FDA Revises a Few Warning Labels

[brain]

As Reported by MSNBC

FDA Strengthens Epilepsy Drug Warning

The Food and Drug Administration is issuing a stronger warning for the epilepsy drug carbamazepine over the possibility of a rare skin disorder, and is recommending patients of Asian ancestry get tested before undergoing treatment using the medication. The warning will be moved to a more prominent location on the drug's labels, and be placed in an existing black box warning that discusses risks for developing anemia.

FDA Strengthens Epilepsy Drug Warning (requires Medscape Account)

[Bernard]

Nice find. Here's the press release from the FDA:

Carbamazepine Prescribing Information to Include Recommendation of Genetic Test for Patients with Asian Ancestry

Connection of genetic information with medication use can improve safe use of product

The U.S. Food and Drug Administration today announced that the manufacturers of drugs containing the active ingredient carbamazepine have agreed to add to the drugs' labeling a recommendation that, before starting therapy with the drugs, patients with Asian ancestry get a genetic blood test that can identify a significantly increased risk of developing a rare, but serious, skin reaction.

Carbamazepine is a drug used for treatment of epilepsy, bipolar disorder, and neuropathic pain. It is sold under the brand names Carbatrol, Equetro and Tegretol.

"Science is now letting us individually treat patients based on how their body might react to a drug," said Janet Woodcock, M.D., FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research. "When being considered for treatment with carbamazepine, genetically high-risk patients can be given a test that will help their health care providers make personalized drug treatment decisions and help avoid potentially serious skin reactions."

The prescribing information for these drugs already includes a warning that for all patients starting carbamazepine therapy, regardless of ethnicity, rare but severe and sometimes life-threatening skin reactions can occur. These life-threatening skin reactions include toxic epidermal necrolysis and Stevens-Johnson syndrome, characterized by multiple skin lesions, blisters, fever, itching and other symptoms.

The risk of these reactions is estimated to be about 1 to 6 per 10,000 new users of the drug in countries with mainly white populations. However, the risk is estimated to be about 10 times higher in some Asian countries.

The skin reaction warnings will be moved to the current boxed warning section of the labeling. The new recommendation that health care providers give patients with Asian ancestry a genetic test before starting treatment will also be added to the boxed warning section.

To screen for this genetic marker, a patient's blood can be drawn by a health care provider and the test administered at a laboratory. It is estimated that about 5 percent of patients being considered for treatment with carbamazepine are of Asian ancestry and would need to have this test.

Studies have found a strong association between certain serious skin reactions and an inherited variant of a gene, HLA-B* 1502, an immune system gene, found almost exclusively in people with Asian ancestry. Patients testing positive for this gene should not be treated with carbamazepine unless the benefit clearly outweighs the increased risk of these serious skin reactions.

Patients who have taken carbamazepine for more than a few months and not experienced any skin reactions are unlikely to ever experience these reactions, regardless of ancestry or genetic test results. Patients currently taking carbamazepine who are concerned about these skin reactions should not stop taking the drug without first consulting their health care provider.

Carbatrol is manufactured by Shire Pharmaceuticals, Wayne, Penn.; Equetro is manufactured by Validus Pharmaceuticals Inc., Parsippany, N.J.; and Tegretol is manufactured by Novartis, East Hanover, N.J. Generic versions of carbamazepine are available.

For Information

FDA Information for Healthcare Professionals: Carbamazepine
http://www.fda.gov/cder/drug/InfoShe...azepineHCP.htm

Carbamazepine Prescribing Information to Include Recommendation of Genetic Test for Patients with Asian Ancestry - FDA

[RobinN]

Isn't this interesting. Rebecca has been complaining that she has a itching sensation on her scalp. She says it gets so bad sometimes she wants to pull her hair out.

[brain]

Yes, that was one of the side effects I had,
I don't even want to think of any anti-epileptic drug's that
starts with a "T" - I'm allergic to them!

PS: And to say I'm not even Asian!

[RobinN]

Thought I had read this somewhere else, sorry about that.
Can't seem to keep all of the information in my head organized. Maybe there is a pill for that. Ya think?

