Prescription Drug Information: PREGABALIN (Page 3 of 9)

5.11 Decreased Platelet Count

Pregabalin treatment was associated with a decrease in platelet count. Pregabalin-treated subjects experienced a mean maximal decrease in platelet count of 20 × 103 /µL, compared to 11 × 103 /µL in placebo patients. In the overall database of controlled trials in adult patients, 2% of placebo patients and 3% of pregabalin patients experienced a potentially clinically significant decrease in platelets, defined as 20% below baseline value and less than 150 × 103 /µL. A single pregabalin-treated subject developed severe thrombocytopenia with a platelet count less than 20 × 103 / µL. In randomized controlled trials, pregabalin was not associated with an increase in bleeding-related adverse reactions.

5.12 PR Interval Prolongation

Pregabalin treatment was associated with PR interval prolongation. In analyses of clinical trial ECG data in adult patients, the mean PR interval increase was 3 to 6 msec at pregabalin doses greater than or equal to 300 mg/day. This mean change difference was not associated with an increased risk of PR increase greater than or equal to 25% from baseline, an increased percentage of subjects with on-treatment PR greater than 200 msec, or an increased risk of adverse reactions of second or third degree AV block.

Subgroup analyses did not identify an increased risk of PR prolongation in patients with baseline PR prolongation or in patients taking other PR prolonging medications. However, these analyses cannot be considered definitive because of the limited number of patients in these categories.

6 ADVERSE REACTIONS

The following serious adverse reactions are described elsewhere in the labeling:
• Angioedema [see Warnings and Precautions (5.1)]
• Hypersensitivity [see Warnings and Precautions (5.2 )]
• Increased Risk of Adverse Reactions with Abrupt or Rapid Discontinuation [see Warnings and Precautions (5.3 )]
• Suicidal Behavior and Ideation [see Warnings and Precautions (5.4 )]
• Peripheral Edema [see Warnings and Precautions (5.5)]
• Dizziness and Somnolence [see Warnings and Precautions (5.6 )]
• Weight Gain [see Warnings and Precautions (5.7)]
• Tumorigenic Potential [see Warnings and Precautions (5.8)]
• Ophthalmological Effects [see Warnings and Precautions (5.9)]
• Creatine Kinase Elevations [see Warnings and Precautions (5.10)]
• Decreased Platelet Count [see Warnings and Precautions (5.11)]
• PR Interval Prolongation [see Warnings and Precautions (5.12 )]

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In all controlled and uncontrolled trials across various patient populations during the premarketing development of pregabalin, more than 10,000 patients have received pregabalin. Approximately 5,000 patients were treated for 6 months or more, over 3,100 patients were treated for 1 year or longer, and over 1,400 patients were treated for at least 2 years.
Adverse Reactions Most Commonly Leading to Discontinuation in All Premarketing Controlled Clinical Studies
In premarketing controlled trials of all adult populations combined, 14% of patients treated with pregabalin and 7% of patients treated with placebo discontinued prematurely due to adverse reactions. In the pregabalin treatment group, the adverse reactions most frequently leading to discontinuation were dizziness (4%) and somnolence (4%). In the placebo group, 1% of patients withdrew due to dizziness and less than 1% withdrew due to somnolence. Other adverse reactions that led to discontinuation from controlled trials more frequently in the pregabalin group compared to the placebo group were ataxia, confusion, asthenia, thinking abnormal, blurred vision, incoordination, and peripheral edema (1% each).
Most Common Adverse Reactions in All Controlled Clinical Studies in Adults
In premarketing controlled trials of all adult patient populations combined (including DPN, PHN, and adult patients with partial-onset seizures), dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, and “thinking abnormal” (primarily difficulty with concentration/attention) were more commonly reported by subjects treated with pregabalin than by subjects treated with placebo (greater than or equal to 5% and twice the rate of that seen in placebo).
Controlled Studies with Neuropathic Pain Associated with Diabetic Peripheral Neuropathy
Adverse Reactions Leading to Discontinuation
In clinical trials in adults with neuropathic pain associated with diabetic peripheral neuropathy, 9% of patients treated with pregabalin and 4% of patients treated with placebo discontinued prematurely due to adverse reactions. In the pregabalin treatment group, the most common reasons for discontinuation due to adverse reactions were dizziness (3%) and somnolence (2%). In comparison, less than 1% of placebo patients withdrew due to dizziness and somnolence. Other reasons for discontinuation from the trials, occurring with greater frequency in the pregabalin group than in the placebo group, were asthenia, confusion, and peripheral edema. Each of these events led to withdrawal in approximately 1% of patients.
Most Common Adverse Reactions
Table 4 lists all adverse reactions, regardless of causality, occurring in greater than or equal to 1% of patients with neuropathic pain associated with diabetic neuropathy in the combined pregabalin group for which the incidence was greater in this combined pregabalin group than in the placebo group. A majority of pregabalin-treated patients in clinical studies had adverse reactions with a maximum intensity of “mild” or “moderate”. Table 4. Adverse Reaction Incidence in Controlled Trials in Neuropathic Pain Associated with Diabetic Peripheral Neuropathy

