FDA releases info about link between Topamax and clefts

"The U.S. Food and Drug Administration (FDA) is informing the public of new data that show that there is an increased risk for the development of cleft lip and/or cleft palate (oral clefts) in infants born to women treated with topiramate (Topamax and generic products) during pregnancy."

Topamax is an anti-seizure drug that is also prescribed for migraine headaches.

You can read the entire FDA announcement here:

http://www.fda.gov/Drugs/DrugSafety/ucm245085.htm

I am sure that for anyone who took this drug and did have a child with a cleft, this announcement is a difficult one. When a medicine is involved there can be a lot of guilt and anger that comes. Remember - we all do our best for our children, and that is all we can do!

Study: Are Arm Restraints Worth It?

Way back when, LeAnn Roling gave me a copy of a presentation she saw at a conference on the use of arm restraints following cleft palate repairs. I'll copy here the content of the slides from the presentation, and I'd love to hear what people think about it.

My personal feelings on restraints are mixed; I felt that Ethan didn't need them a lot of the time, but then heard a couple of horror stories about children causing severe damage to their recent repairs (particularly external repairs of the lip and nose). I just couldn't risk it when it came to the lip repair, but was a lot more loose with the arm restraint use when it came to the soft palate repair.

Anyhow, here is the study:

A Comparison of Palatal Morbidity With and Without Arm Restraints Following Cleft Palate Repair
DeAnn Wilson, BSN, RN
St. John's Mercy Medical Center
St. Louis, Missouri

Literature Review

Rate of Cleft Palate Fistula (CPF) increses:

• With children older than 18 months of age at time of repair
• A cleft that is more extensive (bilateral or unilateral cleft lip and palate)
• With a surgeon who has notably less experience

Type of repair had fewer implications and gender had none.
(Cohen, et al., 1991; Muzaffar, 2001; Rohrich, et al., 1996; Schultz, 1986; Wilhelmi, et al., 2001)

Only 1 study addressed the merits of using arm splints.
This Randomized Control Trial determined there was no difference in CPF rate when arm splints were not used:
28% CPF with arm splints
20% CPF without arm splints

None of the CPF were symptomatic or required treatment
(Jiginni, et al., 1993)

Problem and Purpose
Problem:

• Recovery from a Cleft Palate Repair (CPR) is stressful
• Arm splints:
• Frustrate infants and toddlers who do not like to be restrained
• Hinder parents' ability to hold and comfort their child
• Cause sore spots in the axilla, arm stifness
• Interfere with sleep by inhibiting self repositioning without waking

Purpose: To determine if the rate of CPF was higher without the use of arm splints as compared to those children that used arm splints following a CPR.

Methods

•  A single Craniofacial Surgeon's cleft palate repairs (CPR) over a 5+ year period:
• 2.5 years with arm splints (n=22)
• 3 years without arm splints (n=43)
• Retrospective chart review
• All patients underwent a standardized two-flap CPR with "radical" intravelar veloplasty

Extent of Cleft Palate (CP) and Age at Time of Repair

• With arm splints:
• Complete Cleft Palate:     n=7
• Incomplete Cleft Palate:   n=15
• Age Range: 8-38 months; average = 15 months
• Without arm splints:
• Complete Cleft Palate:     n=24
• Incomplete Cleft Palate:   n=21
• Age Range: 6-32 months; average = 13 months
• All children > 19 months: recently adopted, n=11; other illness, n=3

Results
With arm splints (n=22):

• 1 slit fistula - incomplete CP, 13 months (age at repair)
• 4.5% CPF rate

Without arm splints (n=45):

• 2 slit fistulae
• 1 complete CP (wide); 10 months; antibiotics for prolonged fever and sinus infection
• 1 complete CP (wide); 12 months; IV antibiotics for tracheitis
• 1 partial dehiscence - complete CP, 28 months, developed strep throat 3 days after surgery
• 1 complete dehiscence - incomplete CP, 13 months, screamed for 14 hours day of surgery
• 8.8% CPF rate

Discussion

• For each child that developed a fistula/dehiscence, the parent was asked if they observed the child putting fingers or toys in their mouth
• Each of these parents reported their child did not put anything in their mouths
• The child that developed tracheitis 2 days after surgery was also fed solely via G-Button.
• Most parents reported their child did not put anything in their mouths after surgery
• In the immediate post-op period, those children that used their fingers or pacifiers for comfort would try, but most quickly took them out of their mouths
• Those few children that did continue to use their fingers or pacifiers for comfort woudl adjust the position to their cheek pocket, or simply held their pacifier next to their cheek
• Very few children used bottles after surgery, even though we allowed them

Conclusion
Discontinuation of the use of post-palatoplasty arm splints does not significantly compromise palatal integrity.

Study Provides New Leads into Genetics of Cleft Lip and/or Palate

Here is a link to this article; it may be of interest to you.

http://www.nih.gov/news/health/may2010/nidcr-03.htm