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.

CLARINEX-D 12 HOUR (NDA-021313)

(DESLORATADINE; PSEUDOEPHEDRINE SULFATE)

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

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03/15/2019 (SUPPL-12)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.1 Pregnancy

(Pregnancy and Lactation Labeling Rule (PLLR) Conversion; extensive changes - please refer to labeling)

8.2 Lactation

(Pregnancy and Lactation Labeling Rule (PLLR) Conversion; Additions and/or revisions are underlined)

Risk Summary

Desloratadine and pseudoephedrine both pass into breast milk. There are not sufficient data on the effects of desloratadine on the breastfed infant or the effects of desloratadine on milk production. Pseudoephedrine has been reported to decrease milk production. Pseudoephedrine has been reported to cause irritability in breastfed infants. The decision should be made whether to discontinue nursing or to discontinue CLARINEX-D 12 HOUR Extended Release Tablets, taking into account the developmental and health benefits of breastfeeding, the nursing mother’s clinical need, and any potential adverse effects on the breastfed infant from desloratadine and pseudoephedrine or from the underlying maternal condition.

Data

Human Data

Pseudoephedrine

In a study of eight lactating women, who were 8 to 76 weeks postpartum and received a single dose of 60 mg of pseudoephedrine, the mean 24- hour milk production was reduced by 24%. In the same study, the estimated mean relative infant dose from breast milk (assuming mean milk consumption of 150 mL/kg/day and a maternal dosing regimen of 60 mg pseudoephedrine four times per day) was calculated to be 4.3% of the weight- adjusted maternal dose.

8.3 Females and Males of Reproductive Potential

(Newly Added Subsection)

Infertility

There are no data available on human infertility associated with desloratadine, pseudoephedrine, or the combination. There are no animal fertility studies with the combination or pseudoephedrine alone.

There were no clinically relevant effects of desloratadine on female fertility in rats. A male specific decrease in fertility occurred at an oral desloratadine dose of 12 mg/kg or greater in rats (approximately 65 times the summed AUC-based exposure of desloratadine and its metabolite at the RHD). Male fertility was unaffected at a desloratadine dose of 3 mg/kg (approximately 10 times the summed AUC-based exposure of desloratadine and its metabolite at the RHD).

04/19/2018 (SUPPL-10)

Approved Drug Label (PDF)

6 Adverse Reactions

6.2 Post-Marketing Experience

(additions underlined)

In addition to the adverse reactions reported during clinical trials and listed above, adverse events have been identified during post approval use of CLARINEX-D 12 HOUR Extended Release Tablets. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal to drug exposure.

Adverse events identified from post-marketing surveillance on the use of CLARINEX-D 12 HOUR Extended Release Tablets include:

Cardiac disorders: tachycardia, palpitations

Respiratory, thoracic and mediastinal disorders: dyspnea

Skin and subcutaneous tissue disorders: rash, pruritus

In addition to these events, the following spontaneous adverse events have been reported during the marketing of desloratadine as a single ingredient product:

Nervous system disorders: headache, somnolence, dizzinesspsychomotor hyperactivity, movement disorders (including dystonia, tics, and extrapyramidal symptoms), seizures (reported in patients with and without a known seizure disorder)

Immune system disorders: hypersensitivity reactions (such as urticaria, edema and anaphylaxis)

Investigations: elevated liver enzymes including bilirubin

Hepatobiliary disorders: hepatitis

Metabolism and nutrition disorders: increased appetite

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

PATIENT COUNSELING INFORMATION

17.1Cardiovascular and Central Nervous System Effects

(addition underlined)

Patients should be informed that pseudoephedrine, one of the active ingredients in CLARINEX-D 12 HOUR Extended Release Tablets may cause cardiovascular or central nervous system effects such as insomnia, dizziness, tremor, convulsions or arrhythmia.

PATIENT INFORMATION

(additions underlined)

What should I tell my doctor before taking CLARINEX-D® 12 Hour Extended Release Tablets?

…

have a medical or family history of seizures

…

02/06/2018 (SUPPL-9)

Approved Drug Label (PDF)

6 Adverse Reactions

Additions and/or revisions underlined:

The following adverse reactions are discussed in greater detail in other sections of the label:

Severe Skin Reactions

6.2 Post-Marketing Experience

In addition to these events, the following spontaneous adverse events have been reported during the marketing of desloratadine as a single ingredient product: headache, somnolence, dizziness and rarely hypersensitivity reactions (such as urticaria, edema and anaphylaxis), psychomotor hyperactivity, movement disorders (including dystonia, tics, and extrapyramidal symptoms), seizures, and elevated liver enzymes including bilirubin and, very rarely, hepatitis and increased appetite.

Cases of severe skin reactions such as acute generalized exanthematous pustulosis (AGEP) have been reported with pseudoephedrine-containing products.

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Advise the patient to read the FDA-approved patient labeling (Patient Information).

PATIENT INFORMATION

What are the possible side effects of CLARINEX-D® 12 Hour Extended Release Tablets?

CLARINEX-D 12 Hour Extended Release Tablets may cause serious side effects, including:

Addition of the following:

Severe skin reactions including signs and symptoms such as fever, reddening of the skin, or many small pimples