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FDA Warns Against Using Qualaquin to Treat Leg Cramps

Posted on Jul 8, 2010 02:00:00 PM |

The U.S. Food and Drug Administration has warned against using the malaria drug Qualaquin (quinine sulfate) to treat night time leg cramps. The FDA states the use of the drug in this manner has resulted in serious side effects and prompted the manufacturer to develop a risk management plan aimed at educating health care professionals and patients about the potential risks.



A review of reports submitted to the FDA’s Adverse Event Reporting System (AERS) between April 2005 and Oct. 1, 2008, found 38 U.S. cases of serious side effects associated with the use of quinine, the active drug in Qualaquin.
Quinine use resulted in serious and life-threatening reactions in 24 cases, including low level of platelets in the blood (thrombocytopenia), and hemolytic uremic syndrome/thrombotic thrombocytopenic purpura, a blood disorder that results in clots in small blood vessels around the body that can be accompanied by kidney impairment. Two patients died. Most of those reporting serious side effects took the drug to prevent or treat leg cramps or restless leg syndrome.



“Health care professionals and patients should be aware that FDA has not approved the use of Qualaquin for the treatment or prevention of night time leg cramps,” said Edward Cox, M.D., M.P.H., director, Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “FDA has received reports that some patients have developed serious side effects when taking quinine for night time leg cramps.”



Qualaquin was approved by the FDA in August 2005 to treat uncomplicated malaria caused by the parasite Plasmodium falciparum, an infection that can be life-threatening if untreated. About 1,500 cases of malaria are diagnosed in the United States each year, primarily resulting from travel abroad. Qualaquin is marketed by Philadelphia-based AR Scientific.



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[Source : HealthNewsBlog.com]

Friends of the Blog: Feedback Wanted!

Posted on Jun 27, 2010 03:45:00 PM |

My web stats tell me there are two different types of people who read this blog. One is people who find old posts thanks to Google Search. Google adores both this site and my main Blood Sugar 101 site, so even posts a few years old get a steady stream of visitors.

The other is blog subscribers–people who come in every time I post something new. A few of these regulars post comments. The rest just read and leave. But thanks to the magic of page stats I have the ability to see how many silent regulars we’ve here, too, and there are a lot of you.

As most of my regular readers know, this past year I haven’t had the time I usually have to research and post about the latest diabetes news because, much to my amazement, last June I sold a novel and two sequels to a major publisher. The novel was completed, but the sequels weren’t even begun,and because huge publishers demand that their authors deliver new books very swiftly, I have had to dig in this past year and work my butt off to meet my deadlines.

Since I’ve one more year to go on this current contract I’m not going to be able to post here three times a week for at least another year. That means that when I do post I want to give my devoted readers what they want the most. The question is, what? I hope you, who are reading this current post, can give me some feedback to help me do this.

Typically I do a couple different kinds of post. I comment on really important news about advances or new discoveries in the diabetes field. I warn you about the many highly publicized, poorly designed studies that come up with misleading and sometimes downright perilous conclusions that result from poor study design or cynical manipulations on the part of the companies who fund them.

I also post about the tips and tricks that can help readers lower their blood sugar. Some of these posts may say things that are not news to those of you who have had diabetes but the mail this blog generates recommends that those easy posts are the ones that have the most impact on the many newly diagnosed people who find this site each week.

So tell me. Over the next year, what kinds of posts would you like to see when you find a new post on this blog? What do you find here that you find the most helpful in your ongoing struggle with diabetes?

I realize that readers will have different needs and that some of you might not concur with other’s ideas of what’s most important. That’s good. I want to hear from as many of you as possible to get a feeling for what keeps you coming back and what helps you preserve your health.

Post your ideas in the comments section. What kinds of posts would you like to see here over the months ahead?

 

[Source : Diabetes Update]

Timing Your Metformin Dose

Posted on Jun 24, 2010 05:25:00 AM |

The biggest problem many people have with Metformin is that it causes such misery when it hits their stomachs that they can’t keep taking it even though they know it is the safest and most effective of all the oral diabetes drugs.

In many cases all that’s needed is some patience. After a rocky first few days many people’s bodies calm down and metformin becomes quite tolerable.

If you are taking the regular form of Metformin with meals and still having serious stomach issues after a week of taking metformin, ask your doctor to prescribe the extended release form–metformin ER or Glucophage XR. The extended release form is much gentler in its action.

