Posted On: March 22, 2011

Why is Roche's Accu-CHEK Glucose Meter still on the Market?

Between 1997 and 2009, the FDA received 13 reports of death associated with GDH-PQQ (glucose dehydrogenase pyrroloquinoline quinone) glucose test strips in which there was interference from maltose or other non-glucose sugars. Some of the reports indicated that hypoglycemia, confusion, neurologic deterioration, brain damage and coma occurred prior to death. The medical community sometimes refers to this as fatal iatrogenic hypoglycemia, and its reasonable to suspect that there are significantly more cases of hypoglycemia that go unreported or unidentified.

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Posted On: March 21, 2011

Hair Loss Drugs (Propecia, Avodart) Linked to Sexual Dysfunction and Depression

In an article published in the March 2011 issue of The Journal of Sexual Medicine, researchers from the Boston University School of Medicine seem to have confirmed what recent lawsuits have already alleged, namely that there is a link between the use of dutasteride (Avodart) and finasteride (Proscar and Propecia) and temporary and sometimes permanent sexual dysfunction including erectile dysfunction and loss of labido. Notably, more than double the percentage of men reported erectile dysfunction while on one of the drugs (8%) compared to placebo (4%). Further, a loss of sex drive was reported more than twice as frequently among those taking one of the drugs (4%) compared to placebo (1.8%). Other reported side effects of Avodart, Proscar and Propecia included depression, reduced semen production and growth of male breast tissue.

The most devastating information presented, however, relates to symptoms of the side-effects persisting even after the medication was discontinued. In fact, in a second study reported within the same volume of The Journal of Sexual Medicine, Dr. Michael S. Irwig interviewed 71 otherwise healthy men who reported sexual side effects after taking finasteride and determined the mean duration of the negative sexual impact to be 40 months after stopping the drug. Despite the absence of any such information on the drugs' labeling in the United States, these prolonged side-effects do appear on the updated labeling for these drugs in European nations such as Great Britain, Sweden and Italy.

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Posted On: March 4, 2011

Oral Cleft Birth Defect Risk Increased by Topamax Use

The FDA has placed the anticonvulsant drug Topamax, and its generic equivalent topiramate, in Pregnancy Category D as a result of new data illustrating an increased risk of the development of cleft lip and/or cleft palate (oral clefts) in infants born to women treated with Topamax during the first trimester of pregnancy. The data showed a Pregnancy Category D means that there is positive evidence of fetal risk based upon human data. Topamax is manufactured by Ortho-McNeil-Jannsen and has been marketed in the United States for almost 15 years for the treatment of some patients with epilepsy and for the prevention of migraine headaches. In addition, it has been used off-label for other conditions, many of which are not considered serious. Over four million (4,000,000) patients have filled prescriptions for Topamax and/or topiramate in the United States over the last four years.

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Posted On: March 2, 2011

Another Long-Term Safety Concern with Proton Pump Inhibitor Use

We can now add low magnesium levels to the growing list of side effects caused by Proton Pump Inhibitors (PPIs), like Nexium, Prilosec, Prevacid and Protonix. While PPIs do an incredible job of controlling chronic acid reflux, many researchers now believe that they may also increase your risk of contracting pneumonia, developing bone fractures, (also, see my blog from last Spring), and increasing your risk of a heart attack if taken with a drug like Plavix. It seems as if every couple months, a new warning is issued by the FDA concerning these products.

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