Parents: Why You Should NEVER Let Your Child Take Lamictal for Depression or Mood
When the psychiatrist recommended that my 12-year old son D. start Lamictal® for depression and mood, like any good parent, I asked about the risks. I was told: “the only risk is what is called ‘Lamictal rash,’ a mild rash. If it shows up, we take him off of the drug, and the rash goes away in a few days.” That sounded like a low risk, and I agreed to his starting the medication.
As a patient advocate, however, I was way off my game. I mistakenly trusted the psychiatrist, and I didn’t do my own research. And three weeks later, my son and I learned the hard way why I should not have trusted the psychiatrist, and why I should have done more due diligence.
Lamictal — generic name lamotrigine — is a medication that has FDA approval for use in treating epileptic and other seizures, and in treating bipolar disorder in adults over the age of 18.
For children, Lamictal is used off-label — which means that the drug is being used in a manner and for a purpose not specified in the FDA’s approved packaging label — to treat depression and mood issues.
Many psychiatrists regularly prescribe Lamictal off-label to children, despite the fact that the FDA-approved prescribing instructions state specifically:
“Children and Adolescents (less than 18 years of age): Safety and effectiveness of Lamictal® in patients below the age of 18 years with mood disorders have not been established.”
But this is minor, compared to the fact that the prescribing instructions for Lamictal feature a “black box warning.” A black-box warning is the FDA’s strictest and most serious warning, and outlines adverse effects — set apart in a black box — to call attention to serious or life-threatening risks of the drug.
Here is the text of the FDA black box warning for Lamictal®:
WARNING: SERIOUS SKIN RASHES
Lamictal® can cause serious rashes requiring hospitalization and discontinuation of treatment. The incidence of these rashes, which have included Stevens Johnson syndrome, is approximately 0.8% (8 per 1,000) in pediatric patients (2 to 16 years of age) receiving LAMICTAL as adjunctive therapy for epilepsy and 0.3% (3 per 1,000) in adults on adjunctive therapy for epilepsy. In clinical trials of bipolar and other mood disorders, the rate of serious rash was 0.08% (0.8 per 1,000) in adult patients receiving Lamictal as initial monotherapy and 0.13% (1.3 per 1,000) in adult patients receiving Lamictal as adjunctive therapy. In a prospectively followed cohort of 1,983 pediatric patients (2 to 16 years of age) with epilepsy taking adjunctive Lamictal, there was 1 rash-related death. In worldwide postmarketing experience, rare cases of toxic epidermal necrolysis and/or rash-related death have been reported in adult and pediatric patients, but their numbers are too few to permit a precise estimate of the rate. Other than age, there are as yet no factors identified that are known to predict the 16 risk of occurrence or the severity of rash caused by Lamictal. There are suggestions, yet to be proven, that the risk of rash may also be increased by (1) coadministration of LAMICTAL with valproate (includes valproic acid and divalproex sodium), (2) exceeding the recommended initial dose of LAMICTAL, or (3) exceeding the recommended dose escalation for LAMICTAL. However, cases have occurred in the absence of these factors. Nearly all cases of life-threatening rashes caused by LAMICTAL have occurred within 2 to 8 weeks of treatment initiation. However, isolated cases have occurred after prolonged treatment (e.g., 6 months). Accordingly, duration of therapy cannot be relied upon as means to predict the potential risk heralded by the first appearance of a rash. Although benign rashes are also caused by LAMICTAL, it is not possible to predict reliably which rashes will prove to be serious or life-threatening. Accordingly, LAMICTAL should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug-related. Discontinuation of treatment may not prevent a rash from becoming life threatening or permanently disabling or disfiguring.
I desperately wish I had done a search on Lamictal before letting my son start the drug. Because three weeks after he started the drug, he developed what was seemingly a benign case of conjunctivitis — also known as pink eye — an inflammation of the eye. He was treated with eye drops.
But the next day, his eyes looked worse, he felt achy and feverish, and he developed what appeared to be a cold sore on his mouth. There are angels, and one of them was the very astute nurse, who saw my son and immediately suspected that he had developed Stevens Johnson Syndrome. She called the psychiatrist to demand immediate approval to take him off the Lamictal, and said he needed to go to the ER immediately.
