|
Side Effects: Mother Says Drug Spurred Son's Suicide
Monday, May 19, 2008 - 05:43 PM Updated: 11:11 AM
To watch video online please click here to download the latest version of the Flash plugin.
Sometimes we're willing to accept the bad with the good. The doctor prescribes you a pill that will knock out that head cold, but throughout the healing process can come dizziness, drowsiness, maybe even more headache.
But within the fine print of some prescription drugs can be big-time dangers you may not even realize.
A Lowcountry mother allowed us to share this message through her painful story.
Back in February, Zach Langan, a 15-year-old scholar at Battery Creek High School chose to end his life by stepping in front of a cement truck traveling a busy highway. He left a note behind.
Zach was four months into taking Lamictal, a drug prescribed to treat his seizures for Epilepsy. His dosage increased about a week before his death. Ironically, that's also when the Federal Drug Administration released serious warnings about 11 antiepileptic medications, including Lamictal. After an in-depth study, the FDA alerted health professionals about an increased risk of suicidal thoughts and behaviors in patients who take these drugs to treat epilepsy, bipolar disorder, migraine headaches and other conditions.
Zach’s mother, Chris, believes this was no coincidence and that her son’s death was fueled entirely from that medicine.
"He was always in the right place. He was always where he was supposed to be, until that morning,” Langan said.
A mother wants to hold on as long as she can. But with those teenage years comes a little bit of letting go and hoping they'll remember all the goodness you shared.
"He wasn't your typical teenager. He never experienced with drugs or alcohol. My son was so loved. He had so many friends. Zach was not an unhappy teenager without a reason to live,” Langan said.
But February 7th, something told him he had reason to die.
"The only explanation I can find for the morning my son died is the medication,” she said.
Four months shy of his death, the optimistic teen who shared dreams of one day becoming president started his treatment for epilepsy. His mother, a nurse, kept a close watch.
"I actually did a lot of research on it. I didn't see anything about suicide in any of the research that I read. The first time that I became aware of it was a week before he died,” Langan said.
That's when the FDA issued a warning citing a study where patients receiving antiepileptic drugs had approximately twice the risk of suicidal ideation compared to patients receiving placebo.
"So I called him into the living room and I said, 'Hey, Zach, I just heard this on TV.' And he said, 'I’m good Mom, I'm good.' I said, 'Okay honey, if anything changes, you need to tell me.' But he never did,” Langan remembered.
“There are definitely times when there are no signs that someone may be ready to commit suicide or about to commit suicide,” Dr. Shannon Drayton, Assistant Professor at MUSC said.
Drayton, who works with students at the Medical University of South Carolina's Institute of Psychiatry called this a sticky issue.
"Unfortunately, with Epilepsy, it's not something we have a cure for yet and so patients have to be treated,” Drayton said. “And with all the medications, there are 11 that have the warning on them now and all of them eventually may have this warning. You know, there's really not a lot clinicians can do but educate their patients about the warning signs of suicide and risk factors."
But Dr. Bryant Welch says one of the greatest risk factors is how patients often react to the warnings.
"Yes, the medication will put some people at increased risk,” Welch said. “But the problem is, there are a lot of people it will but at a decreased risk. So, it's not a reason not to use the medication. It's a reason to use the medication with greater awareness, and to stay in close contact with your doctor about any changes."
Chris Langan's greatest hopes, though, are that other parents will notice changes before it's too late and they'll see this as a reminder to never really let go.
"I do want to tell every parent. Hug your child like it's your last hug,” Langan said.
Both the FDA and Lamictal's maker Glaxo-Smith-Kline refused our on-camera interview requests. But both wrote us their reaction to the study's findings.
GSK said "Our own analysis of clinical trial data with Lamictal showed a similar trend but the actual numbers were too small to draw conclusions."
An FDA spokesperson says, "The FDA will work with manufacturers of marketed anti-epileptic drugs to include information about the increased risk of suicidal thoughts and behaviors in the labeling of these products."
