Surgical Risk Stratification in Geriatric Dogs and Cats

By Dr. Zubair Khalid, DVM, MS, PhD · 2026-08-11

Key Takeaways

• Chronological age alone is a weak predictor of surgical risk in geriatric animals; risk is determined by the accumulation of organ dysfunction and frailty, necessitating a structured geriatric assessment beyond just age.
• Comorbidity burden, including cardiovascular (e.g., degenerative valvular disease), renal (e.g., SDMA monitoring for early detection), hepatic, and endocrine diseases, significantly impacts perioperative outcomes and requires thorough assessment and potential optimization.
• Frailty, characterized by unintentional weight loss, reduced activity, and muscle wasting, predicts complications independently of specific organ disease and requires quantification through body and muscle condition scoring.
• Cognitive dysfunction and sensory impairments in geriatric patients increase the risk of postoperative delirium, prolonged recovery, and necessitate adjustments in postoperative care planning and owner expectations.
• Preoperative laboratory assessment should include a minimum database (biochemistry, CBC, urinalysis) with particular attention to renal parameters (SDMA, creatinine), electrolytes (especially sodium), and hepatic enzymes, interpreting results against age-adjusted physiological changes.
• A structured risk scoring system, considering domains like cardiac, respiratory, renal, hepatic, hematologic, nutritional/functional, electrolyte, and cognitive status, aids in stratifying risk and guiding monitoring intensity and intervention levels.

Surgical decision-making in senior and geriatric patients requires a structured appraisal of physiological reserve, comorbid disease, and functional status. Age alone is a weak predictor of perioperative outcome, the accumulation of organ dysfunction and frailty determines risk. This article provides a framework for preoperative risk stratification in dogs and cats over approximately eight and ten years of age, respectively, with emphasis on comorbidity assessment, laboratory interpretation, and the translation of human perioperative risk concepts into small animal practice.

The intended reader is the practicing veterinarian who must decide whether to operate, how to counsel an owner, and which patients warrant intensified monitoring or referral. The article does not address specific anesthetic protocols, drug dosing, or intraoperative management. It focuses instead on the systematic identification of risk factors and the reasoning that connects those findings to predicted complications.

At a Glance

Defining Risk in the Geriatric Surgical Patient

Perioperative risk is the probability of an adverse event attributable to the interaction between patient factors, procedure invasiveness, and institutional capability. In human surgical populations, risk prediction has moved from single-organ scoring toward multidimensional geriatric assessment. The Identification of Seniors at Risk (ISAR) questionnaire, for example, screens elderly patients for frailty and triggers comprehensive geriatric assessment before colorectal surgery, with the goal of preoperative optimization instead of exclusion from care. A retrospective evaluation of this approach found that referred patients were older and carried more risk factors for postoperative delirium than matched controls, yet the assessment pathway did not worsen outcomes, supporting the premise that structured evaluation identifies high-risk patients who benefit from coordinated management.

The same logic applies to veterinary patients. A geriatric dog with compensated mitral valve disease, mild chronic kidney disease, and early cognitive decline faces a different risk profile than a same-aged dog with no detectable comorbidity. The clinician's task is to enumerate these factors, estimate their combined effect, and decide whether optimization is possible before anesthesia and surgery.

Comorbidity Burden and Organ System Assessment

Comorbidity is the presence of one or more additional diseases coexisting with the primary condition requiring surgery. In geriatric small animals, common comorbidities include degenerative valvular disease, chronic kidney disease, hepatopathy, endocrinopathies such as diabetes mellitus and hyperadrenocorticism, and neoplasia. Each system contributes independent risk, and the interactions between systems often exceed the sum of their individual effects.

Cardiovascular assessment deserves particular attention because age-related changes in ventricular compliance and valvular function are common. A geriatric patient may have a murmur that was previously undocumented, and the discovery of new cardiac findings during preoperative examination warrants investigation instead of dismissal. One reported case describes a 14-year-old dog that developed a transient systolic murmur and echocardiographic changes consistent with reduced left ventricular dimensions after oral trazodone administration, with resolution after volume repletion. The case illustrates that cardiovascular findings in geriatric patients are dynamic and may reflect hydration status, drug effects, or autonomic tone instead of fixed structural disease. Repeat assessment after stabilization is therefore essential before attributing risk to a newly detected abnormality.