If that still doesn’t solve your problem, there’s one last strategy that quite a few of us have found helpful. It is to take your metformin later in the day, after you’ve eaten a meal or two. My experience with metformin–and this has been confirmed by other people–is that it can irritate an empty stomach, but if you take it when the stomach contains food it will behave.

There are some drugs where it matters greatly what time of day you take the drug. Metformin in its extended release form isn’t one of them. As the name advocates, the ER version of the pill slowly releases the drug into your body over a period that, from my observations, appears to last 8 to 12 hours. Though it is supposed to release over a full 24 hours, this does not appear to be the case, at least not with the generic forms my insurer will pay for.

Because there seems to be a span of hours when these extended release forms of metformin release the most drug into your blood stream, when you take your dose may affect how much impact the drug has on your blood sugars after meals or when you wake up.

For example, the version I take, made by Teva, releases most strongly in a period that starts 2 hours after I take it and continues strong over the next 8 hours. If I take my full 1500 mg dose first thing in the morning, my blood sugars at lunch will show the impact of the drug most strongly. Dinner will be slightly less affected–i.e. if I ate the same lunch and dinner I’d see slightly better numbers at lunch and I see the least impact on my next mornings fasting blood sugars.

If I take the same full dose at 2 PM I’ll see the strongest effect on my blood sugar after dinner, but I will see a lower fasting blood sugar the next morning than I would if I took the drug first thing in the morning. The trade off is that my breakfast blood sugar will be higher on that schedule if I eat any carbs.

Metformin also builds up a cumulative effect on your fasting blood sugar after you take it for a week. This effect is not dependent on when you take it. If you miss a dose you’ll probably see a small but immediate difference in your post meal blood sugars. But if your stop taking it for a week you will not only see that effect the day after you you stop it, you’ll also see a second notable increase in your fasting blood sugar and pre-meal blood sugar about a week later.

If you’re taking metformin primarily to lower high morning fasting blood sugars, it might make sense to take your full dose right before bed–but the trade off will be that this timing of your dose may give you the weakest coverage before lunch and dinner, which might leave you with higher sugars for many hours of the day which counteract any advantage you might get from having lowered your morning reading.

Some people take half their metformin in the morning and half at night. That might give a more even effect throughout the day but because you smoothe out any peak in the drug’s effect, you might see slightly higher meal time sugars than you would if you took it all at once.

Personally, I’ve learned after a lot of experimentation that taking all my metformin ER in a single dose at 2 PM gives me the most benefits. First of all it keeps me from having stomach discomfort, secondly it gives me a tiny boost with my dinner numbers, and finally it knocks a little bit off my morning reading.

Your results might be different, but you won’t know what works for you unless you test different schedules.

If you want to change the time when you take your metformin there is one rule you must follow: Don’t ever take MORE than your full prescribed dose during a 24 hour period.

If you take all of your metformin at 6 AM don’t take any more until 6 AM the next day. If you’ve been splitting your dose and taking half at 6AM and half at 6 PM don’t take a full dose of metformin until 6 PM the day after your last 6 PM dose.

You don’t want to overlap your doses because you do not want to give yourself an overdose. Overdoses of metformin are very rarely life threatening–there is a case on record of someone surviving an overdose of 63,000 mg–but from personal experience I have the ability to tell you they are unpleasant and can make you feel very sick indeed. My old family doctor prescribed me an overdose years ago after he confused the top dose for the regular with the ER form–the regular can be taken in bigger doses. It made me very ill though I was fine the next day.

Also, if you’re testing a new dosing schedule, give it at least a week before you decide if it is working for you. That’ll let the long term blood levels stabilize.

Another helpful thing to know about metformin is that unlike many medications, it is not one that’ll cause rebound problems if you stop it abruptly. If you stop metformin all that’ll happen is that your blood sugar response will gradually go back to whatever it was before you started taking it. And you can start it back up at any time after that without any problems save the usual side effects people experience the first few days on the drug.

If you are not seeing the expected results from metformin, you might be taking one of the weaker generic forms. My experience and that reported by Dr. Richard K. Bernstein is that various generic brands of metformin vary greatly in their impact.

Many pharmacies will let you try a different generic brand if you want to try it. Dr. Bernstein suggests Glucophage, which was the original patented form of metformin prescribed before the generics came on the market. I haven’t tried it so I have the ability to’t say how useful it is. But if you have a choice, you might ask for it.

