Depression Medication Users v Bristol-Myers Squibb Company (maker of Serzone)

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Depression Drug Can Damage Liver

The Dugan Law Firm is investigating possible legal actions against Bristol-Myers Squibb Company, the maker of the prescription antidepressant Serzone (nefazodone hydrochloride), to recover for liver damage and other injuries suffered by patients taking this drug. The actions allege that the manufacturer either knew or should have known that Serzone is associated with liver failure and other life-threatening complications. Accordingly, the actions assert that the drug is unreasonably dangerous.

According to the Los Angeles Times, eighteen cases of liver failure involving Serzone patients were reported to the federal Food and Drug Administration (FDA) from 1996 to June 2000. Several cases have been described in the medical literature. The FDA approved Serzone in December, 1994. Finally, on January 9, 2002, the FDA ordered a "Black Box" warning to be placed on Serzone packaging due to the liver injuries that have been reported.

In an article titled 'Nefazodone-induced liver failure: report of three cases,' a group of Cincinnati, Ohio physicians reported that three women, 16 to 57 years old, who were taking Serzone developed severe liver damage. Two of the women needed a liver transplant; the third was listed for transplantation but subsequently improved. The women had been taking Serzone for 14 to 28 weeks before the onset of symptoms. The physicians concluded that Serzone is unpredictable in terms of when it can cause liver damage.

One of these three patients, Alissa Robinson, who was only 15 when Serzone was first prescribed for her, has been profiled in an investigative report in the Los Angeles Times. She almost died, had a liver transplant, and now faces a lifetime of uncertain health and worry over how she will pay for her medical care. The newspaper's story reported that, when Serzone was approved, the Food and Drug Administration knew that it had not been shown to be safe for use in children and adolescents. While the manufacturer promised to research the effect of Serzone use on younger patients and to report the results to the FDA, no such results have been provided. The company now says it hopes to report results to the FDA 'in the early part of 2002.'

In a case report titled 'Reversible Nefazodone-induced liver failure,' physicians at the Medical University of South Carolina described a 46-year-old woman who came to the medical clinic with a 2-month history of fatigue. A liver biopsy revealed 'ballooning degeneration and necrosis of hepatocytes in zone III, as well as extensive mixed inflammatory cell infiltrates, with occasional eosinophils.' Four months after stopping Serzone, the woman's liver function tests had returned to normal. The physicians concluded that the woman's 'severe hepatocellular jaundice' was attributable to the Serzone.

In clinical trials before Serzone was approved, several other side-effects were noticed: dry mouth (25%), drowsiness (25%), nausea (22%), dizziness (17%), constipation (14%), weakness (11%), lightheadedness (10%), blurred vision (9%), confusion (7%) and abnormal vision (7%). [The percentages represent the frequency of the occurrence of a particular side effect in the trials.] Serzone also may cause a mood swing called hypomania. Symptoms of hypomania include euphoria, racing thoughts, pressured speech, and excessive energy.

The following side effects may also be linked to Serzone use:

Body as a Whole: Infrequent: allergic reaction, malaise, photosensitivity reaction, face edema, hangover effect, abdomen enlarged, hernia, pelvic pain, and halitosis. Rare: cellulitis.

Cardiovascular System: Infrequent: tachycardia, hypertension, syncope, ventricular extrasystoles, and angina pectoris. Rare: AV block, congestive heart failure, hemorrhage, pallor, and varicose vein.

Dermatological System: Infrequent: dry skin, acne, alopecia, urticaria, maculopapular rash, vesiculobullous rash, and eczema.

Gastrointestinal System: Frequent: gastroenteritis.Infrequent: eructation, periodontal abscess, abnormal liver function tests, gingivitis, colitis, gastritis, mouth ulceration, stomatitis, esophagitis, peptic ulcer, and rectal hemorrhage.Rare: glossitis, hepatitis, dysphagia, gastrointestinal hemorrhage, oral moniliasis, and ulcerative colitis.

Hemic and Lymphatic System: Infrequent: ecchymosis, anemia, leukopenia, and lymphadenopathy.

Metabolic and Nutritional System: Infrequent: weight loss, gout, dehydration, lactic dehydrogenase increased, SGOT increased, and SGPT increased. Rare: hypercholesteremia and hypoglycemia.

Musculoskeletal System: Infrequent: arthritis, tenosynovitis, muscle stiffness, and bursitis. Rare: tendinous contracture.

Nervous System: Infrequent: vertigo, twitching, depersonalization, hallucinations, suicide attempt, apathy, euphoria, hostility, suicidal thoughts, abnormal gait, thinking abnormal, attention decreased, derealization, neuralgia, paranoid reaction, dysarthria, increased libido, suicide, and myoclonus. Rare: hyperkinesia, increased salivation, cerebrovascular accident, hyperesthesia, hypotonia, ptosis, and neuroleptic malignant syndrome.

Respiratory System: Frequent: dyspnea and bronchitis.Infrequent: asthma, pneumonia, laryngitis, voice alteration, epistaxis, hiccup. Rare: hypertension and yawn.

Special Senses: Frequent: eye pain. Infrequent: dry eye, ear pain, abnormality of accommodation, diplopia, conjunctivitis, mydriasis, keratoconjunctivitis, hyperacusis, and photophobia. Rare: deafness, glaucoma, night blindness, and taste loss.

Urogenital System: Frequent: impotence. Infrequent: cystitis, urinary urgency, metrorrhagiaa, amenorrheaa, polyuria, vaginal hemorrhagea, breast enlargementa, menorrhagiaa, urinary incontinence, abnormal ejaculationa, hematuria, nocturia, and kidney calculus. Rare: uterine fibroids enlargeda, uterine hemorrhagea, anorgasmia, and oliguria.

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