DRUGS & MEDICAL DEVICES

More Reports of Chantix Negative Effects

Submitted by jrlaw on Mar 9th, 2009

The Food and Drug Administration announced last they are finally looking into Chantix, a stop smoking medication, to find out how dangerous it might be.

Since the report of Carter Albrecht's unusual behavior and death while taking Chantix, hundreds of other Chantix patients have spoken up about the effects they've experienced. Over the last two months, Ryann Rathbone said she has received countless e-mails from people thanking her for bringing attention to the possible side effects of Chantix.

CLASS 1 RECALL: Bayer Ascensia Contour Blood Glucose Monitoring System

Submitted by jrlaw on Mar 9th, 2009

Bayer Healthcare and FDA notified healthcare professionals and consumers of a Class 1 Recall of Bayer Ascensia Contour Blood Glucose Monitoring System, Product 7152A. This system is used by diabetic patients to measure the amount of glucose in their blood, and as an aid in monitoring the effectiveness of diabetes management.

Accutane Linked to Depression, Lower Serotonin Levels

Submitted by jrlaw on Mar 9th, 2009

Accutane is a drug used to treat severe acne and has been linked to depression among users.

According to researchers Accutane is also linked to decreaded serotonin levels in the brain, which can cause depression and aggressiveness. It has been linked to psychiatric issues including over 250 suicides in the US.

Accutane was first looked at because of the risk of birth defects. Then it was associated to kidney, digestive tract, central nervous system, pancreas, cardiovascular, liver, and auto-immune system problems among others.

A study on mice showed Accutane causes behavior similar to that of a human suffering from depression. This study led to another that focused on the biological and cellular effects of Accutane. The study focused on the production of cells to produce serotonin. In the study the relays between neurons in the brain (which are produced from serotonin) were disrupted.

Serotonin is a hormone found in the brain and other areas of the body and acts as a messenger, transmitting signals between nerve cells. Decrease in the serotonin levels in the brain have been linked to depression, bipolar disorder and anxiety disorders.

Avandia, Actos Diabetes Drugs Double Heart Failure Risk

Submitted by jrlaw on Mar 9th, 2009

Friday, July 27, 2007

Diabetes patients who take the diabetes drugs Avandia or Actos are two times as likely to develop heard problems

According to a report published in the August issue of Diabetes Care, for every 100 people taking either drug, two will develop heart failure within 26 months.

A U.S. government review released Thursday found Avandia's heart risks are far higher than Actos'. An advisory panel hearing Monday will examine whether Avandia's cardiovascular risks warrant a stronger warning label.

Permanent Injunction against PharmaFab Inc., PFab LP prescription and otc drugs

Submitted by jrlaw on Mar 9th, 2009

FDA announced the entry of a Consent Decree of Permanent Injunction against PharmaFab Inc., its subsidiary, PFab LP, and two company officials, to stop the illegal manufacture and distribution of prescription and over-the-counter drug products. The products are illegal because they are not produced according to the required current good manufacturing practice (CGMP) and many also lack required FDA approval. Compliance with CGMP is necessary to ensure that drugs have the requisite safety, identity, strength, quality, and purity.

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