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Delda White wrote: > > Jon -- Loved reading about that terrific new device, the BOOK. Wow, > what a > technological leap forward. These are available now, you say? When > is the > PENCIL going to be on the market. Has the FDA tested these things? > Delda > White ([log in to unmask]) Delda, My sources at the FDA tell me that PENCIL will be released in the not too distant future- Just like pramipexole was due out imminently- which meant 6 months. I have obtained a secret copy of the proposed labeling information and have decided to share it with the LIST. (in abbreviated form) Indications and Use Pencil is the first in a series of devices designed to back up the keyboard or voicemail in the unlikely possibility of battery or power loss or in catastrophic conditions such as hard disk and/or cpu failure. Studies indicate that the device shows promise in other than emergency situations but further study is necessary to confirm this. In the meantime the indications are for use only in the above proven situations and only by practioners familiar with the devise and its use. Contraindications. Allergy to Pencil or its components graphite and wood are contraindications for the prescription of this device Warnings: Pencil should be used with extreme caution with artists and doodlers. They have shown in studies to have the tendency to increase use without adequate medical monitoring and stand the risk of overdose or addiction. Precautions Pencil should be used with extreme caution in suicidal, homicidal or self mutilating patients. People have been reported to ignore their doctors and mothers advice and either accidentally or intentionally poke their eyes out. There are rare reported deaths due to ingestion or impaling during misuse. When misuse is suspected serum graphite levels should be drawn. With abuse carpal tunnel syndrome has been shown to develop. EMG & NCV are indicated to differentiate it from the more benign condition known as writer's cramp. Safety in children under the age of 16 has not been established. Caution should be observed in use in women of childbearing age. Information to Patients (This is still in the draft stage. Currently the company and the FDA are far apart on the issue- the company does not want to give the patient any information except to tell the patient that "it is good for you" and "try it you'll like it"-- The FDA insists on all of the above cautions embossed on the device itself in 2" high letters) Interactions Safety when used with Keyboard has not been adequately studied and therefore patients should be cautioned against this combination. Use in combination with paper is known to cause damage to paper to make it unusable except if Eraser is utilized immediately after use. Use with CRT screen is not recommended. Use by patients with Parkinson's disease and other conditions which cause tremor is not advised. PD patients have been known to aggressively insert Pencil into the nostril of a discourteous store who clerk who was unable to read her handwriting. Anxiety and frustration are common adverse reactions since the loss of keyboard function is usually accompanied by loss of the individuals spell checker operation. Use of PENCIL without the ready availability of DICTIONARY should not be instituted. Adverse reactions: (see above) Abuse Potential: Pencil is a schedule 2 device How Supplied: PENCIL comes in the following strengths PENCIL #1, PENCIL #2, PENCIL #3 and PENCIL # 4 CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT PRESCRIPTION. Delda and others I hope this information is useful to you. Charlie ********************************************************** CHARLES T. MEYER, M.D. MADISON, WISCONSIN **********************************************************