Body system Preferred term

75 mg/day [N=77] %

150 mg/day [N=212] %

300 mg/day [N=321] %

600 mg/day [N=369] %

All PGB* [N=979] %

Placebo [N=459] %

Body as a whole

Asthenia

4

2

4

7

5

2

Accidental injury

5

2

2

6

4

3

Back pain

0

2

1

2

2

0

Chest pain

4

1

1

2

2

1

Face edema

0

1

1

2

1

0

Digestive system

Dry mouth

3

2

5

7

5

1

Constipation

0

2

4

6

4

2

Flatulence

3

0

2

3

2

1

Metabolic and nutritional disorders

Peripheral edema

4

6

9

12

9

2

Weight gain

0

4

4

6

4

0

Edema

0

2

4

2

2

0

Hypoglycemia

1

3

2

1

2

1

Nervous system

Dizziness

8

9

23

29

21

5

Somnolence

4

6

13

16

12

3

Neuropathy

9

2

2

5

4

3

Ataxia

6

1

2

4

3

1

Vertigo

1

2

2

4

3

1

Confusion

0

1

2

3

2

1

Euphoria

0

0

3

2

2

0

Incoordination

1

0

2

2

2

0

Thinking abnormal†

1

0

1

3

2

0

Tremor

1

1

1

2

1

0

Abnormal gait

1

0

1

3

1

0

Amnesia

3

1

0

2

1

0

Nervousness

0

1

1

1

1

0

Respiratory system

Dyspnea

3

0

2

2

2

1

Special senses

Blurry vision‡

3

1

3

6

4

2

Abnormal vision

1

0

1

1

1

0

* PGB: pregabalin
† Thinking abnormal primarily consists of events related to difficulty with concentration/attention but also includes events related to cognition and language problems and slowed thinking. ‡ Investigator term; summary level term is amblyopia

Controlled Studies in Postherpetic Neuralgia

Adverse Reactions Leading to Discontinuation

In clinical trials in adults with postherpetic neuralgia, 14% of patients treated with pregabalin and 7% of patients treated with placebo discontinued prematurely due to adverse reactions. In the pregabalin treatment group, the most common reasons for discontinuation due to adverse reactions were dizziness (4%) and somnolence (3%). In comparison, less than 1% of placebo patients withdrew due to dizziness and somnolence. Other reasons for discontinuation from the trials, occurring in greater frequency in the pregabalin group than in the placebo group, were confusion (2%), as well as peripheral edema, asthenia, ataxia, and abnormal gait (1% each).

Most Common Adverse Reactions

Table 5 lists all adverse reactions, regardless of causality, occurring in greater than or equal to 1% of patients with neuropathic pain associated with postherpetic neuralgia in the combined pregabalin group for which the incidence was greater in this combined pregabalin group than in the placebo group. In addition, an event is included, even if the incidence in the all pregabalin group is not greater than in the placebo group, if the incidence of the event in the 600 mg/day group is more than twice that in the placebo group. A majority of pregabalin-treated patients in clinical studies had adverse reactions with a maximum intensity of “mild” or “moderate”. Overall, 12.4% of all pregabalin-treated patients and 9.0% of all placebo-treated patients had at least one severe event while 8% of pregabalin-treated patients and 4.3% of placebo-treated patients had at least one severe treatment-related adverse event.

