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Sparlon ADHD Drug - FDA Goes Through The Motions

By       Message Evelyn Pringle     Permalink
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Some of the top-selling drugs of all time are those prescribed to treat attention deficit disorders. Drug companies have physicians in every field of medicine pushing these medications and dole out millions of dollars worth of free samples each year to make sure they are passed out like candy.

A new ADHD drug is set to come on the market that supposedly can keep people awake for days at a time with no problems. Just what we needed, especially for hyper little kids.
I wonder if this means they will remain calm as they sit wide-awake watching TV and playing video games for days while the rest of the family sleeps.

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The drug Sparlon is manufactured by Cephalon and is a clone of Provigil, another drug already on the market. Sparlon contains modafinil, the same exact active ingredient contained in Provigil which is approved for the treatment of patients with narcolepsy, sleep apnea and shift work sleep disorder, according to the FDA.

The drug 's approval will be considered by the FDA 's Psychopharmacologic Drugs Advisory Committee at a public hearing scheduled for March 23, 2006.

The day before the Sparlon hearing, the FDA 's Pediatric Advisory Committee is scheduled to meet to discuss neuropsychiatric adverse events and cardiovascular adverse events reported on patients who were treated with ADHD stimulant drugs already on the market.

The drugs under review include Ritalin from Novartis, Adderall and Adderall XR from Shire Pharmaceuticals, Concerta from Johnson & Johnson, and generic versions of Ritalin.

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On February 9 and 10, 2006, the FDA 's Drug Safety & Risk Management Advisory Committee held hearings on the same topic, and after reviewing the information provided at the hearing, the panel recommended that black box labels be added to the labels of all stimulants.

However, the FDA is not bound by the recommendations of its advisory panels, and critics of the drugs say the close 8-7 vote by the panel, means there will be spirited debate within the agency over whether black box labels will be added.

Several members of the panel said they voted for the warning in part, because they were alarmed over the sharp rise in prescriptions written for both children and adults. During the hearing, the committee was informed that between 1999 and 2003, roughly 78 million prescriptions were written for children under the age of 18, and 14 million more were written for adults.

In a stark contrast, only 190 million prescriptions were issued for children and adults during the 12 year period between 1992 and 2004.

According to the FDA numbers on adverse events, between 1999 and 2003, there were 25 deaths reported for persons using ADHD drugs, and 19 were children. The agency also acknowledged that more than 50 cases of cardiovascular-related events were reported in the same time period including stoke, heart attack, hypertension, palpitations and arrhythmia.

Critics say the numbers revealed at the hearings represent a gross understatement because only 1% to 10% of adverse reactions are ever reported to the FDA, and it would therefore be better to add a black box now and remove it later if studies prove there is no link between the stimulants and sudden death and heart disease.

Supporters of the drugs, say the warning is based on inconclusive evidence and would deter physicians from prescribing the medications and scare patients away from taking the drugs.

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Because Cephalon claims Sparlon should not be classified as a stimulant, analysts predict the company could get a boost if the FDA agrees and requires the other drugs to carry a black box warning. One of the issues discussed at the March 23, hearing will likely be how to distinguish Sparlon 's labeling from other ADHD drugs.

If approved, Sparlon will be co-marketed under an agreement with Johnson & Johnson, which will focus on the pediatric market through its McNeil Consumer & Specialty Pharmaceuticals unit.

McNeil 's sales team will promote Sparlon to psychiatrists, pediatric neurologists and pediatricians, while Cephalon 's 400-person sales force will focus on non-pediatric specialists and primary care physicians.

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Evelyn Pringle is a columnist for OpEd News and investigative journalist focused on exposing corruption in government and corporate America.

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