The New York Times today is reporting about a study funded by the National Institute of Mental Health and reported in The American Journal of Psychiatry that drugs which are most often prescribed today to children suffering from schizophrenia, Zyprexa and Risperdal, are no more effective than the older, less expensive drugs used to treat this condition. More significantly, these newer drugs have been shown to be more likely to cause harmful side effects like rapid weight gain. In fact, it is reported that the children receiving Zyprexa gained so much weight that the government oversight panel monitoring safety during the study ordered that the children be taken off Zyprexa. The older drug used for comparison purposes was molindone. On average, those taking Risperdal gained about 9 pounds and those on Zyprexa gained 13 pounds. Both these groups also saw increases in cholesterol and insulin levels which are risk factors for diabetes. In contrast, those taking the older medication molindone gained less than a pound on average and had little changes in cholesterol and insulin levels. One 18 year old who was given Risperdal for several months gained 35 pounds.
The lead researcher on the study, Dr. Linmarie Sikich concluded that the guidelines for treating schizophrenia have to be changed so some of the older, more traditional medications are considered first line treatment. What is important to note is that more than 80 percent of prescriptions written for Zyprexa and Risperdal are not for schizophrenia, but for autism- related aggression, bipolar disorder or ADD issues which are not approved indications for uses of those drugs.
There are a few thoughts to take away from the results of this study. First, I have always believed that when taking medications, generally go for the one that has been on the market the longest because there has been time to really evaluate the potential adverse effects of the drug. It usually takes about 5 years or so for a drug to be on the market before the greater majority of the significant side effects can be seen. This is mainly because the amount of people involved in clinical studies used to get approval of the drug for sale is so small and selective that they can not truly evaluate problems with the drug in the general population. The other thing to be aware of is that many drugs are used “off-label” as is discussed above. In other words, doctors will prescribe the drug for conditions which have not been approved of by the FDA. You should question your doctor when he is prescribing medication about whether the condition for which he is prescribing it for is an “indicated” use or a use approved of by the FDA and addressed in the label for the drug. You shouldn’t necessarily refuse to take the drug if it is being given for a “non-indicated” use, but find out from your doctor the basis upon which he relies on prescribing the medication for the condition he is seeking to treat. Yes, trust your doctor, but don’t do it blindly. You need to ask questions and do your best to inform yourself about the medications he is prescribing for you and your family.
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