Table 5. Adverse Reaction Incidence in Controlled Trials in Neuropathic Pain Associated with Postherpetic Neuralgia

Body system Preferred term

75 mg/d [N=84] %

150 mg/d [N=302] %

300 mg/d [N=312] %

600 mg/d [N=154] %

All PGB* [N=852] %

Placebo [N=398] %

Body as a whole

Infection

14

8

6

3

7

4

Headache

5

9

5

8

7

5

Pain

5

4

5

5

5

4

Accidental injury

4

3

3

5

3

2

Flu syndrome

1

2

2

1

2

1

Face edema

0

2

1

3

2

1

Digestive system

Dry mouth

7

7

6

15

8

3

Constipation

4

5

5

5

5

2

Flatulence

2

1

2

3

2

1

Vomiting

1

1

3

3

2

1

Metabolic and nutritional disorders

Peripheral edema

0

8

16

16

12

4

Weight gain

1

2

5

7

4

0

Edema

0

1

2

6

2

1

Musculoskeletal system

Myasthenia

1

1

1

1

1

0

Nervous system

Dizziness

11

18

31

37

26

9

Somnolence

8

12

18

25

16

5

Ataxia

1

2

5

9

5

1

Abnormal gait

0

2

4

8

4

1

Confusion

1

2

3

7

3

0

Thinking abnormal

0

2

1

6

2

2

Incoordination

2

2

1

3

2

0

Amnesia

0

1

1

4

2

0

Speech disorder

0

0

1

3

1

0

Respiratory system

Bronchitis

0

1

1

3

1

1

Special senses

Blurry vision

1

5

5

9

5

3

Diplopia

0

2

2

4

2

0

Abnormal vision

0

1

2

5

2

0

Eye Disorder

0

1

1

2

1

0

Urogenital System

Urinary Incontinence

0

1

1

2

1

0

* PGB: pregabalin

Thinking abnormal primarily consists of events related to difficulty with concentration/attention but also includes events related to cognition and language problems and slowed thinking.

Investigator term; summary level term is amblyopia
Controlled Studies of Adjunctive Therapy for Partial-Onset Seizures in Adult Patients
Adverse Reactions Leading to Discontinuation
Approximately 15% of patients receiving pregabalin and 6% of patients receiving placebo in trials of adjunctive therapy for partial-onset seizures discontinued prematurely due to adverse reactions. In the pregabalin treatment group, the adverse reactions most frequently leading to discontinuation were dizziness (6%), ataxia (4%), and somnolence (3%). In comparison, less than 1% of patients in the placebo group withdrew due to each of these events. Other adverse reactions that led to discontinuation of at least 1% of patients in the pregabalin group and at least twice as frequently compared to the placebo group were asthenia, diplopia, blurred vision, thinking abnormal, nausea, tremor, vertigo, headache, and confusion (which each led to withdrawal in 2% or less of patients).

Most Common Adverse Reactions
Table 6 lists all dose-related adverse reactions occurring in at least 2% of all pregabalin-treated patients. Dose-relatedness was defined as the incidence of the adverse event in the 600 mg/day group was at least 2% greater than the rate in both the placebo and 150 mg/day groups. In these studies, 758 patients received pregabalin and 294 patients received placebo for up to 12 weeks. A majority of pregabalin-treated patients in clinical studies had adverse reactions with a maximum intensity of “mild” or “moderate”.Table 6. Dose-related Adverse Reaction Incidence in Controlled Trials of Adjunctive Therapy for Partial-Onset Seizures in Adult Patients

