Parker Waichman LLP Injury Alerts
PAXIL AND EFFEXOR Much Too Dangerous For Children and TeenagersFeb 1, 2004 When Prozac was first introduced in 1987, many adults with severe depression or other significant anxieties were given a second chance at leading a normal, happy, worry-free life. For the most part, Prozac delivered on its promises and its benefits seemed to outweigh its potential risks. Prozac’s success soon prompted the development of an entire group of additional drugs which also promised similar results. In recent years, we have even begun to see the development of drugs which are designed to treat specific types of depression and anxiety such as social anxiety and obsessive compulsive disorders.
With the exception of Prozac, the majority of these drugs have been approved for adults only. It was originally assumed that drugs of this nature were simply not suitable for patients under the age of 18 because of the risk of serious known and potentially unknown side-effects. It remains unclear why some doctors began prescribing different anti-depressants to their younger patients.
Children and adolescents are apparently becoming a growing percentage of antidepressant users. Between 1987 and 1996, the use of antidepressants by pediatric patients tripled with the greatest increase after 1991. By 1996, six percent (6%) of American children and teenagers were taking psychotropic medications, primarily antidepressants. The widespread use of antidepressants by children is probably the result of an uncontrolled national experiment in which prescribing physicians are often pediatricians or family doctors with little or no training in psychopharmacology.
Paxil and Effexor are two of the drugs that have been prescribed to minors with the hopes of effectively treating the symptoms of major depressive disorder (MDD). This initiative proved to be ill-advised, however, when it became evident that both drugs, which had worked well for adults, had no place in pediatric medicine. As compared to adults, adolescents are a bit more likely to become agitated or to develop a mania while taking serotonin reuptake inhibitors (SSRIs).
Paxil, manufactured by GlaxoSmithKline, Inc., is a selective SSRI used to treat depression, panic attacks, obsessive compulsive disorder, social anxiety disorder, and general anxiety disorders. SSRI’s work by helping to restore the balance of certain natural substances (neurotransmitters) in the brain. Side effects, which may come and go at any time during treatment, include nervousness, trouble sleeping, drowsiness, fatigue, weakness, nausea, vomiting, diarrhea, loss of appetite, dry mouth, sweating, dizziness, lightheadedness, and changes in sexual function.
When Paxil was first approved in the United States in 1992, it was not recommended for use by children or adolescents under 18. Sometime between then and now, however, that seemed to change. Although the FDA has not approved Paxil for the treatment of MDD or any other pediatric use, the FDA cannot regulate the practice of medicine by individual physicians. Physicians are still able to use a drug in ways other than originally intended on the labeling based solely on their professional judgment and not the pre-existing warnings.
Childhood depression is very different from adult depression. It has been difficult to show that antidepressants are as effective for children as they are for adults. Therefore, there are several major problems with prescribing a powerful drug like Paxil to a child or adolescent. The most significant risk associated with this age group is suicide. The evidence that Paxil was not a prudent choice for minors came after young patients began exhibiting suicidal behavior which their parents claim had not existed before the children began taking Paxil.
One parent actually watched as her daughter locked herself in a bathroom where she began swallowing bottles of pills. As she was being rushed to the hospital, the girl told her mother that she had no idea why she had tried to kill herself and that she was as confused and shocked by her behavior as her parents were.
A major problem with Paxil is that it cannot be abruptly stopped once a course of treatment with it has been started. In fact, Paxil has been linked to more reports of withdrawal symptoms than any other drug in clinical history. The withdrawal symptoms can be extremely dangerous, especially in younger patients. Therefore, if a child is taking Paxil a physician should be consulted to establish and supervise a proper withdrawal plan.
Upon receiving reports that children und 18 years of age were being given Paxil, studies were conducted in both the United Kingdom and the United States. Among the 1,100 children enrolled in clinical trials of Paxil, those taking the drug were nearly three times as likely to consider or attempt suicide as those taking placebos. Moreover, in three well-controlled clinical experiments with children under 18 with MDD, Paxil did not work any better than a placebo in the treatment of the disorder. Clearly, in such a situation, the enormous risks far outweighed any possible benefits.
In response to these findings, the British Medicines and Healthcare Products Regulatory Agency (MHRA) issued a warning which urged doctors not to prescribe the drug to children. Then, in October of 2003, the FDA issued a Public Health Advisory regarding reports of suicidal tendencies in pediatric patients. The report emphasized that of the seven drugs evaluated for the treatment of pediatric MDD, Prozac remains the only one which has been demonstrated as effective in children less than 18 years of age. Significantly, even Prozac was not approved for this kind of usage until 2003.
Even the manufacturer admits that Paxil should not be used to treat pediatric patients. In July of 2003, GlaxoSmithKline issued a letter to health care professionals which, among other things, stated that Paxil should not be used in patients under 18 until further information was made available. The letter also included information about the studies conducted which proved that Paxil did not show greater efficacy than placebo for MDD in children and adolescents.
