Is Risperdal A Dangerous Drug?
Despite its FDA approval, the scientists who have studied Risperdal still do not really know how it works. They know that it blocks the brain’s dopamine receptors to an extent and therefore, it may help certain people suffering from some psychiatric or psychotic conditions. However, they really do not know what sort of long term harms it might be causing.
We now know about some of the side effects such as gynecomastia and some of the dementia related deaths that have been reported. The jury is still out, however, as far as the impact on the brain as a whole.
This is a dangerous drug, and it needs to be prescribed on a limited basis only after other attempts have been made at controlling some of the manic behavior or bipolar disorders or schizophrenia. It should be used more as a second line drug after other attempts have been made to get those disorders controlled.
Risperdal Has Never Been Recalled Because Of Its Negative Side Effects
Certain lots were recalled in 2011 because of an odor that was most likely associated with a chemical preservative that may have been applied during the shipping process or perhaps it was a part of something else that was being shipped.
Those batches were recalled because the odor was causing some gastrointestinal problems when it was ingested. It was not though recalled as far as having no indication that the benefit would outweigh the risk. This medication is still being prescribed and sold today.
Risperdal Can Be Known To Be Addictive
The people at Johnson & Johnson or Janssen certainly say Risperdal is not addictive. They claim there really are no addictive effects, whereas someone who was on the medication would say it certainly is.
Whether the addictive properties were because of the placebo effect or whether the medication was actually triggering some sort of effect in the brain as far as addiction is concerned, people who use this drug usually say they feel like they needed it to get out of bed in the morning. This is something I have heard from many people.
Problems With Risperdal First Started Coming About In 2005
There was a boxed warning added in 2005 regarding dementia related deaths that had been reported. This was interesting because it really was not and is still not indicated for use in elderly patients having manic episodes related to dementia, although it was being promoted and sold for that use.
Unfortunately, a lot of elderly patients with dementia died because of complications associated with Risperdal. That was the first warning. The second somewhat public warning was in 2006. Duke University released a study regarding Risperdal and gynecomastia, which generally speaking is abnormal tissue development in the male breast.
The study from Duke University showed there was a stronger link between gynecomastia and Risperdal than any other psychotic medication. The study also showed that females were more likely to lactate before puberty if they were on Risperdal therapy.
Going forward, the first lawsuit was filed on behalf of a young boy who claimed to have developed gynecomastia as a result of Risperdal therapy. This was in late 2009 or early 2010 and that really got the litigation moving.
In 2012, the Department of Justice announced they were investigating Janssen and Johnson & Johnson for their illegal marketing of the drug. Eventually this culminated in a settlement with 36 states and the District of Columbia and a guilty plea as well as roughly $2.2 billion in fines and civil penalties in November of 2013.
There was a large civil penalty for the very aggressive, off-label marketing of Risperdal to minors and for dementia.
Serious Complications And Symptoms Can Start Showing Themselves Very Early On
People taking Risperdal can observe side effects very quickly, though it would vary on a case by case analysis. There was a study that may have been part of the Duke University study where a young man began appreciable abnormal tissue growth in his breast area and lactation a couple of weeks after using the drug.
These side effects can happen very quickly depending on the body’s ability to absorb the prolactin that is being produced as a result of the Risperdal stimulation, or it could take longer if the body was prepared to deal with that prolactin in a way that did not result in a gynecomastia or lactation.
Doctors Should Make People Aware Of The Issues Surrounding Risperdal
I would hope that a prescribing physician was aware of the Risperdal complications and aware of the huge $2.2 billion fine for off-label marketing.
I would also hope they had knowledge of the Duke study regarding gynecomastia that was done back in 2006. Ultimately, the physician would be the learned intermediary and the go-between between the pharmaceutical company and the patient.
It would be the physician’s responsibility to properly inform that patient of the risks and benefits of Risperdal and to make the decision with the patient whether this is the right drug for whatever ailment the patient had. Otherwise, the patient would never know.
People who are not lawyers generally do not know half the things that are going on in the drug and device world in regards to what could be dangerous according to clinical studies. Information like this does not just come across the plate of the average American consumer.
For more information on Dangers Of Risperdal, a free initial consultation is your next best step. Get the information and legal answers you’re seeking by calling (205) 871-9990 today.
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