Evidence Lacking to Support Use of Compounded Topical Pain Creams

In recent years, there has been a surge in the use of compounded topical pain creams as an alternative to oral pain medications, such as non-steroidal anti-inflammatory drugs and opioids. However, a committee of experts convened by the National Academies of Sciences, Engineering, and Medicine recently concluded that there is a lack of evidence to support the safety and effectiveness of these compounded products.[1]

Drug compounding traditionally involves pharmacists or doctors combining, mixing or altering drug ingredients to create customized medications prescribed for individual patients whose medical needs cannot be met by drugs that have been approved by the Food and Drug Administration (FDA). Unlike FDA-approved drugs, compounded medications have not been evaluated by the agency for safety, effectiveness or quality and therefore pose greater risks to patients.

In response to the growing popularity of compounded topical pain creams, the FDA asked the National Academies to appoint a committee to study the available scientific evidence related to the safety and effectiveness of the ingredients used in these products.[2] In May, the National Academies issued a report with the committee’s findings.[3]

The National Academies committee found that there is little to no publicly available information on the various customized formulations used by pharmacists and physicians across the country to compound topical pain creams. Compounded topical pain creams often contain more than one active ingredient and, astonishingly, sometimes as many as six. The committee noted that the use of such combinations increases the risk of toxicity and drug-drug interactions.

In addition, the National Academies committee found that some compounded topical pain creams contain proprietary ingredients, including various substances known as delivery enhancers that are designed to boost the absorption of the active ingredients into the skin and tissues below the skin. However, certain delivery enhancers, when combined with specific active ingredients, can lead to absorption of the active ingredients into the blood, which may cause unintended effects in other parts of the body (for example, in the central nervous system). The committee found that there currently is little publicly available evidence regarding the quality and safety of these enhancers and other inactive ingredients used in compounded creams.

The National Academies committee looked carefully at 20 active ingredients commonly used in compounded topical pain creams. Of these, only three individual active ingredients — doxepin, lidocaine and naproxen — had evidence of potential effectiveness in compounded topical products.

Given the paucity of evidence supporting the safety and effectiveness of compounded topical pain creams, patients should avoid using these products.
 

References

[1] National Academies of Sciences, Engineering, and Medicine. Compounded topical pain creams: Review of select ingredients for safety, effectiveness, and use. 2020. Washington, DC: The National Academies Press.

[2] Ibid.

[3] National Academies of Sciences, Engineering, and Medicine. News release: There Is a lack of evidence, transparency about ingredients to support use of compounded topical pain creams, says new report. May 13, 2020.