Fact & The FDA (No clinical Studies or Human Trials on Autistic Adults)

I am on a mission seeking justice for my only son Paul Gerard Victorian jr who passed away February 22, 2013, and to advocate for those Autistic Adults who don’t have a voice. They are being administered two dangerous prescription medication RISPERDIAL & ABILIFY. Both of these medications are being given to Autistic Adults and are not FDA approved for Autistic Adults disability. RISPERDIAL &ABILIFY are two antipsychotic medications that are prescribed for the treatment of Schizophrenia, Bipolar disorder, manic depression, and on November 2009 ABILIFY was approved by the FDA for pediatric patients with Autism, that part of a treatment program. But, healthcare providers, psychiatrist, and doctors are prescribing this dangerous drug to “Autistic Adults”; these medications that they are pushing on our low functioning; non verbal Autistic Adults is unjust. They don’t know what is being done to them; they trust their parents and caregivers. Parents and caregivers are being told lies, by the doctors, pharamaceutical company etc. My son paid the ultimate price, he passed away from a cardiac arrest at age 25 from a side effect of the antipsychotic medication ABILIFY, that was not FDA approved for Autism in adults.

In the United States all pharmaceutical product must be tested and approved by the Food and Drug Administrator (FDA) of the United States Government. Before that product can be distributed and sold. The process incorporated sufficient pre-clinical data to support preceding the involvement of human trials. In our case this didn’t happen. I want all families and caregiver to know this medication was not approved for autistic adults. They should be advised of the need for closer observation and communication while taking any medications. Most autistic adults don’t have a voice and I’m gone to speak for them.

 What we uncovered was the warning about ABILIFY that it is an Antipsychotic medication used only for the treatment of schizophrenia, bipolar, depression and Autism in pediatrics with irritability that part of a treatment program. It was alarming. We then look up the pharmaceutical company clinical studies and we astonished to find out that it was not FDA approved for Autistic Adults, There were no Clinical studies or human trials on Autistic Adults so how do they know the effect of this medication. 

 The FDA has a black box warning and precautions in elderly people with dementia, Alzheimer or related psychosis, can cause sudden death and cardiac arrest. On was autistic and if you look at a list of neurological condition and disorder (Brain disorder / degenerative brain disease) you will see that Alzheimer, AUTISM. Dementias are in the same family, and the list goes on. A number of medical conditions can cause psychosis, including prescription drugs, degenerative brain disease, infection that affects the brain. They should include Autism in that Black box warning, they have one clinical study on file now date February 22, 2013 and the patient was my son Paul G Victorian jr. Finding it causes sudden death, cardiac arrest death in Autistic adults as well.

 ABILIFY & RISPERDIAL are both “Antipsychotic” Medication, Kids born with Autism are not psychotic. My son was not psychotic, he was not schizophrenia, he was not bipolar, he was not manic depressive, he was not a kid with irritability of autism, and He was an Adult with autism who passed away at 25 years old from a direct result from the antipsychotic medication ABILIFY. Paul’s sudden death/ cardiac arrest were from the side effect of ABILIFY. That this big 3.2 billion dollar pharmaceutical company failed to warn Autistic adults, Parents & Caregivers about, nor did the Big Pharmaceutical Company do any clinical test or human trials on Autistic Adults.

 The FDA has a black box warning and precautions in elderly people with dementia, Alzheimer or related psychosis, states it can cause sudden death and cardiac arrest. My son was an autistic adult, and if you look at a list of neurological condition and disorder (Brain disorder / degenerative brain disease) you will see that Alzheimer, AUTISM. Dementia is in the same family, and the list goes on. A number of medical conditions can cause psychosis, including prescription drugs, degenerative brain disease, infection that affects the brain. They should include Autism in that Black box warning, they have one clinical study on file now date February 22, 2013 and the patient was my son, his name was Paul G Victorian jr. They need to record his clinical studies and human trials, because it causes sudden death, cardiac arrest death in Autistic adults as well. Those are in the same neurological family as Dementia & Alzheimer. I ask why they made a medication that changes the brain, when they have abnormalities already.  

 Fact#1 there are currently NO MEDICATION FOR THE TREATMENT OF AUTISM!

Facts #2 ABILIFY & RISPERDIAL was not FDA approved for Autistic Adults, disability, No clinical studies or human trials and they are administering this medication to non verbal autistic adults without voices who can’t communicate. Or telling you what they are feeling and going through. And it wasn’t approved for their disability

Fact #3 ABILIFYis an antipsychotic medication, it work by changing the actions of chemical in the brain. It state this medication he was one is used to treat psychotic conditions such as schizophrenia, bipolar, manic depression, and On November 24, 2009 according to Reuters article: FDA approved fro pediatrics patients with autism part of a treatment program.

