Zonegran Birth Defects

Zonegran is also known as the chemical compound Zonisamide (Wiki), an anticonvulsant for use with epileptics with partial-onset seizures (its efficacy has not been established with full seizure patients).

It is also useful for infantile spasm (aka West syndrome, an epileptic disorder in infants) and Lennox-Gastaut syndrome (epilepsy at the onset of childhood).  Like most anticonvulsants, it is used as an adjunctive therapy to a seizure-control program; it has also had limited success in treating the symptoms of Parkinson’s disease (only seven patients were tested) and obesity (three patients with positive results).

The FDA has listed a number of side effects for the medication, the most serious of which include:

  • kidney stone development and mood swings
  • as well as memory loss,
  • dizziness
  •  loss of appetite
  •  irritability and drowsiness.

It also noted the increase in suicidal thoughts and ideations, unusual mood swings (brought about by any anticonvulsive in some patients), and the possibility of heart damage in extreme cases.  In addition, stopping Zonegran was contraindicated, as the FDA noted it can “cause serious problems . . . a patient who has epilepsy can [experience] seizures that will not stop (status epilepticus).”

Zonegran Birth Defects

In the area of Zonegran birth defects, however, the FDA is a good deal more reticent in its opinions, as there is little research (human-centered, in any event) covering the possibility of side effects in human natal incidents.  The FDA confines itself to the advice “Tell your [medical provider] if you plan to become pregnant . . . Zonegran may harm your unborn baby. ”

A fuller picture of the possibility of birth defects may be found in recent animal studies that gave the drug an FDA-centered pregnancy Category C rating (indicating possible harm based upon birth defects found in test animals). (see also paxil birth defects) In several separate experimental venues, pregnant mice, rats and dogs had increased incidents of birth defects, most particularly heart defects, in their newborn baby animals.  When Zonegran was administered to pregnant monkeys, there was an increase in miscarriages (epilepsy.emedtv).

It is plain that more research must be done, although specific research for birth defects in humans is hard to come by (it is natural that a pregnant woman might be hesitant to risk her unborn child in such a study).  For the moment, Zonegran birth defects as a harmful category finds itself confined to the animal kingdom.

For more information on Zonegran, contact your medical professional; also be sure to consult this individual if you are about to embark on a Zonegran program, especially if you are pregnant or planning a pregnancy.

http://epilepsy.emedtv.com/zonegran/zonegran-and-pregnancy.html
http://google2.fda.gov/search?q=cache:WH3HZ-7KmkAJ:www.fda.gov/downloads/Drugs/DrugSafety/
http://en.wikipedia.org/wiki/Zonisamide
http://en.wikipedia.org/wiki/Infantile_spasm
http://en.wikipedia.org/wiki/Lennox-Gastaut_syndrome