According to “Big Pharma” healthcare website Drugs.com (Micromedex, Cerner Multum, and others), “It takes on average 12 years and over US$350 million to get a new drug from the laboratory onto the pharmacy shelf. Once a company develops a drug, it undergoes around three and a half years of laboratory testing, before an application is made to the U.S. Food and Drug Administration (FDA) to begin testing the drug in humans.”
But because it is much easier to obtain adults to volunteer for testing, many drugs, including most antipsychotic meds, conclude FDA approval over those 12 years using adult samples. “Only a few, very small studies have included children and adolescents.” (Antipsychotic Drugs for Children and Adolescents: What You Should Know; Consumer Reports”
This is despite the fact that most powerful medications can have side-effects in some of the patients; often, the medication does not provide <18 information. With antipsychotic meds, children and adolescents, compared with adult patients, suffer higher risks of Type 2 diabetes, extrapyramidal symptoms, and weight gain. “The weight gain is much larger than we thought,” said Christoph Correll, the study’s lead author, who is a psychiatrist and a scientist at the Feinstein Institute for Medical Research in Manhasset, N.Y. “It’s massive, and it’s the medication” that caused it, he said. “Cardiometabolic adverse effects, such as age-inappropriate weight gain, obesity, hypertension, and lipid and glucose abnormalities, are particularly problematic during development because they predict adult obesity, the metabolic syndrome, cardiovascular morbidity, and malignancy.” (Cardiometabolic Risk of Second-Generation Antipsychotic Medications during First Time Use in Children and Adolescents)
Because long-term, large sample-size studies are not available for adolescent use of antipsychotics, this report warns parents to investigate the prescribing doctor’s perspective and prescriptions which should include CBT, parent training, and knowledge about alternative, potentially generic, medications, as well as frequent checkups to assure minimum, effective dosage.
And then, there is a practice among doctors that is totally legal, that goes by the jargon “off label”; this FDA-flexibility to doctors allows them to prescribe medications outside the drug’s FDA approval. So many psychiatrists are experimenting with antipsychotic medications for substance abuse, anxiety, or other symptoms. Consumer Reports expressly cautions that only Abilify, Zyprexa, Seroquel/Seroquel XR and Risperdal (and generic alternative) are approved by the FDA for limited use with children.
If your child or teen is being recommended for one of these meds, ask questions, become well-informed. There are many doctors who have found success with many patients. As a parent, know the background and philosophy of your doctor.