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Pharma company may have downplayed side effects of autism drug

by  /  20 August 2015
Drug dilemma: Risperdal is one of only two drugs approved to treat children with autism, but it carries serious side effects.

Janssen Pharmaceuticals, the leading manufacturer of the widely used autism drug risperidone, omitted data on the drug’s side effects from a 2003 study, according to evidence presented during a lawsuit against the company.

Risperidone, marketed by Janssen as Risperdal, is one of only two drugs approved for autism. It was developed as an antipsychotic for adults with schizophrenia in 1993. Initially, it was not deemed safe for prepubescent children because it can boost levels of prolactin, a hormone that helps new mothers produce milk. Elevated prolactin levels are linked to a range of side effects, including gynecomastia, or growth of breasts, in men and boys.

However, a 2003 study backed by Janssen said it did not find a link between elevated prolactin levels in boys and gynecomastia or other side effects that could result from excess prolactin 1.

In 2006, the Food and Drug Administration (FDA) approved risperidone for easing irritability in children with autism, which may manifest as aggressive outbursts. But the FDA acknowledges that the drug can have dangerous side effects, including severe weight gain. The drug’s label includes a warning that some boys may develop gynecomastia.

In 2013, Janssen settled a lawsuit brought by the FDA for $2.2 billion. The lawsuit alleged that Janssen aggressively marketed Risperdal between 2002 and 2003 for unapproved uses, including in children with autism. A spate of individual lawsuits followed, including one from a now-20-year-old man with autism who grew size 46DD breasts after taking Risperdal between 2002 and 2006. In February, a Philadelphia jury awarded him $2.2 million.

Documents introduced as evidence against Janssen in this case include an early manuscript of the 2003 study that includes two data tables missing from the published version.

Dicey drug:

The study was designed to ferret out potential adverse effects of long-term risperidone use. A team of researchers from Janssen and elsewhere looked at data from 700 children who took risperidone. They reported that prolactin levels rose in these children over the first two months of treatment but returned to normal by five months.

The researchers reported some incidences of what they called SHAP, or ‘side effects hypothetically attributable to prolactin.’ These side effects include gynecomastia, but the study concluded that “there was no direct correlation between elevated prolactin and SHAP.”

The data in the tables introduced in the latest lawsuit directly contradict this finding.

Robyn Frenze, a spokesperson for Janssen Pharmaceuticals, says the company has “acted responsibly regarding informing physicians and patients about the risks and benefits of Risperdal” and plans to vigorously defend itself against claims made in the lawsuit.

Meanwhile, two independent researchers who conducted the study alongside scientists from Janssen have obtained the original data from Janssen. They have spearheaded a reanalysis by an independent biostatistician to see whether the study’s findings are misrepresented in the 2003 article.

“Based on the findings, we will decide whether the paper warrants full retraction, a partial correction or whether the original findings stand,” says one of the researchers, Robert Findling, director of child and adolescent psychiatry at Johns Hopkins University.

The newly surfaced tables show a statistical correlation between elevated prolactin levels and these side effects. According to an article in New Brunswick Today, a Janssen biochemist testified that these tables were never provided to the FDA.

“This is disheartening on many levels,” says Bryan King, professor of psychiatry and behavioral sciences at the University of Washington in Seattle, who was not involved with the study or the lawsuits. “Scientific misconduct is scientific misconduct. I honestly don’t see any difference between withholding something in a deliberate attempt to influence the findings and just making it up.”

Even a full retraction of the study may have no direct impact on risperidone use for autism. The drug’s side effects are widely recognized and included on the drug’s label. Most clinicians prescribe risperidone only when the benefits outweigh the risks, says Edwin Cook, professor of psychiatry at the University of Illinois at Chicago, who was not involved in the study or the lawsuit.

Still, the controversy weighs heavily on a field plagued by distrust of the pharmaceutical industry.

“We absolutely need to be able to work closely with drug companies to move the field forward,” says King. “Something like this tarnishes the industry and that’s very unfortunate, because we absolutely need to be able to work in an environment of trust.”

  1. Findling R.L. et al. J. Clin. Psychiatry 64, 1362-1369 (2003) PubMed
  • Jeenu

    And then the doctors were so ready to precribe it. Just goes to show at the end of the day, more
    pain and suffering to those already suffering and caged in autism world.

    • Karen

      My son was on this 10yrs he had man boobs and gained 6 half stone he stopped taking it had a physchotic eposide and hospilized 11months

  • Anonymous


  • Anonymous

    Thats the Big Pharma for you!

  • Lily B.

    I think that if we are not yet sure about all the causes of autism, doctors should not prescribe medication to treat autism, for all the side effects that these drugs cause.

    When I was diagnosed with asperger’s syndrome my psychiatrist ordered me to take antidepressants also sleeping pills and all I gained from taking those pills were side effects. Broken lips, sleep problems, tachycardia, and I felt more depressed…also once he prescribed me an antipsychotic because when I was talking to him, he could not understand me because I have trouble talking, then he prescribed me an antipsychotic. The next day after I took the pill I began to feel dizzy, nauseous, I could not even walk or eat because I had trouble coordinating my movements, I didn’t have that before taking that pill, then my father called my psychiatrist and told him what was happening to me, then the psychiatrist told me to leave the antipsychotic.

