Islets of Hope diabetes studies and research links
Jack L. Leahy Insulin Therapy: Univ. of Vermont, Burlington. Comprehensive and current clinically based
resource for physicians and residents. Covers background, rationale for optimal
glycemia control in diabetes and standards of care, injection/glucose-monitoring
equipment, dietary practices, application of principles, and prevention and
Michael Bliss The Discovery of Insulin: Bliss's book is a real page-turner and deserves a much wider reading. The
research is solid, and he does a great job of drawing the sometimes sordid
details of medical discovery and controversy. He makes an excellent point that
those of us who are non- diabetics should remember--there's still no cure.
Diabetes Spectrum:This bimonthly magazine translates the latest diabetes research advances into practical treatment advice. Diabetes spectrum is designed for the nurse, educator, dietitian, pharmacist every member of the health care team. More Like This
Is Vitamin E Safe?Despite recent reports that show use of high-dose vitamin E supplements is associated with a higher overall risk of dying, at least one group stands to benefit greatly from the same vitamin. About 40 percent of diabetic patients can reduce their risk of heart attacks and of dying from heart disease taking vitamin E supplements, according to a Technion-Israel Institute of Technology study published in theNovember 2004 Diabetes Care.
FDA Warns Consumers about Brazilian Diet Pills Found to Contain Active Drug
Ingredients Emagrece Sim and Herbathin Dietary Supplements
May be Harmful - FDA, January 13, 2006
Avandamet Warnings Issued. January 6, 2006, ST. LOUIS (MD Consult) - On January 5, 2006, the US Food and Drug
Administration (FDA) and GlaxoSmithKline notified health care professionals about postmarketing reports of new-onset and worsening diabetic macular edema for patients receiving rosiglitazone. In the majority of these cases, the patients also reported concurrent peripheral edema. In some cases, the macular edema resolved or improved after discontinuation of therapy, and in 1 case macular edema resolved after dose reduction.
GlaxoSmithKline products containing this medication include Avandia (rosiglitazone maleate) and Avandamet (rosiglitazone maleate/metformin hydrocholoride), both indicated for the treatment of type 2 diabetes mellitus. This new safety information will be added to product information for prescribers and patient information materials for both Avandia and Avandamet.
Macular edema typically occurs in association with diabetic retinopathy, although it is more likely to occur as retinopathy progresses. Risk factors for macular edema include duration of diabetes, presence of retinopathy, hypertension, and poor glycemic control. Symptoms suggestive of macular edema include blurred or distorted vision, decreased color sensitivity, and decreased dark adaptation.
This notice is intended to alert physicians, nurses, medical technologists, pharmacists and other healthcare professionals of the potential for life-threatening falsely elevated glucose readings in patients who have received parenteral products containing maltose or galactose, or oral xylose, and are subsequently tested using glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) based glucose monitoring systems. The GDH-PQQ method of glucose determination is non-specific for glucose and, in the presence of maltose, xylose, or galactose, may yield falsely elevated glucose readings.
Although this is a known drug-device interaction (1-5), there have been
reports of the inappropriate administration of insulin and consequent life-threatening/ fatal hypoglycemia in response to erroneous test results obtained from patients receiving parenteral products containing maltose. Cases of true hypoglycemia can go untreated if the hypoglycemic state is masked by false elevation of glucose readings. Since hypoglycemia may be life threatening, it is important that health care providers prescribing and/or administering products containing the above sugars be aware of possible interference leading to incorrect results. A preliminary listing of U.S. products that may cause interference is presented in Table 1....
Cymbalta may increase risk for
liver damage, Lilly cautions October 18, 2005. ST. LOUIS (MD Consult) - "On October 17, 2005, Eli Lilly and the US Food and
Drug Administration (FDA) notified health care professionals of a revision to the Precautions/Hepatotoxicity section of the prescribing information for Cymbalta (duloxetine hydrochloride), indicated for treatment of major depressive disorder and diabetic peripheral neuropathic pain..."
