Sabril Warnings and Precautions
Before starting Sabril, it is important to tell your healthcare provider about any other medical issues you have, such as depression, anemia, or a history of suicidal thoughts. Other precautions for using Sabril safely include warnings of potential complications that may occur, such as permanent vision loss, drug interactions, and other potentially serious problems.
What Should I Tell My Healthcare Provider?You should talk with your healthcare provider prior to taking Sabril® (vigabatrin) if you have:
- A history of suicidal thoughts or behaviors
- Kidney disease, such as kidney failure or renal failure
- Congestive heart failure (CHF)
- Any allergies, including to foods, dyes, or preservatives.
Also, let your healthcare provider know if you are:
- Pregnant or thinking of becoming pregnant
You should also tell your healthcare provider about all other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.
Specific Precautions and Warnings With SabrilSome warnings and precautions to be aware of prior to taking this drug include the following:
- Sabril has a high risk for causing permanent vision loss, especially loss of peripheral vision. Due to this risk, Sabril should only be used in situations where the benefits outweigh this risk. Because of this risk, regular vision checks will be necessary, even for young babies. A vision check should be done within four weeks of starting Sabril and at least every three months thereafter (except in certain situations, such as with blind individuals).
- Prescribers and pharmacists must be registered with the special restricted distribution program for this medication (the "SHARE" program) before prescribing or dispensing it. This program is designed to help ensure that only appropriate individuals receive this medication and that appropriate vision monitoring is performed. Patients must also be enrolled in the SHARE program.
- Be aware that parents and even healthcare providers may not be able to notice vision problems in young babies until the vision loss is severe.
- Studies suggest that seizure medications may increase the risk of suicide. Make sure to watch for any unusual behaviors or mood changes, and be sure your family and friends know to keep an eye out for such problems.
- In studies, Sabril sometimes caused changes in the brain (as seen on an MRI). It is not yet clear how important these changes are. Some of the infants who had these brain changes also had abnormal development in motor skills; however, this might have been coincidental.
- In animal studies, Sabril caused nerve problems in the brain. It is unclear if these problems will occur in humans as well.
- Sabril can cause anemia. Your healthcare provider may want to monitor you for this problem.
- This medicine can cause drowsiness, dizziness, and coordination problems. You may want to see how the drug affects you before driving or operating heavy machinery.
- Sabril can cause peripheral neuropathy (nerve problems in the extremities). Typically, this occurs as numbness or tingling in the feet and toes.
- As with all seizure medications, you should not stop taking Sabril suddenly, as this can make seizures worse.
- If you have kidney problems, you will probably need a lower-than-usual Sabril dosage.
- Sabril can cause water retention. However, Sabril-related water retention does not appear to be related to the usual risks associated with water retention, such as high blood pressure or congestive heart failure.
- This drug can cause weight gain. However, if the medication is working, this is a relatively minor side effect. Weight gain can occur without water retention and is not necessarily related to water retention.
- Sabril may react with a few other medications (see Sabril Drug Interactions).
- Sabril is a pregnancy Category C medication. This means that it may not be safe for use during pregnancy, although the full risks are currently unknown (see Sabril and Pregnancy).
- Sabril passes through breast milk in humans. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the drug (see Sabril and Breastfeeding).