Fact #4 ABILIFY states it may cause heart failure, sudden death, or pneumonia in older adults with dementia-related psychosis condition. (Note: Autism is in the degenerative brain disorder family along with Alzheimer, dementia and other brain disease)

Fact #5 it is important for physician to follow vital signs, weight, metabolic laboratory, and study blood glucose, lipids, and electrolytes, renal/level functions. Concerns about the adverse effects are high and risk exists.  (The doctor who prescribe this didn’t do any of this, he called in the medication and raised his dosage twice without and lab work, and he seem the weight increase)

Fact #6 Patients treated with antipsychotic (first or second generation) medication experienced an increased incidence of fatality.

Fact #7 Patients and there families need to be warned about the risk and educated about how to identify early signs, IT states that PATIENTS NEED TO BE MONITORED and the drug must be stopped at the earliest sign of changes.

Fact #8 because of the serious side effects of antipsychotic it is important to closely monitor a patient using the, It also states the Patient should regularly see a therapist or doctor to keep track of symptoms and keep them at bay.

Fact #9 According to the new study at VanderbiltUniversityschool of Medicine,  the highly popular class of drug known as atypical significantly increased patient risk of suffering from a heart attack. My son died from cardiac arrest

Fact #10 Last important facts it states hat this medication can cause elevated blood pressure, elevated blood sugar, elevated cholesterol and severe obesity. It also states that that all this can cause direct harm to the function of the heart. Overall it’s a prescription for cardiac arrest/ sudden death.

FACT #11 my son was an Autistic adult who entrusted his parents with his life, and we trusted a doctor, who neglected our cries for help, then dropped my son as a patient.

 The pharmaceutical company that produces this dangerous drug “NEVER” did any clinical studies or human trials on adults with Autism. They were approved for Autistic kids in November 2009, with behavioral and irritability problems that are part of a treatment program. I don’t want any autistic adult or their families to suffer like mines are. Please I ask you read my story. My son paid the ultimate price.

 I want the FDA to pull these drugs because families and caregivers are not aware that theses medications are not approved for Autistic Adult, They are using our young adults as guinea pigs. We need systematic changes to be made immediately before someone else’s child die in there arms. The FDA job is to place guidelines, rules for these drugs companies to ensure safety of our medications and that all drugs are subjected to proper testing and clinical trials. The Pharmaceutical companies don’t care about the harm that this product is doing as long as it’s making money. This Pharmaceutical Company made billions of dollars selling these products and doctors are pushing it on to our young adults.  Most Autistic adults, who are low functioning, are nonverbal and have communications challenges and some don’t have a voice, my son didn’t. But I promised him over his casket that mommy will speak for him. This last year has been a struggle because I can’t get any help. My baby Paul asked for help the day he took his last breath, and he said Dad help! This is killing my husband because he couldn’t save his one and only son. Now I ask you, close your eyes and picture your one and only son or child saying Mom or Dad help then fall unconscious never to wake up or open there eyes, then be told your son passed away. No, I will NEVER give up seeking justice for my son… God bless you for taking out time and reading this. We need help on this long journey of justice….

 We want the world to know what is happening to Autistic adults with out voices, they can’t speak for them self and society throw them away in group homes or mental institution. I am advocating for change and I hope it start with you… Please help spread the word or if possible refer us to an attorney who cares about justice and change, and not about the money aspect. My one and only son is gone, he was innocent, sinless and he was mines. I will never rest until I receive justice for Paul. A promise I made to him standing at his casket.

Per the FDA Drug & Research December 5, 2013 Letter : in the 75 page pamphlet they sent me, it further proved the Pharmaceutical company the makers of ABILIFY Page 45 of 75 Clinical Studies part, it states Clinical Studies 14.1 Schizophrenia Adult Studies; it also states clinical studies on pediatric patients.Clinical Studies 14.2 Bipolar Disorder Adults studies, Monotherpy studies, Adjunctive therapy, and Pediatric Patients study. These studies are relating to Bipolar disorder.Clinical studies 14.3 Adjunctive Treatment of Major Depressive Disorder the study was only on Adults. Clinical studies 14.4 Irritability associated with Autistic Disorder: PEDIATRIC PATIENTS ONLY! It goes on to say in a 8 week placebo-controlled trials, in pediatrics patients (6 to 17 years of age) who met the DMS-IV criteria for autistic disorder and demonstrated behavior such as tantrums, aggression, self- injurious, behavior etc. My son was not a pediatrics patient with any of these problems he was an adult with autism that was non verbal. The FDA only approved this irritability in autistic pediatrics, but it is being pushed on autistic adults who have some dementia related psychosis. Dementia, Alzheimer, Autism is all brain disorder in the neurological family. Autism is a brain abnormality, and you placed this drug on the market for autism when they NEVER did any studies for autistic adults. The FDA said I should contact an attorney.

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