Epilepsy Drugs to Get Suicide Warnings, FDA Confirms

so many of these drugs are used off label to treat "pain conditions" and other "enigmatic illnesses" so i'm posting this here - AnnEnigma

From newsinferno.com
Date Published: Friday, June 6th, 2008

US regulators are very close to finalizing new suicide warnings for 11 epilepsy drugs, The Wall Street Journal reported today. This past January, the Food & Drug Administration (FDA) issued an Early Communication announcing a safety review of the epilepsy drugs after a study showed they increased patients’ risk of suicidal thoughts and behavior.

The 11 epilepsy drugs slated for a new suicide warning are:

• Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
• Felbamate (marketed as Felbatol)
• Gabapentin (marketed as Neurontin)
• Lamotrigine (marketed as Lamictal)
• Levetiracetam (marketed as Keppra)
• Oxcarbazepine (marketed as Trileptal)
• Pregabalin (marketed as Lyrica)
• Tiagabine (marketed as Gabitril)
• Topiramate (marketed as Topamax)
• Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)
• Zonisamide (marketed as Zonegran)

In addition to treating epilepsy, the anti-seizure medications are used for a variety of other illnesses, including migraines, certain nerve-pain disorders, and psychiatric diseases such as bipolar disorder that themselves carry a risk of suicide.

The FDA began investigating if epilepsy drugs posed any suicide risk in 2005. In doing so, the FDA analyzed almost 200 studies of 11 anti-seizure drugs, some that have been on the market for decades. The studies tracked almost 28,000 people given epilepsy medications and another 16,000 given dummy pills.

According to the FDA, 0.43 percent of drug-treated patients experienced suicidal thoughts or behavior, compared with 0.22 percent of placebo-takers. The higher risk of suicidal thoughts and behaviors was observed at one week after starting a drug and continued to at least 24 weeks. The results were generally consistent among all the different drug products studied and were seen in all demographic subgroups. Overall, four people in the drug-treated groups committed suicide, and none in the placebo groups. For every 1,000 patients, about two more patients taking epilepsy drugs experienced suicidal thoughts than those who took placebo.

In an interview with The Wall Street Journal, Russell Katz, director the FDA’s neuropharmacological drug division confirmed the suicide warnings are coming. “We are working on the labeling changes that we want to get to the companies,” he said. An FDA advisory panel is slated to take up the issue of epilepsy drugs and suicide on July 10, but the Journal speculated the new warnings could come even sooner than that.

At least one drug maker, Pfizer Inc., is less than pleased at this development. Pfizer disputed the FDA’s analysis in a forum this week sponsored by the Epilepsy Study Consortium in New York. Pfizer especially disputes the inclusion of Lyrica - one of the company’s biggest growth drivers -on the FDA’s warning list. Pfizer said that Lyrica accounted for only 6.3% of the total 142 suicidal events cited by the FDA analysis. But the FDA is sticking to its guns, and the new suicide warning will apply to all 11 epilepsy drugs.

Most other epilepsy drug makers are resigned to the label changes, according to the Journal. GlaxoSmithKline, the maker of Lamictal, approached the FDA this year to volunteer changes regarding possible suicidal-behavior risks. Other drug makers may have chosen not to challenge the FDA on suicide warnings because their medications are no longer as lucrative as they once were, as patents on many epilepsy drugs have, or are close to, expiring.

A handy response to all the unsolicited "helpful suggestions"

'Seven genetic types of ME' found

Geneticists have identified a biological basis for seven different subtypes of chronic fatigue syndrome.

The researchers from St George's Hospital, University of London, hope the work could lead to a blood test to distinguish between the forms.

Campaigners hope it will help counter the opinion, which remains in some quarters of the medical profession, that it is a psychological condition.

The research findings are to be presented to a conference in Cambridge.

It's a hard illness to get a handle on, so a clinical test would be the single best way forward for everyone Neil Abbot, ME Research UK

Chronic fatigue syndrome (CFS), also known as ME, is a condition with a diverse range of symptoms but particularly characterised by profound muscle fatigue after physical exertion.

In its most extreme form, CFS/ME leaves sufferers bed-ridden. There is currently no diagnostic test or cure.

It affects around one in 200 people.

'Biologically meaningful'

The St George's study looked at 55 patients from the US and UK with the condition, and carried out a genetic analysis of them and 75 healthy blood donors.

It identified the seven distinct subtypes of CFS/ME identified by a specific genetic pattern.

These were linked to specific symptoms.

Type one had the worst anxiety and depression levels, along with poor sleep and high pain levels.

Type two was characterised by significant post-exercise fatigue and joint and muscle pains, while type three was the mildest form of the disease.

The research identified type four as linked to moderate levels of body pain and sleep problems, with type five having stomach complaints and the most marked muscle weakness.

Type six was specifically connected to fatigue, and type seven had the most severe symptoms including pain, swollen glands and headaches.

