I can understand Lundbeck doing this to a child considering its track record for killing and maiming children, but I can’t understand how the FDA could licence an addictive benzodiazepine (which incidentally can cause aggression and suicidal thoughts) for children as young as 2.
April 05, 2012
Mother Says Seizure Drug Blinded Her Son
GALVESTON, Texas (CN) – A mother claims in court that Lundbeck Pharmaceuticals’ seizure drug Clobazam blinded her 9-year-old son, made his skin slough off, and filled his mouth with blisters.
Kelly Gutierrez sued Lundbeck LLC, Lundbeck Pharmaceuticals Services LLC and H. Lundbeck, on behalf of her son, L.C., in Federal Court. Lundbeck A/S is a Dutch corporation; the other Lundbeck entities are based in Deerfield Park, Ill. “Clobazam is marketed under the names ONFI and Frisium by defendants,” according to the complaint.
According to the complaint, ONFI is a prescription medicine used along with other medicines to treat seizures associated with Lennox-Gastaut syndrome in people 2 years old or older. ONFI was approved for use in the United States in October 2011. Gutierrez says doctors prescribed ONFI to her son to treat his epilepsy/seizure disorder, and the drug was initially successful in controlling his seizures. “However, 3 weeks into the treatment, L.G.’s mother noticed a change in the color of the pigmentation in L.G.’s eyes,” the complaint states. “Several days later, after what looked like chicken pox developed all over his body, L.G. began having difficulty breathing and was taken to the emergency room.
“The next day, L.G.’s mouth filled with severe blisters. Just days later, L.G.’s condition had worsened to the point that he was air lifted to Shriner’s Burn Hospital in Galveston, where he was placed in the intensive care unit.”The surgeries began the next day. So far, L.G. has had four surgeries, including pig skin grafts to replace all the skin that has sloughed off. He now has stitches in his eyes, is blind, horribly disfigured, and suffers horrific pain on a daily basis. “Due to use of ONFI, L.G. developed Steven[s] Johnson Syndrome (SJS) that escalated to TENS (toxic epidermal necrolysis).
“SJS is a rare, serious disorder in which skin and mucous membranes react severely to a medication. SJS begins with flu-like symptoms, followed by painful red or purplish rash that spreads and blisters causing the human skin to die and shed. SJS is treated as a burn, which is why L.G. is currently being treated at Shriner’s in Galveston. “In December 2011, Defendants completed a study linking the use of Frisium to SJS and TEN. Despite having the information, no such information was passed on to medical professionals who might choose to prescribe ONFI to patients like L.G.” (Parentheses in original.)
Gutierrez seeks punitive damages for product liability, negligence and gross negligence.
She is represented by Anthony Buzbee.
Clobazam Adverse Events
Common adverse effects reported by patients receiving clobazam included somnolence, sedation, fever, drooling, constipation, cough, urinary tract infection, insomnia, aggression, fatigue, upper respiratory tract infection, irritability, vomiting, trouble swallowing, problems with coordination, bronchitis, and pneumonia.
The FDA warns that clobazam may increase the risk for suicidal thoughts or behaviors in a very small number of people. Patients taking antiepileptic drugs should be monitored for depression and unusual changes in mood or behavior. Link.
It’s not the first of Lundbeck’s drugs that can cause blindness in children; https://leoniefennell.wordpress.com/2011/05/31/vigabatrin-sabril-which-can-be-used-in-infants-can-cause-blindness-suicide-ideation-and-aggression/