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.

JORNAY PM (NDA-209311)

(METHYLPHENIDATE HYDROCHLORIDE)

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

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09/23/2025 (SUPPL-13)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.7 Long-term Suppression of Growth in Pediatric Patients

Additions and/or revisions underlined:

JORNAY PM is not approved for use and is not recommended in pediatric patients below 6 years of age [see Use in Specific Populations (8.4)].

…

8 Use in Specific Populations

8.4 Pediatric Use

Additions and/or revisions underlined:

The safety and effectiveness of JORNAY PM have not been established in pediatric patients below the age of 6 years.

In studies evaluating extended-release methylphenidate products, patients 4 to <6 years of age had higher systemic methylphenidate exposures than those observed in older pediatric patients at the same dosage. Pediatric patients 4 to <6 years of age also had a higher incidence of adverse reactions, including weight loss.

…

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

MEDICATION GUIDE

Additions and/or revisions underlined:

…

What is JORNAY PM?

JORNAY PM is a central nervous system (CNS) stimulant prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in people 6 years of age and older. JORNAY PM may help increase attention and decrease impulsiveness and hyperactivity in people 6 years of age and older with ADHD.

JORNAY PM is not recommended for use in children under 6 years of age

…

10/13/2023 (SUPPL-10)

Approved Drug Label (PDF)

Boxed Warning

Additions and/or revisions underlined:

WARNING: ABUSE, MISUSE, AND ADDICTION

JORNAY PM has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including JORNAY PM, can result in overdose and death [see Overdosage (10)], and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.

Before prescribing JORNAY PM, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout JORNAY PM treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse and addiction [see Warnings and Precautions (5.1) and Drug Abuse and Dependence (9.2)].

5 Warnings and Precautions

5.1 Abuse, Misuse, and Addiction

Additions and/or revisions underlined:

JORNAY PM has a high potential for abuse and misuse. The use of JORNAY PM exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. JORNAY PM can be diverted for non-medical use into illicit channels or distribution [see Drug Abuse and Dependence (9.2)].

Misuse and abuse of CNS stimulants, including JORNAY PM, can result in overdose and death [see Overdosage (10)], and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.

Before prescribing JORNAY PM, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks and proper disposal of any unused drug. Advise patients to store JORNAY PM in a safe place, preferably locked, and instruct patients to not give JORNAY PM to anyone else.

Throughout JORNAY PM treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction.

5.10 Motor and Verbal Tics, and Worsening of Tourette’s Syndrome

New subsection added:

CNS stimulants, including methylphenidate, have been associated with the onset or exacerbation of motor and verbal tics. Worsening of Tourette’s syndrome has also been reported [see Adverse Reactions (6.2)].

Before initiating JORNAY PM, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor JORNAY PM-treated patients for the emergence or worsening of tics or Tourette’s syndrome, and discontinue treatment if clinically appropriate.

5.8 Acute Angle Closure Glaucoma

New subsection added:

There have been reports of angle closure glaucoma associated with methylphenidate treatment.

Although the mechanism is not clear, JORNAY PM-treated patients considered at risk for acute angle closure glaucoma (e.g., patients with significant hyperopia) should be evaluated by an ophthalmologist.

5.9 Increased Intraocular Pressure and Glaucoma

New subsection added:

There have been reports of an elevation of intraocular pressure (IOP) associated with methylphenidate treatment [see Adverse Reactions (6.2)].

Prescribe JORNAY PM to patients with open-angle glaucoma or abnormally increased IOP only if the benefit of treatment is considered to outweigh the risk. Closely monitor JORNAY PM-treated patients with a history of abnormally increased IOP or open angle glaucoma.

6 Adverse Reactions

Additions and/or revisions underlined:

Abuse, Misuse, and Addiction [see Boxed Warning, Warnings and Precautions (5.1), and Drug Abuse and Dependence (9.2, 9.3)]

…

Acute Angle Closure Glaucoma [see Warnings and Precautions (5.8)]

Increased Intraocular Pressure and Glaucoma [see Warnings and Precautions (5.9)]

Motor and Verbal Tics, and Worsening of Tourette’s Syndrome [see Warnings and Precautions (5.10)

6.2 Postmarketing Experience

Additions and/or revisions underlined:

…

Eye Disorders: Diplopia, Increased intraocular pressure, Mydriasis, Visual impairment

…

Nervous System Disorders: Convulsion, Grand mal convulsion, Dyskinesia, Serotonin syndrome in combination with serotonergic drugs, Motor and Verbal Tics

…

7 Drug Interactions

7.3 Halogenated Anesthetics

New subsection added:

Concomitant use of halogenated anesthetics and JORNAY PM may increase the risk of sudden blood pressure and heart rate increase during surgery. Monitor blood pressure and avoid use of JORNAY PM in patients being treated with anesthetics on the day of surgery.

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

…

Abuse, Misuse, and Addiction

Educate patients and their families about the risks of abuse, misuse, and addiction of JORNAY PM, which can lead to overdose and death, and proper disposal of any unused drug [see Warnings and Precautions (5.1), Drug Abuse and Dependence (9.2,), Overdosage (10)]. Advise patients to store JORNAY PM in a safe place, preferably locked, and instruct patients to not give JORNAY PM to anyone else.

…

Increased Intraocular Pressure (IOP) and Glaucoma

Advise patients that IOP and glaucoma may occur during treatment with JORNAY PM [see Warnings and Precautions (5.9)].

Motor and Verbal Tics, and Worsening of Tourette’s Syndrome

Advise patients that motor and verbal tics and worsening of Tourette’s Syndrome may occur during treatment with JORNAY PM. Instruct patients to notify their healthcare provider if emergence of new tics or worsening of tics or Tourette’s syndrome occurs [see Warnings and Precautions (5.10)].

…

MEDICATION GUIDE

Medication Guide has undergone extensive changes; please refer to label.

06/25/2021 (SUPPL-8)

Approved Drug Label (PDF)

7 Drug Interactions

7.2 Antihypertensive Drugs

New subsection added

JORNAY PM may decrease the effectiveness of drugs used to treat hypertension. Monitor blood pressure and adjust the dosage of the antihypertensive drug as needed [see Warnings and Precautions (5.3)].

7.3 Risperidone

New subsection added

The combined use of methylphenidate with risperidone when there is a change in dose of either or both medications may increase the risk of extrapyramidal symptoms (EPS). Monitor for signs of EPS.