Renal function assessment should include symmetric dimethylarginine (SDMA) in addition to creatinine, because muscle mass loss in geriatric patients can mask declining glomerular filtration rate. Electrolyte disturbances, particularly hyponatremia, are independently associated with adverse postoperative outcomes in human orthopedic populations, where admission hyponatremia affects 13 to 20 percent of elderly hip fracture patients and is linked to increased complications and mortality. The pathophysiology involves hypovolemia, drug effects, and non-osmotic vasopressin release driven by pain and stress. Veterinary patients undergoing emergency surgery share these mechanisms, and a preoperative sodium measurement is a low-cost screen for a correctable abnormality.

Frailty and Functional Status

Frailty is a state of decreased physiological reserve and increased vulnerability to stressors. It is distinct from comorbidity, although the two frequently coexist. A frail patient may have minimal detectable organ disease yet still decompensate under the stress of anesthesia and surgery because homeostatic mechanisms are exhausted.

Clinical indicators of frailty in dogs and cats include unintentional weight loss, reduced activity, muscle wasting, and diminished tolerance of handling or environmental change. These findings are often reported by owners as "slowing down" or "just getting old," and they merit quantification. Body condition scoring should be paired with muscle condition scoring, because a patient can be obese yet sarcopenic. Functional assessment includes observation of gait, ability to rise, and response to hospitalization. A patient that cannot maintain sternal recumbency or becomes disoriented in the hospital carries higher risk for prolonged recovery and postoperative complications.

Cognitive Dysfunction and Delirium Risk

Cognitive impairment is a recognized risk factor for adverse surgical outcomes in human patients. Among older adults with hip fracture, approximately 20 to 40 percent have cognitive impairment, and even mild deficits increase the risk of falls and fractures by two to threefold. After surgery, these patients experience more delirium, slower rehabilitation, and higher mortality. Multidisciplinary co-management models that include geriatric assessment and early mobilization improve outcomes.

Veterinary cognitive dysfunction syndrome shares features with human dementia, including disorientation, altered social interactions, sleep-wake cycle disruption, and house soiling. A patient with pre-existing cognitive decline is more likely to become disoriented in the hospital, resist handling, and experience delayed return to normal behavior after surgery. Owners should be counseled that postoperative care may require additional supervision and that hospitalization itself can be a stressor. The presence of cognitive dysfunction does not preclude surgery, but it should influence the expected recovery trajectory and discharge planning.

Translating Risk Assessment into Clinical Decisions

The goal of preoperative risk stratification is not to generate a single number that dictates whether surgery proceeds. It is to identify modifiable factors, match monitoring intensity to predicted risk, and inform owner communication. A structured approach includes a complete history with attention to medication use, a thorough physical examination with repeat assessment after stabilization, baseline laboratory testing that includes renal and hepatic parameters plus electrolytes, and functional evaluation that captures frailty and cognitive status.

When risk factors are identified, the clinician must decide whether they can be optimized preoperatively. Dehydration can be corrected, electrolyte abnormalities can be addressed, and cardiac findings can be characterized with echocardiography before elective procedures. For urgent or emergency surgery, the risk of delay must be weighed against the benefit of optimization. The decision framework should be explicit and shared with the owner, including the specific complications that are most likely for their patient and the monitoring that will be in place to detect them.

Laboratory Findings and Risk Prediction

Preoperative laboratory data refine risk estimates derived from history and physical examination. In geriatric patients, the threshold for pursuing laboratory testing should be low, and the interpretation should account for age-associated physiological change instead of relying on juvenile reference intervals.

Serum biochemistry, complete blood count, and urinalysis constitute the minimum database for any geriatric surgical candidate. Particular attention belongs to renal parameters, hepatic enzyme activity, total protein and albumin, and electrolyte concentrations. Mild abnormalities that would be tolerated in a younger patient may signal decompensated reserve in a senior animal and warrant correction or further investigation before anesthesia.

Hyponatraemia deserves specific emphasis. In human orthopedic populations, admission hyponatraemia affects approximately 13 to 20% of patients and independently predicts adverse postoperative outcomes, with a further 20 to 30% developing hyponatraemia after admission hyponatraemia in neck of femur fracture, a narrative review of epidemiology, pathophysiology, and outcomes. The mechanisms, including hypovolemia, drug effects, and non-osmotic vasopressin release driven by pain and stress, translate directly to the surgical small animal patient. A geriatric dog or cat presenting for fracture repair with a sodium concentration at the lower end of the reference interval should prompt evaluation of volume status, review of current medications, and consideration of delayed surgery where the fracture can be stabilized conservatively in the interim.

