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.

TRANSDERM SCOP (NDA-017874)

(SCOPOLAMINE)

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

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03/01/2024 (SUPPL-51)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Neuropsychiatric Adverse Reactions

Additions and/or revisions underlined:

Psychiatric Adverse Reactions

… In cases of psychiatric reactions occurring TRANSDERM SC?P should be removed at once. If, despite this, the symptoms persist in a severe form, instruct patients to seek medical attention.

…

Cognitive Adverse Reactions

… If, despite this, the symptoms persist in a severe form, instruct patients to seek medical attention.

…

5.4 Gastrointestinal and Urinary Disorders

Additions and/or revisions underlined:

Scopolamine, due to its anticholinergic properties, can decrease gastrointestinal motility and cause urinary retention. Consider more frequent monitoring during treatment with TRANSDERM SC?P in patients suspected of having intestinal obstruction, patients with pyloric obstruction or patients with impeded flow of urine (e.g., in diseases of the prostate or urinary bladder neck obstruction) and patients receiving other anticholinergic drugs [see Drug Interactions (7.2)]. Discontinue TRANSDERM SC?P in patients who develop difficulty in urination.

5.6 Blurred Vision

Additions and/or revisions underlined:

Scopolamine can cause temporary dilation of the pupils resulting in blurred vision if it comes in contact with the eyes.

Advise patients to wash their hands thoroughly with soap and water and dry their hands immediately after handling the transdermal system, do not touch the system while wearing it, and wash hands and the application site with soap and water after transdermal system removal [see Dosage and Administration (2.1)].

6 Adverse Reactions

6.2 Postmarketing Experience

Additions and/or revisions underlined:

…

General disorders and administration site conditions: application site reactions including burning, rash, pruritus, and blistering

…

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

…

Administration Instructions

Counsel patients on how to apply and remove the transdermal system [see Dosage and Administration (2.1)]:

…

Once the transdermal system has been affixed, avoid touching or applying pressure to the transdermal system, since pressure exerted on it may cause scopolamine to ooze out at the edge.

…

Wash the hands and application site with soap and water after transdermal system removal.

…

Blurred Vision

Inform patients that temporary dilation of the pupils and blurred vision may occur if TRANSDERM SC?P comes in contact with the eyes. Instruct patients to wash their hands thoroughly with soap and water immediately after handling the transdermal system, do not touch the system while wearing it, and wash hands and the application site with soap and water after transdermal system removal [see Dosage and Administration (2.1), see Warnings and Precautions (5.6)].

PATIENT INFORMATION

Additions and/or revisions underlined:

…

What are the possible side effects of TRANSDERM SC?P?

TRANSDERM SC?P may cause serious side effects, including:

…

an unusual reaction called acute psychosis. Tell your doctor if you have any of these symptoms:
- confusion
- agitation
- rambling speech
- hallucinations (seeing or hearing things that are not there)
- paranoid behaviors and delusions (false belief in something)
  If you experience any of the above symptoms, your doctor may stop your treatment with TRANSDERM SC?P. If your symptoms continue and they are severe, get medical help.
  …

03/01/2019 (SUPPL-43)

Approved Drug Label (PDF)

4 Contraindications

Addition of the following to the 2nd bullet concerning belladonna alkaloids:

Reactions have included rash generalized and erythema.

5 Warnings and Precautions

Extensive changes to this section; please refer to label for complete information. Below are the updated subsection titles:

5.1 Acute Angle Closure Glaucoma

5.2 Neuropsychiatric Adverse Reactions

5.3 Eclamptic Seizures in Pregnant Women

5.4 Gastrointestinal and Urinary Disorders

5.5 Drug Withdrawal/Post-Removal Symptoms

5.6 Blurred Vision

5.7 Magnetic Resonance Imaging (MRI) Skin Burns

6 Adverse Reactions

Newly created bulleted line listing:

Acute Angle Closure Glaucoma
Neuropsychiatric Adverse Reactions
Eclamptic Seizures in Pregnant Women
Gastrointestinal and Urinary Disorders
Drug Withdrawal/Post-Removal Symptoms
Blurred Vision
MRI Skin Burns

6.1 Clinical Trials Experience

Revised as below:

Motion Sickness

The most common adverse reaction (approximately two thirds) was dry mouth. Less common adverse reactions, included drowsiness (less than one sixth), blurred vision and dilation of the pupils.

