Health & Medicine Week - Aug. 21, 2006
A recent study provides evidence of a molecular genetic link of endometriosis to ovarian cancer.
"Histopathology and epidemiology studies have consistently demonstrated a strong link between endometriosis and endometriosis-associated ovarian cancers (EAOCs) - in particular, the endometrioid and clear cell subtypes. However, it is still unclear whether endometriosis is a precursor to EAOCs, or whether there is an indirect link because similar factors predispose to both diseases," according to investigators writing in the International Journal of Cancer.
A.H. Prowse and colleagues of the University of Oxford wrote, "In order to search for evidence of clonal progression, we analyzed ...
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Friday, September 08, 2006
Thursday, September 07, 2006
Women: Hidden disease affects 1 in 4
DAVID POWLES
07 September 2006 08:35
A plea has been made for sufferers of a “hidden” disease which affects at least one in four women to get together.
Endometriosis is a painful, chronic disease which is known to affect 25pc of women, but may be suffered by many more who don't realise it.
Jodie Brighten, from Coniston Close, in West Earlham, has suffered from endometriosis for the last three-and-a half years but has been unable to find anyone to talk to who understands what she is going through.
As the nearest support group is in Cambridge, she is now trying to set up a network of sufferers in and around Norwich.
The 25-year-old said: “It can be really quite nasty and does often mean I have to take time off work. Although my family and partner have been very supportive, it can sometimes be hard because unless you suffer from it you cannot be fully aware of the pain it can cause.
“You also have a problem where other women may think you are just complaining about normal period pains, but it is a lot worse than that. It would be really helpful to just have someone to talk to or email who understands.”
Miss Brighten, who works at the Norfolk and Norwich University Hospital, says there was also a lack of understanding of the disease within the medical profession.
She said: “I had to go and see quite a few GPs before they found out what it was. Originally they just believed it was normal period pains.
“It is quite likely that women may think their symptoms are normal when they are not.”
Following her diagnosis, Miss Brighten underwent surgery and hormone treatment, but this has failed to cure the disease.
One known sufferer in the public eye is singer Louise Redknapp, whose subsequent infertility problems meant it took four years for her and husband Jamie, a football pundit, to have a baby.
Despite endometriosis' commonness, very little is known about the cause of the disease. It occurs when the tissue which lines the uterus - the endometrium - is found elsewhere in the body so that when a woman has a period the blood which builds up cannot be shed.
This can result in internal bleeding, inflammation, chronic pain, infertility, fatigue and diarrhoea.
What is endometriosis?
Where the cells that are normally found lining the uterus (the womb) are also found in other areas of the body but usually within the pelvis. Each month this tissue outside of the uterus, under normal hormonal control, is built up and then breaks down and bleeds in the same way as the lining of the uterus. This internal bleeding into the pelvis, unlike a period, has no way of leaving the body. This leads to inflammation, pain and the formation of scar tissue. Endometrial tissue can also be found in the ovary where it can form cysts.
The cause is unknown but several theories have been put forward including retrograde menstruation, lymphatic or circulatory spread, genetic predisposition to the condition, immune dysfunction and environmental causes - such as dioxin exposure.
The more common symptoms of endometriosis include painful and or heavy periods, mood swings, painful sex, infertility, fatigue and problems when opening bowels. It is a common condition which affects two million people in the UK.
The only way to diagnose endometriosis is by a laparoscopy. This is an operation in which a telescope (a laprascope) is inserted into the pelvis via a small cut near the navel. This allows the surgeon to see the pelvic organs and any endometrial implants and cysts. This is normally day surgery.
There are a range of treatments available to women with endometriosis including hormonal treatment, surgery and complementary therapies.
The National Endometriosis Society helpline is on 0808 8082227. The group's website address is at www.endo.org.uk
Miss Brighten can be contacted via e-mail at jbrister1975@aol.com
Do you have a health story for the Evening News? Contact health reporter Sarah Hall on 01603 772426 or email sarah.hall2@archant.co.uk
07 September 2006 08:35
A plea has been made for sufferers of a “hidden” disease which affects at least one in four women to get together.
Endometriosis is a painful, chronic disease which is known to affect 25pc of women, but may be suffered by many more who don't realise it.
Jodie Brighten, from Coniston Close, in West Earlham, has suffered from endometriosis for the last three-and-a half years but has been unable to find anyone to talk to who understands what she is going through.
