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.

M.V.I.-12 (NDA-008809)

(ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E)

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

Download Data

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11/09/2017 (SUPPL-73)

Approved Drug Label (PDF)

4 Contraindications

(addition underlined)

M.V.I.-12 is contraindicated in patients who have:

A history of known hypersensitivity to any of the vitamins or excipients in M.V.I.-12.
An existing hypervitaminosis.

5 Warnings and Precautions

5.1 Aluminum Toxicity

(additions underlined)

…

Patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 micrograms per kg per day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration. To prevent aluminum toxicity monitor periodically aluminum levels with prolonged parenteral administration of M.V.I.-12.

5.4 Hypervitaminosis A

(additions underlined)

Hypervitaminosis A, manifested by nausea, vomiting, headache, dizziness, blurred vision, has been reported in patients with renal failure receiving 1.5 mg/day retinol and in patients with liver disease. Therefore, supplementation of renal failure patients and patients with liver diseases with vitamin A, an ingredient found in M.V.I.-12, should be undertaken with caution. Blood levels of Vitamin A should be monitored periodically.

6 Adverse Reactions

(additions underlined)

…

The following adverse reactions associated with the use of M.V.I.-12 were identified in clinical studies or postmarketing reports. Because some of these reactions were 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.

Dermatologic: rash, erythema, pruritus CNS: headache, dizziness, agitation, anxiety Ophthalmic: diplopia.

8 Use in Specific Populations

8.1 Pregnancy

(addition underlined)

M.V.I.-12 has not been studied in pregnant women. Pregnant women should follow the U.S. Recommended Daily Allowances for pregnancy, because their vitamin requirements may exceed those of nonpregnant women.

8.3 Nursing Mothers

(addition underlined)

M.V.I.-12 has not been studied in lactating women. Lactating women should follow the U.S. Recommended Daily Allowances for their condition, because their vitamin requirements may exceed those of nonlactating women. Caution should be exercised when M.V.I.-12 is administered to a nursing woman.

8.4 Pediatric Use

(additions underlined)

M.V.I.-12 is indicated for the prevention of vitamin deficiency in pediatric patients age 11 years and above on warfarin anticoagulant therapy receiving parenteral nutrition. Safety and effectiveness of M.V.I.-12 in pediatric patients below the age of 11 years have not been established.

8.5 Geriatric Use

(new subsection added)

Reported clinical experience has not identified differences in responses between the elderly and younger patients.

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

PATIENT COUNSELING INFORMATION

(additions underline)

Instruct patients (if age appropriate) and caregivers:

To watch for and immediately report signs of allergic reactions (i.e. urticaria, periorbital and digital edema.
To watch for and immediately report signs of hypervitaminosis A, manifested by nausea, vomiting, headache, dizziness, blurred vision, if patients have renal impairment.

…