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FDA NEWS RELEASE For Immediate Release: Jan. 25, 2010 FDA Approves New Treatment for Type 2 Diabetes The U.S. Food and Drug Administration today approved Victoza (liraglutide), a once-daily injection to treat type 2 diabetes in some adults. Victoza is intended to help lower blood sugar levels along with diet, exercise, and selected other diabetes medicines. It is not recommended as initial therapy in patients who have not achieved adequate diabetes control on diet and exercise alone. Insulin is a hormone that helps prevent sugar (glucose) from building up in the blood. People with type 2 diabetes have difficulty making and using insulin. Victoza is in a class of medicines known as glucagon-like peptide-1 (GLP-1) receptor agonists that help the pancreas make more insulin after eating a meal. "Diabetes is a leading cause of death and disability, with more than 1.5 million new cases diagnosed annually," said Mary Parks, M.D., director, Division of Metabolism and Endocrinology Products in the FDAs Center for Drug Evaluation and Research. "Controlling blood sugar levels is very important to preventing or reducing the long term complications of diabetes, and Victoza offers certain patients with type 2 diabetes a treatment option for controlling their blood glucose levels." In five clinical trials involving more than 3,900 people, pancreatitis (inflammation of the pancreas) occurred more often in patients who took Victoza than in patients taking other diabetes medicines. Victoza should be stopped if there is severe abdominal pain, with or without nausea and vomiting, and should not be restarted if pancreatitis is confirmed by blood tests. Victoza should be used with caution in people with a history of pancreatitis. The most common side effects observed with Victoza were headache, nausea, and diarrhea. Other side effects included allergic-like reactions such as hives. Victoza was not associated with an increased risk for cardiovascular events in people who were mainly at low risk for these events. FDA approved Victoza, however, with several post-marketing requirements under the Food and Drug Administration Amendments Act (FDAAA) to ensure that the company will conduct studies to provide additional information on the safety of this product. In addition to a cardiovascular safety study to specifically evaluate the cardiovascular safety of Victoza in a higher risk population, the company also is required to conduct a 5-year epidemiological study using a health claims database to evaluate thyroid and other cancer risks as well as risks for seriously low blood glucose levels (hypoglycemia), pancreatitis, and allergic reactions. To specifically evaluate the risk of medullary thyroid cancer, the company is required to establish a cancer registry to monitor the rate of this type of cancer in the United States over the next 15 years. In animal studies, Victoza caused tumors of the thyroid gland in rats and mice. Some of these tumors were cancers, which were significantly increased in rats who received excessive doses that were 8-times higher than what humans would receive. It is not known if Victoza could cause thyroid tumors or a very rare type of thyroid cancer called medullary thyroid cancer in people. For this reason, Victoza should not be used as the first-line treatment for diabetes until additional studies are completed that support expanded use. Also, Victoza should not be used in people already at risk for medullary thyroid cancer, such as those who have medullary thyroid cancer in the family or those with a rare genetic condition known as Multiple Endocrine Neoplasia syndrome type 2. To ensure the safe and effective use of this product, Victoza was approved with a Risk Evaluation and Mitigation Strategy consisting of a Medication Guide and a Communication Plan to help patients and providers understand the risks of Victoza and to ensure that the benefits of the drug outweigh the risk of acute pancreatitis and the potential risk of medullary thyroid cancer. Victoza is manufactured by Novo Nordisk of Bagsvaerd, Denmark. For more information: # |
Author: inkvisitor
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FDA press release – Victoza
This was released today:Quote: -
Nipro GlucoPro Insulin Syringes Recall
Received this recall notice:Quote:
Nipro Medical Corporation and FDA notified healthcare professionals of a voluntary nationwide recall of all GlucoPro Insulin Syringes. These syringes may have needles that detach from the syringe. If the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into the syringe, or remain in the skin after injection. This recall includes all product codes and lot numbers with expiration dates before 2011-11 (November 1, 2011). Product was distributed nationwide, including Puerto Rico. Consumers who have GlucoPro Insulin Syringes should stop using and return them to point of sale for reimbursement.
Read the complete MedWatch 2010 Safety summary, including a link to the firm press release, at:
Nipro GlucoPro Insulin Syringes: Recall
Recall — Firm Press Release
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Nipro Medical Corporation Issues a Voluntary Recall of All GlucoPro Insulin Syringes
Contact:
Jessica Oswald
305.599.7174 x249
(EST: 9 am – 5 pm)FOR IMMEDIATE RELEASE – January 21, 2010 – Nipro Medical Corporation, Miami FL, is initiating a nationwide recall of all GlucoPro Insulin Syringes (This does not include the GlucoPro syringe specific for use with the Amigo Insulin pump). These syringes may have needles that detach from the syringe. If the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into the syringe, or remain in the skin after injection.
Consumers who have GlucoPro Insulin Syringes should stop using and return them to point of sale for reimbursement.
This recall includes all product codes and lot numbers with expiration dates before 2011-11 (Nov 1, 2011).
Product Code Lot # Expiry date
JD+01U3008-5C A08022 2011-11
JD+01U3013-5C A08013 2011-06
JD+01U3013-5C A08017 2011-08
JD+01U3108-5C A08013 2011-06
JD+01U3108-5C A08017 2011-08
JD+03U3008-5C C08022 2011-11
JD+03U3013-5C C08013 2011-06
JD+03U3013-5C C08017 2011-08
JD+03U3108-5C C08013 2011-06
JD+03U3108-5C C08017 2011-08
JD+05U3008-5C B08022 2011-11
JD+05U3013-5C B08013 2011-06
JD+05U3013-5C B08017 2011-08
JD+05U3108-5C B08013 2011-06
JD+05U3108-5C B08017 2011-08The firm voluntarily recalled the products after learning of the possibility of needle detachment. FDA has been apprised of this action.
No injuries have been reported to date.
Product was distributed nationwide, including Puerto Rico.
Company is notifying its distributors and customers by Fax and Email and is arranging for return of all recalled products.
Consumers with questions may contact the company at 305.599.7174 x249.
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Pseudo hyperglycemia?
For the past few months I have been reducing my carb intake (in general) and testing much more often and have had better a1c results and less fluctuation (I also switched from Lantus to Levemir and from Humalog to Novolog recently and I think these changes helped this transition, too).Since I am eating less carbs I have of course been taking less rapid acting to cover them – since I know my carb:insulin pretty well, I can cover extras pretty reliably, too.
So earlier I had a cookie and bolused accordingly. A little later I started getting what felt like typical hyperglycemic feelings (for me, this fuzzy/anxious sensation). I test, figuring the cookies packed more punch than I thought and surprise, my BS is 117. This has happened before when I have eaten more carbs at a time than normal.
Fwiw, I don’t *usually* feel the effects of high blood sugar until about 160 mg/dL.So the question – do you think there is such a thing as pseudo hyperglycemic symptoms?