As the nearest support group is in Cambridge, she is now trying to set up a network of sufferers in and around Norwich.
The 25-year-old said: “It can be really quite nasty and does often mean I have to take time off work. Although my family and partner have been very supportive, it can sometimes be hard because unless you suffer from it you cannot be fully aware of the pain it can cause.
“You also have a problem where other women may think you are just complaining about normal period pains, but it is a lot worse than that. It would be really helpful to just have someone to talk to or email who understands.”
Miss Brighten, who works at the Norfolk and Norwich University Hospital, says there was also a lack of understanding of the disease within the medical profession.
She said: “I had to go and see quite a few GPs before they found out what it was. Originally they just believed it was normal period pains.
“It is quite likely that women may think their symptoms are normal when they are not.”
Following her diagnosis, Miss Brighten underwent surgery and hormone treatment, but this has failed to cure the disease.
One known sufferer in the public eye is singer Louise Redknapp, whose subsequent infertility problems meant it took four years for her and husband Jamie, a football pundit, to have a baby.
Despite endometriosis' commonness, very little is known about the cause of the disease. It occurs when the tissue which lines the uterus - the endometrium - is found elsewhere in the body so that when a woman has a period the blood which builds up cannot be shed.
This can result in internal bleeding, inflammation, chronic pain, infertility, fatigue and diarrhoea.
What is endometriosis?
Where the cells that are normally found lining the uterus (the womb) are also found in other areas of the body but usually within the pelvis. Each month this tissue outside of the uterus, under normal hormonal control, is built up and then breaks down and bleeds in the same way as the lining of the uterus. This internal bleeding into the pelvis, unlike a period, has no way of leaving the body. This leads to inflammation, pain and the formation of scar tissue. Endometrial tissue can also be found in the ovary where it can form cysts.
The cause is unknown but several theories have been put forward including retrograde menstruation, lymphatic or circulatory spread, genetic predisposition to the condition, immune dysfunction and environmental causes - such as dioxin exposure.
The more common symptoms of endometriosis include painful and or heavy periods, mood swings, painful sex, infertility, fatigue and problems when opening bowels. It is a common condition which affects two million people in the UK.
The only way to diagnose endometriosis is by a laparoscopy. This is an operation in which a telescope (a laprascope) is inserted into the pelvis via a small cut near the navel. This allows the surgeon to see the pelvic organs and any endometrial implants and cysts. This is normally day surgery.
There are a range of treatments available to women with endometriosis including hormonal treatment, surgery and complementary therapies.
The National Endometriosis Society helpline is on 0808 8082227. The group's website address is at www.endo.org.uk
Miss Brighten can be contacted via e-mail at jbrister1975@aol.com
Do you have a health story for the Evening News? Contact health reporter Sarah Hall on 01603 772426 or email sarah.hall2@archant.co.uk
Wednesday, September 06, 2006
Explaining Endo "The Spoon Theory"
Previous Entry Add to memories! Next Entry
Spoon Theory
This is for those who have questioned what we mean when we talk about spoons...
The Spoon Theory
by ???
My best friend and I were in the diner, talking. As usual, it was very late and we were eating French fries with ranch dressing. Like normal girls our age, we spent a lot of time in the diner while in college, and most of the time we spent talking about boys, music or trivial things, that seemed very important at the time. We never got serious about anything in particular and spent most of our time laughing.
As I went to take some of my medicine with a snack as I usually did, she watched me with an awkward kind of stare, instead of continuing the conversation. She then asked me out of the blue what it felt like to have endometriosis and be sick. I was shocked not only because she asked the random question, but also because I assumed she knew all there was to know about endo. She came to doctors with me, she saw me when it hurt just to walk, and throw up in the bathroom. She had seen me cry in pain, what else was there to know?
I started to ramble on about pills, and aches and pains, but she kept pursuing, and didn't seem satisfied with my answers. I was a little surprised as being my roommate in college and friend for years; I thought she already knew the medical definition of endo. Then she looked at me with a face every sick person knows well, the face of pure curiosity about something no one healthy can truly understand. She asked what it felt like, not physically, but what it felt like to be me, to be sick.
As I tried to gain my composure, I glanced around the table for help or guidance, or at least stall for time to think. I was trying to find the right words. How do I answer a question I never was able to answer for myself? How do I explain every detail of every day being effected, and give the emotions a sick person goes through with clarity. I could have given up, cracked a joke like I usually do, and changed the subject, but I remember thinking if I don’t try to explain this, how could I ever expect her to understand. If I can’t explain this to my best friend, how could I explain my world to anyone else? I had to at least try.