Potential for dispensing errors
prompts change in labeling for Novolog insulins. September 15, 2005. ST. LOUIS (MD Consult) - On August 26, 2005, Novo Nordisk Incorporated and
the US Food and Drug Administration notified pharmacists of an initiative implemented to help prevent dispensing errors. Until recently, the product packaging for NovoLog Mix 70/30, a premixed insulin analog, and NovoLog, a rapid-acting insulin analog, were very similar.
FDA Warns: Phenergan Can Cause Death In Children Under Age 2. February 18, 2005. ST. LOUIS (MD Consult) - On February 16, 2005, the U.S. Food and Drug Administration (FDA) Safety Information and Adverse Event Reporting Program, MedWatch, announced a change to the prescribing information for Phenergan (promethazine). In January 2005 the drug's manufacturer, Wyeth, notified health care professionals of revisions to the Contraindications, Warnings/Use in Pediatric Patients, and Dosage and Administration sections of the medication's labeling. Phenergan is contraindicated for use in pediatric patients younger than 2 years of age because of the potential for fatal respiratory depression.
Counterfeit Drugs Purchased in Mexico Unsafe, Warns FDA. May 11, 2005, ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) issued an alert on May 10, 2005, warning the public about the sale of counterfeit versions of Lipitor (atorvastatin calcium), Viagra (sildenafil citrate), and an unapproved product promoted as "generic Evista" (raloxifene hydrochloride) to US consumers at pharmacies in Mexican border towns.
GlaxoSmithKline Products Seized Due to Violation of Good Manufacturing Practice. March 10, 2005. ST. LOUIS (MD Consult) - In a response to ongoing concerns about manufacturing quality, on March 4, 2005, the U.S. Food and Drug Administration (FDA) and the Department of Justice initiated seizures of Paxil CR (paroxetine) and Avandamet (rosiglitazone maleate/metformin hydrochloride) tablets manufactured by GlaxoSmithKline, Inc. (GSK). Manufacturing practices for the two drugs, approved to treat depression and panic disorder (Paxil CR) and type II diabetes (Avandamet), failed to meet the standards laid out by the FDA that ensure product safety, strength, quality, and purity.
FDA Warns Consumers Supplement Liqiang 4 Could Be Dangerous. July 6, 2005. ST. LOUIS (MD Consult) - On July 1, 2005, the US Food and Drug Administration (FDA) issued a nationwide warning to consumers not to take Liqiang 4 Dietary Supplement Capsules because they contain glyburide, a drug that could have serious, life-threatening consequences in some persons.
Glyburide is a drug used to lower blood sugar and is safe and effective when used as labeled in FDA-approved medications. Persons who have low blood sugar or
those with diabetescan receive dangerously high amounts of glyburide by consuming Liqiang 4. Consumers should immediately stop using these products and seek medical attention, especially if they are currently being treated with diabetes drugs or if they have symptoms of fatigue, excessive hunger, profuse sweating, or numbness of the extremities. Consumers who have this product should dispose of it immediately.
FDA approved drugs - 2005
Drug Approved for Treatment of Iron Overload due to blood transfusions. On November 3, 2005, pharmaceutical company Novartis announced the approval of Exjade (deferasirox) by the US Food and Drug Administration (FDA). Exjade, the first once-daily oral iron chelator, has been approved for the treatment of chronic iron overload due to blood transfusions in adults and children aged 2 years and older. 11/04/2005
Exjade is the only iron chelator administered as a drink (the tablets are dispersed in a glass of orange juice, apple juice, or water), compared with the current standard of care, which often requires a subcutaneous infusion lasting 8 to 12 hours per night, for 5 to 7 nights per week for as long as the patient continues to receive blood transfusions or has excess iron within the body. As a
result, many patients may have stopped or avoided iron chelation therapy, thus
risking the toxic effects of iron overload.
