Dilantin Cerebellar  Atrophy Warning

Dilantin Use Associated with Cerebellum Atrophy

Dilantin (phenytoin) is an anticonvulsant drug manufactured by Pfizer and in use since the 1950s as the preferred choice in the treatment of epileptic seizures.

Dilantin is also used off-label—for purposes not cleared or approved by the U.S. Food and Drug Administration—for the treatment of bipolar disorder, anxiety, depression, and attention deficit hyperactivity disorder (ADHD), among others.

The most severe adverse reaction associated with Dilantin involves significant brain structure changes.

Long-term Dilantin use has been associated with brain degeneration caused by cerebellar atrophy.

Cerebellar atrophy involves the shrinking and loss of neurons and neuronal connections in the cerebellum, which is located at the base of the brain.

The cerebellum is the part of the brain that handles movement and coordination and is also involved in speech, balance, posture, and coordination. Cerebellar atrophy is a sub-type of cerebral atrophy (brain degeneration as a whole).

Cerebellar atrophy is what is known as a focal cerebral atrophy, meaning that it only impacts one part of the brain.

The personal injury attorneys at Sheehan LLP are closely monitoring the research tying Dilantin use with brain injury. The firm continues to offer free legal consultations to individuals with questions about filing a Dilantin lawsuit.

Dilantin Cerebellar  Atrophy

Dilantin Long - Term Cerebellar Atrophy Side Effect

Dilantin cerebellar atrophy

Cerebellar atrophy and

Skull thickening due to chronic phenytoin therapy

Cerebellar atrophy and generalized thickening of the skull vault has been seen in patients using Dilantin (phenytoin) long - term.

cerebellar atrophy is shrinkage of the brain, sometimes affecting the whole brain or just part of it and it can occur by long term use of Dilantin.

Cerebellar atrophy, or loss of brain issue in the cerebellum, may be caused by long-term use of Dilantin, particularly with use of high doses.



Cerebellar Atrophy in Patients With Long-term

Phenytoin Exposure and Epilepsy


Gershon C. Ney, MD; George Lantos, MD; William B. Barr, PhD; Neil Schaul, MD


Objective: Cerebellar atrophy has been noted in patients with phenytoin exposure. This finding has been attributed

by some investigators to seizures, but by others to phenytoin.  Previous studies included patients with mental retardation

and convulsive seizures. We undertook a study in a group of nonretarded patients with partial epilepsy to better elucidate

the cause of the cerebellar atrophy.


Interventions: All patients and controls underwent magnetic resonance imaging.


Main Outco•e Measure: Degree of cerebellar atrophy.


Design: Case control study.


Setting: Referral population from an epilepsy center.


Results: The magnetic resonance imaging scans were reviewed in a blind fashion. A rating was assigned to each

scan based on the degree of cerebellar atrophy. Cerebellar atrophy was significantly more pronounced in patients

than in controls. No correlation was found between cerebellar atrophy and variables reflective of seizure severity or degree of phenytoin exposure.



Patients: Thirty-six patients with partial epilepsy and long-term phenytoin exposure were selected from a consecutive

sample of a&~pissions to an epilepsy center. Patients with histories of ethanol abuse, perinatal distress,

anoxia, status epilepticus, or neurodegenerative disorders were excluded. Age- and sex-matched controls were

selected from a pool of healthy volunteers and patients who had undergone magnetic resonance imaging for complaints

of headache and dizziness.



Conclusion: Cerebellar atrophy may be seen in phenytoin-exposed patients with epilepsy in the absence of

generalized tonic-clonic seizures or preexistent brain damage.  Whether it is the phenytoin or the seizures that play

the primary etiologic role remains unanswered. These factors may be synergistic.

(Arch Neurol. 1994;51:767-771)


Medication Guides Drugs

2016-12-29 | www.fda.gov/drugs/drugsafety/ucm085729.htm

... 2016 version]; Dilantin (phenytoin) Chewable/ER [2015 version]; Dilantin-125 (phenytoin) [2016 version]; Dolophine (methadone ...

CSV "Item Code",NDC11,"Proprietary Name","Dosage Form" ... For Industry

2016-12-29 | www.fda.gov/downloads/forindustry/datastandards/structuredproductlabeling/ucm363569.csv

... 0071-0369-40,00071036940,Dilantin,"CAPSULE, EXTENDED RELEASE", ANDA,ANDA084349,"HUMAN PRESCRIPTION DRUG",19760827,,EA. ...

PDF Reference ID: 4032065

2016-12-23 | www.accessdata.fda.gov/drugsatfda_docs/label/2016/020659s064,022417s016lbl.pdf

... Zarontin, Ethosuximide), divalproex (Depakote, Divalproex Sodium), or phenytoin (Dilantin, Phenytek) • medicine for ...

Global Drug Supply 12/6/16 Inspections and Compliance

2016-12-20 | www.fda.gov/iceci/enforcementactions/warningletters/2016/ucm533718.htm

... Metoprolol CR. Betaloc CR. Pentosan. Elmiron. Phenytoin. Dilantin. Pramipexole. Sifrol. Rosuvastatin. Crestor. Salbutamol/Ipratropium. Duolin. ...

PDF Dilantin (phenytoin) Injection (NDA 10151) and Oral ...

2016-12-06 | www.accessdata.fda.gov/.../appletter/2016/008762Orig1s057,s058,010151Orig1s044,s045ltr.pdf

... Drug Applications (sNDA) submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Dilantin (phenytoin) Injection ...