At that moment, the spoon theory was born. I quickly grabbed every spoon on the table; hell I grabbed spoons off of the other tables. I looked at her in the eyes and said “Here you go, you have Endometriosis”. She looked at me slightly confused, as anyone would when they are being handed a bouquet of spoons. The cold metal spoons clanked in my hands, as I grouped them together and shoved them into her hands.
I explained that the difference in being sick and being healthy is having to make choices or to consciously think about things when the rest of the world doesn’t have to. The healthy have the luxury of a life without choices, a gift most people take for granted.
Most people start the day with unlimited amount of possibilities, and energy to do whatever they desire, especially young people. For the most part, they do not need to worry about the effects of their actions. So for my explanation, I used spoons to convey this point. I wanted something for her to actually hold, for me to then take away, since most people who get sick feel a “loss” of a life they once knew. If I was in control of taking away the spoons, then she would know what it feels like to have someone or something else, in this case endo, being in control.
She grabbed the spoons with excitement. She didn’t understand what I was doing, but she is always up for a good time, so I guess she thought I was cracking a joke of some kind like I usually do when talking about touchy topics. Little did she know how serious I would become?
I asked her to count her spoons. She asked why, and I explained that when you are healthy you expect to have a never-ending supply of "spoons". But when you have to now plan your day, you need to know exactly how many “spoons” you are starting with. It doesn’t guarantee that you might not lose some along the way, but at least it helps to know where you are starting. She counted out 12 spoons. She laughed and said she wanted more. I said no, and I knew right away that this little game would work, when she looked disappointed, and we hadn't even started yet. I’ve wanted more "spoons" for years and haven’t found a way yet to get more, why should she? I also told her to always be conscious of how many she had, and not to drop them because she can never forget she has endo.
I asked her to list off the tasks of her day, including the most simple. As, she rattled off daily chores, or just fun things to do; I explained how each one would cost her a spoon. When she jumped right into getting ready for work as her first task of the morning, I cut her off and took away a spoon. I practically jumped down her throat. I said " No! You don’t just get up. You have to crack open your eyes, and then realize you are late. You didn’t sleep well the night before. You have to crawl out of bed, and then you have to make your self something to eat before you can do anything else, because if you don’t, you can't take your medicine, and if you don’t take your medicine you might as well give up all your spoons for today and tomorrow too." I quickly took away a spoon and she realized she hasn’t even gotten dressed yet. Showering cost her a spoon, just for washing her hair and shaving her legs. Reaching high and low that early in the morning could actually cost more than one spoon, but I figured I would give her a break; I didn’t want to scare her right away. Getting dressed was worth another spoon. I stopped her and broke down every task to show her how every little detail needs to be thought about. You cannot simply just throw clothes on when you are sick. I explained that I have to see what clothes I can physically put on, if I'm feeling bloated, any pants that bind are out of the question. If I have a burn on my stomach from the heating pad, I need a loose fitting top, and so on... and then you need to factor in another 5 minutes for feeling badly that it took you 2 hours to do all this.
I think she was starting to understand when she theoretically didn’t even get to work, and she was left with 6 spoons. I then explained to her that she needed to choose the rest of her day wisely, since when your “spoons” are gone, they are gone. Sometimes you can borrow against tomorrow’s "spoons", but just think how hard tomorrow will be with less "spoons". I also needed to explain that a person who is sick always lives with the looming thought that tomorrow may be the day that a cold comes, or an infection, or any number of things that could be very dangerous. So you do not want to run low on "spoons", because you never know when you truly will need them. I didn’t want to depress her, but I needed to be realistic, and unfortunately being prepared for the worst is part of a real day for me.
We went through the rest of the day, and she slowly learned that skipping lunch would cost her a spoon, as well as standing on a bus, or even having an alcoholic drink with friends. She was forced to make choices and think about things differently. Hypothetically, she had to choose not to run errands, so that she could eat dinner that night.
When we got to the end of her pretend day, she said she was hungry. I summarized that she had to eat dinner but she only had one spoon left. If she cooked, she wouldn’t have enough energy to clean the pots. If she went out for dinner, she might be too tired to drive home safely. Then I also explained, that I didn’t even bother to add into this game, that she was so nauseous, that cooking was probably out of the question anyway. So she decided to make soup, it was easy. I then said it is only 7pm, you have the rest of the night but maybe end up with one spoon, so you can do something fun, or clean your apartment, or do chores, but you can’t do it all.