PONV

Common adverse reactions, occurring in at least 3% of patients in PONV clinical trials are shown in Table 1.

Table 1 Common Adverse Reactions* in Surgical Patients for the Prevention of PONV

7 Drug Interactions

Newly created subsections; please refer to label for complete information.

7.1 Drugs Causing Central Nervous System (CNS) Adverse Reactions

7.2 Anticholinergic Drugs

7.3 Oral Drugs Absorbed in the Stomach

7.4 Interaction with Gastric Secretion Test

8 Use in Specific Populations

8.1 Pregnancy

8.2 Lactation

PLLR conversion; extensive changes. Please refer to label for complete information.

8.4 Pediatric Use

Additions and/or revisions underlined:

Safety and effectiveness in pediatric patients have not been established. Pediatric patients are particularly susceptible to the adverse reactions of scopolamine; including mydriasis, hallucinations, amblyopia and drug withdrawal syndrome. Neurologic and psychiatric adverse reactions, such as hallucinations, amblyopia and mydriasis have also been reported.

8.5 Geriatric Use

Additions and/or revisions underlined:

In other clinical experience, elderly patients had an increased risk of neurologic and psychiatric adverse reactions, such as hallucinations, confusion, dizziness and drug withdrawal syndrome. Consider more frequent monitoring for CNS adverse reactions during treatment with Transderm Sc?p in elderly patients.

8.6 Renal or Hepatic Impairment

Additions and/or revisions underlined:

Transderm Sc?p has not been studied in patients with renal or hepatic impairment. Consider more frequent monitoring during treatment with Transderm Sc?p in patients with renal or hepatic impairment because of the increased risk of CNS adverse reactions.

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

MEDICATION GUIDE

Newly created from information contained in the prior Patient Information document.

PATIENT COUNSELING INFORMATION

Extensive changes; please refer to label for complete information.

03/01/2019 (SUPPL-44)

Approved Drug Label (PDF)

4 Contraindications

Addition of the following to the 2nd bullet concerning belladonna alkaloids:

Reactions have included rash generalized and erythema.

5 Warnings and Precautions

Extensive changes to this section; please refer to label for complete information. Below are the updated subsection titles:

5.1 Acute Angle Closure Glaucoma

5.2 Neuropsychiatric Adverse Reactions

5.3 Eclamptic Seizures in Pregnant Women

5.4 Gastrointestinal and Urinary Disorders

5.5 Drug Withdrawal/Post-Removal Symptoms

5.6 Blurred Vision

5.7 Magnetic Resonance Imaging (MRI) Skin Burns

6 Adverse Reactions

Newly created bulleted line listing:

Acute Angle Closure Glaucoma
Neuropsychiatric Adverse Reactions
Eclamptic Seizures in Pregnant Women
Gastrointestinal and Urinary Disorders
Drug Withdrawal/Post-Removal Symptoms
Blurred Vision
MRI Skin Burns

6.1 Clinical Trials Experience

Revised as below:

Motion Sickness

The most common adverse reaction (approximately two thirds) was dry mouth. Less common adverse reactions, included drowsiness (less than one sixth), blurred vision and dilation of the pupils.

PONV

Common adverse reactions, occurring in at least 3% of patients in PONV clinical trials are shown in Table 1.

Table 1 Common Adverse Reactions* in Surgical Patients for the Prevention of PONV

7 Drug Interactions

Newly created subsections; please refer to label for complete information.

7.1 Drugs Causing Central Nervous System (CNS) Adverse Reactions

7.2 Anticholinergic Drugs

7.3 Oral Drugs Absorbed in the Stomach

7.4 Interaction with Gastric Secretion Test

8 Use in Specific Populations

8.1 Pregnancy

8.2 Lactation

PLLR conversion; extensive changes. Please refer to label for complete information.

8.4 Pediatric Use

Additions and/or revisions underlined:

8.5 Geriatric Use

Additions and/or revisions underlined:

8.6 Renal or Hepatic Impairment

Additions and/or revisions underlined:

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

MEDICATION GUIDE

Newly created from information contained in the prior Patient Information document.

PATIENT COUNSELING INFORMATION

Extensive changes; please refer to label for complete information.