FOCALIN package Insert Update- new side fx listed

[Guest guest]

Focalin is one of two pharmaceuticals on the Changing Minds Foundation's protocol. (the other is Prozac). I think people should be aware of this postmarketing information they are now admitting about Focalin (methylphenadate derivative like Ritalin), and now they have decided to include on the package insert. This must be pretty recent because the package insert at the FDA site is still dated 2004. The side effects they discussed but did NOT place on the package insert are of even more concern to me.

Liorahttp://www.dailyrx.com/news-article/adhd-medication-include-previously-excluded-side-effects-17835.html{http://www.dailyrx.com/news-article/adhd-medication-include-previously-excluded-side-effects-17835.html}(dailyRx) posted March 1, 2012

Earlier this month, the FDA reviewed the labels for ADHD medication and decided to add two new side effects to the drugs Focalin and Focalin XR.

Although the FDA panel also discussed adding [observed] side effects including depression, hallucinations and thoughts of suicide, the FDA decided not to include these events in the labeling of said ADHD medications.

Talk to your doctor about the best medication for ADHD

The two new side effects that will be included in the box label for Focalin and Focalin XR are angioedema,

a swelling of the skin, and anaphylaxis, an allergic reaction that may result in fatality. As of present, the FDA has not included any neuropsychiatric symptoms on the new drug labels, although the FDA did agree to continue monitoring the adverse effects of such drugs.

"Members raised concerns that many of the neuropsychiatric

symptoms were not included in the label — such as hallucinations, depression, suicidal ideation — and some members thought they should be considered for inclusion in the label," says Sandy Walsh, spokeswoman for the FDA.

Perhaps one of the reasons the FDA didn’t include these events was because it wants to make labeling uniform across this class of ADHD medications. {i.e. are they really saying that they left these observed effects quietly at the doorstep for bureaucratic conveniences?? Here http://www.drugenquirer.com/side_effects/methylphenidate/dexmethylphenidate/focalin.html (http://www.drugenquirer.com/side_effects/methylphenidate/dexmethylphenidate/focalin.html) it says Focalin is already containing a black box warning as a psychoactive stimulant, and classed in the same category as cocaine and morphine, because it is highly addictive! Liora}

The last time ADHD medication labels were reviewed was back in 2006 when

the FDA decided not to update the labels on ADHD medications.inset box: dailyRx talks about ADHD

ADD/ADHD

It is estimated that 5% of American adults, or 18 million people, are diagnosed with ADHD, and anywhere from 2% to 16% of school aged children

as well.

ADD/ADHD is one of the most common childhood mental illnesses and can last into adolescence and adulthood. Patients have difficulty focusing and paying attention, controlling behavior and impulsivity, and sometimes problems with learning and listening. The resulting behavior can make school and life at home very difficult for the patients and their families. It is believed that a combination of genetic predisposition and environmental factors cause it.end of article. all the Best in Health,Liora Pearlman , ModeratorMomFriend Me At Facebook! https://www.facebook.com/profile.php?id=546828969and, Please consider calling me at 5130 3931 or texting 139 1030 6022 if it is time sensitive.