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.
CONCERTA (NDA-021121)
(METHYLPHENIDATE HYDROCHLORIDE)
Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)
10/13/2023 (SUPPL-49)
Boxed Warning
Additions and/or revisions underlined:
WARNING: ABUSE, MISUSE, AND ADDICTION
CONCERTA 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 CONCERTA, 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 CONCERTA, 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 CONCERTA 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 AddictionNew subsection added:
CONCERTA has a high potential for abuse and misuse. The use of CONCERTA exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. CONCERTA 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 CONCERTA, 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 CONCERTA, 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 CONCERTA in a safe place, preferably locked, and instruct patients to not
give CONCERTA to anyone else.
Throughout CONCERTA treatment, reassess each patient’s risk of abuse, misuse,
and
addiction and
frequently monitor for signs and symptoms of abuse, misuse, and addiction.
New subsection added
There have been rare reports of angle closure glaucoma associated with methylphenidate treatment.
Although the
mechanism is not clear, CONCERTA-treated patients considered at risk for acute
angle closure glaucoma (e.g., patients with significant hyperopia) should be
evaluated by an ophthalmologist.
New subsection added:
There have been reports of an elevation of intraocular pressure (IOP) associated with methylphenidate treatment [see Adverse Reactions (6.5)].
Prescribe CONCERTA to patients with open-angle glaucoma or abnormally increased IOP only if the benefit of treatment is considered to outweigh the risk. Closely monitor CONCERTA-treated patients with a history of abnormally increased IOP or open angle glaucoma.
New subsection added:
CNS stimulants, including methylphenidate, have been associated with the onset or exacerbation of motor and verbal tics [see Adverse Reactions (6.2, 6.5)]. Worsening of Tourette’s syndrome has also been reported.
Before initiating CONCERTA, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor CONCERTA-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:
Abuse, Misuse, and Addiction [see Boxed Warning, Warnings and Precautions (5.1)]
…
Peripheral Vasculopathy, including Raynaud’s Phenomenon [see Warnings and Precautions (5.7)]
…
Acute Angle Closure Glaucoma [see Warnings and Precautions (5.11)]
Increased Intraocular Pressure and Glaucoma [see Warnings and Precautions (5.12)]
Motor and Verbal Tics, and Worsening of Tourette’s Syndrome [see Warnings and Precautions (5.13)]
…
6.5 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
7.4 Halogenated AnestheticsNew subsection added:
Concomitant use of halogenated anesthetics and CONCERTA may increase the risk of sudden blood pressure and heart rate increase during surgery. Monitor blood pressure and avoid use of CONCERTA 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 CONCERTA, 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 CONCERTA in a safe place, preferably locked, and instruct patients to not give CONCERTA to anyone else.
Risks to Patients with Serious Cardiac Disease
Advise patients that there are potential risks to patients with serious cardiac disease, including sudden death, with CONCERTA use. Instruct patients to contact a healthcare provider immediately if they develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease [see Warnings and Precautions (5.2)].
Increased Blood Pressure and Heart Rate
Advise patients that CONCERTA can cause elevations in blood pressure and heart rate [see Warnings and Precautions (5.3)].
Psychiatric Risks
Advise patients that CONCERTA, at recommended doses, can cause psychotic or manic symptoms, even in patients without a prior history of psychotic symptoms or mania [see Warnings and Precautions (5.4)].
…
Suppression of Growth
Advise patients, caregivers, and family members that CONCERTA may cause slowing of growth and weight loss [see Warnings and Precautions (5.8)].
Increased Intraocular Pressure (IOP) and Glaucoma
Advise patients that IOP and glaucoma may occur during treatment with CONCERTA [see Warnings and Precautions (5.12)].
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 CONCERTA. 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 (5.13)].
…
MEDICATION GUIDE
Medication Guide has undergone extensive changes; please refer to label.