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IDDT United States
Disetronic Infusion Pumps not for sale in the US or Canada
December 2003
The Food and Drug Administration [FDA] inspected the
Disetronic Infusion Pump manufacturing plant in Switzerland early in
2003 and found that it did not conform to the regulations in a
number of areas. In the absence of compliance with these regulations
the reliability of these pumps cannot be guaranteed. This could
result in problems with the pump so that it could lead to under or
over dosing of insulin infusion. As a result of this Disetronic
pumps will not be sold in the US or Canada until the manufacturing
processes have been improved to ensure the reliability of the pumps
and approval granted by the FDA.
Letters have been sent from the company to existing pump users and
to all physicians who have prescribed Disetronic pumps to their
patients. Further information can be obtained from the company by
calling 1-800-281-1986.
DISCONTINUATION OF NOVOLIN® L (Lente®, Novo Nordisk) INSULIN
Novo Nordisk will be discontinuing Novolin® L (Lente® ), human
insulin zinc suspension [rDNA origin]).
Under current order and consumption levels, retail pharmacies will
deplete their supplies of Novolin® L by approximately October 1,
2003.
Novo Nordisk offer the following advice:
• The following treatment options should be
considered: Lente® insulin, which is available from another
manufacturer as Humulin® L. NPH, Ultralente®, or Lantus® (insulin
glargine) are other options for basal insulin replacement.
• There is a difference in the time of action profile (insulin
absorption and action) of these insulin preparations, which should
be considered when switching patients from Lente® insulin to other
insulin formulations.
• Any change in insulin therapy should be made cautiously and under
medical supervision.
If you require further information, you can contact:
Novo Nordisk Information Hotline: 1-800-727-6500
Monday through Friday, between the hours of 8:00 a.m. and 7:00 p.m.
EST.
‘Human’ and Animal Insulin Reviewed - Cochrane Review 2002
DISCONTINUATION OF NOVOLIN® L (Lente®, Novo Nordisk) INSULIN
July 2003
Novo Nordisk will be discontinuing Novolin® L (Lente® ), human insulin zinc suspension [rDNA origin]).
Under current order and consumption levels, retail pharmacies will deplete their supplies of Novolin® L by approximately October 1, 2003.
Novo Nordisk offer the following advice:
· The following treatment options should be considered: Lente® insulin, which is available from another manufacturer as Humulin® L. NPH, Ultralente®, or Lantus® (insulin glargine) are other options for basal insulin replacement.
· There is a difference in the time of action profile (insulin absorption and action) of these insulin preparations, which should be considered when switching patients from Lente® insulin to other insulin formulations.
· Any change in insulin therapy should be made cautiously and under medical supervision.
If you require further information, you can contact:
Novo Nordisk Information Hotline: 1-800-727-6500 Monday through Friday, between the hours of 8:00 a.m. and 7:00 p.m. EST.
------------------------------
·
HbA1c
test at home in the US
January 2003
Metrika Inc. have been granted marketing approval by the FDA for a pager sized monitor to enable people to measure their HbA1cs at home to obtain immediate results. The results are obtained in 8 minutes from a small drop of blood.
It has been available on prescription since February 2002 but now is available without prescription. The monitor, A1cNow™ is available by mail order or through pharmacies at a cost of US $22-25.
Further information is available by visiting Matrika’s website http://www.a1cnow.com/ or by ringing toll-free number 877-A1C-4-YOU [877-212-4968]
---------------------------------------------
·
Medicare
News
Cover for glaucoma testing
From January 1st 2002 the federal health insurance programme now covers an annual glaucoma test for the following groups of Medicare recipients:
· People with diabetes
· People with a family history of glaucoma
· High risk groups such as African Americans aged 50 and over because they are five times more likely to develop glaucoma than Americans of European decent.
Glaucoma affects 3 million Americans and early detection and treatment helps to prevent blindness.
Cover for nutritional therapy
Also from January 1st 2002 Medicare covers medical nutrition therapy for people with diabetes as well as those with kidney disease. This decision was based on a study carried out by the Institute of Medicine showing that nutritional therapy with a registered dietician was cost effective for the elderly and improved their quality of life.
--------------------------------------
·
Lilly
statement that insulin types and brands are NOT the same
July 2002
One of our members in the United States received her ‘annual pack’ from insulin manufacturer, Eli Lilly. It was interesting in this latest package was a letter from Dr John H. Holcombe, Lilly’s Medical Advisor as follows:
Lilly’s response to the recent actions of some pharmacy chains to switch Lilly insulin patients to Novo or private label (i.e. ReliOn) insulin.
Is it safe to Switch Brands of Insulin?
All insulin brands of insulin are NOT the same. We at Lilly firmly believe that a pharmacy should not switch your brand without your physician’s approval.