Symmetric dimethylarginine (SDMA) provides earlier detection of declining renal function than creatinine alone, particularly in cachectic geriatric patients with reduced muscle mass. A mild SDMA elevation in an otherwise stable patient should not automatically cancel surgery, but it should influence fluid planning, drug selection, and monitoring intensity. The interaction between cardiovascular status and renal function is bidirectional, and a patient with subclinical kidney disease may decompensate under anesthesia if perfusion is not maintained.

Thyroid testing is indicated in any geriatric cat with unexplained weight loss, tachycardia, or behavioral change, and in dogs with symmetric non-pruritic alopecia, lethargy, or bradycardia. Untreated hyperthyroidism increases the risk of intraoperative tachyarrhythmia and hypertensive crisis, while hypothyroid dogs may exhibit impaired drug metabolism and prolonged recovery.

Hematology and Coagulation Assessment

Anemia in the geriatric surgical patient reduces oxygen-carrying capacity and narrows the margin for intraoperative blood loss. A packed cell volume below 25% warrants investigation of the underlying cause before elective procedures, and a transfusion threshold should be planned in advance for procedures with anticipated hemorrhage. Thrombocytopenia, even when mild, should be confirmed by blood smear examination and repeated testing, as clumping artefact is common in feline samples.

Coagulation testing is not required for every geriatric patient, but it is indicated when there is a history of spontaneous bruising, prolonged bleeding from venepuncture sites, hepatobiliary disease, or anticipated major surgery. A buccal mucosal bleeding time can be performed in the clinic when platelet function is in question, though this test is operator-dependent and less reliable in cats.

Structured Risk Scoring

A structured risk score converts the accumulated findings into a reproducible estimate of perioperative risk. The score does not replace clinical judgment, but it provides a shared framework for decision-making, client communication, and comparison of serial assessments.

The following scoring system is designed for geriatric dogs and cats undergoing any surgical procedure. It weights organ system dysfunction, functional compromise, and laboratory derangements according to their demonstrated impact on perioperative outcomes. Each domain is scored independently, and the total guides the recommended level of monitoring and intervention.

Total score interpretation: 0 to 4, low risk, proceed with standard monitoring. 5 to 9, moderate risk, pursue optimization of identified abnormalities, extend perioperative monitoring, and consider referral for advanced imaging or specialist consultation. 10 to 14, high risk, delay elective surgery until correctable abnormalities are addressed, plan for intensive care, and discuss prognosis and treatment limitations with the owner. 15 or greater, very high risk, surgery is only justified when it is life-saving or when the procedure itself will resolve the underlying abnormality, for example drainage of a septic abdomen.

The score should be recalculated after any period of stabilization. A patient who scores 12 on presentation with a strangulating intestinal obstruction may score 6 after 24 hours of fluid therapy, decompression, and electrolyte correction, and this change is clinically meaningful.

The Preoperative Checklist

A standardized checklist reduces omission errors and ensures that the risk assessment is documented consistently. The checklist should be completed at the time of surgical booking and again on the morning of surgery, as geriatric patients can deteriorate rapidly.

The checklist serves as a communication tool between the surgeon, anesthetist, and nursing team. Each team member should be empowered to stop the procedure if a checklist item cannot be completed or if a new abnormality is detected on the morning of surgery.

Decision Points That Change the Plan

The risk assessment should produce specific modifications to the surgical and perioperative plan, also a label of high or low risk. A patient with compensated mitral regurgitation may proceed with elective surgery provided that heart rate is controlled, fluids are administered cautiously, and an ECG is monitored continuously. The same patient with a history of recent syncope requires echocardiography before surgery and a discussion about whether the procedure can be delayed.

Renal disease changes drug selection, fluid rate, and the threshold for using non-steroidal anti-inflammatory drugs. A cat with an SDMA of 18 µg/dL may be an acceptable candidate for ovariohysterectomy with balanced crystalloid support, but the same cat should not receive an NSAID without careful consideration of alternative analgesia MSD Veterinary Manual, Professional Edition.