Although the company was taking responsibility for their product by drafting the aforementioned letter, GlaxoSmithKline has previously been accused of manipulating data to downplay the suicide risk of Paxil. However, Glaxo is not the only pharmaceutical company to be suspected of such questionable business practices in an industry where the truth often has a difficult time making its way to the surface. In this case, there remains the additional, and quite serious, problem posed by physicians who continue to prescribe Paxil and other powerful antidepressants to their younger patients.
Clearly, Paxil is not a proper choice for pediatric patients no matter how severe their depression might be. It must be regarded as a powerful drug which, along with the other antidepressants such as Zoloft, Celexa, Lexapro, Luvox, and Effexor should only be taken by adults.
Effexor, or Effexor XR, manufactured by Wyeth, is a powerful serotonin and norepinephrine reuptake inhibitor (SNRI) used to treat depression by affecting the levels of serotonin and norepinephrine in the brain. Adverse reactions, found mostly in people simultaneously taking MAOI inhibitors, include tremor, myoclonus, diaphoresis, nausea, vomiting, flushing dizziness, hyperthermia, seizures, and death. Other side effects may include anorexia, constipation, dizziness, dry mouth, ejaculation problems, impotence, insomnia, nausea, nervousness, sleepiness, sweating, weakness, impaired judgment and motor skills, and elevated blood pressure. Clearly, Effexor is not a drug to be taken lightly even by adults. Effexor is extremely similar to Paxil in many ways and therefore most of the information listed above applies here as well.
Effexor was first approved in 1993. Wyeth apparently warned doctors that tests revealed Effexor caused an increased risk of suicidal behavior in children. The long lasting version of the drug, Effexor XR, was found to cause hostility and suicide-related events such as suicidal ideation and self-harm. No children in the tests actually committed suicide. Two percent (2%) of patients taking Effexor reported thoughts about suicide as compared with no reports (0%) in the placebo group. The same percentage also displayed hostility.
The caution regarding Effexor appeared only after the regulations on Paxil were released in the UK and the United States. Effexor should no longer be prescribed to pediatric patients. In addition, any patients under the age of 18 already taking the drug should not abruptly terminate its use, but should consult their physician immediately. While in adults the withdrawal symptoms associated with Effexor are not quite as severe as those experienced with Paxil, pediatric patients often react differently and, thus, withdrawing from Effexor may pose greater risks when a child or adolescent is involved.
In August of 2003, Wyeth, in a maneuver similar to that of GlaxoSmithKline, issued a letter to health care professionals informing them of the aforementioned study involving long-lasting Effexor XR. The letter also indicated that the benefit-risk balance for pediatric patients should be assessed carefully and that any patients under the age of 18 taking Effexor should be monitored closely and any change in their behavior reported immediately.
A 14-year-old girl named Jame Tierney was prescribed Effexor to ease migraines. It worked for about 8 months but then her migraines worsened. At that point, her neurologist doubled the dosage she was taking. Within two weeks, her parents watched as her personality changed drastically. She was angry, combative and just generally unhappy and depressed. She contemplated killing herself and then made one attempt to cut her wrists. It was until almost a year before her mother learned that Effexor was an antidepressant, not a headache drug, and that it was unapproved for minors. Jame stopped taking the drug, even though her neurologist warned her about the withdrawal symptoms. Although her personality returned to normal, she suffered severe withdrawal symptoms which included vomiting, headaches, muscle aches, and disequilibrium and she was forced to stay home from school for months. She eventually began taking vitamin and enzyme supplements, her symptoms dissipated and her headaches now rarely return.
Jame’s story is worrisome for a number of reasons. First: She was given a powerful antidepressant drug as a treatment for migraine headaches. Second: The dosage was doubled when the headaches worsened. Third: A drug which was meant to cure depression in adults actually made Jame experience depression when she had never been a depressed person. Fourth: Physicians are too quick to prescribe certain powerful drugs to children and adolescents. Fifth: It is extremely important for parents to research and understand as much as they can about the drugs that are being prescribed to their children. (See last month’s Newsletter regarding Accutane).
The important thing to remember about Paxil and Effexor is that theses drugs were never approved for pediatric use. Even in the most extreme cases of child or adolescent depression, the only drugs which should be considered as appropriate are the ones which are safe and have been specifically approved for use by minors. At this time, the only antidepressant which seems to fit these criteria is Prozac. Eventually, there will undoubtedly be additional options for treating MDD in children and adolescents. The key, however, is to not attempt to rush that day by forcing children to take powerful drugs designed for adults only. In the case of Paxil, Effexor, and several other antidepressants, the risks children and adolescents face are simply not worth any benefit the drugs may provide.
Parents and guardians of children suffering from MDD or other psychological disorders must be well-informed about which drugs have been approved specifically for pediatric use and the risks associated with those drugs as well as with drugs which are intended for use by adults. Parents are encouraged to ask questions of their child’s doctors concerning the drugs he or she is prescribing. Our children are much too precious to be the subject of some misguided or ill-advised presumption by any doctor that it is acceptable to experiment with prescription drugs.
If your child is currently taking Paxil or Effexor, you should immediately contact a qualified physician to plan a monitored course of withdrawal from the drug. If you suspect that your child has suffered any injury as a result of having taken either Paxil or Effexor, please contact Parker & Waichman for a free case evaluation.