I rarely see her emotional, so when I saw her upset I knew maybe I was getting through to her. I didn’t want my friend to be upset, but at the same time I was happy to think finally maybe someone understood me a little bit. She had tears in her eyes and asked quietly “How do you do it? Do you really do this everyday?” I explained that some days were worse then others; some days I have more spoons then most. But I can never make it go away and I can’t forget about it, I always have to think about it. I handed her a spoon I had been holding in reserve. I said simply, “I have learned to live life with an extra spoon in my pocket, in reserve. You need to always be prepared”
Its hard, the hardest thing I ever had to learn is to slow down, and not do everything. I fight this to this day. I hate feeling left out, having to choose to stay home, or to not get things done that I want to. I wanted her to feel that frustration. I wanted her to understand, that everything everyone else does comes so easy, but for me it is one hundred little jobs in one. I need to think about the weather, my temperature that day, and the whole day's plans before I can attack any one given thing. When other people can simply do things, I have to attack it and make a plan like I am strategizing a war. It is in that lifestyle, the difference between being sick and healthy. It is the beautiful ability to not think and just do. I miss that freedom. I miss never having to count "spoons".
After we were emotional and talked about this for a little while longer, I sensed she was sad. Maybe she finally understood. Maybe she realized that she never could truly and honestly say she understands. But at least now she might not complain so much when I can't go out for dinner some nights, or when I never seem to make it to her house and she always has to drive to mine. I gave her a hug when we walked out of the diner. I had the one spoon in my hand and I said “Don’t worry. I see this as a blessing. I have been forced to think about everything I do. Do you know how many spoons people waste everyday? I don’t have room for wasted time, or wasted “spoons” and I chose to spend this time with you.”
Ever since this night, I have used the spoon theory to explain my life to many people. In fact, my family and friends refer to spoons all the time. It has been a code word for what I can and cannot do. Once people understand the spoon theory they seem to understand me better, but I also think they live their life a little differently too. I think it isn’t just good for understanding endometriosis, but anyone dealing with any disability or illness. Hopefully, they don’t take so much for granted or their life in general. I give a piece of myself, in every sense of the word when I do anything. It has become an inside joke. I have become famous for saying to people jokingly that they should feel special when I spend time with them, because they have one of my "spoons".
Spoon Theory
This is for those who have questioned what we mean when we talk about spoons...
The Spoon Theory
by ???
My best friend and I were in the diner, talking. As usual, it was very late and we were eating French fries with ranch dressing. Like normal girls our age, we spent a lot of time in the diner while in college, and most of the time we spent talking about boys, music or trivial things, that seemed very important at the time. We never got serious about anything in particular and spent most of our time laughing.
As I went to take some of my medicine with a snack as I usually did, she watched me with an awkward kind of stare, instead of continuing the conversation. She then asked me out of the blue what it felt like to have endometriosis and be sick. I was shocked not only because she asked the random question, but also because I assumed she knew all there was to know about endo. She came to doctors with me, she saw me when it hurt just to walk, and throw up in the bathroom. She had seen me cry in pain, what else was there to know?
I started to ramble on about pills, and aches and pains, but she kept pursuing, and didn't seem satisfied with my answers. I was a little surprised as being my roommate in college and friend for years; I thought she already knew the medical definition of endo. Then she looked at me with a face every sick person knows well, the face of pure curiosity about something no one healthy can truly understand. She asked what it felt like, not physically, but what it felt like to be me, to be sick.
As I tried to gain my composure, I glanced around the table for help or guidance, or at least stall for time to think. I was trying to find the right words. How do I answer a question I never was able to answer for myself? How do I explain every detail of every day being effected, and give the emotions a sick person goes through with clarity. I could have given up, cracked a joke like I usually do, and changed the subject, but I remember thinking if I don’t try to explain this, how could I ever expect her to understand. If I can’t explain this to my best friend, how could I explain my world to anyone else? I had to at least try.
At that moment, the spoon theory was born. I quickly grabbed every spoon on the table; hell I grabbed spoons off of the other tables. I looked at her in the eyes and said “Here you go, you have Endometriosis”. She looked at me slightly confused, as anyone would when they are being handed a bouquet of spoons. The cold metal spoons clanked in my hands, as I grouped them together and shoved them into her hands.