Hepatic disease alters the metabolism of many anesthetic and analgesic drugs and increases the risk of hypoglycemia and coagulopathy. Preoperative administration of vitamin K is indicated when biliary obstruction or portosystemic shunting is suspected, and glucose should be monitored during longer procedures.

The decision to refer a patient to a specialist center should be made early instead of after a complication has occurred. Factors that favour referral include the need for advanced imaging, echocardiography, or 24-hour nursing care, the requirement for equipment not available in the practice, and the surgeon's assessment that their own experience with the procedure is limited. The American College of Veterinary Surgeons provides owner-facing summaries of surgical conditions and expected outcomes that can support client discussions about referral.

Species-Specific Considerations

Cats differ from dogs in several respects that affect surgical risk stratification. Feline patients are more prone to stress-related decompensation, and a cat that is fractious or anxious may have a heart rate and blood pressure that do not reflect its resting state. The physical examination should be performed with minimal restraint, and the use of oral anxiolytics such as trazodone may facilitate handling, though cardiovascular effects should be considered. A case report describes a geriatric dog that developed a transient heart murmur and echocardiographic changes after oral trazodone administration, with resolution after volume expansion transient echocardiographic and cardiovascular changes temporally associated with trazodone administration in a geriatric dog. This highlights the importance of repeat examination after any new medication and the interaction between hydration status and drug effects.

Feline patients also have a higher prevalence of subclinical hypertrophic cardiomyopathy, and a gallop rhythm or dynamic murmur should prompt echocardiography before anesthesia. Cats are less tolerant of hypothermia than dogs, and active warming should begin before induction instead of after the patient is already cold.

Dogs are more likely to present with age-related neoplasia, and the surgical plan should include a discussion of margins, staging, and the possibility of additional procedures such as lymph node biopsy. Brachycephalic breeds require particular attention to upper airway assessment, and the presence of stenotic nares or an elongated soft palate increases the risk of postoperative respiratory obstruction.

Geriatric patients with cognitive dysfunction present a distinct challenge. They may not tolerate hospitalization, may become disoriented in an unfamiliar environment, and are at higher risk of postoperative delirium. In human orthopedic patients, cognitive impairment is present in 20 to 40% of hip fracture cases and is associated with worse outcomes including more delirium and higher mortality management of hip fracture in older adults with cognitive impairment, a narrative review. The veterinary equivalent is a patient that vocalises, paces, or becomes aggressive after surgery, which increases the risk of incisional complications and prolongs hospitalization. Preoperative discussion with

Recognized Complications and Early Detection

The most consequential perioperative failures in geriatric patients are not anesthetic deaths but delayed recognition of deteriorating organ function. Cardiovascular decompensation presents as progressive hypotension refractory to fluid boluses, worsening metabolic acidosis, or arrhythmias on continuous electrocardiography. Early detection requires serial measurement of blood pressure, heart rate, and perfusion parameters at intervals no longer than 15 minutes during the recovery period, when vasodilation from residual anesthetic drugs overlaps with pain-related sympathetic withdrawal.

Delirium and acute cognitive decline represent a distinct failure mode that is frequently misattributed to pain or residual sedation. The distinguishing feature is fluctuation: delirious patients show waxing and waning awareness over hours, whereas sedated patients improve steadily. In human hip fracture populations, delirium is among the most prominent postoperative complications, particularly in those with pre-existing cognitive impairment, and it predicts slower recovery and higher mortality. In dogs and cats, the equivalent presentation is unexplained vocalisation, pacing, inappropriate elimination, or uncharacteristic aggression beginning 12 to 72 hours after surgery. Detection depends on baseline cognitive assessment before surgery, because comparison against the preoperative state is the only reliable discriminator.

Hyponatraemia is an under-recognized postoperative complication. In older human orthopedic patients, admission hyponatraemia affects 13 to 20% of cases, and a further 20 to 30% develop in-hospital hyponatraemia, predominantly after surgery. The veterinary analogue is the geriatric patient receiving perioperative intravenous fluids who develops lethargy, weakness, or seizures without an obvious surgical cause. Serial electrolyte measurement, not single-point sampling, is required because mild hyponatraemia (75 to 85% of human cases) is clinically silent until it worsens.

