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.

ADHANSIA XR (NDA-212038)

(METHYLPHENIDATE HYDROCHLORIDE)

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

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06/25/2021 (SUPPL-5)

Approved Drug Label (PDF)

7 Drug Interactions

7.1 Clinically Important Drug Interactions

Addition of the following to Table 3

Antihypertensive Drugs

Clinical Impact: ADHANSIA XR may decrease the effectiveness of drugs used to treat hy- pertension [see Warnings and Precautions (5.3)].

Intervention: Monitor blood pressure and adjust the dosage of the antihypertensive drug as needed.

Examples: Potassium-sparing and thiazide diuretics, calcium channel blockers, angiotensin- converting-enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), beta blockers, centrally acting alpha-2 receptor agonists

Risperidone

Clinical Impact: Combined use of methylphenidate with risperidone when there is a change, whether an increase or decrease, in dosage of either or both medications, may increase the risk of extrapyramidal symptoms (EPS).

Intervention: Monitor for signs of EPS.

07/03/2019 (SUPPL-1)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trial Experience

(Additions and/or revisions are underlined)

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Clinical Trials Experience with Other Methylphenidate Products in Children, Adolescents, and Adults with ADHD

Commonly reported (greater than or equal to 2% of the methylphenidate group and twice the rate of the placebo group) adverse reactions from placebo-controlled trials of methylphenidate products include: appetite decreased, weight decreased, nausea, abdominal pain, dyspepsia, dry mouth, vomiting, insomnia, anxiety, nervousness, restlessness, affect lability, agitation, irritability, dizziness, vertigo, tremor, blurred vision, blood pressure increased, heart rate increased, tachycardia, palpitations, hyperhidrosis, and pyrexia.

Adult Patients with ADHD

The most common adverse reactions (incidence of greater than or equal to 5% and at least twice placebo) of ADHANSIA XR occurring in controlled trials in adults were insomnia, dry mouth, and decreased appetite.

Table 1 lists the adverse reactions that occurred greater than or equal to 2% of adult patients and greater than placebo among ADHANSIA XR-treated adult patients.

(Extensive revisions to table 1; please refer to labeling)

Table 1: Adverse Reactions Occurring in greater than or equal to 2% of Adult Patients with ADHD on ADHANSIA XR and Greater than Patients Taking Placebo in a 4-week Clinical Trial

Pediatric Patients (12 to 17 years) with ADHD

The most common (incidence greater than or equal to 5% and at least twice placebo) adverse reactions reported in pediatric patients (12 to 17 years) were decreased appetite, insomnia, and weight decreased.

Table 2 lists the adverse reactions that occurred greater than or equal to 2% of pediatric patients (12 to 17 years) and greater than placebo among ADHANSIA XR-treated pediatric patients (12 to 17 years).

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

MEDICATION GUIDE

(Extensive changes; please refer to labeling)