Drug manufacturers are mandated by the United States government to pass the requirements of the Food and Drug Administration (FDA) before their products are sold to the public. The FDA inspect everything that is related to the making and use of the drug or medical devices to ensure public safety. Checking the safety of the drug and devices is a very important task and the agency has made guidelines on how to test the safety of these products. All the advantages and disadvantages of the products are laid out through the help of drug study but there are some information such as long term effects may not be available during the time of testing.
A post-marketing drug study is required after the drug has been approved to have a through sweep of information that may have been left out during the testing process. The adolescents and young adults who are under medications using selective serotonin reuptake inhibitors (SSRIs) were observed to be at high risk of having increased suicidal tendencies. Most of the young girls and boys taking them have tried killing or harming themselves when they felt that the urge was too much for them to bear.
Healthcare workers were advised by the FDA in their press release to monitor and inform the guardians and the patients themselves of the possible risks that they are exposed to. Drug manufactures of SSRIs were asked by the FDA to include a black box warning in their label to warn the public of the risks.This black box warning is the most severe form of drug labeling that may be given to any medications. The first four weeks of treatment remains the time when they have the strongest inclination to hurt themselves.
A study entitled “Treatment for Adolescent with Depression Study (TADS)” was even funded by the National Institute of Mental Health (NIMH) to understand the effects of using antidepressants in adolescent patients. Each person may have a unique experience while they are taking the drug, researchers believe. To be more effective, mental health experts combined psychotherapy and medications in their treatment. There are several news reports stating that parents of children who took Zoloft from different states are filing lawsuits against Zoloft.
URL References:
nimh.nih.gov/health/topics/child-and-adolescent-mental-health/antidepressant-medications-for-children-and-adolescents-information-for-parents-and-caregivers.shtml
fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108905.htm
fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/ucm100211.pdf
{ 0 коментара… прибавете свой сега }