One last issue I haven never seen reported before is this. If you have trouble sleeping at night because you frequently have to get up to pee, it might be superior to take your metformin before 3 PM because metformin might increase your need to pee at night. This is probably because the kidneys help remove it from the body and work harder in the 8 hours after you take the dose.

 

[Source : Diabetes Update]

Heat Harms Insulin, Meters, and Even Some Oral Drugs!

Posted on Jun 22, 2010 07:17:00 AM |

A recent article in Science Daily reports on a presentation given at this week’s meeting of the Endocrine Society.

It’s worth a look: Science Daily: Many People with Diabetes Do Not Know or Heed Dangers of Hot Weather

Unfortunately, while the points it makes are true, a much superior title would have been Many physicians and pharmacies don’t know or heed the dangers of hot weather.

Just this week I heard from someone whose insurance forces him to get his medications from a mail order service that refuses to ship insulin overnight or with any protection against temperature. This, although the insulin manufacturer documented for this person that when insulin sits in a hot truck it dies.

Meters and test strips can also become unusable if left in a hot vehicle. I’ve cooked a whole vial of strips by leaving them on a automobile seat when it was in the 90s outside.

The Science Daily article points out that even pills can be ruined by heat. That was new to me but I’m no stranger to the phenomenon where one month’s Metformin works a whole lot better than another’s. Sadly, I am also no stranger to the phenomenon where when you complain to a pharmacy that your insulin is weak or there seems to be something wrong with your pills, they assure you it couldn’t possibly be true and that no one else has complained about them.

No one else probably has complained, because they probably assumed it was something in their own physiology that made their blood sugars suddenly shoot up. Given the vague way that most people with Type 2 are prescribed insulin and their lack of understanding of how insulin doses should correlate tightly with blood sugars, it is no surprise that customers pay for their insulin and accept whatever they’re given, even if it barely works.

Sadly, the problems caused by temperature are not limited to heat. I took an insulin pen with me, in my purse, when I dined at a restaurant last December when outside temperatures dropped to a low in the very low 20s. Although I was only outside for maybe ten minutes, that was enough to freeze the pen. A faulty fridge can do the same thing. If you see ice crystals in your milk or vegetables, chances are any insulin you had in the fridge is toast, too.

But just try getting a replacement from your health insurance when your insulin pen dies. Good luck!

Because pharmacies get their insulin from wholesalers who won’t ship it overnight or with temperature buffering anymore, there’s no simple solution to this problem. The insulin you buy from the pharmacies is just as apt to have sat in a hot truck for three days as the mail order stuff.

Physicians aren’t aware of this problem, and neither, based on my experience, are pharmacists. That means if you suddenly see unexplained high blood sugars after using a vial of bad insulin, the doctor might just raise your dose rather than insist that your pharmacy replace the vial.

What makes it more of a problem is that this issue is fairly. Five years ago mail order pharmacies always shipped insulin overnight with cold packs. The switch to sending it in hot slow trucks is a recent, cost slicing move–one that’s going to result in more blindness, amputation and death for those who use dead insulin and more hypos for those who get used to weakened insulin and then get a vial of full strength.

I wish I had some sage words of advice to offer about how to deal with this. About all I can do is assure you that if you are experiencing major fluctuations in blood sugar response from vial to vial or pen to pen it might not be your physiology at fault.

If you use small doses, it is also a good idea to remember that some insulins weaken over time no matter what you do. I found Levemir very likely to weaken. On the other hand when I used Apidra it stayed potent for many months even though it was not refrigerated. The Apidra I used was a sample my doctor gave me since my insurance wouldn’t pay for it. When the physician got another batch, mailed to her in the summer, it arrived dead. No insulin can survive temperatures in the very high 90s for very long.

If you have a good vial or pen, protect it from heat and cold. A Frio pack works well for this. Don’t leave your meter in a hot or cold vehicle, either. And remember that even ten minutes of exposure, as you walk to a restaurant on a very hot or very cold day might be enough to weaken your insulin or render it useless.

Post your experiences with this issue in the comments, along with any solutions you might have found!
 

[Source : Diabetes Update]

Woman Shoots Herself in the Arm to Get Medical Treatment

Posted on Jun 15, 2010 03:00:00 PM |

A Michigan woman shot herself in an effort to get treatment for her painful shoulder injury. She doesn’t have health insurance and was desperate to halt the pain. The woman’s effort failed. Her injury was not considered serious enough for her to get treatment. She could also face charges for firing the weapon within city limits. Take a look:





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[Source : HealthNewsBlog.com]