Wednesday, March 30, 2011

Drug Used For Neuropathic Pain Relieves Discomfort From Abdominal Adhesions: Henry Ford Study

Pregabalin, FDA-approved for neuropathic pain (pain caused by shingles and peripheral neuropathy), effectively reduced abdominal pain and improved sleep in women with adhesions, according to a Henry Ford study.

Adhesion pain, a common complication after abdominal or pelvic surgery, currently lacks effective therapy. Adhesions can also form after infections in the bowel such as diverticulitis.

"Many patients in the study went from debilitating pain to complete resolution of pain on pregabalin," says Ann Silverman, M.D., senior staff gastroenterologist at Henry Ford Hospital and lead author of the study.

Study results were presented at the American College of Gastroenterology's Annual Scientific Meeting in San Diego.

"Aside from the use of analgesics, additional surgery is the only treatment option for abdominal pain from adhesions but repeat surgery can lead to more adhesions," says Dr. Silverman.

The estimates of abdominal adhesion formation following surgery have been found to be as high as 100 percent in certain studies. Surgery is only recommended for bowel obstruction.

The randomized Henry Ford study looked at 18 women who received the drug or a look-alike placebo. All patients had previous abdominal surgery and were similar in age. The first eight weeks was a randomized placebo controlled trial of pregabalin followed by a four-week open label study in which all patients received the active study drug.

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Pregabalin Side Effects

Brand Names: Lyrica

Please note - some side effects for Pregabalin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at or 1-800-FDA-1088 (1-800-332-1088).

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Side Effects of Pregabalin - for the Consumer


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Pregabalin:

Blurred vision; changes in sexual function; constipation; dizziness; drowsiness; dry mouth; gas; headache; increased appetite; lightheadedness; stomach pain; trouble concentrating; weight gain.

Seek medical attention right away if any of these SEVERE side effects occur when using Pregabalin:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue, unusual hoarseness); burning, numbness, or tingling of the hands, feet, or skin; chest pain; confusion; fast or irregular heartbeat; fever, chills, or persistent sore throat; inability to control urination; loss of coordination; memory loss; muscle aches, pain, tenderness, or weakness (especially if this occurs with a fever or general feeling or discomfort); new or unusual skin sores; new or worsening mental or mood changes (eg, anxiety, depression, restlessness, irritability, panic attacks, feeling "high," behavior changes, suicidal thoughts or attempts); new or worsening seizures; reddened, blistered, swollen, or peeling skin; shortness of breath or wheezing; speaking problems; sudden, unexplained weight gain; swelling of the hands, feet, or ankles; tremor; trouble sleeping; trouble walking; unusual bruising or bleeding; unusual tiredness or weakness; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


Side Effects by Body System - for Healthcare Professionals

Nervous system

Nervous system side effects including dizziness (up to 38%), somnolence (up to 28%), ataxia (up to 20%), tremor (up to 11%), neuropathy (up to 9%), abnormal thinking (up to 9%), abnormal gait (up to 5%), confusion (up to 7%), speech disorder (up to 7%), amnesia (up to 6%), incoordination (up to 6%), twitching (up to 5%), vertigo (up to 4%), myoclonus (up to 4%), euphoria (up to 3%), and nervousness (up to 1%) have been reported. Anxiety, depersonalization, hypertonia, hypesthesia, decreased libido, nystagmus, paresthesia, stupor, and twitching have been reported frequently. Abnormal dreams, agitation, apathy, aphasia, circumoral paresthesia, dysarthria, hallucinations, hostility, hyperalgesia, hyperesthesia, hyperkinesia, hypokinesia, hypotonia, increased libido, myoclonus, and neuralgia have been reported infrequently. Addiction, cerebellar syndrome, cogwheel rigidity, coma, delirium, delusions, dysautonomia, dyskinesia, dystonia, encephalopathy, extrapyramidal syndrome, Guillain-Barre syndrome, hypoalgesia, intracranial hypertension, manic reaction, paranoid reaction, peripheral neuritis, psychotic depression, schizophrenic reaction, torticollis, and trismus have been reported rarely.


Metabolic side effects including peripheral edema (up to 16%), weight gain (up to 16%), edema (up to 6%), and hypoglycemia (up to 3%) have been reported. Decreased glucose tolerance and urate crystalluria have been reported rarely.


Gastrointestinal side effects including dry mouth (up to 15%), constipation (up to 7%), increased appetite (up to 6%), vomiting (up to 3%), flatulence (up to 3%), nausea and diarrhea have been reported. Gastroenteritis has been reported frequently. Cholecystitis, cholelithiasis, colitis, dysphagia, esophagitis, gastritis, gastrointestinal hemorrhage, melena, mouth ulceration, pancreatitis, rectal hemorrhage, and tongue edema have been reported infrequently. Aphthous stomatitis and esophageal ulcer have been reported rarely.


