Skip to content

Who Should Not Use Diclofenac Sodium Topical Gel? A Comprehensive Guide

4 min read

According to the FDA, diclofenac sodium topical gel has serious boxed warnings regarding cardiovascular thrombotic events, including heart attack and stroke, especially for those with existing heart disease. This makes understanding who should not use diclofenac sodium topical gel essential for patient safety.

Quick Summary

This guide outlines the critical health conditions and patient profiles for whom diclofenac sodium topical gel is contraindicated. It covers risks related to heart conditions, allergies, pregnancy, and compromised skin, detailing who must avoid or use it with caution.

Key Points

  • Heart Bypass Surgery: Diclofenac sodium topical gel is contraindicated right before or after coronary artery bypass graft (CABG) surgery due to increased risk of heart attack and stroke.

  • Late-Term Pregnancy: Avoid diclofenac gel from 20 weeks gestation onward, as it can cause fetal renal dysfunction and other complications.

  • NSAID Allergies: Individuals with a history of allergic reactions to aspirin or other NSAIDs should not use diclofenac gel due to the risk of severe reactions.

  • Pre-existing Conditions: Patients with heart disease, severe kidney disease, advanced liver disease, or a history of GI bleeding require extreme caution and close medical supervision.

  • Damaged Skin: Never apply diclofenac gel to open wounds, infected areas, or damaged skin to prevent increased systemic absorption and altered effects.

  • Concomitant Medication: Do not use diclofenac gel with oral NSAIDs unless directed by a doctor, as this increases the risk of serious side effects.

In This Article

Diclofenac sodium topical gel is a nonsteroidal anti-inflammatory drug (NSAID) commonly used to relieve pain from osteoarthritis. While it offers targeted pain relief with less systemic absorption than oral NSAIDs, it is not without risk. Certain health conditions and circumstances make its use unsafe, requiring some individuals to avoid it entirely.

Absolute Contraindications: Who Must Avoid Diclofenac Topical Gel

There are several conditions under which diclofenac sodium topical gel should never be used, as the risks significantly outweigh any potential benefits.

Known Allergies to NSAIDs or Diclofenac

Individuals who have a known hypersensitivity or a history of allergic reactions to aspirin or other NSAIDs (such as ibuprofen or naproxen) should not use diclofenac gel. This includes a history of aspirin-sensitive asthma, which can lead to severe, and sometimes fatal, bronchospasms and other allergic-type reactions. Severe skin reactions, like Stevens-Johnson Syndrome (SJS), can also occur and can be life-threatening.

Coronary Artery Bypass Graft (CABG) Surgery

Diclofenac is contraindicated for pain relief immediately before or after coronary artery bypass graft (CABG) surgery. The use of NSAIDs in this setting significantly increases the risk of serious cardiovascular events, including heart attack and stroke.

Late-Term Pregnancy (20 weeks gestation and later)

For pregnant women, diclofenac is strongly discouraged from around 20 weeks gestation and is absolutely contraindicated after 30 weeks. Use during this period can harm the unborn baby, potentially causing premature closure of the fetal ductus arteriosus and fetal renal dysfunction, which can lead to low amniotic fluid.

Application on Damaged Skin

Topical diclofenac should not be applied to non-intact or damaged skin, such as open wounds, infections, burns, or severe eczema. Applying it to compromised skin can increase systemic absorption and alter the drug's effectiveness and safety profile.

Conditions Requiring Extreme Caution and Medical Supervision

For certain health conditions, diclofenac sodium topical gel should be used only under strict medical supervision and if the benefits clearly outweigh the risks. Close monitoring is essential for these individuals.

Heart Disease and Hypertension

Patients with known heart disease, including a history of heart attack, stroke, or high blood pressure, face an increased risk of serious cardiovascular events with NSAID use, including topical formulations. Diclofenac can cause fluid retention, leading to or worsening heart failure. Blood pressure should be monitored, as NSAIDs can raise blood pressure.

Advanced Kidney or Liver Disease

While systemic absorption is low, it is not zero. For patients with advanced kidney disease, any amount of systemic diclofenac could worsen renal function. Similarly, those with severe liver disease, such as cirrhosis, are more susceptible to the hepatotoxic effects of diclofenac, which could lead to liver necrosis or failure. Periodic monitoring of liver and kidney function is crucial for patients with pre-existing conditions.

