Paxil is an antidepressant drug that has been prescribed for millions of children and teenagers who are suffering from depression. Since the early 2000s when a study was published stating the drug was safe for this age group, it has been a fundamental treatment option for many doctors working with adolescents. However, a new report has been published refuting the earlier study’s claim.
Paxil Not Safe for Kids and Teens
The new study reviews the clinical trial data from 14 years ago. The results revealed that teens had a greater risk of certain side effects from taking Paxil, which included suicidal tendencies. The new analysis reveals 11 of the 275 young adults in the study had thoughts of suicide or self-harm, whereas the original study only reported five incidents of suicidal thoughts or thoughts of self-harm. Another aspect of the study that was not widely discussed was that the study revealed Paxil had no more of an impact on treating depression in adolescents in a positive way than the placebo given to the test group did.
This report is not the first indication that Paxil isn’t safe for children and teens. The U.S. Food and Drug Administration investigated the drug in 2002 and advised doctors the following year not to prescribe it for depression in teens. The manufacturer of the drug, GlaxoSmithKline, was fined $3 billion in 2012 for marketing Paxil for unapproved uses. The manufacturer was also cited for failing to report the safety information to the agency.
Concerns with the Original Trial
A study must have its objectives approved by a board, but in this case, it appears that the study reported on modified versions of its objectives. Events that occurred during the study, such as suicide attempts, were not reported correctly. GSK has since provided additional data and 77,000 pages, which were not included in the original findings, for the new research. This additional data resulted in the new study revealing different findings that indicate Paxil is not safe for use with teenage patients.
What this means for doctors, patients, and their families is an increased awareness of the dangers of the drug. Paxil is the only medication of its kind to be prescribed for depression, but other types of medication do exist for the treatment of depression. A doctor should weigh the severity of the depression with the dangers of Paxil and monitor patients more closely.
Parents and patients should be informed of the potential benefits and the potential risks before taking the drug. Parents and patients are now aware of the risks of Paxil. They should watch for side-effects and they should not assume these side-effects are symptoms of the depression. Any side-effects should be reported to the doctor immediately.
It is the responsibility of the drug manufacturer to provide adequate warnings of the risks for taking the medication. When a company fails to do so, it puts patients at risk. In this case, the impact can have life-threatening effects. If you or a loved one has taken Paxil and suffered side effects, you may be eligible for compensation in a personal injury or wrongful death lawsuit. It’s important to meet with an attorney who will review your case and provide legal advice on your situation.
Contact a New Orleans Defective Drug Attorney
The dangerous drug attorneys of The Olinde Firm want to help you and help your family recover compensation if you or a loved one has been injured by a dangerous drug. Contact our office at (504) 587-1440 or 1-800-587-1889 to schedule a free legal consultation with a New Orleans defective drug attorney. Our attorneys represent clients in Louisiana and throughout the United States.