Body System Preferred Term

150 mg/d [N = 185] %

300 mg/d [N = 90] %

600 mg/d [N = 395] %

All PGB* [N = 670]† %

Placebo [N = 294] %

Body as a Whole

Accidental Injury

7

11

10

9

5

Pain

3

2

5

4

3

Digestive System

Increased Appetite

2

3

6

5

1

Dry Mouth

1

2

6

4

1

Constipation

1

1

7

4

2

Metabolic and Nutritional Disorders

Weight Gain

5

7

16

12

1

Peripheral Edema

3

3

6

5

2

Nervous System

Dizziness

18

31

38

32

11

Somnolence

11

18

28

22

11

Ataxia

6

10

20

15

4

Tremor

3

7

11

8

4

Thinking Abnormal‡

4

8

9

8

2

Amnesia

3

2

6

5

2

Speech Disorder

1

2

7

5

1

Incoordination

1

3

6

4

1

Abnormal Gait

1

3

5

4

0

Twitching

0

4

5

4

1

Confusion

1

2

5

4

2

Myoclonus

1

0

4

2

0

Special Senses

Blurred Vision§

5

8

12

10

4

Diplopia

5

7

12

9

4

Abnormal Vision

3

1

5

4

1

* PGB: pregabalin
† Excludes patients who received the 50 mg dose in Study E1.
‡ Thinking abnormal primarily consists of events related to difficulty with concentration/attention but also includes events related to cognition and language problems and slowed thinking.
§ Investigator term; summary level term is amblyopia.

Controlled Studies with Fibromyalgia

Adverse Reactions Leading to Discontinuation
In clinical trials of patients with fibromyalgia, 19% of patients treated with pregabalin (150 to 600 mg/day) and 10% of patients treated with placebo discontinued prematurely due to adverse reactions. In the pregabalin treatment group, the most common reasons for discontinuation due to adverse reactions were dizziness (6%) and somnolence (3%). In comparison, less than 1% of placebo-treated patients withdrew due to dizziness and somnolence. Other reasons for discontinuation from the trials, occurring with greater frequency in the pregabalin treatment group than in the placebo treatment group, were fatigue, headache, balance disorder, and weight increased. Each of these adverse reactions led to withdrawal in approximately 1% of patients.

Most Common Adverse Reactions Table 9 lists all adverse reactions, regardless of causality, occurring in greater than or equal to 2% of patients with fibromyalgia in the ‘all pregabalin’ treatment group for which the incidence was greater than in the placebo treatment group. A majority of pregabalin-treated patients in clinical studies experienced adverse reactions with a maximum intensity of “mild” or “moderate”.

Table 9. Adverse Reaction Incidence in Controlled Trials in Fibromyalgia

System Organ Class Preferred term

150 mg/d [N=132] %

300 mg/d [N=502] %

450 mg/d [N=505] %

600 mg/d [N=378] %

All PGB* [N=1517] %

Placebo [N=505] %

Ear and Labyrinth Disorders

Vertigo

2

2

2

1

2

0

Eye Disorders

Vision blurred

8

7

7

12

8

1

Gastrointestinal Disorders

Dry mouth

7

6

9

9

8

2

Constipation

4

4

7

10

7

2

Vomiting

2

3

3

2

3

2

Flatulence

1

1

2

2

2

1

Abdominal distension

2

2

2

2

2

1

General Disorders and Administrative Site Conditions

Fatigue

5

7

6

8

7

4

Edema peripheral

5

5

6

9

6

2

Chest pain

2

1

1

2

2

1

Feeling abnormal

1

3

2

2

2

0

Edema

1

2

1

2

2

1

Feeling drunk

1

2

1

2

2

0

Infections and Infestations

Sinusitis

4

5

7

5

5

4

Investigations

Weight increased

8

10

10

14

11

2

Metabolism and Nutrition Disorders

Increased appetite

4

3

5

7

5

1

Fluid retention

2

3

3

2

2

1

Musculoskeletal and Connective Tissue Disorders

Arthralgia

4

3

3

6

4

2

Muscle spasms

2

4

4

4

4

2

Back pain

2

3

4

3

3

3

Nervous System Disorders

Dizziness

23

31

43

45

38

9

Somnolence

13

18

22

22

20

4

Headache

11

12

14

10

12

12

Disturbance in attention

4

4

6

6

5

1

Balance disorder

2

3

6

9

5

0

Memory impairment

1

3

4

4

3

0

Coordination abnormal

2

1

2

2

2

1

Hypoesthesia

2

2

3

2

2

1

Lethargy

2

2

1

2

2

0

Tremor

0

1

3

2

2

0

Psychiatric Disorders

Euphoric Mood

2

5

6

7

6

1

Confusional state

0

2

3

4

3

0

Anxiety

2

2

2

2

2

1

Disorientation

1

0

2

1

2

0

Depression

2

2

2

2

2

2

Respiratory, Thoracic and Mediastinal Disorders

Pharyngolaryngeal pain

2

1

3

3

2

2

* PGB: pregabalin
Controlled Studies in Neuropathic Pain Associated with Spinal Cord Injury