I explained that the difference in being sick and being healthy is having to make choices or to consciously think about things when the rest of the world doesn’t have to. The healthy have the luxury of a life without choices, a gift most people take for granted.
Most people start the day with unlimited amount of possibilities, and energy to do whatever they desire, especially young people. For the most part, they do not need to worry about the effects of their actions. So for my explanation, I used spoons to convey this point. I wanted something for her to actually hold, for me to then take away, since most people who get sick feel a “loss” of a life they once knew. If I was in control of taking away the spoons, then she would know what it feels like to have someone or something else, in this case endo, being in control.
She grabbed the spoons with excitement. She didn’t understand what I was doing, but she is always up for a good time, so I guess she thought I was cracking a joke of some kind like I usually do when talking about touchy topics. Little did she know how serious I would become?
I asked her to count her spoons. She asked why, and I explained that when you are healthy you expect to have a never-ending supply of "spoons". But when you have to now plan your day, you need to know exactly how many “spoons” you are starting with. It doesn’t guarantee that you might not lose some along the way, but at least it helps to know where you are starting. She counted out 12 spoons. She laughed and said she wanted more. I said no, and I knew right away that this little game would work, when she looked disappointed, and we hadn't even started yet. I’ve wanted more "spoons" for years and haven’t found a way yet to get more, why should she? I also told her to always be conscious of how many she had, and not to drop them because she can never forget she has endo.
I asked her to list off the tasks of her day, including the most simple. As, she rattled off daily chores, or just fun things to do; I explained how each one would cost her a spoon. When she jumped right into getting ready for work as her first task of the morning, I cut her off and took away a spoon. I practically jumped down her throat. I said " No! You don’t just get up. You have to crack open your eyes, and then realize you are late. You didn’t sleep well the night before. You have to crawl out of bed, and then you have to make your self something to eat before you can do anything else, because if you don’t, you can't take your medicine, and if you don’t take your medicine you might as well give up all your spoons for today and tomorrow too." I quickly took away a spoon and she realized she hasn’t even gotten dressed yet. Showering cost her a spoon, just for washing her hair and shaving her legs. Reaching high and low that early in the morning could actually cost more than one spoon, but I figured I would give her a break; I didn’t want to scare her right away. Getting dressed was worth another spoon. I stopped her and broke down every task to show her how every little detail needs to be thought about. You cannot simply just throw clothes on when you are sick. I explained that I have to see what clothes I can physically put on, if I'm feeling bloated, any pants that bind are out of the question. If I have a burn on my stomach from the heating pad, I need a loose fitting top, and so on... and then you need to factor in another 5 minutes for feeling badly that it took you 2 hours to do all this.
I think she was starting to understand when she theoretically didn’t even get to work, and she was left with 6 spoons. I then explained to her that she needed to choose the rest of her day wisely, since when your “spoons” are gone, they are gone. Sometimes you can borrow against tomorrow’s "spoons", but just think how hard tomorrow will be with less "spoons". I also needed to explain that a person who is sick always lives with the looming thought that tomorrow may be the day that a cold comes, or an infection, or any number of things that could be very dangerous. So you do not want to run low on "spoons", because you never know when you truly will need them. I didn’t want to depress her, but I needed to be realistic, and unfortunately being prepared for the worst is part of a real day for me.
We went through the rest of the day, and she slowly learned that skipping lunch would cost her a spoon, as well as standing on a bus, or even having an alcoholic drink with friends. She was forced to make choices and think about things differently. Hypothetically, she had to choose not to run errands, so that she could eat dinner that night.
When we got to the end of her pretend day, she said she was hungry. I summarized that she had to eat dinner but she only had one spoon left. If she cooked, she wouldn’t have enough energy to clean the pots. If she went out for dinner, she might be too tired to drive home safely. Then I also explained, that I didn’t even bother to add into this game, that she was so nauseous, that cooking was probably out of the question anyway. So she decided to make soup, it was easy. I then said it is only 7pm, you have the rest of the night but maybe end up with one spoon, so you can do something fun, or clean your apartment, or do chores, but you can’t do it all.