The ER doctor confirmed a diagnosis of Stevens Johnson Syndrome, a life-threatening disease, triggered by certain drugs — including Lamictal — that can cause lesions on all the external and internal mucous membranes. In some cases, this immune attack progresses to Toxic Epidermal Necrolysis (TEN), where the skin essentially dies, and all or part of the skin can slough off. At that point, patients need to be treated like third-degree burn patients, and are at risk of septicemia and death. If they survive, they often require disfiguring skin grafts. Stevens Johnson Syndrome can also attack the corneas of the eyes, and can result in partial or full blindness, and lifelong vision and eye problems.
At his point, my son was developing a rash on his face, his chest, his back, his hands, his feet, and dozens of lesions were appearing in his mouth, down his throat, and on his lips. We had no idea what course the Stevens Johnson Syndrome would take, but after briefly researching the condition, I was terrified.
My patient advocacy background finally started kicking in, and I reached out to a dear friend and colleague, Teri Cochrane, a superb holistic nutritionist, who offered a great deal of advice on how to calm a raging immune system. I also contacted my friend of several decades, renowned patient advocate and author Julia Schopick, founder of the patient advocacy site Honest Medicine. More miracles were on the way, because Julia happens to be friends with Jean McCawley, the founder and executive director of — drum roll please — the Stevens Johnson Syndrome Foundation! Jean’s harrowing story of her infant daughter’s battle with Stevens Johnson Syndrome is told brilliantly in Julia Schopick’s book, Honest Medicine. I was able to speak with Jean, who gave me a thorough briefing and rundown on the course of Stevens Johnson Syndrome, what to expect, questions to ask, and treatment options. She gave me a crash course on the condition, and fully prepared me to advocate for my son. Jean created the SJS Foundation after her infant daughter suffered a serious case of SJS that left her with partial blindness and disabilities. Jean’s selfless mission is now to spread the word, help prevent SJS, support SJS sufferers, and make sure that patients and their families know their options.
We moved my son from a smaller regional medical center to a larger hospital that had a full pediatric unit, as well as a burn unit, in case he developed TEN. At the hospital, my son was admitted to the pediatric unit, and given an IV. By that point, less than 48 hours since the onset of the eye irritation, his mouth, throat, and lips were filled with more than 70 open sores. He was unable to even open his mouth, and his eyes were swollen. The boy lying listlessly in the bed bore no resemblance to my handsome son.
The doctors told us that we needed to wait to see how the Stevens Johnson Syndrome would progress.
Jean from the Stevens Johnson Foundation had suggested that I reach out to one of her advisers, Dr. Bernard Cohen, a professor of Dermatology and Pediatrics at Johns Hopkins University. I was able to speak by phone with Dr. Cohen, who further armed me with a wealth of information on treatment options, criteria for discharge from the hospital, and more. Dr. Cohen compassionately and patiently explained everything I needed to know to better advocate for my son. He was encouraged that the nurse had identified the condition so early, and withdrew him from the drug. He said that this was an important factor in halting progression of Stevens Johnson Syndrome.
Over the next several days, the whites of D.’s eyes became blood red, his vision blurry, his face swelled, and dozens of lesions showed up on his face. More lesions appeared on his torso, hands and feet. But the worst were the mouth lesions. If you’ve ever had a cold sore or canker sore inside your mouth, you know how painful that can be. My son had more than 70 in his mouth, down his throat, on his gums, and all over his lips. He couldn’t eat, and could barely drink a sip of water. He required round-the-clock pain medication, including periodic doses of morphine via his IV, to get his pain level down from a 10.
At that point, because he did not progress to TEN and the life-threatening skin sloughing, my son’s case was declared to be “mild” Stevens Johnson Syndrome. That’s a medical term. “Mild” Stevens Johnson essentially means that you are not going to be left fully or partially blind, permanently disfigured with skin grafts, or dead. We were told over and over again how “lucky” my son was to have “mild” Stevens Johnson Syndrome. This was said by medical professionals in front of my son, who, through swollen, cracked and lesion-covered lips, vehemently asked, “Do I LOOK ‘lucky’?”