Adverse Reactions Leading to Discontinuation

In clinical trials of adults with neuropathic pain associated with spinal cord injury, 13% of patients treated with pregabalin and 10% of patients treated with placebo discontinued prematurely due to adverse reactions. In the pregabalin treatment group, the most common reasons for discontinuation due to adverse reactions were somnolence (3%) and edema (2%). In comparison, none of the placebo-treated patients withdrew due to somnolence and edema. Other reasons for discontinuation from the trials, occurring with greater frequency in the pregabalin treatment group than in the placebo treatment group, were fatigue and balance disorder. Each of these adverse reactions led to withdrawal in less than 2% of patients.

Most Common Adverse Reactions

Table 10 lists all adverse reactions, regardless of causality, occurring in greater than or equal to 2% of patients for which the incidence was greater than in the placebo treatment group with neuropathic pain associated with spinal cord injury in the controlled trials. A majority of pregabalin-treated patients in clinical studies experienced adverse reactions with a maximum intensity of “mild” or “moderate”.Table 10. Adverse Reaction Incidence in Controlled Trials in Neuropathic Pain Associated with Spinal Cord Injury

System Organ Class Preferred term

PGB* (N=182)

Placebo (N=174)

%

%

Ear and labryrinth disorders

Vertigo

2.7

1.1

Eye disorders

Vision blurred

6.6

1.1

Gastrointestinal disorders

Dry mouth

11.0

2.9

Constipation

8.2

5.7

Nausea

4.9

4.0

Vomiting

2.7

1.1

General disorders and administration site conditions

Fatigue

11.0

4.0

Edema peripheral

10.4

5.2

Edema

8.2

1.1

Pain

3.3

1.1

Infections and infestations

Nasopharyngitis

8.2

4.6

Investigations

Weight increased

3.3

1.1

Blood creatine phosphokinase increased

2.7

0

Musculoskeletal and connective tissue disorders

Muscular weakness

4.9

1.7

Pain in extremity

3.3

2.3

Neck pain

2.7

1.1

Back pain

2.2

1.7

Joint swelling

2.2

0

Nervous system disorders

Somnolence

35.7

11.5

Dizziness

20.9

6.9

Disturbance in attention

3.8

0

Memory impairment

3.3

1.1

Paresthesia

2.2

0.6

Psychiatric disorders

Insomnia

3.8

2.9

Euphoric mood

2.2

0.6

Renal and urinary disorders

Urinary incontinence

2.7

1.1

Skin and subcutaneous tissue disorders

Decubitus ulcer

2.7

1.1

Vascular disorders

Hypertension

2.2

1.1

Hypotension

2.2

0

* PGB: Pregabalin
Other Adverse Reactions Observed During the Clinical Studies of Pregabalin

Following is a list of treatment-emergent adverse reactions reported by patients treated with pregabalin during all clinical trials. The listing does not include those events already listed in the previous tables or elsewhere in labeling, those events for which a drug cause was remote, those events which were so general as to be uninformative, and those events reported only once which did not have a substantial probability of being acutely life-threatening.

Events are categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse reactions are those occurring on one or more occasions in at least 1/100 patients; infrequent adverse reactions are those occurring in 1/100 to 1/1,000 patients; rare reactions are those occurring in fewer than 1/1,000 patients. Events of major clinical importance are described in the Warnings and Precautions section (5).