I rarely see her emotional, so when I saw her upset I knew maybe I was getting through to her. I didn’t want my friend to be upset, but at the same time I was happy to think finally maybe someone understood me a little bit. She had tears in her eyes and asked quietly “How do you do it? Do you really do this everyday?” I explained that some days were worse then others; some days I have more spoons then most. But I can never make it go away and I can’t forget about it, I always have to think about it. I handed her a spoon I had been holding in reserve. I said simply, “I have learned to live life with an extra spoon in my pocket, in reserve. You need to always be prepared”
Its hard, the hardest thing I ever had to learn is to slow down, and not do everything. I fight this to this day. I hate feeling left out, having to choose to stay home, or to not get things done that I want to. I wanted her to feel that frustration. I wanted her to understand, that everything everyone else does comes so easy, but for me it is one hundred little jobs in one. I need to think about the weather, my temperature that day, and the whole day's plans before I can attack any one given thing. When other people can simply do things, I have to attack it and make a plan like I am strategizing a war. It is in that lifestyle, the difference between being sick and healthy. It is the beautiful ability to not think and just do. I miss that freedom. I miss never having to count "spoons".
After we were emotional and talked about this for a little while longer, I sensed she was sad. Maybe she finally understood. Maybe she realized that she never could truly and honestly say she understands. But at least now she might not complain so much when I can't go out for dinner some nights, or when I never seem to make it to her house and she always has to drive to mine. I gave her a hug when we walked out of the diner. I had the one spoon in my hand and I said “Don’t worry. I see this as a blessing. I have been forced to think about everything I do. Do you know how many spoons people waste everyday? I don’t have room for wasted time, or wasted “spoons” and I chose to spend this time with you.”
Ever since this night, I have used the spoon theory to explain my life to many people. In fact, my family and friends refer to spoons all the time. It has been a code word for what I can and cannot do. Once people understand the spoon theory they seem to understand me better, but I also think they live their life a little differently too. I think it isn’t just good for understanding endometriosis, but anyone dealing with any disability or illness. Hopefully, they don’t take so much for granted or their life in general. I give a piece of myself, in every sense of the word when I do anything. It has become an inside joke. I have become famous for saying to people jokingly that they should feel special when I spend time with them, because they have one of my "spoons".
FDA Safety Changes: Catapres-TTS, Noroxin, and Synarel
August 23, 2006 — The US Food and Drug Administration (FDA) has approved safety labeling revisions to advise that use of clonidine patches during magnetic resonance imaging may cause skin burns; concomitant use of nonsteroidal anti-inflammatory drugs and quinolones such as norfloxacin may be linked to an increased risk for convulsive seizures; and use of nafarelin nasal spray during pregnancy is contraindicated.
Use of Clonidine Patch (Catapres-TTS) During MRI Procedures May Lead to Burns
On April 13, the FDA approved safety labeling revisions for clonidine 0.1-, 0.2-, and 0.3-mg transdermal therapeutic system (Catapres-TTS 1, 2, and 3, made by Boehringer Ingelheim Pharmaceuticals, Inc) to warn of the risk for skin burns associated with their use during magnetic resonance imaging (MRI) procedures.
The FDA has received several reports of skin burns at the patch site in patients wearing an aluminized transdermal system during MRI scanning. Because the clonidine patch contains aluminum, its removal prior to the procedure is recommended.
Clonidine transdermal systems are indicated for use alone or with other agents in the treatment of hypertension.
Concomitant Use of NSAIDs With Norfloxacin (Noroxin) May Increase Seizure Risk
On May 16, the FDA approved safety labeling revisions for norfloxacin (Noroxin tablets, made by Merck and Co, Inc) to advise caution with concomitant use of nonsteroidal anti-inflammatory drugs (NSAIDs).
According to the FDA, concurrent administration of NSAIDs, such as ibuprofen and naproxen, with a quinolone, such as norfloxacin, may increase the risk for central nervous system stimulation and convulsive seizures.
Norfloxacin is indicated for the treatment of adults with urinary tract infections, sexually transmitted diseases, and prostatitis caused by susceptible strains of designated microorganisms.
Nafarelin Acetate Nasal Spray (Synarel) Contraindicated in Pregnancy
On April 12, the FDA approved safety labeling revisions for nafarelin acetate nasal solution (Synarel, made by Pfizer, Inc) to include warnings related to a new indication that allows its use for the management of endometriosis (including pain relief and lesion reduction) in women aged 18 years and older; the maximum duration of therapy is 6 months.
The recommended daily dose of nafarelin for endometriosis is 1 spray (200 µg) into one nostril in the morning and another 200-µg spray into the other nostril in the evening. Treatment should be initiated between days 2 and 4 of the menstrual cycle.
