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.

DEXILANT SOLUTAB (NDA-208056)

(DEXLANSOPRAZOLE)

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

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10/24/2016 (SUPPL-3)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Presence of Gastric Malignancy

In adults, symptomatic response to therapy with DEXILANT does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a PPI. In older patients, also consider an endoscopy. (additions and/or revisions underlined)

5.5 Cutaneous and Systemic Lupus Erythematosus (additional section)

Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs. These events have occurred as both new onset and an exacerbation of existing autoimmune disease. The majority of PPI-induced lupus erythematosus cases were CLE.

The most common form of CLE reported in patients treated with PPIs was subacute CLE (SCLE) and occurred within weeks to years after continuous drug therapy in patients ranging from infants to the elderly. Generally, histological findings were observed without organ involvement.

Systemic lupus erythematosus (SLE) is less commonly reported than CLE in patients receiving PPIs. PPI associated SLE is usually milder than non-drug induced SLE. Onset of SLE typically occurred within days to years after initiating treatment primarily in patients ranging from young adults to the elderly. The majority of patients presented with rash; however, arthralgia and cytopenia were also reported.

Avoid administration of PPIs for longer than medically indicated. If signs or symptoms consistent with CLE or SLE are noted in patients receiving DEXILANT, discontinue the drug and refer the patient to the appropriate specialist for evaluation. Most patients improve with discontinuation of the PPI alone in 4 to 12 weeks. Serological testing (e.g., ANA) may be positive and elevated serological test results may take longer to resolve than clinical manifestations.

6 Adverse Reactions

The following serious adverse reactions are described below and elsewhere in labeling:

(Addition of the following)

Cutaneous and Systemic Lupus Erythematosus
Cyanocobalamin (Vitamin B-12) Deficiency

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

MEDICATION GUIDE

Read this Medication Guide before you start taking DEXILANT or DEXILANT SoluTab …

What is the most important information I should know about DEXILANT or DEXILANT SoluTab?

DEXILANT or DEXILANT SoluTab may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor.

DEXILANT or DEXILANT SoluTab can cause serious side effects, including:

A type of kidney problem (acute interstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including DEXILANT or DEXILANT SoluTab, may develop a kidney problem called acute interstitial nephritis that can happen at any time during treatment with DEXILANT or DEXILANT SoluTab. Call your doctor if you have a decrease in the amount that you urinate or if you have blood in your urine.
Certain types of lupus erythematosus. Lupus erythematosus is an autoimmune disorder (the body’s immune cells attack other cells or organs in the body). Some people who take PPI medicines, including DEXILANT or DEXILANT SoluTab, may develop certain types of lupus erythematosus or have worsening of the lupus they already have. Call your doctor right away if you have new or worsening joint pain or a rash on your cheeks or arms that gets worse in the sun.

Talk to your doctor about your risk of these serious side effects if you take DEXILANT or DEXILANT SoluTab.

What are the possible side effects of DEXILANT or DEXILANT SoluTab?

DEXILANT or DEXILANT SoluTab may cause serious side effects, including:

See “What is the most important information I should know about DEXILANT or DEXILANT SoluTab?”
Interaction with warfarin. Taking warfarin with a PPI medicine may lead to an increased risk of bleeding… (addition underlined)

PATIENT COUNSELING INFORMATION

Adverse Reactions (additions underlined)

Advise patients to report to their healthcare provider if they experience any signs or symptoms consistent with:

Cutaneous and Systemic Lupus Erythematosus
Cyanocobalamin (Vitamin B-12 Deficiency)

07/08/2016 (SUPPL-1)

Approved Drug Label (PDF)

6 Adverse Reactions

Clinical Trials Experience

Pediatrics (additional section added)

The safety of DEXILANT capsules was evaluated in controlled and single-arm clinical trials including 166 pediatric patients,12 to 17 years of age for the treatment of symptomatic non-erosive GERD, healing of EE, maintenance of healed EE and relief of heartburn. The adverse reaction profile was similar to that of adults. The most common adverse reactions that occurred in greater than or equal to 5% of patients were headache, abdominal pain, diarrhea, nasopharyngitis and oropharyngeal pain.

Other Adverse Reactions (additional subheading added)

See the full prescribing information for lansoprazole for other adverse reactions not observed with DEXILANT.

8 Use in Specific Populations

Hepatic Impairment (addition of adult to sentence)

In a study of adult patients…

Pediatric Use (additional information below)

The safety and effectiveness of DEXILANT capsules have been established in pediatric patients 12 to 17 years of age for the healing of all grades of EE. The safety and effectiveness of DEXILANT capsules and DEXILANT SoluTab have been established in pediatric patients 12 to 17 years of age for the maintenance of healed EE and relief of heartburn, and treatment of heartburn associated with symptomatic non-erosive GERD.
Use of DEXILANT in this age group is supported by evidence from adequate and well-controlled studies of DEXILANT capsules in adults with additional safety, efficacy and pharmacokinetic data in pediatric patients 12 to 17 years of age.
The adverse reaction profile in patients 12 to 17 years of age was similar to adults.
The safety and effectiveness of DEXILANT have not been established in pediatric patients less than 12 years of age.

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

MG - What are the possible side effects of DEXILANT?

DEXILANT may cause serious side effects, including:

The most common side effects of DEXILANT in adults include: (updated sentence with new words underlined)
The most common side effects in children 12 to 17 years of age include: (addition of section)
- headache
- stomach pain
- diarrhea
- pain or swelling (inflammation) in your mouth, nose or throat

MG - What is DEXILANT? (updated)

DEXILANT delayed-release capsules (DEXILANT capsules) are used in adults people 12 years of age and older:
For up to 6 months in adults and up to 16 weeks in children 12 to 17 years of age to continue healing of erosive esophagitis and relief of heartburn
DEXILANT SoluTab delayed-release orally disintegrating tablets (DEXILANT SoluTab) is used in people 12 years of age and older:
For up to 6 months in adults and up to 16 weeks in children 12 to 17 years of age to continue healing of EE and relief of heartburn
It is not known if DEXILANT is safe and effective in children under 12 years of age.