The approval of Exjade is expected to greatly enhance the acceptance of iron chelation therapy, especially for children, and offer a new alternative to the burdensome continuous infusion therapy.
Combination Children's Vacine Approved. September 7, 2005, ST. LOUIS (MD Consult) - Merck & Co, Inc, announced on September 6, 2005, that the US Food and Drug Administration has approved the combination vaccine Proquad (measles, mumps, rubella, and varicella virus vaccine live) for simultaneous vaccination against measles, mumps, rubella, and varicella in children aged 12 months to 12 years. Proquad is the first vaccine approved in the United States to help protect against these 4 diseases in a single shot. Proquad is also approved for use in children 12 months to 12 years of age if a second dose of measles, mumps, and rubella vaccine is to be administered
ActosPlus Approved by the FDA
New Combo Japanese Diabetes Drug OK'd: Takeda Pharmaceutical Co. has obtained U.S. Food and DrugAdministration approval for a new combination of insulin sensitizing drugs, Actoplus Met is a combination of Actos and Metformin. Associated Press, August 30, 2005.
Byetta (Exenatide) Approved for Treatment in Type 2 Diabetes Company: Amylin/Eli Lilly Approval Status: Approved April, 2005
Byetta (exenatide), derived from a compound found in the saliva of the Gila monster, a large lizard native to the southwestern US, is a functional analog of Glucagon-Like Peptide-1 (GLP-1), a naturally occuring peptide which enhances insulin secretion in response to elevated plasma glucose levels. By mimicking the function of GLP-1, the drug helps more strongly activate this pathway to improve glycemic control.
Byetta is specifically indicated as adjunctive therapy to improve glycemic control in patients with Type 2 diabetes mellitus who are taking metformin, a sulfonylurea, or a combination of both, but have not achieved adequate glycemic control.
Increlex Receives FDA Approval, August 26, 2005 - Increlex (mecasermin), a drug from Tercicia was approved fby the FDA in August 2005 for the treatment of growth failure in pedicatric patients. Increlex contains recombinant-DNA-engineered human insulin-like
growth factor-1 (rhIGF-1). It is designed to replace natural IGF-1 in pediatric
patients who are deficient, promoting normalized statural growth. Also, see Mosby's Drug Consult..... "For more than 30 years, growth hormone has been the only treatment option endocrinologists have had for children with short stature due to hormonal deficiency," said Philippe Backeljauw, MD, Division of Endocrinology, Cincinnati Children's Hospital and a coinvestigator in the phase III trial conducted for Increlex. "The availability of Increlex will enable physicians to offer a more specific treatment for children whose growth failure is linked to abnormally low
blood IGF-1 levels."
Exubera (inhaled insulin) - FDA Approves Inhaled Insulin Exubera - The Food and Drug Administration finally approved the first inhaled insulin. Exubera is an inhaled powder made of recombinant human insulin (produced through a genetic engineering process) for the treatment of adult patients with type 1 and type 2 diabetes. 01/27/2006
Exubera's headline history:
FDA Delays Approval of Inhaled Insulin: "The Food and Drug Administration is delaying a final decision on the first inhalable form of insulin for three months while it reviews chemistry data on the diabetes treatment." Associated Press, October 28, 2005
FDA Panel Urges Approval of Inhaled Insulin: Exubera Offers People With Diabetes an
Alternative to Insulin Injections. Sept. 8, 2005 (Washington) -- A government advisory panel has backed approval of the first insulin inhaler. The device offers people with diabetes an alternative to insulin injections for controlling their blood sugar. Todd Zwilich, Wed Md News, September 8, 2005.
Exubera Could Be Approved By October 2005. UBS maintained a buy rating and $34 price target on the healthcare giant. ... The FDA committee voted 7-2 in favor of approval of Exubera for type 1 and 2 diabetes. The inhaled insulin is being developed with partners Sanofi-Aventis.
