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.

POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER (NDA-019904)

(POTASSIUM CHLORIDE)

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

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06/13/2022 (SUPPL-21)

Approved Drug Label (PDF)

5 Warnings and Precautions

WARNINGS

Additions and/or revisions underlined:

…

Hyperchloremia

In patients with or at risk of hyperchloremia, Potassium Chloride Injection may exacerbate or result in hyperchloremia. Monitor plasma chloride levels and renal function in such patients.

06/20/2019 (SUPPL-20)

Approved Drug Label (PDF)

5 Warnings and Precautions

WARNINGS

(Additions and/or revisions underlined)

Hyperkalemia

…

PATIENTS REQUIRING HIGHLY CONCENTRATED SOLUTIONS SHOULD BE KEPT ON CONTINUOUS CARDIAC MONITORING AND UNDERGO FREQUENT TESTING FOR SERUM POTASSIUM AND ACID-BASE BALANCE, ESPECIALLY IF THEY RECEIVE DIGITALIS.

Tissue Damage and Thrombophlebitis

When infusing concentrated potassium solutions, including Potassium Chloride Injection, care must be taken to prevent paravenous administration or extravasation because such solutions may be associated with tissue damage, which may be severe and include vascular, nerve, and tendon damage, leading to surgical intervention, including amputation. Secondary complications including pulmonary embolism from thrombophlebitis have been reported as a consequence of tissue damage from potassium chloride.

…

Administer intravenously only with a calibrated infusion device at a slow, controlled rate. Highest concentrations (400 mEq per L) should be exclusively administered via central intravenous route. Whenever possible, administration via a central route is recommended for all concentrations of Potassium Chloride Injection for thorough dilution by the blood stream and decreasing the risk of extravasation and to avoid pain and phlebitis associated with peripheral infusion. Correct placement of the catheter should be verified before administration.

Hyponatremia

Monitoring of serum sodium is particularly important for hypotonic fluids. Potassium Chloride Injection has an osmolarity of 200 to 799 mOsmol/L.

Potassium Chloride Injection may cause hyponatremia. The risk for hyponatremia is increased, in pediatric patients, elderly patients, postoperative patients, those with psychogenic polydipsia and in patients treated with medications that increase the risk of hyponatremia (such as certain diuretic, antiepileptic and psychotropic medications).

Acute hyponatremia can lead to acute hyponatremic encephalopathy characterized by headache, nausea, seizures, lethargy and vomiting. Patients with brain edema are at particular risk of severe, irreversible and life-threatening brain injury.

Avoid Potassium Chloride Injection in patients with or at risk for hyponatremia. If use cannot be avoided, monitor serum sodium concentrations.

High volume infusion must be used with close monitoring in patients with cardiac or pulmonary failure, and in patients with non-osmotic vasopression release (including SIADH), due to the risk of hospital-acquired hyponatremia.

Fluid Overload

Depending on the volume and rate of infusion, and the patient’s underlying clinical condition, the intravenous administration of Potassium Chloride Injection can cause electrolyte disturbances such as overhydration/hypervolemia and congested states including central (e.g., pulmonary edema) and peripheral edema.

Avoid Potassium Chloride Injection in patients with or at risk for fluid and/or solute overloading. If use cannot be avoided, monitor fluid balance, electrolyte concentrations and acid base balance as needed and especially during prolonged use.

PRECAUTIONS

(Additions and/or revisions underlined)

Drug Interactions

Other Products that Cause Hyperkalemia

Administration of Potassium Chloride Injection in patients treated concurrently or recently with other products that can cause hyperkalemia or increase the risk of hyperkalemia (e.g., potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, cyclosporine and tacrolimus) increases the risk of severe and potentially fatal hyperkalemia, in particular in the presence of other risk factors for hyperkalemia. Avoid use of Potassium Chloride injection in patients receiving such products. If use cannot be avoided, monitor serum potassium concentrations.

Other Drugs that Increase the Risk of Hyponatremia

Administration of Potassium Chloride Injection in patients treated concomitantly with drugs associated with hyponatremia may increase the risk of developing hyponatremia. Avoid use of Potassium Chloride Injection in patients receiving drugs that may increase the risk of hyponatremia, such as diuretics and antiepileptics. Drugs that increase the vasopressin effect reduce renal electrolyte free water excretion and may also increase the risk of hyponatremia following treatment with intravenous fluids.

If use cannot be avoided, monitor serum sodium concentrations.

6 Adverse Reactions

(Additions and/or revisions underlined)

…

Metabolism and nutrition disorders: Hyperkalemia, hyponatremia

…

Nervous System Disorders: Hyponatremic encephalopathy

01/07/2017 (SUPPL-14)

Approved Drug Label (PDF)

5 Warnings and Precautions

PRECAUTIONS

Addition of the following:

General

Do not connect flexible plastic containers in series in order to avoid air embolism due to possible residual air contained in the primary container.