The FDA says it anticipates that labeling changes will be applied broadly to the entire class of drugs. They plan to address this again in July, we'll be sure to follow what decisions they make.
Suicidality and Antiepileptic Drugs
FDA ALERT [1/31/2008] - The FDA has analyzed reports of suicidality (suicidal behavior or ideation) from placebo-controlled clinical studies of eleven drugs used to treat epilepsy as well as psychiatric disorders, and other conditions. These drugs are commonly referred to as antiepileptic drugs (see the list below). In the FDA’s analysis, patients receiving antiepileptic drugs had approximately twice the risk of suicidal behavior or ideation (0.43%) compared to patients receiving placebo (0.22%). The increased risk of suicidal behavior and suicidal ideation was observed as early as one week after starting the antiepileptic drug and continued through 24 weeks. The results were generally consistent among the eleven drugs. Patients who were treated for epilepsy, psychiatric disorders, and other conditions were all at increased risk for suicidality when compared to placebo, and there did not appear to be a specific demographic subgroup of patients to which the increased risk could be attributed. The relative risk for suicidality was higher in the patients with epilepsy compared to patients who were given one of the drugs in the class for psychiatric or other conditions.
All patients who are currently taking or starting on any antiepileptic drug should be closely monitored for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.
This information reflects FDA’s current analysis of available data concerning these drugs. Posting this information does not mean that FDA has concluded there is a causal relationship between the drug products and the emerging safety issue. Nor does it mean that FDA is advising health care professionals to discontinue prescribing these products. FDA intends to update this document when additional information or analyses become available.
The following is a list of antiepileptic drugs* included in the analyses:
Labeling and approval history from Drugs@FDA.
• Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
• Felbamate (marketed as Felbatol)
• Gabapentin (marketed as Neurontin)
• Lamotrigine (marketed as Lamictal)
• Levetiracetam (marketed as Keppra)
• Oxcarbazepine (marketed as Trileptal)
• Pregabalin (marketed as Lyrica)
• Tiagabine (marketed as Gabitril)
• Topiramate (marketed as Topamax)
• Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)
• Zonisamide (marketed as Zonegran)
* Some of these drugs are also available in generic form.
But within the fine print of some prescription drugs can be big-time dangers you may not even realize.
A Lowcountry mother allowed us to share this message through her painful story.
Back in February, Zach Langan, a 15-year-old scholar at Battery Creek High School chose to end his life by stepping in front of a cement truck traveling a busy highway. He left a note behind.
Zach was four months into taking Lamictal, a drug prescribed to treat his seizures for Epilepsy. His dosage increased about a week before his death. Ironically, that's also when the Federal Drug Administration released serious warnings about 11 antiepileptic medications, including Lamictal. After an in-depth study, the FDA alerted health professionals about an increased risk of suicidal thoughts and behaviors in patients who take these drugs to treat epilepsy, bipolar disorder, migraine headaches and other conditions.
Zach’s mother, Chris, believes this was no coincidence and that her son’s death was fueled entirely from that medicine.
"He was always in the right place. He was always where he was supposed to be, until that morning,” Langan said.
A mother wants to hold on as long as she can. But with those teenage years comes a little bit of letting go and hoping they'll remember all the goodness you shared.
"He wasn't your typical teenager. He never experienced with drugs or alcohol. My son was so loved. He had so many friends. Zach was not an unhappy teenager without a reason to live,” Langan said.
But February 7th, something told him he had reason to die.
"The only explanation I can find for the morning my son died is the medication,” she said.
Four months shy of his death, the optimistic teen who shared dreams of one day becoming president started his treatment for epilepsy. His mother, a nurse, kept a close watch.
"I actually did a lot of research on it. I didn't see anything about suicide in any of the research that I read. The first time that I became aware of it was a week before he died,” Langan said.
That's when the FDA issued a warning citing a study where patients receiving antiepileptic drugs had approximately twice the risk of suicidal ideation compared to patients receiving placebo.