Gastrointestinal (GI) Bleeding and Ulcers

Patients with a history of peptic ulcer disease or GI bleeding are at higher risk for serious GI adverse events, including bleeding, ulceration, and perforation, with NSAID use. This risk is heightened with concomitant use of alcohol, smoking, or other medications that increase bleeding risk.

Breastfeeding

The use of diclofenac while breastfeeding is generally not recommended. Although only small amounts may pass into breast milk, the potential effects on the nursing infant are unknown. The decision to use it requires a careful benefit-risk assessment with a healthcare provider.

Comparison of Diclofenac Topical Use in Different Patient Groups

Patient Group Absolute Contraindication Cautious Use with Supervision Why the Caution/Avoidance?
Healthy Adult N/A N/A Generally safe for targeted pain relief; lowest risk of adverse effects.
CABG Patient (Pre/Post-surgery) Yes N/A High risk of fatal cardiovascular events (heart attack, stroke).
Aspirin-Sensitive Asthmatic Yes N/A Risk of severe allergic reactions, including life-threatening bronchospasm.
Pregnant (after 20 weeks) Yes No (after 20 weeks) Significant risk of harm to the fetus (renal dysfunction, premature ductus arteriosus closure).
Severe Kidney Disease Patient Avoid Extreme Caution Can worsen existing renal dysfunction; use only if benefits outweigh risks.
Severe Liver Disease Patient Avoid Extreme Caution Higher risk of systemic toxicity and potential liver necrosis.
Patient on Oral NSAIDs Avoid N/A Combining topical and oral NSAIDs increases the risk of adverse effects.
Damaged Skin Patient Yes N/A Increased systemic absorption and altered tolerability.

How to Minimize Risk When Using Diclofenac Topical Gel

For those who are able to use diclofenac gel safely, it is still important to follow precautions to minimize risk.

  • Use as Directed: Follow dosage and application instructions precisely. Use the lowest effective dose for the shortest possible duration to minimize systemic exposure.
  • Avoid Combined NSAID Use: Do not use diclofenac gel in combination with oral NSAIDs (like ibuprofen) or other topical NSAIDs unless instructed by a doctor, as this increases the risk of side effects.
  • Monitor for Adverse Reactions: Stay alert for any signs of adverse effects, such as gastrointestinal bleeding (black stools, vomiting blood), cardiovascular issues (chest pain, shortness of breath), or severe skin reactions (blisters, rash).
  • Sun Protection: Protect treated areas from natural and artificial sunlight, as diclofenac can cause photosensitivity.

Conclusion

While diclofenac sodium topical gel can be a valuable tool for managing localized pain, it is not suitable for everyone. Patients with known NSAID allergies, those undergoing heart bypass surgery, and pregnant women in their later stages must avoid it. Significant caution and medical consultation are also necessary for individuals with heart, kidney, or liver disease, as well as those with a history of GI bleeding. Always consult with a healthcare provider to determine if diclofenac gel is appropriate for your specific health needs and to discuss safer alternatives if necessary. For more comprehensive information on this medication, refer to the MedlinePlus Drug Information on Diclofenac Topical.

Frequently Asked Questions

No, if you have a history of allergic reactions to aspirin or other NSAIDs, you should not use diclofenac sodium topical gel. This could trigger a severe and potentially life-threatening reaction.

People with heart problems, including those with a history of heart attack, heart failure, or hypertension, should use diclofenac gel with extreme caution and only under a doctor's supervision. It carries a boxed warning about increased cardiovascular risk.

Diclofenac gel should be avoided from 20 weeks of pregnancy onward. After 30 weeks, it is strictly contraindicated due to the risk of harm to the fetus.

Diclofenac gel should be used with extreme caution in patients with severe kidney or liver disease, and may be contraindicated. Its use can potentially worsen these conditions, so a doctor must supervise its application.

No, diclofenac gel should not be applied to open wounds, infected areas, burns, or other damaged skin. This can increase systemic absorption and may cause adverse effects.

No, using diclofenac gel concurrently with oral NSAIDs is not recommended, as it increases the risk of side effects, including gastrointestinal and cardiovascular events.

Use of diclofenac while breastfeeding is generally not recommended. You should consult your doctor to weigh the potential benefits against the potential risks to the infant.

References

  1. 1
  2. 2
  3. 3
  4. 4
  5. 5
  6. 6
  7. 7
  8. 8
  9. 9
  10. 10
  11. 11
  12. 12

Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.