The type and brand of insulin you use have been clearly selected by your personal physician, based on your diabetes history and need for blood sugar control. Thus, your physician – not your physician – is the medical professional who should be primarily responsible for any changes to your insulin therapy.
In fact a statement mandated by the Food and Drug Administration [FDA] on every insulin product cautions that changing your type or manufacturer of insulin should be done only under medical supervision. Your blood sugar control may need additional monitoring when switching brands, even if it is the same type of insulin.
No pharmacy can force you to switch your insulin brand. Simply insist on the same Lilly insulin you have always relied on. If you are concerned about any pharmacy switching your insulin, please call us at 1-888-88LILLY
IDDT would not disagree with a word of this!
It is interesting that Lilly makes this statement soon after Novo Nordisk start to sell their insulin at a much lower price through the huge pharmacy chain Walmart under the name of ReliOn. It is equally interesting that Lilly do not apply this advice to their own pork insulins which are increasingly not stocked by many pharmacies, so people have to change to the insulin that is in stock, needless to say, ‘human’ insulin.
So to people in the US that are being told by their pharmacy that pork insulin is no longer available when it actually is, we would say, use Dr Holcombe’s letter to maximum advantage!
It letter clearly states that you should NOT change the TYPE of insulin you are using, so apply this to pork insulin and to quote Dr Holcombe “Simply insist on the same Lilly insulin you have always relied on.” So insist that you are supplied with pork insulin. He also says that the insulin you are using has been prescribed for your particular needs, so if pork satisfies your needs, don’t change to ‘human’!
-----------------------------------------------
· FDA WARN OF SAFETY CONCERNS ABOUT AVANDIA AND ACTOS
April 2002
Avandos [rosiglitazone] and Actos [pioglitazone] are both drugs for the treatment of Type 2 diabetes. In the UK they should only to be used in combination with one of the other oral drugs for Type 2 diabetes, metformin or a sulphonylurea and only when adequate blood glucose control cannot be achieved with these drugs. However in the US Avandia and Actos can used either on their own or in combination with either of the other two drugs. Neither of them is approved for use with insulin.
They belong to a class of drugs known as the thiazolidinediones or glitazones and the first drug of this type, troglitazone [Rezulin] was withdrawn from the market following at least 92 known deaths in the US from liver failure and/or congestive heart failure. The withdrawal in the US hit headlines because the FDA delayed this withdrawal for as long as 2 years despite adverse reports from a group of its advisers. It was withdrawn in the UK within 6 weeks of arriving on the market.
Avandos and Actos are successors to troglitazone and from the outset prescribing doctors have been advised that patients using either of these drugs should have regular liver function tests. It has also been known that they can cause fluid retention [oedema] that can lead to congestive heart failure, especially in people with an existing heart condition.
New Warning from the US Food and Drug Administration [FDA] 26.4.02
On April 26th 2002 the FDA issued a new warning advisory notice warning that the class of drugs thiazolidinediones or glitazones, which includes Avandia and Actos, may cause fluid retention that can progress to heart failure.
· They should not be used in people who have or have had heart failure, fluid retention or active liver disease.
· Patients who develop oedema, shortness of breath, weakness, fatigue or sudden weight gain should advise their doctor immediately
They also warn that it is important to note that people with Type 2 diabetes are at an increased risk of diabetes related complications such as heart failure whether they take any specific type of diabetes treatment or not.
Following discussions with the FDA, the manufacturers of Avandia and Actos have issued letters to health professionals reminding them of these safety concerns.
Note: Neither Avandia or Actos is approved for use with insulin.
Trials of use with Avandia and Actos with insulin
In two 26-week trials involving 611 people with Type 2 diabetes, two different doses of Avandia plus insulin were compared to insulin treatment alone. The participants included people with long standing type 2 diabetes and a high prevalence of cardiovascular conditions. There was an increased rate of heart failure and other cardiovascular side effects in patients taking Avandia and insulin compared to those taking insulin alone or a placebo. Similar results were found in another study comparing Actos plus insulin with insulin only therapy.
Notes:
1. It is has to be noted that Takeda Chemical Industries, Japan's largest drugmaker, warned Japanese doctors of potential dangerous side-effects of its diabetes drug Actos as early as October 2000. The company was urged to issue the warning by the Health and Welfare Ministry after five of the 90,000 Actos users in Japan suffered non-fatal heart failure.
2. In November 2001, Health Canada warned Canadians of their safety concerns related to the use of Avandia and Actos. Their reasons were the same as those of the FDA although they were issued 6 months sooner. Health Canada said that neither of these drugs should be used in patients with acute heart failure or active liver disease and patients who develop oedema, shortness of breath, weakness, fatigue or sudden weight gain should advise their doctor immediately. At the time these warnings were issued four deaths had been associated with Avandia.
-------------------------------------------------
·
Increased
security on flights affects people with diabetes.