"So I called him into the living room and I said, 'Hey, Zach, I just heard this on TV.' And he said, 'I’m good Mom, I'm good.' I said, 'Okay honey, if anything changes, you need to tell me.' But he never did,” Langan remembered.
“There are definitely times when there are no signs that someone may be ready to commit suicide or about to commit suicide,” Dr. Shannon Drayton, Assistant Professor at MUSC said.
Drayton, who works with students at the Medical University of South Carolina's Institute of Psychiatry called this a sticky issue.
"Unfortunately, with Epilepsy, it's not something we have a cure for yet and so patients have to be treated,” Drayton said. “And with all the medications, there are 11 that have the warning on them now and all of them eventually may have this warning. You know, there's really not a lot clinicians can do but educate their patients about the warning signs of suicide and risk factors."
But Dr. Bryant Welch says one of the greatest risk factors is how patients often react to the warnings.
"Yes, the medication will put some people at increased risk,” Welch said. “But the problem is, there are a lot of people it will but at a decreased risk. So, it's not a reason not to use the medication. It's a reason to use the medication with greater awareness, and to stay in close contact with your doctor about any changes."
Chris Langan's greatest hopes, though, are that other parents will notice changes before it's too late and they'll see this as a reminder to never really let go.
"I do want to tell every parent. Hug your child like it's your last hug,” Langan said.
Both the FDA and Lamictal's maker Glaxo-Smith-Kline refused our on-camera interview requests. But both wrote us their reaction to the study's findings.
GSK said "Our own analysis of clinical trial data with Lamictal showed a similar trend but the actual numbers were too small to draw conclusions."
An FDA spokesperson says, "The FDA will work with manufacturers of marketed anti-epileptic drugs to include information about the increased risk of suicidal thoughts and behaviors in the labeling of these products."
The FDA says it anticipates that labeling changes will be applied broadly to the entire class of drugs. They plan to address this again in July, we'll be sure to follow what decisions they make.
Suicidality and Antiepileptic Drugs
FDA ALERT [1/31/2008] - The FDA has analyzed reports of suicidality (suicidal behavior or ideation) from placebo-controlled clinical studies of eleven drugs used to treat epilepsy as well as psychiatric disorders, and other conditions. These drugs are commonly referred to as antiepileptic drugs (see the list below). In the FDA’s analysis, patients receiving antiepileptic drugs had approximately twice the risk of suicidal behavior or ideation (0.43%) compared to patients receiving placebo (0.22%). The increased risk of suicidal behavior and suicidal ideation was observed as early as one week after starting the antiepileptic drug and continued through 24 weeks. The results were generally consistent among the eleven drugs. Patients who were treated for epilepsy, psychiatric disorders, and other conditions were all at increased risk for suicidality when compared to placebo, and there did not appear to be a specific demographic subgroup of patients to which the increased risk could be attributed. The relative risk for suicidality was higher in the patients with epilepsy compared to patients who were given one of the drugs in the class for psychiatric or other conditions.
All patients who are currently taking or starting on any antiepileptic drug should be closely monitored for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.
This information reflects FDA’s current analysis of available data concerning these drugs. Posting this information does not mean that FDA has concluded there is a causal relationship between the drug products and the emerging safety issue. Nor does it mean that FDA is advising health care professionals to discontinue prescribing these products. FDA intends to update this document when additional information or analyses become available.
The following is a list of antiepileptic drugs* included in the analyses:
Labeling and approval history from Drugs@FDA.
• Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
• Felbamate (marketed as Felbatol)
• Gabapentin (marketed as Neurontin)
• Lamotrigine (marketed as Lamictal)
• Levetiracetam (marketed as Keppra)
• Oxcarbazepine (marketed as Trileptal)
• Pregabalin (marketed as Lyrica)
• Tiagabine (marketed as Gabitril)
• Topiramate (marketed as Topamax)
• Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)
• Zonisamide (marketed as Zonegran)
* Some of these drugs are also available in generic form.











digg it
Save This Page