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 FDA reports 51 deaths of attention drug patients By Lisa Richwine
 9 minutes ago

 Deaths of 51 U.S. patients who took widely prescribed drugs to treat
 attention deficit disorder prompted regulators to start watching for heart
 attacks, high blood pressure and other problems in 2004, a report released
 on Wednesday said.  

[Fred A. Baughman Jr., MD: Good, they're going to "start watching." Isn't that special. Clearly they are in bed with Big Pharma, tied to the lie that ADHD and all psychiatric disorders/chemical imbalances are actual diseases]

 The U.S. Food and Drug Administration staff did not say the drugs were
 responsible for the fatalities, but they urged close monitoring for "the
 rare occurrence of pediatric sudden death during stimulant therapy."

 "These reports themselves do not establish a causal relationship between
 these medications and cardiovascular adverse events," wrote Dr. Gerald Dal
 Pan, director of the FDA's Office of Drug Safety, in a separate notice on
 the agency Web site.

 The information was released one day ahead of an FDA advisory panel 
 on how best to study potential risks from the drugs, which include Shire
 Pharmaceuticals Group Plc's Adderall and Novartis AG's Ritalin.

 FDA staff scientists and experts will provide updated information at the
 meeting about serious health problems that have been reported, the agency

 Use of drugs to treat attention deficit hyperactivity disorder, or ADHD, 
 controversial before the cardiac issue emerged, with many doctors and
 parents arguing the medicines are overprescribed.

 The FDA said it decided to seek input from an advisory panel after reports
 of sudden death, high blood pressure, heart attacks and strokes among some
 of the millions of adults and children who have taken the medicines.

 Through 2003, 24 deaths were reported from 1999 through 2003 among U.S.
 patients who took Adderall for ADHD, the FDA staff report said. The agency
 excluded cases that appeared linked to intoxication from multiple drugs or
 other causes.

 Another 16 deaths were reported through 2003 in U.S. patients who took
 Ritalin or other ADHD drugs known as methylphenidates, the report said.
 Eleven deaths were reported among other drugs besides Adderall in the
 amphetamine class, it said.

 "Conclusions about the relative safety of these two stimulant therapies
 cannot be made on the basis of this analysis," the FDA staff said. 

[Fred A. Baughman Jr., MD: Why is there no system that would give more definitive post-marketing data. Why? Because Big Pharma greases the palms necessary to assure there will be no such meaningful data, none to impact their income from the drugging of normal children (the definition of which is poisoning). ]

 Thirty additional deaths of methylphenidate patients were recorded but 
 were either non-U.S. cases or occurred outside the review period, the 

 Shire spokesman Matthew Cabrey said data have not shown any correlation
 between Adderall and the sudden deaths reported among children. He said 
 company supports the FDA's review of the matter.

 Health Canada temporarily suspended Adderall sales last year after 20
 reports of sudden death in people who took it. The agency allowed Adderall
 back on the market after concluding it could not prove the drug was more
 risky than other therapies.

 Novartis said its own review found no increased risk of cardiovascular
 problems in patients who took methylphenidates compared with the general

[Fred A. Baughman Jr., MD: Isn't it reassuring that Shire and Novartis, the pushers find that no risks accrue from the drugs]

 The FDA also has been studying if ADHD drugs may be related to psychiatric

 Republican Sen. Charles Grassley (news, bio, voting record) charged the 
 had taken a "disjointed" approach to the drugs over the past year. In a
 letter to the agency, the Iowa Republican suggested a "comprehensive" 
 of all ADHD medicines.

 Shares of British firm Shire fell 3.2 percent to 890.2 pence in London
 trading. Novartis shares gained 5 cents to close at $54.70 on the New York
 Stock Exchange.

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