The FDA warned that because safe use of nafarelin during pregnancy has not been established clinically, pregnancy must be ruled out prior to initiation of treatment.
The warning was based on data from animal studies, showing that administration of nafarelin to pregnant rats during fetal organogenesis yielded major fetal abnormalities, dose-related increases in fetal mortality, and dose-related decreases in fetal weight. According to the FDA, these effects are expected consequences of nafarelin-related hormonal changes.
The FDA notes that despite nafarelin's inhibitory effects on ovulation and menstruation, contraception is not ensured, particularly when successive doses are missed. Patients should be counseled regarding use of nonhormonal contraceptives during therapy; those who conceive must discontinue treatment and be apprised of potential risks to the fetus.
As with other drugs that stimulate the release of gonadotropins or induce ovulation, ovarian cysts may occur during the first 2 months of nafarelin therapy. Many, but not all, of these events have been reported in women with polycystic ovarian disease. Although spontaneous resolution of the enlargements generally occurs within 4 to 6 weeks of treatment, some cases may require discontinuation of therapy and/or surgical intervention.
Gonadotropin-releasing hormone agonists such as nafarelin have also been linked to rare postmarketing reports of pituitary apoplexy secondary to infarction of the gland. A majority of these cases yielded a diagnosis of pituitary adenoma, mainly occurring within 2 weeks of the first nafarelin dose and some within the first hour. Symptoms included sudden headache, vomiting, visual changes, ophthalmoplegia, altered mental status, and sometimes cardiovascular collapse.
Nafarelin acetate nasal solution was approved previously for the treatment of central precocious puberty (also known as gonadotropin-dependent precocious puberty) in children of both sexes.
http://www.fda.gov/medwatch/safety/2006/apr06.htm
http://www.fda.gov/medwatch/safety/2006/may06.htm
Learning Objectives for This Educational Activity
Upon completion of this activity, participants will be able to:
* Describe the potential for burns in patients wearing clonidine patches during magnetic resonance image scanning.
* Identify the potential for convulsive seizures in patients receiving nonsteroidal anti-inflammatory drugs and norfloxacin tablets.
* Describe the appropriate use of nafarelin nasal spray for the treatment of endometriosis.
Pearls for Practice
* As with other aluminized transdermal systems, use of clonidine patches during magnetic resonance imaging for patients with hypertension may cause local burns. Patches should be removed prior to the procedure.
* Concurrent use of nonsteroidal anti-inflammatory drugs with norfloxacin or other quinolones may increase the risk for central nervous stimulation and convulsive seizures in adult patients with urinary tract infections, sexually transmitted diseases, and prostatitis caused by susceptible strains of designated microorganisms. Caution is advised when prescribing this drug combination.
* Because its safety has not been established, use of nafarelin therapy for endometriosis is contraindicated in women who are or may become pregnant. Pregnancy should be ruled out prior to initiation of therapy. Patients should be counseled regarding use of nonhormonal contraceptives during therapy; those who conceive must discontinue treatment and be apprised of potential risks to the fetus. In animal studies, nafarelin use during organogenesis was linked to major fetal abnormalities, dose-related increases in fetal mortality, and dose-related decreases in fetal weight. The FDA also warned of the risk for ovarian cysts and postmarketing reports of pituitary apoplexy related to nafarelin use.
FDA Safety Changes: Catapres-TTS, Noroxin, and Synarel
http://www.medscape.com/viewarticle/543557
Use of Clonidine Patch (Catapres-TTS) During MRI Procedures May Lead to Burns
On April 13, the FDA approved safety labeling revisions for clonidine 0.1-, 0.2-, and 0.3-mg transdermal therapeutic system (Catapres-TTS 1, 2, and 3, made by Boehringer Ingelheim Pharmaceuticals, Inc) to warn of the risk for skin burns associated with their use during magnetic resonance imaging (MRI) procedures.
The FDA has received several reports of skin burns at the patch site in patients wearing an aluminized transdermal system during MRI scanning. Because the clonidine patch contains aluminum, its removal prior to the procedure is recommended.
Clonidine transdermal systems are indicated for use alone or with other agents in the treatment of hypertension.
Concomitant Use of NSAIDs With Norfloxacin (Noroxin) May Increase Seizure Risk
On May 16, the FDA approved safety labeling revisions for norfloxacin (Noroxin tablets, made by Merck and Co, Inc) to advise caution with concomitant use of nonsteroidal anti-inflammatory drugs (NSAIDs).