October 2001
As a result of the New York disaster, there is increased security at airports and on flights. There are to be no sharp objects in hand luggage and this clearly affects people requiring insulin because syringes, pen injection devices and blood testing lancets are all sharp objects and therefore fit into this category. However airports and airlines have recognised the need for people with diabetes to inject on flights and therefore special regulations have been made to enable people requiring insulin to take the necessary equipment on board the aircraft.
The regulations are different in the UK and the US and currently are as follows:
The United Kingdom
People treated with insulin require a letter from their GP to allow syringes and other equipment to be carried in hand luggage. The letter must clearly state that you have diabetes and will need to inject during the flight. The letter will also need to refer to any further supplies in the baggage in the hold. Without such a letter you may not be allowed to take your medication on board. It is recommended that the letter be obtained well ahead of the expected date of your flight.
IDDT recommends that you contact your airline for its exact policy but to be on the safe side it is sensible to obtain a doctor’s letter.
Canada
The increased security on flights in Canada are similar to the UK in that you must have a doctor’s letter stating that you have diabetes and that you need to carry insulin and all your other equipment with you. In Canada there has always been a demand for people with diabetes to carry a letter from their doctor to this effect when flying although this has not necessarily been adhered to in the past.
The United States
The following information applies to airports in all 50 United States and was supplied to the American Diabetes Association.
1. Because of concerns over forgeries, prescriptions and doctors’ letters are not sufficient to allow people with diabetes to carry syringes and other equipment on board.
2. Passengers may board with syringes and other insulin delivery systems only if they can produce a vial of insulin with a professional, pharmaceutical pre-printed label that clearly identifies the medication. NO EXCEPTIONS WILL BE MADE. Since the prescription label is on the outside of the box, it is recommended that passengers refrain from discarding their insulin box and come prepared with their vial of insulin in its original pharmaceutically labelled box.
3. Passengers who have diabetes not requiring insulin but who need to test their blood glucose may carry their lancets on board as long as the lancets are capped and are brought on with a glucose meter that has the name embossed on the meter eg ‘One Touch’, ‘Accucheck’.
4. Glucagon should be kept in its original pre-printed pharmaceutically labelled container.
--------------------------------------------
· Anti-cholesterol drug withdrawn from the market after being linked to 31 deaths
August 8 2001
Bayer, the well known German pharmaceutical company have withdrawn their lipid lowering drug, cerivastin [Baycol] from the market in every country except Japan. Baycol has been linked to 31 deaths in the US and at least 9 in other countries caused by the destruction of muscle cells that are then released into the bloodstream. This condition is known as rhabdomyolysis and can be life threatening. The people most at risk from Baycol are elderly people on high doses and especially when used in combination with another cholestrol drug, gemfibrozil. 12 of the US deaths were in people also taking gemfibrozil.
Baycol is one of the range of drugs called statins that reduce cholesterol. All statins have been linked to the side effect of muscle destruction but Baycol has been linked to significantly more cases than its competitors. One of the other well-known statins is Lipitor and this is now likely to replace Baycol as the biggest seller. The FDA , the US drug regulatory body, say that there are no plans to strengthen the warnings on the other statins but people taking them who suffer muscle pain should visit their doctor to review their medication. The other symptoms of rhabdomyolysis are weakness, tenderness, fever, dark urine, nausea and vomiting. If people become aware that they are developing this muscle disease they can stop the drug and recover.
Public Citizen, the consumer advocacy group in the US, is preparing to petition the FDA to strengthen warnings on all statins by requiring that all patients receive warnings of the risk of rhabdomyolysis.
People with diabetes are at greater risk of heart disease and therefore if their cholesterol levels are higher than normal, they are likely to receive treatment with statins.
--------------------------------------------------
· GlucoWatch Launched in the UK
Not a replacement for conventional finger prick blood glucose tests!
June 12 2001
Recently Cygnus announced the launch of the GlucoWatch Biographer in the UK, the new monitoring system to check blood glucose levels. It measures blood glucose levels every 20minutes and an alarm sounds if the blood glucose levels are too low. However, many of the articles in the press are misleading and could cause harm to people with diabetes who may purchase such a device. It was not made clear that this development is yet far from a safe replacement for conventional finger pricking blood glucose testing.
In clinical studies conducted by the manufacturer, 25% of the time the GlucoWatch results differed from finger prick testing by more than 30%. In addition, it sometimes gave erroneous readings and was less effective at detecting very low blood glucose levels, the very reason that people need such a device with a reliable alarm system! It would not measure at all if the arm was too sweaty and caused mild to moderate skin irritation in at least 50% of patients.
The approval granted by the FDA in the US is rightly strictly limited. In the US it will be only be available on prescription to people 18 and over and because of the potential for error the FDA advises that the GlucoWatch should be used in conjunction with conventional finger prick tests.
