Sodium Hypochlorite Inclusion In Antiseptic Drug TFM Sought By Alcavis

Sodium hypochlorite .05% to .5% should be classified as safe and effective in the OTC Tentative Final Monograph for Healthcare Antiseptic Drug Products, Alcavis International says in a Feb. 20 citizen petition.

"The long historical use of sodium hypochlorite for wounds, burns and other medical indications, as well as recent and current use of the ingredient as a topical antiseptic," demonstrate that it "should be considered to have been used for a material time, and to a material extent," the petition says.

Gaithersburg, Md.-based Alcavis, which changed its name from Amuchina International effective Jan. 1, markets hypochlorite solutions in products such as ExSept and ExSept Plus , which contain .055% and .1% of the ingredient, respectively. The firm sells hypochlorite solutions in several countries; they have been available in the U.S. since 1986.

The three-year-old ExSept formulation and the recently launched ExSept Plus are sold to clinics and hospitals, Alcavis said.

The firm also submitted a citizen petition to FDA in January 1999 asking that hypochlorite be added to the OTC First Aid Antiseptic Drug Products TFM; the ingredient often is used as a preoperative antiseptic, gynecological wash and burn antiseptic.

As with the prior petition, Alcavis claims hypochlorite has a long history of both antiseptic and disinfectant applications.

Unlike other antiseptics, hypochlorite "offers a unique combination of a non-sensitizing topical antimicrobial with significant antimicrobial activity against a broad spectrum of microorganisms [with] a low toxicity," Alcavis notes.

Products containing hypochlorite provide necessary and "effective non-sensitizing alternatives to povidone iodine" and other ingredients covered under the TFM that are known skin sensitizers, the company asserts.

More than 20 published and unpublished studies "have established that buffered sodium hypochlorite solutions do not inhibit wound healing, and are essentially non-irritating," the firm continues.

Extensive data on hypochlorite's safety and efficacy are cited in the petition as well, including studies on the ingredient's toxicology, mutagenicity and carcinogenicity.

In a study examining potential blood levels of the ingredient after its use, researchers looked at how 2 mL of .11% hypochlorite solution broke down in 8 mL of both human and dog blood after five seconds. Blood levels of the solution were recorded by measuring the amount of chlorine left in the blood.

The petition notes that "decomposition of the sodium hypochlorite after exposure to the blood was so rapid that no available chlorine could be measured after five seconds of mixing."

Summing up the body of research conducted on hypochlorite's safety, Alcavis states that due to a "lack of negative toxicological information...[hypochlorite] should be considered non-carcinogenic, non-mutagenic, and essentially non-toxic for the proposed use, at the proposed concentrations."

With regard to efficacy, one of the studies cited in the petition compared .05% and .11% hypochlorite solution with 1% silver sulfadiazine cream for the treatment of burn patients.

The researchers found "patients treated with the sodium hypochlorite solution tolerated their treatment with less pain, had a lower incidence of dermatitis, and showed faster wound healing than those treated with silver sulfadiazine cream," Alcavis says.

Alcavis' request that sodium hypochlorite be added to the antiseptic drug products TFM is the second such petition in the past few weeks. On Feb. 11, Ciba Specialty Chemicals proposed adding triclosan to the TFM, citing new in vitro and in vivo data which "substantially augment" evidence in favor of classifying the ingredient as Category I (¹ (Also see "Triclosan Efficacy Studies Support “Significant” Antimicrobial Effect – Ciba" - Pink Sheet, 25 Feb, 2002.), p. 11).

Ciba's proposal came on the heels of a Sept. 13 submission concerning the antimicrobial's safety that it filed along with six other triclosan manufacturers (² (Also see "Triclosan Antiseptic Category I Status Requested By CIBA" - Pink Sheet, 24 Sep, 2001.), p. 7).

In its most recent "unified agenda," FDA estimates the healthcare antiseptics monograph will be finalized by December.