WARNINGS

Addition of the following:

TO AVOID POTASSIUM INTOXICATION, DO NOT INFUSE THESE SOLUTIONS …

Potassium Chloride Injection should be administered with extreme caution, if at all, to patients with conditions predisposing to hyperkalemia and/or associated with increased sensitivity to potassium, such as patients with:

severe renal impairment,
acute dehydration,
extensive tissue injury or burns,
certain cardiac disorders such as congestive heart failure or AV block,
potassium-aggravated skeletal muscle channelopathies (e.g., hyperkalemic periodic paralysis, paramyotonia congenita, and potassium-aggravated myotonia/paramyotonia).
Potassium Chloride Injection should be administered with caution to patients who are at risk of experiencing hyperosmolality, acidosis, or undergo correction of alkalosis (conditions associated with a shift of potassium from intracellular to extracellular space) and patients treated concurrently or recently with agents or products that can cause hyperkalemia.
If used in high-risk patients, especially close monitoring and careful dose selection and adjustment is required …

FREQUENT TESTING FOR SERUM POTASSIUM AND ACID-BASE BALANCE, ESPECIALLY IF THEY RECEIVE DIGITALIS ...

Administration of concentrated potassium solutions can cause cardiac conduction disorders (including complete heart block) and other cardiac arrhythmias at any time during infusion. Continuous cardiac monitoring is performed to aid in the detection of cardiac arrhythmias due to a sudden increase in serum potassium concentration (e.g., when potassium infusion is started), or transient or sustained hyperkalemia.

Frequently, mild or moderate hyperkalemia is asymptomatic and may be manifested only by increased serum potassium concentrations and, possibly, characteristic EKG changes. However, fatal arrhythmias can develop at any time during hyperkalemia.

Serum potassium levels are not necessarily indicative of tissue potassium levels. When infusing concentrated potassium solutions care must be taken to prevent paravenous administration or extravasation because such solutions may be associated with tissue damage, which may be severe and include vascular, nerve, and tendon amage, leading to surgical intervention, including amputation. Secondary complications including pulmonary embolism from thrombophlebitis have been reported as a consequence of tissue damage from potassium chloride.

Administer intravenously only with a calibrated infusion device at a slow, controlled rate. Highest concentrations (300 and mEq per L) should be exclusively administered via central intravenous route. Whenever possible, administration via a central route is recommended for all concentrations of Potassium Chloride Injection for thorough dilution by the blood stream and decreasing the risk of extravasation and to avoid pain and phlebitis associated with peripheral infusion. Correct placement of the catheter should be verified before administration …

6 Adverse Reactions

Revised as follows:

The following adverse reactions associated with the use of Potassium Chloride Injection were identified in postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish a causal relationship to drug exposure.

Immune system disorders: Hypersensitivity, as manifested by rash and angioedema

Metabolism and nutrition disorders: Hyperkalemia

Cardiac disorders: Cardiac arrest*, asystole*, ventricular fibrillation*, bradycardia

*as a manifestation of rapid intravenous administration and/or of hyperkalemia

Respiratory, Thoracic, and Mediastinal Disorders: Dyspnea

General disorders and administration site conditions: Chest pain, infusion site thrombosis,

infusion site phlebitis, infusion site erythema, infusion site swelling, infusion site pain, infusion site irritation, and/or a burning sensation.

The following adverse reactions were reported in association with extravasation: Skin necrosis, skin ulcer, soft tissue necrosis, muscle necrosis, nerve injury, tendon injury, and vascular injury.

7 Drug Interactions

Newly added section:

Potassium Chloride Injection should be used with caution in patients treated concurrently or recently with agents or products that can cause hyperkalemia or increase the risk of hyperkalemia, such as potassium sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, or the immunosuppressants cyclosporine and tacrolimus.

Administration of potassium in patients treated with such agents is associated with an increased risk of severe and potentially fatal hyperkalemia, in particular in the presence of other risk factors for hyperkalemia.

8 Use in Specific Populations

NURSING MOTHERS

Additions and/or revisions underlined:

It is not known whether this drug is present in human milk. Because many drugs are present in human milk, caution should be exercised when Potassium Chloride Injection is administered to a nursing mother.

Pediatric Use

Additions and/or revisions underlined:

These products should not be used in children at this time. Safety and effectiveness of Potassium Chloride Injection in pediatric patients have not been established by adequate and well-controlled studies.

Pregnancy

Additions and/or revisions underlined:

There are no adequate, well controlled studies with Potassium Chloride Injection in pregnant women and animal reproduction studies have not been conducted with this drug. Therefore, it is not known whether potassium chloride injection can cause fetal harm when administered to a pregnant woman. Potassium chloride injection should be given during pregnancy only if potential benefit justifies the potential risk to the fetus.