IDDT comment on the GlucoWatch - This development is a very welcome step forward for people with diabetes, especially to people who have lost their warnings symptoms of low blood glucose levels so putting them at risk of coma. However, it is important that an overzealous approach to the advantages does not obscure the necessary warnings and precautions associated with this device.
--------------------------------------------------
· CP PHARMACEUTICALS APPLIED FOR A U.S. MARKETING AUTHORISATION FOR BEEF insulins.
November 24, 2000
CP applied for marketing authorisation for beef insulin in 1999, but the application was turned down. CP representatives were present at a meeting of the FDA that was designed to validate and make transparent how they make their decisions. The reasons for refusal even to consider the application were twofold:
1. Insufficient bio-availability data: CP knew that this would probably be the case when the application was submitted, but they needed to know the extent of the "deficiencies". It is arguable whether any new data is required – the Swiss, Finnish and now Swedish regulatory authorities needed none, but CP is prepared to conduct the additional testing.
2. The FDA stance regarding BSE: Even if CP had been able to comply with the requirements for the required dossier, their application would have been refused. The FDA insist on having proof of the absence of the BSE prion, even though one can never prove a negative. The British, Australian, Finnish and Swedish authorities have no similar concerns - or if they have them, have accepted the fully documented assurances of our suppliers and ourselves. There is no way, for the time being, round this obstacle. For the time being, until the FDA recognises that a validated analytical test for the BSE prion exists, there is no way forward, despite CP’s very considerable efforts. Having no way forward dissuades CP from generating, any further bio-availability data at considerable expense, that the rest of the world does not require.
---------------------------------------------------
·
JDF
Position Statement on Animal Insulin
December 6, 1999
The
recent decision by US companies to discontinue the production of beef
insulin has caused great concern among some people with diabetes in the
USA who currently use this type of insulin. JDF recognizes that most
people who take animal-derived (i.e. beef and pork) insulins can be
safely switched to synthetic human insulin.
However, we also acknowledge that good medical practice dictates that
decisions concerning the type of insulin used by people with diabetes
should be made by the patients and their physicians and that, if
animal-derived insulin is deemed appropriate, this option should remain
available to them.
In this regard, JDF will continue to provide information on obtaining
animal-derived insulin manufactured outside of the United States to
interested patients and physicians.
To learn about the process and procedure for personal importation of beef insulin and for more information on this issue, please contact:
The Insulin Dependent Diabetes Trust U.S.
PO Box 3271, Crossville, TN 38557
1-800-276-2091 and 1-800-276-3531 (toll free direct lines)
-----------------------------------------------
·
SAFETY
WARNING FOR USERS OF DISETRONIC PUMPS
14 March 2001
Disetronic issued the following warnings to users of the H-TRON or H-TRONplus insulin pump in contact with water
Dear Patient,
The safe use and reliability of Disetronic's products is our highest priority. Therefore, we ask that you read this letter and supplement carefully. A few pump wearers have reported experiencing hypoglycemic episodes (low blood sugar) after swimming or bathing, and some sought medical care. They also reported in such cases that their pump had apparently delivered more insulin than was programmed. Analysis of the insulin pumps returned to us revealed that water had entered the pumps. The source of the water entry was determined to be cracks in the pump housing or other leaks where water was able to get into the electronic compartment.
In response to these reports, Disetronic has researched the issues and performed tests on similar pumps. Disetronic damaged pumps to a comparable degree and put them in water to observe their behavior. The security system of each of the pumps tested signaled an alarm (ERROR 7) as expected and immediately placed the pump in the "STOP" mode, as designed. At this point, testing has not been able to duplicate the reported events.
However, for now, we ask that you follow these new instructions to help assure safe use of the pump with regard to contact with water:
· Avoid any contact of the insulin pump with water
· Change pump batteries (PowerPacks) only in a dry environment
· When changing a battery, check that the black "O" rings are correctly installed and seat properly
· Read and follow the enclosed supplement to the Reference Manual and place it with your Reference Manual
Disetronic is continuing to investigate, and will update you when new information becomes available on this topic. With the exception of these instructions with regard to the use of your pump in water, you can continue to experience the benefits of insulin pump therapy provided by your H-TRON or H-TRONplus insulin pump.
We apologize for any inconvenience these new guidelines may cause you, and we thank you for your support and the confidence you have shown in our products. We would be happy to answer any questions you may have. You can request a call from your local Disetronic representative and view the answers to frequently asked questions about this topic on our web site at www.disetronic-usa.com. You may also call us toll free at 1-877-852-8661 from 8:00 a.m. to 5:00 p.m. Central Standard Time.
For more information contact:
Disetronic Medical Systems, Inc.
Tel: 1-800-280-7801 E-Mail: info@disetronic-usa.
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