The Rise and Fall of a Popular Wound Care Ointment
Xenaderm, an ointment composed of trypsin, balsam peru, and castor oil, was once a commonly used topical treatment for pressure sores (decubitus ulcers) and other skin wounds [1.3.2, 1.7.3]. Its three active ingredients were purported to work together to promote healing. Trypsin, a proteolytic enzyme, was included to act as a debriding agent, breaking down and removing dead (necrotic) tissue from the wound bed [1.7.1, 1.7.2]. Balsam Peru was intended to stimulate blood flow to the area, acting as a capillary bed stimulant, while also providing mild antibacterial effects [1.7.1, 1.7.7]. Finally, castor oil was included to help in the formation of new epithelial tissue and reduce pain [1.7.1, 1.7.2].
Despite its widespread use, particularly in nursing home settings, Xenaderm operated in a gray area of pharmaceutical regulation. Its manufacturer, Healthpoint Ltd., launched the product in 2002 without obtaining approval from the U.S. Food and Drug Administration (FDA) [1.4.2]. The company's strategy involved modeling Xenaderm after products that existed before 1962, a tactic used to try to bypass the extensive and expensive FDA approval process required for new drugs [1.6.4]. However, this approach ultimately led to the product's downfall.
The Core Reasons for Discontinuation: FDA Scrutiny and Legal Challenges
The primary reason why Xenaderm was discontinued stems from its status as an unapproved new drug [1.3.2]. The U.S. Department of Justice filed a complaint against Healthpoint Ltd., alleging that the company knowingly marketed an unapproved product and caused false claims to be submitted to federal health programs like Medicare and Medicaid [1.2.1, 1.6.5].
A critical issue was the inclusion of trypsin. As far back as the 1970s, the FDA had reviewed trypsin-containing products and determined that trypsin was "less-than-effective" for its intended use as a debriding agent [1.2.1, 1.4.2]. Following this determination, the FDA rescinded market approval for such products. Consequently, drugs deemed "identical, related, or similar" to these less-than-effective drugs became ineligible for reimbursement under Medicaid and Medicare [1.2.3]. The government alleged that Healthpoint was aware of, or recklessly disregarded, these FDA notices but continued to promote Xenaderm as eligible for reimbursement, leading to millions of dollars in improper payments from federal programs [1.2.1, 1.3.1]. Internal company communications even revealed that a clinical researcher admitted the safety and efficacy data for Xenaderm was "cruelly insufficient" to meet FDA standards [1.2.2, 1.3.1].
In December 2012, Healthpoint Ltd. agreed to a settlement to resolve the False Claims Act allegations, paying up to $48 million [1.6.4]. Following this legal pressure, the company voluntarily ceased all manufacturing of Xenaderm on May 7, 2013, and stopped all sales and distribution on September 30, 2013 [1.6.1].
Understanding Xenaderm's Alternatives
With Xenaderm no longer available, healthcare providers have turned to a variety of other options for wound care. These alternatives range from other combination ointments to advanced wound dressings and biologic products. The choice of alternative depends on the wound type, severity, and clinical goals (e.g., debridement, moisture management, infection control).
Some products, like Venelex, contain two of Xenaderm's original ingredients—balsam peru and castor oil—but omit the problematic trypsin [1.5.6]. Other alternatives focus on different mechanisms of action entirely.
Comparison of Wound Care Alternatives
| Product/Category | Key Ingredients/Type | Mechanism of Action | Primary Use |
|---|---|---|---|
| Xenaderm (Discontinued) | Trypsin, Balsam Peru, Castor Oil | Enzymatic debridement, increased blood flow, and promotion of epithelialization [1.7.1]. | Chronic skin ulcers, pressure sores [1.4.2]. |
| Enzymatic Debriding Agents | Collagenase | Breaks down collagen in necrotic tissue to clean the wound bed. | Wounds with dead tissue requiring debridement. |
| Hydrocolloid Dressings | Gel-forming agents (e.g., carboxymethylcellulose) | Creates a moist wound environment to promote autolytic debridement and healing. | Lightly to moderately exuding wounds. |
| Silver Dressings | Ionic Silver | Provides broad-spectrum antimicrobial action to prevent or manage wound infections. | Infected wounds or wounds at high risk of infection. |
| Venelex Ointment | Balsam Peru, Castor Oil | Increases blood flow and aids in wound healing, without the enzymatic debriding agent [1.5.6]. | Wound management, similar indications to Xenaderm but without trypsin [1.5.6]. |
| Acellular Dermal Matrices | Donated Human or Animal Dermis | Provides a scaffold for the patient's own cells to repopulate and regenerate tissue [1.5.4]. | Complex, non-healing wounds like diabetic foot ulcers [1.5.4]. |
Conclusion
The story of why Xenaderm was discontinued serves as a significant case study in pharmaceutical regulation and marketing ethics. The product was removed from the market not due to immediate, widespread patient harm, but because its manufacturer, Healthpoint Ltd., failed to secure FDA approval and marketed it based on what the government deemed to be false pretenses regarding its regulatory status and eligibility for federal reimbursement [1.2.1, 1.6.4]. The FDA's prior determination that its key ingredient, trypsin, was ineffective for debridement undermined the clinical rationale for its use and its financial viability in settings reliant on Medicare and Medicaid [1.2.3, 1.4.2]. Ultimately, a combination of regulatory enforcement and significant legal and financial penalties led to the product's permanent withdrawal from the market [1.6.1]. Healthcare professionals have since adapted by utilizing a wide array of other evidence-based and FDA-approved wound care products.
For further reading on unapproved drugs, one authoritative source is the FDA's page on Unapproved Drugs.
