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.

DIACOMIT (NDA-207223)

(STIRIPENTOL)

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

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04/15/2026 (SUPPL-6)

Approved Drug Label (PDF)

6 Adverse Reactions

6.2 Postmarketing Experience

Newly added subsection:

The following adverse reactions have been identified during postapproval use of DIACOMIT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Infections and infestations: Pneumonia

07/14/2022 (SUPPL-3)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.5 Risks in Patients with Phenylketonuria

Additions and/or revisions underlined:

Phenylalanine can be harmful to patients with phenylketonuria (PKU). DIACOMIT for oral suspension contains phenylalanine, a component of aspartame. Each 250 mg packet contains 1.40 mg phenylalanine; each 500 mg packet contains 2.80 mg phenylalanine. Before prescribing DIACOMIT for oral suspension to a patient with PKU, consider the combined daily amount of phenylalanine from all sources, including DIACOMIT for oral suspension.

DIACOMIT capsules do not contain phenylalanine.

5.6 Suicidal Behavior and Ideation

Additions and/or revisions underlined:

…

Table 2 shows absolute and relative risk by indication for all evaluated AEDs.

Table 2. Risk by Indication for Antiepileptic Drugs in the Pooled Analysis

…

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

…

Table 3 lists the adverse reactions that occurred in 5% or more of DIACOMIT-treated patients and at a rate greater than in patients on placebo in the 2 randomized, double-blind, placebo- controlled, clinical trials in patients with Dravet syndrome (Study 1 and Study 2).

Table 3. Adverse Reactions in 5% or More of DIACOMIT-Treated Patients and More Frequently than on Placebo in Patients with Dravet Syndrome (Study 1 and Study 2)

…

Adverse Reactions in Pediatric Patients 6 months to Less Than 2 Years of Age

In five open-label studies including pediatric patients 6 months to less than 2 years of age with Dravet syndrome, a total of 106 patients received DIACOMIT, with 81 patients exposed for at least 6 months, and 69 patients exposed for at least 1 year. Adverse reactions in pediatric patients with Dravet syndrome who were 6 months to less than 2 years of age were similar to those seen in patients in Study 1 and Study 2.

8 Use in Specific Populations

8.4 Pediatric Use

Additions and/or revisions underlined:

The safety and effectiveness of DIACOMIT have been established for the treatment of seizures associated with Dravet syndrome in patients taking clobazam who are 6 months and older and weighing 7 kg or more. Use of DIACOMIT in this pediatric population is supported by 2 multicenter placebo-controlled, double-blind randomized studies in patients 3 to 18 years of age with additional pharmacokinetic and safety data in patients 6 months to less than 3 years of age [see Clinical Studies (14)].

The safety and effectiveness of DIACOMIT have not been established in pediatric patients below the age of 6 months or who weigh less than 7 kg.

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

MEDICATION GUIDE

Additions and/or revisions underlined:

…

What is DIACOMIT?

DIACOMIT is a prescription medicine used along with clobazam to treat seizures in people with Dravet syndrome who are 6 months of age and older and weighing 15 pounds (7 kg) or more.

DIACOMIT has not been shown to be able to treat seizures associated with Dravet syndrome without the use of clobazam.

It is not known if DIACOMIT is safe and effective in children under 6 months of age or who weigh less than 15 pounds (7 kg).

…