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Vigpoder Side Effects

Generic name: vigabatrin

Note: This document provides detailed information about Vigpoder Side Effects associated with vigabatrin. Some dosage forms listed on this page may not apply specifically to the brand name Vigpoder.

Applies to vigabatrin: oral powder for solution, oral tablet.

Important warnings This medicine can cause some serious health issues

Oral route (powder for solution; tablet)

Vigabatrin can cause permanent bilateral concentric visual field constriction, including tunnel vision that can result in disability.

In some cases, vigabatrin may also decrease visual acuity.Risk increases with increasing dose and cumulative exposure, but there is no dose or exposure to vigabatrin known to be free of risk of vision loss.Risk of new and worsening vision loss continues as long as vigabatrin is used, and possibly after discontinuing vigabatrin.Baseline and periodic vision assessment is recommended for patients on vigabatrin.

However, this assessment cannot always prevent vision damage.Vigabatrin is available only through a restricted program called the Vigabatrin REMS Program.

Further information is available at www.vigabatrinREMS.com or 1-866-244-8175.

Precautions

It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may cause permanent vision loss. Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. It is very important that your ophthalmologist (eye doctor) check your child's or your eyes within 4 weeks after starting treatment, every 3 months during treatment, and about 3 to 6 months after stopping treatment with this medicine.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine (eg, magnetic resonance imaging or MRI).

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Make sure the doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you, your child, or your caregiver notice any of these side effects, tell your doctor right away.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away. Your doctor may want you to join a pregnancy registry for patients taking a seizure medicine.

This medicine may cause some people to become drowsy, sleepy, tired, or weak than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are drowsy or not alert.

Check with your doctor right away if you or your child are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.

This medicine may increase your weight and cause swelling in your hands, ankles, or feet. Your doctor may need to check your weight on a regular basis while you are using this medicine. Talk to your doctor about ways to prevent weight gain.

Do not suddenly Stop taking vigabatrin (the active ingredient contained in Vigpoder) without checking first with your doctor. Your doctor may want to gradually reduce the amount you are using before stopping it completely. Stopping this medicine suddenly may cause seizures.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Vigpoder

Along with its needed effects, vigabatrin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking vigabatrin:

More common side effects

  • blue-yellow color blindness
  • blurred vision
  • decreased vision or other vision changes
  • eye pain
  • increase in seizures
  • loss of memory
  • problems with memory

Less common or rare side effects

  • uncontrolled rolling eye movements

Get emergency help immediately if any of the following symptoms of overdose occur while taking vigabatrin:

Symptoms of overdose

Other side effects of Vigpoder

Some side effects of vigabatrin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common side effects

  • agitation
  • burning, tingling, or prickly sensations
  • clumsiness or unsteadiness
  • confusion
  • constipation
  • diarrhea
  • dizziness
  • double vision or seeing double
  • increased movement
  • joint pain
  • mental depression
  • sleepiness or unusual drowsiness
  • stomach pain
  • trembling
  • tremor
  • trouble sitting still

Less common side effects

  • aggression
  • headache
  • increased saliva
  • muscle weakness
  • nausea
  • poor concentration
  • speech disorder
  • trouble sleeping
  • unusual thoughts
  • vomiting
  • weight gain

For healthcare professionals

Applies to vigabatrin: oral liquid, oral powder for reconstitution, oral tablet.

General adverse events

The more commonly reported adverse reactions have included headache, somnolence, fatigue, dizziness, weight gain, tremor and visual field defects. This drug can cause permanent vision loss.[Ref]

Ocular

Based on adult studies, 30 percent or more of patients can be affected with bilateral concentric visual field constriction ranging in severity from mild to severe. Severe cases may be characterized by tunnel vision to within 10 degrees of visual fixation, which can result in disability. In some cases, damage can occur to the central retina and may decrease visual acuity.[Ref]

Nervous system

Magnetic Resonance Imaging (MRI) Abnormalities in Infants:

Abnormal MRI signal changes characterized by increased T2 signal and restricted diffusion in a symmetric pattern involving the thalamus, basal ganglia, brain stem, and cerebellum have been observed in some infants treated with this drug for infantile spasms. Some infants exhibited coincident motor abnormalities, but no causal relationship has been established.[Ref]

Dermatologic

Psychiatric

Metabolic

Other

Hematologic

Endocrine

The following birth defects have been reported during the postmarketing period: congenital cardiac defects, congenital external ear anomaly, congenital hemangioma, congenital hydronephrosis, congenital male genital malformation, congenital oral malformation, congenital vesicoureteric reflux, dentofacial anomaly, dysmorphism, fetal anticonvulsant syndrome, hamartomas, hip dysplasia, limb malformation, limb reduction defect, low set ears, renal aplasia, retinitis pigmentosa, supernumerary nipple, and talipes.

Gastrointestinal

Genitourinary

Hepatic

Musculoskeletal

Respiratory

Cardiovascular

Immunologic

See also:

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics."

2. Cerner Multum, Inc. "Australian Product Information."

3. (2009) "Product Information. Sabril (vigabatrin)." Lundbeck Inc

Frequently asked questions

Further information

Vigpoder side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.