My son was on an IV for seven out of his eight days of hospitalization. Multiple IVs were inserted over that time — painful even in the hands of skilled nurses. Like many Stevens Johnson Syndrome patients, he also developed a painful case of urethritis. He had painful dry eyes, with severe photophobia — light sensitivity — and had to have numerous painful and stinging eye drop treatments daily. Throughout his hospitalization, he was in pain, and was only able to drink, and eat a limited number of soft foods the last three days. By the time of his discharge, the skin on his lips had sloughed off entirely, leaving raw pink skin, which then scabbed over. For two weeks, including after his discharge, his lips would scab, crack, bleed profusely, slough off, and then start all over again. Even now, almost 3 weeks since his Stevens Johnson crisis started, he still has scabby patches on his lips that crack and bleed.
And THAT, fellow parents, is “mild” Stevens Johnson Syndrome.
My son still needs monthly followup with a corneal specialist for the next six months, to confirm that there is no permanent damage to his corneas or conjunctiva. At that point, we will know whether he is left with a lifelong case of chronic Dry Eye Syndrome as a result of his Stevens Johnson Syndrome. But otherwise, he has made a good recovery — NO thanks to his psychiatrist, or the greedy drug companies who downplay the risks their drugs pose to children.
MY ADVICE
FOR PARENTS: Unless it is a life and death situation and there is NO OTHER OPTION, I would caution you to NEVER let doctors prescribe Lamictal to your children.
FOR PSYCHIATRISTS: To my son’s psychiatrist, and to ANY psychiatrist who cavalierly puts children on Lamictal off-label for depression and mood:
Stevens Johnson Syndrome is not as rare as you are being told. Cases like my son’s “mild” Stevens Johnson Syndrome are being misclassified as “mild Lamictal rash” to downplay the actual risks. Even though it’s not a common occurence, I have a question: Can you live with giving a child a chronic lifelong condition, blinding them, disabling them, or killing them by prescribing an off-label drug with black box warnings, when there are other, safer alternatives not linked to Stevens Johnson Syndrome? Just for the record: If I were a psychiatrist, I know I COULD NOT.
And for the psychiatrists, again, here’s a reminder of what “mild” Stevens Johnson looks like.
RESEARCH! NEVER allow your children — or yourself — to be prescribed a drug without doing comprehensive research on the potential side effects. I will NEVER make this mistake again, believe me!
LEARN MORE ABOUT STEVENS JOHNSON SYNDROME. While Lamictal is one of the key drugs linked to the condition, there are a number of other drugs, including a number of antibiotics — and even over-the-counter pain medications like ibuprofen — that are known triggers.
REACH OUT FOR HELP. If I hadn’t reached out, I wouldn’t have had the support of Teri Cochrane, Julia Schopick, Jean McCawley, and Dr. Bernard Cohen, who all helped ensure a better outcome for my son.
THANK YOUR NURSES. According to Johns Hopkins’ Dr. Cohen, the nurse who picked up on my son’s Stevens Johnson Syndrome within 36 hours of symptoms, and ensured he stopped the drug immediately, was a true hero. I agree! Her quick action likely prevented my son from advancing beyond the so-called “mild” version of the condition, and potentially saved him from blindness, disfigurement, or even death. (From the bottom of my heart, thank you, Rose!)
IF YOUR CHILD IS ON LAMICTAL: One thing Dr. Cohen mentioned is that a common early Stevens Johnson Syndrome symptom in children is conjunctivitis–which is surprisingly not listed on the warnings. If you have a child on Lamictal and they develop conjunctivitis, seek rapid medical attention, and at that time, I also recommend you speak with your child’s doctor to have them stop taking the the medication immediately.
DONATE TO THE STEVENS JOHNSON SYNDROME FOUNDATION: The Stevens Johnson Syndrome Foundation is working to help prevent the condition, raise awareness, and provide support to families so they know the state-of-the-art treatment options. Every donation counts!
