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FDA finds increase in suicide symptoms for patients using seizure medications

Rating

4 Star

FDA finds increase in suicide symptoms for patients using seizure medications

Our Review Summary

The focus of this story is recently published data showing a slight increase in the absolute risk of suicide and suicidal symptoms in patients treated with certain anti-seizure medications compared with placebo.  The story appropriately provides context for this new information–and educates the health consumer in the process by presenting this data in both relative and absolute terms.  However, the story could have been improved by giving info on how often these medications are prescribed and/or how common the illnesses are.

The story is well-balanced. A range of clinicians, caregivers and pharmaceutical spokespeople are interviewed.  Regarding the latter, the story notes that findings from pharma-sponsored research were either more positive, or similar to that of the FDA’s review. The interviews in this story provide context for the increased risk of suicidality, and help patients weigh the risks and benefits of taking these medications. 

The focus of the story is a potential harm of anti-seizure medication, namely, an increased risk of suicidal thoughts or behaviors. The story does not note other, less serious harms of these drugs. These can include weight gain, mental confusion and an upset stomach.  The story notes only newer pharmacological treatments. No other treatments are discussed.  The story might have been enhanced by giving more info on alternative treatments along with their pros/cons.  

While cost is not the focus of the story, it is important information, especially for epileptic and bipolar patients who often take medications for life.  The drugs under discussion are fairly expensive drugs (approximately. $150-200/month for newer drugs); however, there are older, less expensive medications that might work as well for some people. 

 

Criteria

Does the story adequately discuss the costs of the intervention?

Satisfactory

The story does not mention the average cost of these drugs.  This is important information, especially for epileptic and bipolar patients who often take medications for most of their life.  

The drugs under discussion are fairly expensive drugs (approximately. $150-200/month for the newer drugs). There are older, and less expensive medications that might work as well for some people. 

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The story mentions cons of not treating epilepsy with anti-seizure meds. You want to be able to balance the benefits against the potential harms. The story does not note the number needed to treat to prevent a seizure, or similar consumer-friendly data. This information would be useful in light of the FDA review, especially for patients considering stopping these drugs, and for patients thinking about the the long-term benefits.

Does the story adequately explain/quantify the harms of the intervention?

Satisfactory

The focus of the story is a potential harm of treatment, namely, an increased risk of suicidal thoughts or behaviors. The story notes the risks are greater for epileptics than for those taking  the same medications for psychiatric conditions or for chronic pain. The story does not note other, less serious harms of these drugs, which can include weight gain, mental confusion and an upset stomach. Discussion of other side effects would be useful information if patients are considering the full risks and benefits of taking this class of medication over the long-term.

Does the story seem to grasp the quality of the evidence?

Satisfactory

The story does an excellent job describing the FDA review and explaining both the relative and absolute data. This helps the consumer make a more informed decision when weights the benefits and risks of certain anti-seizure medications.

Does the story commit disease-mongering?

Satisfactory

The story does not engage in disease-mongering.   The story would have been improved by giving info on how often these medications are prescribed AND/OR how common the illnesses are.

Does the story use independent sources and identify conflicts of interest?

Satisfactory

The story does a good job citing a range of clinicians, patients and pharmaceutical spokespeople.  Regarding the latter, the story notes that findings from pharma-sponsored research were either more positive, or similar to that of the FDA’s review. The interviews in this story provide context for the new information; however, Dr. Nierenberg makes a blanket statement about the risks not outweighing the benefits. For some of these drugs, the benefit in bipolar disorder has not been shown.We are not told if Dr. Nierenberg or Dr. Harden receive pharmaceutical funding.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

The story notes some pharmacological treatments available for patients with epilepsy.  No other treatments are discussed.  The story might have been enhanced by giving more info on alternative treatments along with some pros/cons.  

Other available drug treaments include: phenobarbital, phenytoin, carbamazepine, valproate, gabapentin, lamotrigine, topiramate, levetriacetam, oxcarbazepine, zonisamide, felbamate.

Does the story establish the availability of the treatment/test/product/procedure?

Satisfactory

The story notes some pharmacological treatments available for epilepsy.  The story notes these same medications may also be used to treat chronic pain, mood disorders and headaches. The risks of suicidality are not as great in non-epileptics.

Does the story establish the true novelty of the approach?

Satisfactory

The focus is recently published data (http://www.fda.gov/bbs/topics/NEWS/2008/NEW01786.html) showing a slight increase in the absolute risk of suicide and suicidal symptoms in patients treated with certain anti-seizure medications compared with placebo.  The story appropriately provides context for this new information (and educates the health consumer in the process) by presenting this data in both relative and absolute terms, as well as citing a range of sources to provide clinical context.

Does the story appear to rely solely or largely on a news release?

Satisfactory

There is independent reporting and no evidence that information in this story is taken directly from a press release.

Total Score: 8 of 10 Satisfactory

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