Best Evidence Analyses and Commentary


Rectiv Approved for Anal Fissures
Gabriella Lucarelli, PharmD Candidate, 2012

Approved: June 21, 2011

Rectiv, approved on June 21, 2011 is the only FDA approved prescription medication for moderate to severe pain associated with anal fissures/ fistula [1]. It is expected to be available in the first quarter of 2012. Anal fissures have been associated with internal anal sphincter (IAS) hypertonia. The basal tone is affected by many substances including nitric oxide. In patients with anal fistulas, the concentration of nitric oxide is low in the IAS [2], [3]. Free radicals formed by Rectiv help to regulate the contractile state of smooth muscle. Intra-anal application of Rectiv reduces sphincter tone and resting intra-anal pressure [2],[3] One inch of Rectiv ointment is applied intra-anally every 12 hours for 3 weeks. Use of a finger covering is recommended1. Rectiv should be avoided in patients with severe anemia, glaucoma, hypotension, PDE5 inhibitor use, or increased intracranial pressure [1]. The most common side effect with anal administration of Rectiv is headaches, which can be treated with an analgesic [1].

Other conservative treatments may also be used concomitantly such as increased fiber intake, plenty of liquids, warm sitz bath, and bulk forming laxatives. A paper published in Colorectal Disease in 2008 stated the use of conservative treatments in addition to local anesthetics (hydrocortisone cream) and analgesics will heal a proportion of acute anal fissures [2],[3]. Reoccurrence rates were reduced from 68% to16% at 1 year following continued conservative management [3]. Medical management of acute anal fissure should be treated with a combination of conservative treatments and topical diltiazem 2% cream [3]. Diltiazem cream is helpful in the treatment of anal fissures because it blocks calcium ion entry in vascular smooth muscle causing muscle relaxation and vascular dilation [3]. Chronic fissures should be managed with diltiazem 2% cream topically twice a day for 6-8 weeks [3]. However, diltiazem is not currently approved for the treatment of anal fissures/fistula. Rectiv, being the first approved medication for this indication will aid in relief to these patients.

References:

1. Rectiv [package insert]. ProStrakan, Inc., Bedminster, NJ; June 2011.http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021359s000lbl.pdf. Accessed July 27, 2011.

2. Altomare, D. F., G. A. Binda, and S. Canuti, et. al. "The Management of Patients with Primary Chronic Anal Fissure: a Position Paper." Technical Coloproctology 15.2 (2011): 135-41. Print.

3. Cross, K. L. R., E. J. D. Massey, A. L. Fowler, and J. R. T. Monson. "The Management of Anal Fissure: ACPGBI Position Statement." Colorectal Disease 10 (2008): 1-7. Print.


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