Symlin Approved by the FDA - A new antihpyerglycemia drug, pramlintide acetate
(brand name Symlin), has been approved by the FDA for people with type 1 diabetes whose A1C levels are not in an acceptable target range. It is also approved for those with type 2 diabetes who use insulin and are not meeting their A1C objectives.
Pramlintide is a synthetic form of the hormone amylin normally produced by the beta cells along with insulin.
Amylin, insulin, and a third hormone called glucagon all work together to maintain normal glucose levels. Studies show a modest improvement in A1C levels for individuals adding pramlintide to their diabetes care routine.
A press release from Amylin Pharmaceuticals, the company that makes Symlin, warns that not all patients may be suitable for administration of pramlintide as it increases a risk for severe hypoglycemia. Pramlintide’s primary side effect for new patients is nausea, however, patients
can learn to adjust their dose thereby minimizing discomfort. Read the Symlin Press Release
Dual Purpose Drugs: New Medications Targeting Both Blood Sugar and Fats
New Diabetes Drug May Control Cholesterol: Experimental Pill Targets Blood Fat as Well as Sugar; Reuters, June 13, 2005. If approved, Pargluva, or muraglitazar, would
be the first insulin sensitizer to target lipids as well. Pargluva is being
developed by Bristol-Myers Squibb and Merck & Co. Inc.
Diabetes Technology & Therapeutics, December 2004, Volume 6, No. 6: Thiazolidinediones (rosiglitazone & pioglitazone): A Review of Their Mechanisms of Insulin Sensitization, Therapeutic Potential, Clinical Efficacy, and Tolerability.
Drugs rejected by FDA or failed in clinical trials
MK-767: "Licensed from a Japanese drugmaker, this pill
was to be the first of a class of drugs that would control cholesterol and
blood sugar. Millions of Americans have Type 2 diabetes, in which the body
stops responding to or producing insulin. Current medicines control blood sugar
levels but don't help with cholesterol. Cardiovascular disease causes 80% of
deaths among diabetics. MK-767 turned out to cause cancer in rats, but fortunately
several similar drugs are in development by other companies."
FDA Alerts US Residents to Recall of
Counterfeit Lipitor Sold in the United KingdomAugust 5, 2005. ST. LOUIS (MD Consult) - On July 29, 2005, the US Food and Drug
Administration (FDA) alerted US residents to the recent recall of a batch of
counterfeit Lipitor (atorvastatin) sold in the United Kingdom (UK). Lipitor is
used to treat high cholesterol. The counterfeit Lipitor 20-mg tablets were recalled in the United Kingdom on
July 28, 2005. Health authorities in the United Kingdom stated that initial
results of tests performed on the counterfeit drugs do not indicate this product
poses an immediate risk to patients; however, they advise patients to stop
taking the drug and to return it to the pharmacy where they obtained it. UK
pharmacies are being advised to return all remaining stock of this batch to
Pfizer Ltd, the manufacturer of Lipitor.
Herbal products contain drugs for
3-6-2000, By Mary Ann Hellinghausen; Sacramento, Calif.Five brands of herbal products found to contain prescription drugs used to treat diabetes could be dangerous to consumers, especially those with diabetes, warn the California Department of Health Services (CDHS) and the Food and Drug Administration (FDA). The
recalled products are: Diabetes Hypoglucose Capsules and Pearl Hypoglycemic Capsules, both sold by Chinese Angel Health Products of Santa Monica, Calif.; Sino American’s Zhen Qi Capsules; and Tongyi Tang Diabetes Angel Pearl Hypoglycemic Capsules and Tongyi Tang Diabetes Angel Hypoglycemic Capsules.
Rezulin was recalled by the FDA in March of 2000 due to 94 liver-related deaths associated with rezulin use.
Diabetes Technology & Therapeutics: December 2004, Volume 6, No. 6. Noninvasive Ultrasonic Transdermal Insulin Delivery in Rabbits Using the Light-Weight Cymbal Array. Study in ultrasonic insulin injection for noninvasive drug therapy. (.pdf format)