Type four and type six were the most common forms of the condition.

Dr Jonathan Kerr, who led the St George's research, said: "We must now determine what these sub-types represent, as they appear to be biologically meaningful, and discover their natural history and possibilities for treatment."

Neil Abbot, of ME Research UK, which is organising the conference along with the Irish ME Trust, said: "The discovery of a 'thumb-print' for the illness would be the single greatest advance that could be made because, at the moment, diagnosis is on the basis of a set of vague symptoms association with other illnesses.

"It's a hard illness to get a handle on, so a clinical test would be the single best way forward for everyone."

Story from BBC NEWS:
http://news.bbc.co.uk/go/pr/fr/-/2/hi/health/7378440.stm

Published: 2008/05/05 23:02:16 GMT

© BBC MMVIII

Are YOU Bendy Too?

It took me 9 years before I realized how big a role my hypermobility was playing in my health. It was that discovery which finally led to my recent diagnosis of Ehlers-Danlos Syndrome (it's a collagen disorder of several different variations )

The drawing above, the Beighton Score, is what a medical professional will use to rate your "bendiness", tho it's not the be all and end all on the subject.

more on the subject soon...

CFS/FMS RULES OF ETIQUETTE

PERSONAL HYGIENE
1. Decisions about which body part to wash depend on which doctor you're seeing today, i.e., face/ears for the ENT; feet for the podiatrist; arms for blood tests; etc...
2. Proper use of toiletries can forestall bathing for several days. However, if you live alone, deodorant is a waste of good money.
3. Read labels carefully. Ever notice how much the can of room freshener resembles the can of deodorant?
4. Remember to warn your spouse before kissing if you've just taken your herbal remedies, since your breath now smells like grass.

IN THE KITCHEN
1. If you can't remember what it is you're cooking in the pot, whatever it is, it can probably use more salt.
2. Do not toss that cold cup of coffee into the dryer or set the iron in the refrigerator to cool off, no matter how good an idea it may seem at the time.
3. When your husband tells you "Don't worry about dinner, just throw some frozen chicken in the oven and forget it", DON'T forget it.
4. When everything INCLUDING the can opener is dirty, it may be time to wash some dishes.
5. It's bad manners to fall asleep at the table, especially in the food.
6. If you're having a bad day, there's nothing better than pizza and quiet.

DRIVING ETIQUETTE
1. Always place a Post-It Note on the dashboard telling you where you're going. And when you get there, place another on the dashboard that says HOME.
2. Never relieve yourself from a moving vehicle, especially when driving.
3. Always carry an electronic homing device in your car and with you so you can find your car in the parking lot.

TIPS FOR ALL OCCASIONS
1. If you have to vacuum the bed, it's time to change the sheets.
2. If you take the dog for a walk, make sure he brings you back.
3. Nevermind about taking one day at a time. Just stick to one thing at a time.
4. Try to spend at least 45 minutes each morning doing one get-up.
5. Work at learning something new every day, like sitting up, for example...
6. Remember to breathe when napping. It's unnerving to wake up and see vultures staring at you.
7. Learn to understand your "body language":
Joints - "I ache! It's going to rain!"
Stomach - "You're getting me upset!"
Nose - "Oh, oh, I'm getting a cold!"
Head - "Stop it, all of you! I'm getting a migraine!"

The Burden of Proof Rests Heavier on Misunderstood Illnesses.

Here at a time when the FDA is finally approving drugs for the treatment of fibromyalgia (Lyrica being the first so far) the media pipes up with the, "Is It Real?" question again - some outlets more politely than others e.g. the recent New York Times article - I won't even bother to link to the other articles in that vein which have been quite a bit more insulting. Feeding a portion of this latest rash of articles is the fact that Dr. Frederick Wolfe, who had originally "discovered" fibro in the early 90's has now decided it's a psychosomatic illness.

I'm of two minds about the situation. The reality of the condition I don't feel is in question. The fact that doctors allow it to be the final diagnosis and cease looking any deeper I feel is a problem.

Having been diagnosed with fibro and CFS a decade ago, I'm angry it took me 10 years to get the more accurate diagnosis of Ehlers-Danlos. There are a portion of doctors treating Fibromyalgia (and to be fair, CFS) as a wastebasket diagnosis. Can't figure it out? Blood work odd but not overtly dangerous? Fibromyalgia!

Do I believe this collections of symptoms labeled Fibromyalgia exist? Absolutely! Do I believe that once that diagnosis is received it's the end of the diagnostic road. Emphatically NO! There are subsets within both Fibromyalgia and CFS, and until a larger portion of the medical community starts taking a serious look at that effective treatment and true respect of these illnesses are a ways off I fear.

ah the frustration. i managed to get locked out of blogger.com (how many people can do that?) by getting crossovers with my google account and another email. as a relatively computer literate individual i can't believe it took 5 months to straighten that out. some days i really wish computers would quit "simplifying" my life for me [sigh].