Antidepressants May Be Harmful to Children

FDA Issues Warning About Antidepressants

WASHINGTON D.C. — March 26, 2004 — Patients taking common antidepressants such as Zoloft, Paxil, and Prozac, should be closely monitored for adverse drug reactions, including suicidal behavior, increased depression, and violence, according to the Food and Drug Administration (FDA). The agency asked drug manufacturers to include stronger warnings on package inserts for these drugs (FDA Public Health Advisory, March 22, 2004). It also advised doctors to pay special attention to drug side effects when they first prescribe an antidepressant, change its dosage, or withdraw the medication.

Antidepressants may cause anxiety, panic attacks, insomnia, irritability, hostility, impulsiveness, severe restlessness, and mania. A patient’s medication should be discontinued, the FDA says, if any of these symptoms are severe, or were not part of the original problem. Drugs should be tapered off slowly because abrupt medication changes can be dangerous.

Although the FDA found evidence that prescription drug–induced symptoms may lead to increased suicide risk and depression, it plans to continue studying the issue. Researchers from Columbia University in New York will write a review for the agency by September, when another hearing will be held (Tucson Citizen, March 23, 2004).

Ten Drugs From Prozac to Wellbutrin

Ten drugs are involved in the FDA warning: Prozac (fluoxetine); Zoloft (sertraline); Paxil (paroxetine); Luvox (fluvoxamine); Celexa (citalopram); Lexapro (escitalopram); Wellbutrin (bupropion); Effexor (venlafaxine); Serzone (nefazodone); and Remeron (mirtazapine). Except for Wellbutrin and Remeron, these medications are in the category known as “selective serotonin reuptake inhibitors” or SSRIs.

Serotonin (5–hydroxytryptamine) is a neurotransmitter that is created in the central nervous system. A selective serotonin reuptake inhibitor or SSRI acts on serotonin to reduce its reentry into nerve cells, therefore allowing it to build up within the brain. This may help patients with depression, who are thought to have brains that are deficient in serotonin.

The list of manufacturers of these antidepressants reads like a “Who’s Who” in the medical drug world. The companies include Eli Lilly, Bristol–Myers Squibb, Pfizer, and SmithKline Beecham. This is big business—more than 157 million prescriptions for antidepressants were written in the United States in 2002, and the number may be increasing.

Approved Uses for Antidepressants

Prozac is the only antidepressant approved by the FDA to treat depression in children. Some physicians have prescribed antidepressants other than Prozac for teenagers and children, however, in the belief that the drugs are safe and effective. Because the FDA does not regulate the practice of medicine, doctors are free to use an FDA–approved drug in ways other than that indicated on the labeling.

The FDA has approved Prozac, Zoloft, and Luvox for treating children with obsessive compulsive disorder. The agency has approved none of the antidepressant drugs for use alone in treating manic depression or bipolar disorder, either in adults or children.

Bipolar disorder is characterized by alternating periods of extreme moods, from severe depression to high elation or mania. Prescribing only an antidepressant to a patient with bipolar disorder may increase his or her chances of becoming agitated and manic. Therefore, the FDA warns, doctors should screen patients carefully to find out if they are bipolar before prescribing an antidepressant. This warning should also be included on the antidepressant package insert, the agency says.

One of the antidepressants, Serzone, has been linked to liver failures and deaths. A consumers’ group, Public Citizen, has filed a lawsuit against the FDA, charging the agency with unlawfully failing to act on a petition to ban the drug. The lawsuit does not address the issue of possible increased suicides and depression from use of the drug. (See Consumer Group Sues FDA to Ban Antidepressant Serzone.)

Linking Children’s Suicides to Antidepressant Use

The latest FDA health warning follows an emotional FDA Advisory meeting in February in which physicians, epidemiologists, and the public offered testimony about depression. Parents spoke about children who had suffered serious injuries or committed suicide while taking antidepressants. Lisa Van Syckel’s 15–year old daughter, who had Lyme disease, was mistakenly treated for depression and put on Paxil. She became suicidal and violent, Ms. Van Syckel said. A 14–year old who was prescribed Effexor for her migraine headaches became self–destructive, violent, and angry. Some teenage suicides were linked to Zoloft and Paxil use.

Dr. Ann Blake Tracy, who had previously testified before the FDA Advisory Committee in 1991, again asked that the ten antidepressant drugs be banned. She expressed concern about prescribing them to children and the elderly, whose systems may be particularly sensitive. Two physicians, Dr. Irving Kirsch and Dr. David Antonuccio, questioned the therapeutic benefit of antidepressants for children. They said that good meaningful clinical results had not been demonstrated. Other physicians believed that the medications were necessary and helpful in controlling childhood depression.

In 1991, Dr. Cynthia R. Pfeffer reported on 20 controlled studies involving a total of 4,100 children taking antidepressants. The antidepressants included all those involved in the current FDA warnings except for Lexapro and Wellbutrin, which were not yet available. Dr. Pfeffer pointed out that the antidepressants appeared to increase suicidal thoughts and suicide attempts. At that time the FDA “could not rule out an increased risk of suicidality [suicide] for any of these medications.” Dr. Pfeffer again presented these studies at the FDA Advisory hearing in February 2004 (see Pediatric Depression and Its Treatment).

Opinions About the New Warning

As can be expected, the medical community and mental health advocacy groups were swift in expressing opinions about the new FDA health warnings. “It’s a step in the right direction because the better informed doctors and parents are, the better care kids get,” said child psychiatrist Harold Koplewicz, director of the New York University Child Study Center (Tucson Citizen, March 23, 2004). Vera Hassner Sharav, president of the Alliance for Human Research Protection, a New York patient advocacy group, commented “Doctors are going to be on the line not to prescribe [antidepressants] as if they were pacifiers” (Washington Post, March 23, 2004).

“I think psychiatric drugs are both over–prescribed and under–prescribed,” said Dr. Samuel Barondes of University of California at San Francisco. “A lot of psychiatric drugs are prescribed by doctors who are seeing patients for very short periods of time, and find it very easy if someone is complaining of some form of distress to give them just a prescription for Prozac or something like that,” he said. “Among that population are some people who should not be taking that drug.” (HealthWatch, March 22, 2004). Although he cautions that antidepressants can have serious side effects, he hopes that the FDA action does not unnecessarily scare away those who may benefit from some of these antidepressants.

Dr. Eva Ritvo, an associate professor of psychiatry at the University of Miami, agreed. “A depressed patient needs to be watched closely, particularly in the initial stages of treatment or when the dosage is raised.” She went on to say, however, that “...untreated depression is dangerous and takes a huge toll on people’s lives, and we can only hope this warning doesn’t discourage people from seeking treatment” (New York Times, March 24, 2004).

At Brayton Purcell, we are concerned about the safety and effectiveness of both prescription and over–the–counter medications. Although the FDA oversees the drug manufacturing process, we have seen that the agency’s approval of a specific drug does not always guarantee that it is safe. In fact, the FDA may pull a harmful drug off the market after it has already caused significant damage to patients.

Individuals who have taken an unsafe drug may be at risk for serious health problems and should be medically monitored. If you have questions about your legal rights concerning medical drugs, please feel free to contact us at Brayton Purcell. We have been representing injured consumers and their families for over 20 years and are well–versed in medical/legal issues. There is no charge for an initial consultation.