For Diabetics who need to enure the pain and discipline required in the use or injection pens, the following article is nice to know…read more below…

Medingo’s insulin patch approved; shares rocket

By Nick Taylor, 30-Jul-2009

Medingo’s insulin dispensing patch has been approved by the US Food and Drug Administration (FDA), sending shares in its parent company soaring to a 12 month high.

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I was shocked to hear that melamine was found in infant’s milk powder manufactured in China. How can these manufacturers not consider the harm to innocent babies who rely on milk as their only source of nutrition? Not only is this happening in China, the very fact that unscrupulous activities can deceive the public is frightening. Hence, the FDA has taken the right approach not to assume anything. Here’s the latest excerpt from FDA on this matter…..

In a guidance issued 6 Aug 2009, the U.S. Food and Drug Administration says that certain pharmaceutical ingredients used in the manufacture or preparation of drug products should be tested for melamine.

Melamine is a synthetic chemical with a variety of industrial uses including the production of resins and foams, cleaning products, fertilizers and pesticides. If ingested in sufficient amounts, melamine can result in kidney failure and death.

Although the FDA has no reason to believe that the U.S. pharmaceutical supply is contaminated with melamine, recent events involving pet and livestock food products in the United States, and milk products for infants in China, underscore the potential problem.

The guidance is an initial measure by the agency in working with pharmaceutical manufacturers, repackers, other suppliers and pharmacists to conduct melamine testing. The agency invites comments on the guidance, available online and titled “Guidance for Industry: Pharmaceutical Components At Risk for Melamine Contamination“.

“The FDA urges implementation of appropriate controls to assure consumers that melamine contamination will not happen in the pharmaceutical supply chain,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “We look forward to working with industry on this serious public health concern.”

The FDA identifies specific pharmaceutical ingredients in the guidance that are recommended to be screened for the presence of melamine. The guidance also recommends the use of FDA-published methods for this testing that are used to detect the presence of melamine in food proteins. These tests rely on equipment that is generally available to pharmaceutical manufacturers or contract testing labs. The agency also is developing a sampling and testing program for pharmaceutical ingredients at risk for melamine contamination.

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I saw this article, first published in June 13 2009 and felt it important to share….

FDA Issues Public Health Advisory Regarding Levemir Insulin

The U.S. Food and Drug Administration has learned that some stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. have reappeared and are being sold in the U.S. market. Three lots or a total of 129,000 vials of this product were stolen in all. These stolen insulin vials may not have been stored and handled properly and may be dangerous for patients to use.

The FDA has received one report of a patient who suffered an adverse event due to poor control of glucose levels after using a vial from one of these three lots.

The agency is advising patients who use Levemir insulin to:

1. Check your personal supply of insulin to determine if you have Levemir insulin from one of the following lots: XZF0036, XZF0037, and XZF0038. Patients can locate the lot number on the side of the box of insulin and also on the side of the vial.

2. Do not use your Levemir insulin if it is from one of these lots. Replace it with a vial of Levemir insulin from another lot. If you must switch to another brand of insulin for any reason, first contact your healthcare provider as another insulin product may require adjustments in dosing.

3. Always visually inspect your insulin before using it. Levemir is a clear and colorless solution.

4. Contact the Novo Nordisk Customer Care Center at 800-727-6500 for what to do with vials from these lots or if you have any other questions.

For more information:
Novo Nordisk news release

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Here’s some shocking news about unsanitary conditions which I would like to share….. here’s what the FDA article on 7 August 2009 states:

At the request of the U.S. Food and Drug Administration, U.S. Marshals today seized tuna salad sandwiches and other food products from Bearden Sandwich Company Inc., doing business as Southern Belle Sandwich Company, in Baton Rouge, La.

The seized products, totaling more than $72,000, violate the Federal Food, Drug, and Cosmetic Act because the products have been prepared, packed, and held under unsanitary conditions whereby they may have become contaminated with filth or rendered injurious to the public’s health (the Act uses the term “insanitary” to describe such conditions). In addition, the tuna fish salad sandwiches were processed under conditions that violate Seafood Hazard Analysis Critical Control Point (HACCP) regulations.

“When FDA investigators find violations inside a company’s facility, we will do what is necessary to keep insanitary and potentially harmful products out of consumers’ hands,” said Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs. “Companies that are not complying with our laws will be subject to enforcement actions.”

Recent FDA inspections found evidence of widespread and active rodent and insect infestation, filthy conditions, and poor employee practices, such as allowing food-processing utensils to lie on the floor near live insects.

The company distributes products to convenience and retail stores in southern Louisiana; Mobile, Ala.; Montgomery, Ala.; and Crestview, Fla.

The FDA has not received reports of illnesses associated with consumption of the products. The FDA urges consumers who may have purchased the products to dispose of them in a safe manner and wash their hands thoroughly after handling the products. “Safe disposal” means avoiding bare-hand contact with the recalled products, discarding them in a way that will not allow people and pets to retrieve them, and washing items that came in contact with the products, including hands, with warm, soapy water.
Consumers can also report problems, including adverse reactions, to the FDA district office consumer complaint coordinator.

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