Drug Safety-related Labeling Changes (SrLC)
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Guide
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.
COTEMPLA XR-ODT (NDA-205489)
(METHYLPHENIDATE)
Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)
09/23/2025 (SUPPL-21)
10/13/2023 (SUPPL-12)
Boxed Warning
Additions and/or revisions underlined:
COTEMPLA XR-ODT 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 COTEMPLA XR-ODT, 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 COTEMPLA XR-ODT, 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 COTEMPLA XR-ODT 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 AddictionAdditions and/or revisions underlined:
COTEMPLA XR-ODT has a high potential for abuse and misuse. The use of COTEMPLA XR-ODT exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. COTEMPLA XR-ODT 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 COTEMPLA XR-ODT, 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 COTEMPLA XR-ODT, 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 COTEMPLA XR-ODT in a safe place, preferably locked, and instruct patients to not give COTEMPLA XR-ODT to anyone else. Throughout COTEMPLA XR-ODT treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction.
Additions
and/or revisions underlined:
Sudden death has occurred in patients with structural cardiac abnormalities or other serious cardiac disease who were treated with CNS stimulants at the recommended ADHD dosages.
Avoid COTEMPLA
XR-ODT use in patients with known structural cardiac abnormalities,
cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or
other serious cardiac disease.
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, COTEMPLA XR-ODT-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 COTEMPLA XR-ODT to patients with open-angle glaucoma or abnormally increased IOP only if the benefit of treatment is considered to outweigh the risk. Closely monitor COTEMPLA XR-ODT-treated patients with a history of abnormally increased IOP or open angle glaucoma.
5.10Motor 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 COTEMPLA XR-ODT, assess the family history and clinically evaluate patientsfor tics or Tourette’s syndrome. Regularly monitor COTEMPLA XR-ODT-treated patients for the emergence or worsening of tics or Tourette’s syndrome, and discontinue treatment if clinically appropriate.
6 Adverse Reactions
Additions and/or revisions underlined:
The following are discussed in more detail in other sections of the labeling:
Known hypersensitivity to methylphenidate or other ingredients of Cotempla XR-ODT [see Contraindications (4)]
Hypertensive crisis when used concomitantly with monoamine oxidase inhibitors [see Contraindications (4) and Drug Interactions (7.1)]
Abuse, Misuse, and Addiction [see Boxed Warning, Warnings and Precautions (5.1), and Drug Abuse and Dependence (9.2, 9.3)]
Risks to patients with serious cardiac disease [see Warnings and Precautions (5.2)]
Increased blood pressure and heart rate [see Warnings and Precautions (5.3)]
Psychiatric adverse reactions [see Warnings and Precautions (5.4)]
Priapism [see Warnings and Precautions (5.5)]
Peripheral vasculopathy, including Raynaud’s phenomenon [see Warnings and Precautions (5.6)]
Long-term suppression of growth in pediatric patients [see Warnings and Precautions (5.7)]
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
…
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDEMedication Guide has undergone extensive changes; please refer to label.