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.

RECLAST (NDA-021817)

(ZOLEDRONIC ACID)

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

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02/03/2026 (SUPPL-32)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.5 Atypical Fractures Including Femoral Fractures

Subsection title revised

Additions and/or revisions underlined

Atypical, low-energy, or low trauma fractures of the femoral shaft have been reported during treatment with bisphosphonates, including zolendronic acid, in patients with osteoporosis. Atypical femur and other fractures most commonly occur with minimal or no trauma to the affected area. These fractures occurred anywhere in the femoral shaft from just below the lesser trochanter to above the supracondylar flare and are transverse or short oblique in orientation without evidence of comminution. Atypical fractures of other bones have also been reported. They may be bilateral. These fractures can also occur in osteoporotic patients who have not been treated with bisphosphonates. Concomitant treatment with glucocorticoids may also induce these fractures.

Prodromal pain in the affected area, usually presenting as dull, aching thigh pain, weeks to months before a complete fracture occurs.

Any patient with a history of bisphosphonate exposure who presents with thigh or groin pain should be suspected of having an atypical fracture and should be evaluated to rule out an incomplete femur fracture. Bony pain in other locations should also be considered for evaluation of atypical fracture. Patients presenting with an atypical femur fracture should also be assessed for symptoms and signs of fracture in the contralateral limb. Risk/benefit of continuing bisphosphonate therapy should be re-evaluated in these patients and interruption of bisphosphonate therapy should be considered.

6 Adverse Reactions

Newly added information

The following clinically significant adverse drug reactions are described elsewhere in the labeling:

Drugs with Same Active Ingredient [see Warnings and Precautions (5.1)]
Hypocalcemia and Mineral Metabolism [see Warnings and Precautions (5.2)]
Renal Impairment [see Warnings and Precautions (5.3)]
Osteonecrosis of the Jaw [see Warnings and Precautions (5.4)]
Atypical Fractures Including Femoral Fractures [see Warnings and Precautions (5.5)]
Musculoskeletal Pain [see Warnings and Precautions (5.6)]
Patients with Asthma [see Warnings and Precautions (5.7)]

6.2 Postmarketing Experience

Additions and/or revisions underlined:

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.

The following adverse reactions have been identified during post approval use of Reclast or bisphosphonate products:

. . .

Musculoskeletal

Low-energy femoral shaft and subtrochanteric fractures, and atypical fractures of other bones [see Warnings and

Precautions (5.5)]

. . .

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

MEDICATION GUIDE

Additions and/or revisions underlined:

What is the most important information I should know about RECLAST?

. . .

4. Unusual breaks in thigh and other bones

. . .

4. Unusual breaks in thigh and other bones.

Some people have had unusual bone breaks, including thigh bone when taking RECLAST. A break in the thigh bone can feel like a new pain in your hip, groin, or thigh. People taking RECLAST can also have breaks in other bones.

. . .

04/29/2020 (SUPPL-28)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.1 Pregnancy

(PLLR conversion, please refer to label for complete information)

8.2 Lactation

(PLLR conversion)

Risk Summary

There are no data on the presence of zoledronic acid in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breast-feeding should be considered along with the mother’s clinical need for Reclast and any potential adverse effects on the breast-fed child from Reclast or from the underlying maternal condition.

8.3 Females and Males of Reproductive Potential

(PLLR conversion)

Infertility

There are no data available in humans. Female fertility may be impaired based on animal studies demonstrating adverse effects of Reclast on fertility parameters.

07/07/2017 (SUPPL-27)

Approved Drug Label (PDF)

6 Adverse Reactions

6.2 Post-Marketing Experience

(addition underlined)

…

Hypophosphatemia Hypophosphatemia has been reported.

04/14/2016 (SUPPL-22)

Approved Drug Label (PDF)

6 Adverse Reactions

Post-Marketing Experience

Osteonecrosis of other bones

Cases of osteonecrosis of other bones (including femur, hip, knee, ankle, wrist and humerus) have been reported; causality has not been determined in the population treated with Reclast.

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

PATIENT COUNSELING INFORMATION

During treatment with zoledronic acid, patients should be instructed to maintain good oral hygiene and undergo routine dental check-ups. If they experience any oral symptoms, they should immediately report them to their physician or dentist.