Risperdal manufacturer admits lying about safety

[catatonic]

Johnson&Johnson/Janssen Pharmaceuticals is sending out letters to physicians and hospitals this week to let them know it lied about the safety of the anti-psychotic medication Risperdal. Janssen didn't bother to report that Risperdal poses a serious risk of FATAL side effects, as well as other potentially unpleasant outcomes such as stroke, diabetes, and boys with lactating breasts. Thanks a lot!

No, they're not doing this voluntarily out of concern for patient safety. They were ordered to tell the truth by the FDA.

You can read about it in Medical News Today:
www.medicalnewstoday.com/medicalnews.php?newsid=11204

And in the Washington Post:
www.washingtonpost.com/wp-dyn/articles/A12138-2004Jul24.html

The Washington Post article also mentions a federal whistleblower lawsuit filed against several drug manufacturers alleging that their aggressive marketing tactics are responsible for drug misuse that has harmed and even killed children. Specifically cited are Risperdal, Trileptal, Paxil, Topamax. (Pfizer recently settled a similar suit against its drug Neurontin -- which was used off-label for ADHD and bipolar -- for $430 million.)

There's a summary of the lawsuit here:
www.courttv.com/news/2004/0707/drugmarketing_ap.html

It's explained in much better detail here:
www.ahrp.org/infomail/04/07/07.html

[rosyred45]

I read the first 3 and had to stop reading the last, that is sickening to think that the drug companies work like that

I feel for the families of anyone dependant on medication to help them in any way, shape or form. My parents are both on blood pressure medicine and dad is on medication for controlling his sugar level.

It took the doctor 10 years to tell my mom, You could stand to loose a few pounds, and not need X and X for your blood pressure.....talk about being ticked off. I'll never go to him again.

[Amsmom]

I am fortunate to have an excellent child psychiatrist who has already informed me of these terrifying side effects. He has reassured me that the dose my ds is on is not enough to cause these horrifying effects. Still, putting my child on it was one of the hardest decisions I ever had to make. I pray that none of you ever have to go through the experience of pediatric bipolar disorder with your child. It is absolutely heartwrenching. When it gets to the point that anti-psychotics must be given to save your child from hurting himself, you have to make a painful decision, no matter how scared you are. Knock wood, my child is doing well and is closely monitored by his dr.

[GSDMommy]

no fun.....but I agree with Am's mom......there are sometimes you have to take the risks in order that the child may have the luxury to grow up and be a functioning part of society. If it weren't for risperdal, I don't know what I would be dealing with with my oldest. Having two bi-polar/ADHD boys, the anti-psychotics are sometimes the only way to reach them and keep them safe.
I think it is unconscionable that a drug company hides/obfuscates the truth about their product because in reality it will make more parents who's children are fine on it nervous enough to pull the kids off it anyway. They are shooting themselves in the foot !

One other question I had, they mention the lactating boys in Florida.....it would be interesting to know what other meds they were on with the risperdal. Rarely is risperdal going to be the only med , it isn't a first line anti-psychotic!

I hope the press isn't just making this into a news opportunity and will be a little more exploratory about this.

Hope no parents end up coming under fire for keeping their children on this med from people who think they are "saving" the kids from the "evil" parents who give the kids "bad" medicines........

What a complicated world, eh?

[stew4me]

Wow Kayley was on Trileptal for about a year or so. It infuriates me that people will do anything for a dollar.

[catatonic]

It infuriates me that people will do anything for a dollar.

Yep!! What REALLY REALLY burns me up is that we're forced to trust these drug companies to tell us whether our medications are safe. It can be very difficult to decide whether or not to use medication, or confusing to decide which medication to use, so we rely on our physicians' expertise...when they're being fed the same skewed information we are! How can you make an informed decision when you don't have accurate information? People die as a result of drug company lies and ommisions, but as long as revenues outpace lawsuits, they don't worry about it. (Viagra is a classic example of a drug whose fatal side effects were concealed until legal action forced the manufacturer to act, and even then they did it in a slimy, sneaky way, so that I bet most people outside the medical profession are not aware that hundreds of men died as a direct result of taking this drug!) You do have to take risks sometimes when choosing a treatment, but it's only right that we know accurately what those risks are!

[GSDMommy]

What I read in the articles, all of them....was that the omissions were in the promotional materials. The "scare sheets" that come with the meds were accurate as far as I read.

I think the people who are to blame more heavily in that case are the doctors....I sincerely hope that the doctors aren't making medication choices according to the "ads" they get! I'd like to think that most of the doctors make their minds up based on the pharmacology of the medication. Always ask questions of your doctor! If they can't answer the more in depth questions, check the med out on the internet !

[ohmama]

I think unless your doctor is a psychopharmacologist (a psychiatrist specializing in medicine) or one who takes the time to research these meds, that you run the risk of having your doctor prescribe meds according to the sales people they deal with.

From what I've seen it's like a big meat market mentality with some of these doctors. So many parents go into the doctors office and tell the doctor what to prescribe and the doctor will do it without hesitation. Is it because they don't know themselves anymore than the parent? It gives trial and error a whole new meaning.

[GSDMommy]

My family doctor won't mess with anything terribly complicated. She draws the line with an anti-depressant but if you have other meds, she refers to a phsychiatrist.

I have been blessed with good psychiatrists, the ones who prefer NOT to medicate kids and are known for being stingy with meds. They don't have a huge case load because people who are more likely to try to push for a med aren't going to automatically get it from them. I know there are lots of different types of doctors and styles of medicating....and each one works for different people.

The meat market environment is also the fault of the insurance companies who are maximizing their bottom line by forcing the pay outs lower and in some cases completely refusing payouts until people complain. The system isn't perfect, but I have no idea what would fix it :-(

Wonder what Canada has going for this situation?

[HooDunnit]

I don't quite see why this thread is in the support forum. I am going to see if it can be moved to the medication forum eventually.

In the case of the antipsychotics, I think that we should be thankful that the pharmaceutical companies have been able to develop them. I am sure that they have saved many lives.

As far as the news article is concerned, the pharmaceutical company that makes Risperdal failed to amend print information as they were required to do, with respect to side effects, etc. This is a serious omission for sure.