Common Errors and Corrective Actions

The most frequent error is treating age itself as the risk factor instead of the diseases that accumulate with age. A healthy 15-year-old cat undergoing dental extraction may carry lower risk than a 7-year-old dog with undiagnosed cardiomyopathy. The corrective action is to score organ system dysfunction explicitly, using physical examination, blood pressure measurement, and targeted laboratory testing, before assigning a risk category.

A second error is accepting a single abnormal laboratory value as definitive. A mildly elevated creatinine in a dehydrated patient, or a transient heart murmur that appears after anxiolytic administration, may reflect reversible physiology instead of fixed disease. One case report describes a geriatric dog that developed a new systolic murmur and echocardiographic changes suggestive of concentric hypertrophy after oral trazodone, with complete resolution after volume repletion. The lesson is not that trazodone is contraindicated, but that cardiovascular findings obtained under conditions of stress or hypovolemia require re-evaluation before they drive surgical decisions.

A third error is failing to adjust monitoring intensity to the risk category. Low-risk patients receive the same monitoring interval as high-risk patients, which means the high-risk patient's deterioration is detected late. Monitoring frequency, also monitoring modality, should be prescribed in the perioperative plan.

Limitations of the Evidence

The veterinary literature contains few prospective studies of surgical risk stratification in geriatric patients. Most guidance derives from human geriatric medicine, where structured screening tools such as the Identification of Seniors at Risk questionnaire have been evaluated in surgical populations. The transferability of these instruments to dogs and cats is uncertain because they depend on self-reported functional status, which has no veterinary analogue. Expert opinion differs on whether a veterinary frailty score should weight mobility, body condition, or comorbidity count most heavily, and no consensus instrument has been validated.

The evidence base is also limited by the difficulty of distinguishing anesthetic mortality from surgical mortality in retrospective cohorts. Studies that report complication rates rarely separate deaths attributable to anesthetic drug effects, surgical technique, progression of underlying disease, or owner decisions to limit postoperative care. This uncertainty should be acknowledged when discussing prognosis with owners.

Referral and Escalation Criteria

Referral to a specialist is warranted when the risk assessment identifies a comorbidity that exceeds the practice's monitoring capacity. Specific triggers include echocardiographic evidence of significant valvular disease or myocardial dysfunction, arrhythmias requiring continuous electrocardiographic monitoring beyond the practice's capability, and renal disease requiring central venous pressure measurement or advanced fluid therapy. Specialist consultation is also appropriate when the planned procedure is elective and the risk category is high, because the option to defer or modify surgery should be explored before proceeding.

Laboratory involvement is indicated when coagulation testing is required but not available in-house, when blood typing and crossmatching are needed for patients with a history of transfusion, or when endocrine testing is needed to distinguish stable from unstable disease. The American College of Veterinary Surgeons provides specialist summaries of surgical conditions and expected outcomes that can support owner discussions about prognosis, and the MSD Veterinary Manual offers species-specific guidance on perioperative management of common comorbidities.

Regulatory reporting obligations vary by jurisdiction. The American Veterinary Medical Association publishes practice resources that address professional standards and client communication, while international standards for animal health and welfare are set by the World Organization for Animal Health. Clinicians should consult their regional veterinary board for specific reporting requirements regarding anesthetic deaths or suspected adverse drug reactions.

Troubleshooting Guide

Frequently Asked Questions

How should I adjust my risk assessment when advanced imaging or echocardiography is unavailable?

Prioritize the physical examination and targeted laboratory data you can obtain. A resting heart rate, pulse quality, auscultation for murmurs or arrhythmias, and mucous membrane assessment provide meaningful cardiovascular information without specialised equipment. If a new murmur appears after anxiolytic administration in a geriatric patient, repeat the examination after rehydration and reassess before proceeding, as transient cardiovascular changes can occur with such drugs transient echocardiographic changes with trazodone in a geriatric dog. When echocardiography is unavailable, document the limitation in the medical record and select anesthetic and monitoring strategies that accommodate the uncertainty. Referral for advanced imaging is appropriate when the procedure is elective and the suspected lesion would change the surgical plan.

What constitutes adequate documentation of the risk assessment process?

