Scientists at The Scripps Research Institute have created healthy adult mice out of mouse skin cells.

The study, published in Nature, showed that adult cells can be reprogrammed backward in their development, until they have the characteristics of embryonic stem cells.


Observers said it was remarkable and promising news for the future of stem cell research.

Researchers hope that the Study’s results ultimately lead to the ability to treat diabetes, Alzheimer's, Parkinson's, hearing loss, or spinal cord damage with a patient's own cells. It is preferable to use the patient’s own cells over another’s cells because of the risk of rejection.

Researchers estimate that these treatments are at least 15 to 20 years away.


Reprogramming mouse skin cells to grow into complete mice required a decade's worth of advances in mouse genetics, genetic engineering, stem cell biology and reproductive technology.

Today, the skin-derived mice continue to live in air-conditioned comfort in La Jolla.


http://www.nature.com/stemcells/2007/0706/070607/full/stemcells.2007.6.html

Labels: alzheimer's, diabetes, embryonic stem cell, hearing loss, Mice, Parkinson's, skin cells, spinal code, stem cell

FDA acknowledges four recent studies that observed the use of the insulin, Lantus and possible risk for cancer. Three of the four studies suggest an increased risk for cancer associated with use of Lantus. See http://www.diabetologia-journal.org/cancer.html.

Currently, the FDA recommends that patients consult their doctor before stopping their insulin therapy. Patients should not stop their therapy on their own. Uncontrolled blood sugar levels can pose both immediate and long-term serious adverse effects.

Similar to human insulin, Lantus is used to control blood sugar in people with Type 1 and Type 2 diabetes. Lantus is a long-acting insulin that is only approved for once-a-day dosage delivered by under the skin injections.

In all four studies, the length of patient follow-up was shorter than what is necessary to evaluate for cancer risk from drug exposure. Further, the studies were inconsistent within themselves and with each other, which raises the question if there really is an association between Lantus and cancer. Additionally, differences in patient characteristics in the various treatment groups may have contributed to a finding of increased cancer risk.

Nonetheless, FDA is reviewing the safety data for Lantus to better understand the risk, if any, for cancer associated with use of Lantus. FDA is also communicating with Lantus if any additional studies are needed to evaluate the safety and efficacy of Latus.

FDA requests that any adverse events associated with Lantus be reported to their MedWatch program.

he FDA can be contacted via:
Online at www.fda.gov/medwatch/report.htm
Phone at 1-800-FDA-1088
Fax at 1-800-FDA-0178, using the MedWatch Form 3500
(available at www.fda.gov/medwatch/ getforms.htm)
Mail, using the postage-paid MedWatch Form 3500 (see above), to MedWatch, 5600
Fishers Lane, Rockville, MD 20852-9787

For more information please see: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders

Labels: cancer, diabetes, FDA, insulin, Lantus

Yesterday on June 15, 2009 Hi-Tech Pharmaceuticals recalled its weight loss supplement Stamina-Rx. Stamina-Rx contains benzamidenafil, an undeclared and not FDA-approved ingredient.

Hi-Tech Pharmaceuticals, Inc. of Norcross, GA manufacturers Stamina-Rx.

On May 1, 2009, the FDA notified Hi-Tech that its lab analysis of Lot 08141578, Exp. 9/10 of Stamina-Rx contains − benzamidenafil − a Phosphodiesterase Type 5 (PDE5) inhibitor. PDE5 inhibitors, like FDA-approved sildenafil, tadalafil, and vardenafil treat erectile dysfunction (ED).

Benzamidenafil is not FDA-approved, and poses a threat to consumers. Benzamidenafil can interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and may be most susceptible to adverse effects from this product.

In addition to the one lot described above, Hi-Tech is recalling all other lots of Stamina-Rx because it is an unapproved new drug and misbranded new drug in violation of the Federal Food, Drug and Cosmetic Act (the Act). Stamina-Rx is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling posted on certain web-based and print media.

Hi-Tech has been under a Consent Decree of Permanent Injunction with the FDA since September 23, 2003. In accordance with the Decree, the FDA determined that additional corrective actions were necessary for Hi-Tech to achieve compliance with the Act and the Decree and therefore, on May 1, 2009 the FDA ordered Hi-Tech to recall all lots of Stamina-Rx to the consumer level.

Customers who have this product in their possession should stop using it immediately. For more information regarding the recall contact: Hi-Tech Pharmaceuticals, Inc., Norcross, GA 30071 at toll-free 1-888-855-7919 from 9:00 AM - 5:00 PM EST.

Please report any adverse events associated with Stamina-Rx to the FDA’s MedWatch program.

The FDA can be contacted via:
Online at www.fda.gov/medwatch/report.htm
Phone at 1-800-FDA-1088
Fax at 1-800-FDA-0178, using the MedWatch Form 3500
(available at www.fda.gov/medwatch/ getforms.htm)
Mail, using the postage-paid MedWatch Form 3500 (see above), to MedWatch, 5600
Fishers Lane, Rockville, MD 20852-9787

For more information please see: http://www.fda.gov/Safety/Recalls/ucm167139.htm

Labels: diabetes, FDA, Hi-Tech, Stamina-Rx, viagra

Those suffering from Type II diabetes, beware. The FDA has recently announced that they are issuing a new Black Box warning on the Type II diabetes medicines, Actos and Avandia. Both of these drugs have been connected with an increased risk for heart attacks and heart-related deaths. Anyone who has taken Actos or Avandia could potentially be at risk.

The warning urges physicians prescribing Actos and Avandia to watch their patients for signs of heart problems. Some symptoms of a heart problem are: shortness of breath, edema (retaining of fluid causing swelling of extremities), and excessive or rapid weight gain. Anyone experiencing any of these symptoms and taking Actos or Avandia should contact their doctor immediately.

Type II diabetes is a disorder that is characterized by high blood glucose due to an insulin deficiency. The insulin resistance is caused because the cells do not respond appropriately to insulin. Unlike Type I diabetes, Type II is a problem of cellular response to insulin rather then a problem with the production of insulin. The prevalence rate of diabetes have doubled from 1990-2005, causing the Center for Disease Control to declare it an epidemic.

For more information see:
The FDA warning: http://www.fda.gov/medwatch/SAFETY/2002/summary-actos-avandia.PDF
The American Diabetes Association Website: http://www.diabetes.org/

Labels: Actos, Avandia, diabetes, edema, heart attack, myocardial infarction, Type II