweating which can lead to overheating and heat injury.

Other

PLR conversion; please refer to label for complete information