Record the American Society of Anesthesiologists status or equivalent score, the specific comorbidities identified, baseline laboratory values, and the functional or frailty indicators used. Document the planned monitoring modalities and the contingency plan for recognized complications. Note any discussions with the owner regarding expected outcomes, including the possibility of postoperative delirium or cognitive decline, which is a recognized concern in elderly surgical patients postoperative management in older adults with cognitive impairment. If a procedure is postponed or modified, record the reason and the specific criteria that must be met before rescheduling. This record supports continuity of care and provides a defensible basis for clinical decisions.

How do I counsel an owner who is reluctant to pursue recommended preoperative testing?

Explain that the testing is designed to identify conditions that could turn a routine procedure into a complicated one. Frame the discussion around specific risks for their pet instead of generic warnings. For example, a mild electrolyte disturbance such as hyponatraemia is common in elderly patients and is independently associated with worse postoperative outcomes hyponatraemia in elderly fracture patients. Correcting that abnormality before surgery is inexpensive compared with managing postoperative complications. Offer a tiered approach: minimum database now, additional testing only if the initial results or examination findings indicate a need. This respects financial constraints while maintaining a safe standard of care.

Does the risk assessment differ for a geriatric cat compared with a geriatric dog?

Yes, in several practical respects. Cats are more likely to mask cardiovascular disease, and auscultatory findings may be subtle despite significant structural disease. Routine handling and premedication can induce significant stress responses in cats, so the assessment should include behavioral considerations and the potential need for anxiolysis before examination. The reference intervals for cardiac biomarkers and thyroid testing differ between species, and hyperthyroidism in cats can create a high-output cardiac state that complicates risk stratification. The general framework of comorbidity assessment, frailty evaluation, and laboratory screening applies to both species, but the specific thresholds and common differential diagnoses must be interpreted species-specifically MSD Veterinary Manual species-specific guidance.

What should I do when the ideal monitoring equipment is not available?

Identify which monitors are essential for the planned procedure and which are desirable. A Doppler flow detector, pulse oximeter, and electrocardiogram cover most soft tissue procedures in geriatric patients. Capnography and blood pressure measurement become essential for thoracic procedures or patients with known cardiac disease. When equipment is limited, adjust the anesthetic plan to rely more heavily on frequent physical assessment: mucous membrane color, capillary refill time, pulse quality, and jaw tone. Extend the recovery period and monitor manually at more frequent intervals. Document the equipment limitations and the compensatory monitoring plan in the record. Consider whether the procedure can be safely performed at a referral facility when the monitoring gap is substantial.

How should I present the risk assessment to a referring veterinarian who expects same-day surgery?

Explain that the preoperative assessment is a clinical intervention, not administrative delay. The referring veterinarian may not have had the opportunity to perform a full geriatric workup, and the findings from that workup can change the surgical approach or the need for postoperative intensive care. If the assessment reveals a correctable abnormality, such as dehydration or electrolyte disturbance, outline the specific corrective steps and the expected timeline. Provide a written summary of the findings and the revised plan. This positions the assessment as collaborative instead of obstructive and gives the referring veterinarian clear language to use with the owner. The goal is a shared understanding that the procedure will proceed when the patient is in the best achievable condition ACVS guidance on surgical decision making.

Related Clinical & Scientific Guides

• Perioperative Antibiotic Prophylaxis: Timing and Selection
• Surgical Approaches to the Femur and Stifle
• Fracture Healing Assessment: Radiographic and Clinical Evaluation

References and Further Reading

• Evaluation of preoperative geriatric assessment of elderly patients with colorectal carcinoma. A retrospective study.. 2015.
• Management of hip fracture in older adults with cognitive impairment: a narrative review.. 2026.
• Transient echocardiographic and cardiovascular changes temporally associated with trazodone administration in a geriatric dog.. 2026.
• Hyponatraemia in Neck of Femur Fracture: A Narrative Review of Epidemiology, Pathophysiology, and Outcomes.. 2026.
• American College of Veterinary Surgeons Animal Health Resources. American College of Veterinary Surgeons.
• MSD Veterinary Manual, Professional Edition. MSD Veterinary Manual.
• American Veterinary Medical Association Practice Resources. American Veterinary Medical Association.
• WOAH Terrestrial Animal Health Code. WOAH.

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• Surgical Approaches to the Gastrointestinal Tract

This article is educational professional reference material for veterinary audiences. It is not a substitute for veterinary diagnosis, individual clinical judgment, current product labeling, or applicable regulatory requirements.