Injury to Child Paxil 06/04/2003 New Jersey 14 Year Old Girl Becomes Suicidal & Violent : Lawsuit Summary:

Paragraph one reads [in part]: "for prescribing their 14-year-old daughter anti-depressants that allegedly caused her to become violent and suicidal".

http://www.c-n.com/news/c-n/story/0,2111,718588,00.html

Lawsuit: Anti-depressants harmed teen

By GIOVANNA FABIANO Staff Writer

Published in the Courier News on April 6, 2003

A Flemington couple are suing several doctors and four New Jersey hospitals, including Hunterdon and Somerset medical centers, for prescribing their 14-year-old daughter anti-depressants that allegedly caused her to become violent and suicidal. William and Lisa Van Syckel claim doctors misdiagnosed their daughter's condition and negligently prescribed anti-depressants, including Paxil, between April 2000 and April 2001, causing the girl to suffer "pain, discomfort and extreme emotional damage," according to the civil suit.

Also named in the suit are Summit Hospital; the University of Medicine and Dentistry of New Jersey; University Behavioral Healthcare; doctors Joseph Donnellan at Somerset Medical Center; Seung Lee at Summit Hospital; Ileana Bernal at University Behavioral Healthcare; and Robert C. Bransfield of Red Bank.

The Van Syckels are accusing the doctors and hospitals of medical malpractice and lack of informed consent.

Their daughter, who later tested positive for Lyme disease and Bartonella, was not properly evaluated, according to the suit. The drugs she was prescribed -- specifically Paxil -- were not approved by the Food and Drug Administration for use in children, the suit said.

Their claims coincide with those of some parent organizations and consumer groups who have complained that doctors prescribe anti-depressants to children and adolescents, even though many are not FDA-approved for children.

The groups also say too few studies have been done to determine if the medications are safe for that age group.

In January, Prozac became the first of the newer anti-depressants, called selective serotonin reuptake inhibitors -- also known as SSRIs -- to be approved by the FDA for use in children with depression.

The Van Syckels' suit claims that their daughter, now a senior at Hunterdon Central Regional High School, was an honor-roll student at St. John's International School in Waterloo, Belgium, until 1999, when her parents and younger brother returned to the United States after spending more than five years abroad.

After starting high school in the fall of 1999, Mrs. Van Syckel said her daughter was having trouble adjusting to life in Hunterdon County.

"She had come from a private school of 60 classmates to Hunterdon Central, where she had well over 500 classmates," Mrs. Van Syckel said.

"She kept complaining she was tired, she wasn't making friends fast enough, and she had never had that problem before."

In April 2000, after the teenager complained of shortness of breath, headaches and a loss of appetite, her parents took her to Somerset Medical Center in Somerville, where she was diagnosed with depression and anorexia nervosa and prescribed Zoloft. Donnellan gradually increased the dosage during the next two weeks.

The lack of informed consent charge relates to couple's claim that within hours of taking Zoloft, their daughter complained to doctors she was uncomfortable taking it, and she had the urge to hurt herself, but the information was allegedly withheld from her parents, Mrs. Van Syckel said.

During the next month, the girl continued to be admitted and released from Somerset and Hunterdon medical centers with symptoms of chest pain and vomiting and again was diagnosed with depression and anorexia.

After she was prescribed Paxil in late May 2000, her parents say she became nervous and anxious. At the first increase in dosage, she suffered abdominal pain, began to self-mutilate and became confrontational and verbally abusive, according to the suit filed in February in state Superior Court, Flemington.

The teen's physical and emotional problems became more severe, resulting in further increases in the Paxil dosage that summer. By Sept. 28, she attempted to kill herself, the suit said.

The self-mutilation and suicidal thoughts continued, with doctors prescribing other medications, including Prozac, Remeron and Celexa, until the end of April 2001, when Michelle tested positive for Lyme disease and Bartonella.

She is now being treated with antibiotics and has had no suicidal thoughts or depression symptoms during the past two years, her mother said.

"The bottom line is that her suicide attempts started when she was taking Paxil, and these drugs are not approved for the use in children," said Mrs. Van Syckel, who has become a self-proclaimed child advocate since her daughter's ordeal.

"There is no data available stating that long-term use is safe for the growing brains of children and adolescents."

Depression affects about 2.5 percent of children and up to 8.3 percent of adolescents in the United States, according to the National Institute of Mental Health. Symptoms can include feelings of worthlessness, difficulty sleeping and concentrating, depressed mood and loss of interest in activities.

Somerset and Hunterdon medical centers declined to comment on the civil suit, and Summit Hospital and UMDNJ did not return calls for comment.

Jennifer Potter -- a clinical assistant professor at Rutgers University's School of Pharmacy and a clinical pharmacist specializing in psychology at Princeton Medical Center -- said Paxil and other SSRIs wouldn't cause violent or suicidal behavior unless the patient had a history of bipolar disorder.

"As long as the medication is used for a specific indication -- for example, if she (the girl) was diagnosed with depression -- it's more than suitable. Antidepressants are also used in patients who may have weight issues because they can promote weight gain to increase appetite," Potter said.

"All of the drug companies for any antidepressant always suggest caution to be taken in patients who are suicidal. It's hard to determine whether suicidal behavior that exhibits itself after the drug is initiated due to the drug or due to the depression," she said.

But Donald Marks, an Alabama physician and former director of research at Hoffman Laroche, said SSRIs, which include Paxil, Zoloft, Prozac, Luvox and Celexa, have been associated with "problems with thought and judgment and also with aggression and agitation."

Marks specializes in the adverse effects of drugs and is familiar with the girl's case. He said physicians should refrain from prescribing anti-depressants to children and adolescents.

"It's a real problem because a child in the adolescent years has swirling emotions, and there are many demands and pressures placed on them, and in many cases, they need more time with their parents, counseling, and they need involvement in their community so they can grow up to be functional members in their society," Marks said.

"The last thing to do with a child is to put them on drugs, but doctors in general aren't aware that the SSRI group of medications can exacerbate these problems," he said. "Paxil can exacerbate mania, and somebody doesn't have to be bipolar to become manic as a result."

Although the couple are asking for an undisclosed amount of money, Mrs. Van Syckel said she believes it is her duty to make people aware of the dangers of antidepressants in children.

"We went through a horrible ordeal, and I almost lost my daughter. If I can save the life of just one child by coming out against these doctors and drug companies, it will be worth it," she said.

-Giovanna Fabiano can be reached at (908) 782-2300 or gfabiano@c-n.com.

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