    I have not even received psychological therapy by my psychiatrist, he keeps saying (since a couple of years) that we will have the psychological therapy but every time I go to his office he only ask me if I cried in the last days and if my answer is yes, he increases the dose of antidepressants for me, or he prescribed me another antidepressant. That makes me feel tired, misunderstood and hopeless.

    • Tabitha

      Hi. See a psychologist or a counselor if you want talking therapy help the psychiatrists mainly just prescribe medication. I don’t believe us Aspies need to have psychiatrists prescribe us meds-they don’t help especially in the long term. Connect with fellow Aspies or some hobby group you like to help ease your loneliness. Do things like self care-eating well, getting enough nutrients, going for walks/other exercise, sunlight, fresh air, rest, positive supportive people in your life, sleep, having colorful items around you to brighten your mood, get rid of the negative things in your life. Things like chamomile tea to drink, lavender oil to smell, taking a bath/shower help to relax. Being Aspie has its difficulties but its good to know what that you are one now you know and can stop feeling like you have to fit in to something that isn’t you. There is things you can do to help reduce anxiety and depression, increase social skills, manage sensory issues. So look into it, treat the things that are bothering you in a more natural holistic positive way, connect with others similar to where you want your life to go and may your journey be peaceful and joyful and well. 🙂

      • Lily B.

        Hi, Tabitha

        Thank you very much for your suggestions. I really appreciate it. I will try and do all of these things.

        Best regards,
        Lily B.

  • kathy

    my son who is now 17 has been on various doses of Risperdone we see none of these side effects guess we are lucky

  • Nick

    My son was on it briefly his DR. Said Risperdol had minimal side effects I believed it until until my coworkers son began to grow breast after taking it. I had to send my son out of NY state to prevent the drug cartel big pharma and their paid off government workers from forcing me to medicate my son. It is getting scary between vaccines and prescription drugs being pushed 24/7 356 I am sick of it I hope more people are ready to stand up and say enough is enough ! I am ready !!!

  • Heather

    It’s really not fair to blame physicians for this. A good doctor reads research and ascertains from clinical trials whether a drug is safe and effective for clinical use. In the case of Risperdal the research was positive and it was approved by the FDA in 2006 indicating that it was safe. For some children the risk associated with aggression towards self and others may be greater than the dangers of weight gain and gynecomastia so it is up to parents and physicians to weigh out the risks versus the benefits together. The real culprits are the drug companies, who driven primarily by monetary gain, intentionally mislead those reading their research findings in order to make a quick buck. In cases of scientific misconduct all consumers of the research are victims (physicians, therapists, scientists, parents) along with the child since decisions made from this fraudulent information can be detrimental to the livelihood of a young person. This (unfairly) results in guilt and shame for the person who made the decision to use evidence-based practice when designing a treatment plan. There is no room in the medical, scientific or educational communities for this type of research and swift and decisive action should be taken if the investigation indicates the data were manipulated to make the drug appear safer and better to the community at large.

  • Sharie

    Gynecomastia is most definitely an unacceptable side effect. But there is little attention paid to the permanent side effects of neuroleptic drugs, namely a movement disorder called tardive dyskinesia. My daughter suffered all the symptoms of TD, all the while being dismissed by doctors who were brainwashed by the manufacturer into thinking it was a harmless “good” drug for kids with autism. Years after discontinuing Risperdal, she still struggles with tardive akathisia and tardive tourettism, making her life all the more difficult. Long range studies on the developing brains of children and use of antipsychotics is necessary.

  • Anonymous

    Why the hell would you give a child a powerful antipsychotic anyway? Today, children are on drugs left and right. The pill pushers (doctors) are getting kickbacks. It’s obvious. Or they wouldn’t shove them down their throats. UGH. The world of medicine SICKENS me! I don’t even want to be on my antidepressant, antianxiety and mood stabilizer (to make the antidepressant effective). So why would the kids want to be on this crap, or the parents allow them to be put on it??!!?? *sigh*

  • S

    Many autism spectrum children have methylation and detoxification genetic vulnerabilities that make it challenging to break down drugs. A good number of them have defects on the cytochrome P450 pathway. If these defects are serious, then the child would be labeled a “poor responder” and RIsperdal would be contra-indicated. The shame is that almost no psychiatrist would even know to order these tests, so many children/adults are given this drug when it could kill them.

  • anon

    Risperdal made me gain 20 pounds in one month and changed my metabolism (which was already low due to hypothyroid) for the worse. I was 120-130 lbs before Risperdal – no longer on it – now I am 214 lbs. I wish I could go back in time and never take this drug. Also, just went off WellButrin as I discovered it can cause the irritability I was experiencing. Furthermore, I might not have needed any psychiatric medicine if it weren’t for the Accutane prescribed for acne when I was 15 and 21. It was originally developed as a brain cancer drug that is essentially vitamin A toxicity inducing cell apopsis. Now years later a lot of people are having long-term side effects from Accutane such as pains in their bones. But no compensation for the sufferers as the legal system is rigged thanks to those in Congress are influenced by those who have the money (pharmaceutical corporations) and not to the citizens they are supposed to represent. PS. A possible side effect of the MMR and some other vaccines is encephalopathy (brain damage)that could manifest as autism (the encephalopathy affecting the speech/language, social, and even motor planning part of the brain.)

  • anon

    correction: Accutane depletes natural vitamin A

  • Ethyl

    Thank you, Jessica. We need to wake up.


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