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
. 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 , . 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 , 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 . The most common side effect with anal administration
of Rectiv is headaches, which can be treated with an analgesic .
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 ,. Reoccurrence
rates were reduced from 68% to16% at 1 year following continued conservative management . Medical management of acute anal fissure should be
treated with a combination of conservative treatments and topical diltiazem 2% cream . 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 . Chronic
fissures should be managed with diltiazem 2% cream topically twice a day for 6-8 weeks . 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.
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.