General side effects including infection (up to 14%), accidental injury (up to 11%), headache (up to 9%), asthenia (up to 7%), pain (up to 5%), chest pain (up to 4%), facial edema (up to 3%), flu syndrome (up to 2%), and back pain (up to 2%) have been reported. Abdominal pain and fever have been reported frequently. Abscess, cellulitis, chills, malaise, neck rigidity, overdose, pelvic pain, photosensitivity reaction, and suicide attempt have been reported infrequently. Ascites, granuloma, hangover effect, intentional injury, retroperitoneal fibrosis, shock, and suicide have been reported rarely.


Ocular side effects including visual field changes (13%), reduced visual acuity (7%), and blurred vision (6%) have been reported. Conjunctivitis and diplopia have been reported frequently. Abnormality of accommodation, blepharitis, dry eyes, eye hemorrhage, hyperacusis, photophobia, retinal vascular disorder, and retinal edema have been reported infrequently. Anisocoria, blindness, corneal ulcer, exophthalmos, extraocular palsy, iritis, keratitis, keratoconjunctivitis, miosis, mydriasis, night blindness, ophthalmoplegia, optic atrophy, papilledema, parosmia, ptosis, and uveitis have been reported rarely.

Blurred vision resolved in the majority of cases with continued dosing. Less than 1% of patients discontinued pregabalin treatment due to vision related events (primarily blurred vision).

Patients should be informed that they should notify their physician if changes in vision occur. If visual disturbance persists, further assessment should be considered. Furthermore, more frequent assessment should be considered for patients who are already routinely monitored for ocular conditions.


In a cohort study of 333 diabetic patients who received pregabalin for at least 2 years, the average weight gain was 5.2 kg. Pregabalin associated weight gain was related to dose and duration or exposure.

Other side effects including weight gain have been reported. In controlled clinical trials of up to 13 weeks, weight gain of 7% or more over baseline has been reported in 8% of pregabalin-treated patients. Otitis media and tinnitus have been reported frequently. Taste loss, and taste perversion have been reported infrequently.


Cardiovascular side effects including edema, primarily peripheral edema (6%) have been reported. Deep thrombophlebitis, heart failure, hypotension, syncope, and postural hypotension have been reported infrequently. Depressed ST and ventricular fibrillation have been reported rarely. There have been postmarketing reports of angioedema.

Specific symptoms of angioedema have included swelling of the face, mouth (tongue, lips, and gums), and neck (throat and larynx). There have also been reports of life-threatening angioedema with respiratory compromise requiring emergency treatment. Pregabalin should be discontinued immediately in patients with these symptoms. Caution is recommended if prescribing pregabalin to patients who have had a previous episode of angioedema. In addition, patients who are taking other drugs associated with angioedema (e.g., angiotensin converting enzyme inhibitors [ACE-inhibitors]) may be at increased risk of developing angioedema.


Respiratory side effects including dyspnea (up to 3%) and bronchitis (up to 3%) have been reported. Apnea, atelectasis, bronchiolitis, hiccup, laryngismus, lung edema, lung fibrosis, and yawn have been reported rarely.


Genitourinary side effects including urinary incontinence (up to 2%) have been reported. Anorgasmia, impotence, and urinary frequency have been reported frequently. Abnormal ejaculation, albuminuria, amenorrhea, dysmenorrhea, dysuria, hematuria, kidney calculus, leukorrhea, menorrhagia, metrorrhagia, nephritis, oliguria, and urinary retention have been reported infrequently. Acute kidney failure, balanitis, bladder neoplasm, cervicitis, dyspareunia, epididymitis, female lactation, and glomerulitis have been reported rarely. Two cases of unilateral painful gynecomastia have also been reported.


Musculoskeletal side effects including myasthenia (1%) have been reported. Arthralgia, leg cramps, myalgia, and myasthenia have been reported frequently. Arthrosis has been reported infrequently. Generalized spasm has been reported rarely.


Oncologic side effects including an unexpectedly high incidence of hemangiosarcoma have been reported in animal studies after pregabalin was given their diet for two years. In clinical studies comprised of 6,396 patient-years of exposure, new or worsening-preexisting tumors were reported in 57 patients. It is not known if the incidence seen in these clinical studies is or is not affected by treatment.


Hypersensitivity side effects including allergic reactions have been reported frequently. Allergic reactions have included skin redness, blisters, hives, rash, dyspnea, and wheezing. Pregabalin should be discontinued immediately in patients with these symptoms. Anaphylactoid reactions have been reported rarely.


Hematologic side effects including ecchymosis have been reported frequently. Anemia, eosinophilia, hyperchromic anemia, leukocytosis, leukopenia, lymphadenopathy, and thrombocytopenia have been reported infrequently. Myelofibrosis, polycythemia, decreased prothrombin, purpura, and thrombocytopenia have been reported rarely.


Dermatologic side effects including pruritus have been reported frequently. Alopecia, dry skin, eczema, hirsutism, skin ulcer, urticaria, and vesiculobullous rash have been reported infrequently. Angioedema, exfoliative dermatitis, lichenoid dermatitis, melanosis, petechial rash, purpuric rash, pustular rash, skin atrophy, skin necrosis, skin nodule, Stevens-Johnson syndrome, and subcutaneous nodule have been reported rarely.


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