Body as a Whole – Frequent: Abdominal pain, Allergic reaction, Fever, Infrequent: Abscess, Cellulitis, Chills, Malaise, Neck rigidity, Overdose, Pelvic pain, Photosensitivity reaction, Rare: Anaphylactoid reaction, Ascites, Granuloma, Hangover effect, Intentional Injury, Retroperitoneal Fibrosis, Shock

Cardiovascular System – Infrequent: Deep thrombophlebitis, Heart failure, Hypotension, Postural hypotension, Retinal vascular disorder, Syncope; Rare: ST Depressed, Ventricular Fibrillation

Digestive System – Frequent: Gastroenteritis, Increased appetite; Infrequent: Cholecystitis, Cholelithiasis, Colitis, Dysphagia, Esophagitis, Gastritis, Gastrointestinal hemorrhage, Melena, Mouth ulceration, Pancreatitis, Rectal hemorrhage, Tongue edema; Rare: Aphthous stomatitis, Esophageal Ulcer, Periodontal abscess

Hemic and Lymphatic System – Frequent: Ecchymosis; Infrequent: Anemia, Eosinophilia, Hypochromic anemia, Leukocytosis, Leukopenia, Lymphadenopathy, Thrombocytopenia; Rare: Myelofibrosis, Polycythemia, Prothrombin decreased, Purpura, Thrombocythemia, Alanine aminotransferase increased, Aspartate aminotransferase increased

Metabolic and Nutritional Disorders – Rare: Glucose Tolerance Decreased, Urate Crystalluria

Musculoskeletal System – Frequent: Arthralgia, Leg cramps, Myalgia, Myasthenia; Infrequent:
Arthrosis; Rare: Chondrodystrophy, Generalized Spasm

Nervous System – Frequent: Anxiety, Depersonalization, Hypertonia, Hypoesthesia, Libido decreased, Nystagmus, Paresthesia, Sedation, Stupor, Twitching; Infrequent: Abnormal dreams, Agitation, Apathy, Aphasia, Circumoral paresthesia, Dysarthria, Hallucinations, Hostility, Hyperalgesia, Hyperesthesia, Hyperkinesia, Hypokinesia, Hypotonia, Libido increased, Myoclonus, Neuralgia; Rare: Addiction, Cerebellar syndrome, Cogwheel rigidity, Coma, Delirium, Delusions, Dysautonomia, Dyskinesia, Dystonia, Encephalopathy, Extrapyramidal syndrome, Guillain-Barré syndrome, Hypalgesia, Intracranial hypertension, Manic reaction, Paranoid reaction, Peripheral neuritis, Personality disorder, Psychotic depression, Schizophrenic reaction, Sleep disorder, Torticollis, Trismus

Respiratory System – Rare: Apnea, Atelectasis, Bronchiolitis, Hiccup, Laryngismus, Lung edema, Lung fibrosis, Yawn

Skin and Appendages – Frequent: Pruritus, Infrequent: Alopecia, Dry skin, Eczema, Hirsutism, Skin ulcer, Urticaria, Vesiculobullous rash; Rare: Angioedema, Exfoliative dermatitis, Lichenoid dermatitis, Melanosis, Nail Disorder, Petechial rash, Purpuric rash, Pustular rash, Skin atrophy, Skin necrosis, Skin nodule, Stevens-Johnson syndrome, Subcutaneous nodule

Special senses – Frequent: Conjunctivitis, Diplopia, Otitis media, Tinnitus; Infrequent: Abnormality of accommodation, Blepharitis, Dry eyes, Eye hemorrhage, Hyperacusis, Photophobia, Retinal edema, Taste loss, Taste perversion; Rare: Anisocoria, Blindness, Corneal ulcer, Exophthalmos, Extraocular palsy, Iritis, Keratitis, Keratoconjunctivitis, Miosis, Mydriasis, Night blindness, Ophthalmoplegia, Optic atrophy, Papilledema, Parosmia, Ptosis, Uveitis

Urogenital System – Frequent: Anorgasmia, Impotence, Urinary frequency, Urinary incontinence; Infrequent: Abnormal ejaculation, Albuminuria, Amenorrhea, Dysmenorrhea, Dysuria, Hematuria, Kidney calculus, Leukorrhea, Menorrhagia, Metrorrhagia, Nephritis, Oliguria, Urinary retention, Urine abnormality; Rare: Acute kidney failure, Balanitis, Bladder Neoplasm, Cervicitis, Dyspareunia, Epididymitis, Female lactation, Glomerulitis, Ovarian disorder, Pyelonephritis

Comparison of Gender and Race

The overall adverse event profile of pregabalin was similar between women and men. There are insufficient data to support a statement regarding the distribution of adverse experience reports by race.

Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

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