Are Intuniv side effects something to be concerned with? A parent guide distributed by Shire Pharmaceuticals was criticized by the FDA’s Division of Drug Marketing, Advertising and Communication (DDMAC ). According to the DDMAC, the risk factors involved with taking this new drug were downplayed. This drug is not a benign one. It is important to know exactly what the Intuniv side effects are, and how they can affect a child.
DDMAC contacted Shire Pharmaceuticals and requested they stop giving out their Intuniv patient starter kit. This included a parent guide, ADHD support guide in office brochures and other info. The criticizing agency said the materials passed out featured a child in a monster suit, with before and after images. According to the DDMAC, it gave the impression that the drug will take care of behavior problems of children diagnosed with ADHD. The FDA asserted that this impression is not supported by science. In addition, Intuniv side effects were camouflaged in very small print.
The DDMAC also objected to the guide promoting the drug as “improving symptoms both night and day.” This, the DDMAC asserted, was misleading, and implies that Intuniv is effective for all 24 hours of the day. And some of the material did not even mention the risks associated with the drug. In fact, a brochure holder for the material claimed effectiveness for the drug without any mention of its possible hazards. Were the risks mentioned anywhere on this promotional material? Yes, on the back of the brochure holder, where no reader was ever likely to look.
And their criticism did not stop there. The DDMAC discovered that promotional material for this ADHD drug minimized the risks by not presenting them prominently, comparable with the claims of benefits. (Which were in large and colorful headers.) Where did the risk information appear? In a small font, single spaced, and most often, only at the end of each piece.
What are some of the Intuniv side effects? This drug is actually a long acting form of Tenex, a medicine used to treat high blood pressure. This explains some of the side effects associated with it. Some of these side effects are low blood pressure, low heart rate, fainting and sleepiness. Parents are advised to get medical help immediately if their child experiences any of these symptoms. In addition, a patient on this drug may also experience nausea, stomach pain and dizziness.
This is not the miracle drug Shire Pharmaceuticals would like you to believe it is.
The effectiveness of Intuniv, just beyond nine weeks of use, has not been established for children 6 years old. However, what is even more menacing, is that the safety of Intuniv beyond two years of treatment has not been established for children 6 years and older. And for children under 6, no safety or effectiveness of this drug has been established. The idea of putting young children on a drug originally designed to handle high blood pressure seems extreme, especially since the science of this drug is openly questioned by the FDA.
When parents are informed that their children exhibit ADHD symptoms, they may wish to choose to research non-drug treatments. The addition of fish oil to the diet (advised even by Pediatrics, the official journal of the American Academy of Pediatrics) can easily be tried. And eliminating white sugar from the diet may have excellent results. There are other recommended ways to handle ADHD without exposing a young child to intuniv side effects.