Tarnow Articles

Paxil: Exploring The Controversies 

The antidepressant Paxil made news this June. Recent data from more than 1,000 pediatric patients revealed that the patients taking Paxil had double the incidence of suicidal thoughts and behavior compared to patients taking placebo. This information produced a chain of events:

• June 11, 2003 - The United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) issued an advisory that Paxil may increase the risk of self-harm in patients less than 18 years old. The statement read, "It has become clear that the benefits of [Paxil] in children for the treatment of depressive illness do not outweigh these risks." The warning did not extend to adults or to conditions other than depression in children.
• June 19, 2003 - The United States FDA advised that children and adolescents should not take Paxil due to elevated suicide risk. The FDA also recommended that patients do not stop the Paxil without contacting their physicians.

Paxil is classified as a selective serotonin reuptake inhibitor, or SSRI. Of all the SSRI's, Paxil appears to cause the most difficulty upon discontinuation. It can produce a withdrawal syndrome associated with agitation and anxiety, as well as a wide variety of other complaints. The physical complaints include symptoms such as abnormal dreams, dizziness, sensory disturbances, nausea, and sweating. The sensory disturbances have been described as "electric shock" feelings, numbness, or tingling. For most patients, these symptoms are quite annoying but self-limited and not life threatening. However, adding agitation and anxiety while a patient is depressed certainly creates additional problems. As a group, adolescents are challenging as they commonly resist medication compliance. They are the group most likely to stop or skip a dosage of prescribed medication. Therefore, the adolescents are the most likely group to develop withdrawal symptoms while they are still experiencing acute depressive symptoms. This could exacerbate the existing depression, potentially leading to an increase in suicidal thinking.

One problem that Child Psychiatrists are aware of with Paxil is a common side effect in children called "akathesia". This is a reaction to the sudden release of serotonin. Children will describe it like feeling they have "ants in their pants". They become more hyperactive and impulsive. They may do dangerous activities out of character for them. In our experience, children with biologic disorders like ADHD are more prone and sensitive to this side effect. If not treated, these children can get so agitated they may become suicidal.

Another situation that may lead to suicidal ideation with Paxil as well as the other SSRI's is using them with Bipolar patients. Antidepressants can precipitate Mania in a patient who has the genetics for Bipolar Disorder. This diagnosis is made by taking a careful history, but the manifestations of the disease may not have presented themselves yet in children. In our opinion, this is why it is so important that a Child Psychiatrist be involved in the decision to use psychiatric medications in children.

Although the data reported a 2:1 increase in suicidal ideations, no child or adolescent in the study actually committed suicide. This data also pertained only to patients taking Paxil with depression. An increase in suicidal thoughts was not reported in patients treated for anxiety or obsessive compulsive disorder.

Recognizing that withdrawal symptoms associated with Paxil were creating difficulties with patients, Glaxo-SmithKlein, the manufacturer of Paxil, has created an extended release version. Paxil-CR has a longer half-live, which greatly decreases the symptoms of medication withdrawal upon discontinuation. By changing from Paxil to Paxil-CR, a patient may have an easier titration and discontinuation process.

Despite this alarming data, Paxil remains an effective medication for treating a multitude of psychiatric symptoms including depression, social anxiety, panic disorder, obsessive compulsive disorder, and other anxiety symptoms. In many of my own patients, the depressive symptoms have responded to no other medication. Fortunately, the extended release version offers the benefit of Paxil with less side effects overall. In patients wishing to either continue or discontinue Paxil, I have found transitioning to the controlled release form beneficial.

In conclusion, all of the antidepressants can potentially cause side effects, which may exacerbate an existing problem. For this reason, close communication and follow up visits are extremely important upon initiation of treatment or making medication changes. For example, both Dr. Tarnow and I expect to see a patient within a month if a medication change is made. This applies especially to children and