I went in to pick up a refill on this med and and was told that the brand (Trileptal) was no longer available. How do they do that?
POOF!
They said that the generic is available. Thought I read that this generic was just approved.

[speber]

First I heard of that! On the bright side, I should only have to pay a generic copay now!...




...but that's little compensation if breakthrough seizures start occuring due to crappy generic formulations.

[RobinN]

So... why wouldn't a doctor that makes so much money from our illnesses, call the patient and tell them this information? They can call me so that I don't miss an appointment, but they can't call to tell me there are some issues with the medication that has been recommended and this is what you should do about it?
Mind Boggling

[RobinN]

Talked with Rebecca's doctor today. She didn't even seem to know of the increased risk factor put out by the FDA. I told her Rebecca's symptoms, and it included a sore throat for the last two days. She has requested that she be taken off of her fourth medicine.

[Tate]

Isn't this interesting. Rebecca has been complaining that she has a itching sensation on her scalp. She says it gets so bad sometimes she wants to pull her hair out.

I used to get very bad itchy sensation when I was taking tegretol..... but not just on my scalp, mainly upper arms back and the top of my thighs but also my scalp.....

Does she ever get a itchy sort of pin prick feeling on her skin when she gets hot... for example in the shower or whilst our side in the sun...even if she is only in the sun for a little while...

I havnt had that since I stopped taking tegretol...
yay.... I was missing my hot showers in winter!

Mwahhhssssssss
Take care every one!!!!!!!
Tate

[alivenwell]

I do not take generics at all. It's more expensive, but at least I know the drug levels and the fillers are the same as the last prescription I bought at the drug store.
Frankly, I don't trust generics.

[RobinN]

From what I have read here, I wouldn't either. I was told however that they were not able to get the brand and the only one available was the generic. Now.. that sounds a bit scary.

Tate - the itching has been recently. She would have patches that itched. Last week it was on her side. Earlier on it was on her back. The scalp has been going on for a while, and mostly in the front. I was getting text messaged all day long that it was driving her crazy. When I received one message that said she was scared, I knew a phone call needed to be made.

So now we are coming down off of this one...

[Tate]

I am not against generics..... I am now taking a generic lamictal....... I dont know if it is just coincedance or not but i got pretty bad muscle pain mainly in my calves thighs and alot in my back as a side effect... i got a generic from the pharmacy or I had to wait till the next day..... I had some at home but I would have had to get some one to go pick em up, i didnt notice much well nothing, then my sister asks me right towards the end of the script how my muscles were feeling, you know i hadnt even noticed but it really had eased off.... I cant be sure it was because I was taking a generic..... my point was more that I havnt had any ill side effects what so ever.... i have used them with antibiotics a fair bit...... and again never a ill side effect.........

i think it would have alot to do with each individual and that persons sensitivity as well......

take care all
Tate x

[alivenwell]

I am not against generics..... I am now taking a generic lamictal....... I dont know if it is just coincedance or not but i got pretty bad muscle pain mainly in my calves thighs and alot in my back as a side effect... i got a generic from the pharmacy or I had to wait till the next day..... I had some at home but I would have had to get some one to go pick em up, i didnt notice much well nothing, then my sister asks me right towards the end of the script how my muscles were feeling, you know i hadnt even noticed but it really had eased off.... I cant be sure it was because I was taking a generic..... my point was more that I havnt had any ill side effects what so ever.... i have used them with antibiotics a fair bit...... and again never a ill side effect.........

i think it would have alot to do with each individual and that persons sensitivity as well......

take care all
Tate x

Maybe a combination of drugs did that one? They interact in so many weird ways.

Of course, here in the USA, I've lost a lot of faith in the FDA after that wheat gluten scare and the recent recall of many toys made in China with lead on them. My dog also gets food without the wheat gluten now. It's just not worth the risk. Peanut butter with salmonella, etc.

Symptoms like that could be caused by any product off the store shelves anymore. I seriously worry about that and buy organic stuff. It's more expensive, but they probably monitor its manufacturing and packaging.

Brand name Lamictal works fine for me right now with a little dark chocolate on the side and a good long walk outside for stress management so I do not worry too much about this crap.