According to the FDA, concurrent administration of NSAIDs, such as ibuprofen and naproxen, with a quinolone, such as norfloxacin, may increase the risk for central nervous system stimulation and convulsive seizures.
Norfloxacin is indicated for the treatment of adults with urinary tract infections, sexually transmitted diseases, and prostatitis caused by susceptible strains of designated microorganisms.
Nafarelin Acetate Nasal Spray (Synarel) Contraindicated in Pregnancy
On April 12, the FDA approved safety labeling revisions for nafarelin acetate nasal solution (Synarel, made by Pfizer, Inc) to include warnings related to a new indication that allows its use for the management of endometriosis (including pain relief and lesion reduction) in women aged 18 years and older; the maximum duration of therapy is 6 months.
The recommended daily dose of nafarelin for endometriosis is 1 spray (200 µg) into one nostril in the morning and another 200-µg spray into the other nostril in the evening. Treatment should be initiated between days 2 and 4 of the menstrual cycle.
The FDA warned that because safe use of nafarelin during pregnancy has not been established clinically, pregnancy must be ruled out prior to initiation of treatment.
The warning was based on data from animal studies, showing that administration of nafarelin to pregnant rats during fetal organogenesis yielded major fetal abnormalities, dose-related increases in fetal mortality, and dose-related decreases in fetal weight. According to the FDA, these effects are expected consequences of nafarelin-related hormonal changes.
The FDA notes that despite nafarelin's inhibitory effects on ovulation and menstruation, contraception is not ensured, particularly when successive doses are missed. Patients should be counseled regarding use of nonhormonal contraceptives during therapy; those who conceive must discontinue treatment and be apprised of potential risks to the fetus.
As with other drugs that stimulate the release of gonadotropins or induce ovulation, ovarian cysts may occur during the first 2 months of nafarelin therapy. Many, but not all, of these events have been reported in women with polycystic ovarian disease. Although spontaneous resolution of the enlargements generally occurs within 4 to 6 weeks of treatment, some cases may require discontinuation of therapy and/or surgical intervention.
Gonadotropin-releasing hormone agonists such as nafarelin have also been linked to rare postmarketing reports of pituitary apoplexy secondary to infarction of the gland. A majority of these cases yielded a diagnosis of pituitary adenoma, mainly occurring within 2 weeks of the first nafarelin dose and some within the first hour. Symptoms included sudden headache, vomiting, visual changes, ophthalmoplegia, altered mental status, and sometimes cardiovascular collapse.
Nafarelin acetate nasal solution was approved previously for the treatment of central precocious puberty (also known as gonadotropin-dependent precocious puberty) in children of both sexes.
http://www.fda.gov/medwatch/safety/2006/apr06.htm
http://www.fda.gov/medwatch/safety/2006/may06.htm
Learning Objectives for This Educational Activity
Upon completion of this activity, participants will be able to:
* Describe the potential for burns in patients wearing clonidine patches during magnetic resonance image scanning.
* Identify the potential for convulsive seizures in patients receiving nonsteroidal anti-inflammatory drugs and norfloxacin tablets.
* Describe the appropriate use of nafarelin nasal spray for the treatment of endometriosis.
Pearls for Practice
* As with other aluminized transdermal systems, use of clonidine patches during magnetic resonance imaging for patients with hypertension may cause local burns. Patches should be removed prior to the procedure.
* Concurrent use of nonsteroidal anti-inflammatory drugs with norfloxacin or other quinolones may increase the risk for central nervous stimulation and convulsive seizures in adult patients with urinary tract infections, sexually transmitted diseases, and prostatitis caused by susceptible strains of designated microorganisms. Caution is advised when prescribing this drug combination.
* Because its safety has not been established, use of nafarelin therapy for endometriosis is contraindicated in women who are or may become pregnant. Pregnancy should be ruled out prior to initiation of therapy. Patients should be counseled regarding use of nonhormonal contraceptives during therapy; those who conceive must discontinue treatment and be apprised of potential risks to the fetus. In animal studies, nafarelin use during organogenesis was linked to major fetal abnormalities, dose-related increases in fetal mortality, and dose-related decreases in fetal weight. The FDA also warned of the risk for ovarian cysts and postmarketing reports of pituitary apoplexy related to nafarelin use.
FDA Safety Changes: Catapres-TTS, Noroxin, and Synarel
http://www.medscape.com/viewarticle/543557
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