FDA recommends recall of Avandia diabetes drug due to heart-related deaths

by Aleksander Phillips

Millions of diabetics have been prescribed Avandia, which is sold by GlaxoSmithKline PLC, since it came on the market in 1999.

However, in May 2007, Avandia was linked to a 43 percent greater risk of heart attack and death in a scientific analysis published by the New England Journal of Medicine.

Upon the release of the 2007 study, GlaxoSmithKline downplayed the report and encouraged continued use of Avandia.  Dr. Lawson McCartney, who led Glaxo’s diabetes drug development, said, “We remain very confident in the safety and of course in the efficacy of Avandia as an important diabetic medicine.”

But a piece in today’s New York Times says hundreds of people taking Avandia needlessly suffer heart attacks and heart failure every month, according to confidential Food and Drug Administration (FDA) reports obtained by the newspaper, recommending the drug be removed from the market.

The reports say that if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia damages the heart.

Avandia, whose generic name is rosiglitazone, is intended to treat Type 2 diabetes.  It was linked to 304 deaths during the third quarter of 2009.

In cases such as this, where a drug maker refuses to pull a potentially fatal medication off the market, doesn’t the FDA have the authority to force a recall?  Not necessarily.  The FDA has authority to force a “black box warning” be placed on the drug, but does not have explicit power to force a company to remove the drug from the market, in the interest of free commerce.  As long as the risks and benefits of a drug are fully disclosed to a patient and the patient voluntarily consents to its use, the FDA has no power to interfere in that patient’s treatment.

Article link: FDA recommends recall of  Avandia

Understanding and dealing with Bipolar Disorder

Buckeyepsych.com Image
Buckeyepsych.com Image

Bipolar Disorder is a mental illness that will cause mood, energy and intellectual processes to cycle.Between 3% and 5% of Americans have bipolar disorder. That is about 4 million people. Bipolar disorder used to be called “manic depression” because that term described the most severe cases. The term bipolar was adopted in a effort to describe how this disorder has symptoms that range between two “poles”.

The symptoms of Bipolar disorder vary along a spectrum in which the symptoms can be very different from one person to the next. Two people with bipolar disorder can look and act very different. Symptoms can varies from one hour to the next, from one day to the next, one week to the next, or they can cycle over a period of months.

Many people with this disorder can go undiagnosed for years. In rare cases, there are distinct manic episodes followed by an episode of pure depression. People are more likely to go see a doctor when they are depressed and so many people are misdiagnosed and are told they suffer from depression. As result, they are treated for depression with little or no benefit.

Symptoms of a Depressive Episode

  • Persistent sad, down or empty moods
  • Feeling helpless, hopeless and pessimistic
  • Feelings of guilt or being worthlessness
  • Loss of interest or pleasure in ordinary activities
  • Decreased energy, a feeling of fatigue or of being “slowed down”
  • Difficulty concentrating, remembering, or making decisions
  • Restlessness or irritability
  • Sleeping too much or excessively
  • Loss of appetite and weight loss
  • Increased appetite and weight gain

In a depressed phase of bipolar disorder, a person can have great difficulty thinking. These people tend to thinking more slowly. In a deep depression that will often stare off and seem disconnected from others. There is a loss of creativity and they have difficulty seeing the relationship between events, feeling and thoughts. They tend to remember depressing times and can’t remember better times. The depression tends to deepen and become worse before it changes. The slide into depression is emotionally painful as the person realizes that their life feels less interesting, less rewarding and less meaningful. Nothing seems to matter. Desire and motivation tends to slip away. They tend to isolate and come to feel like they can’t do anything to feel better. They believe their situation won’t change, will be this way forever and that their situation is hopeless (even when it is not). They forget about things in life that matter. Many depressed people try to fight their depression by involving their self in stimulating and high risk behavior or drug and alcohol abuse. Depressed people are drawn to and find momentary relief using stimulants like cocaine, meth, tobacco and amphetamines. This can include drugs like Adderall and Ritalin that are used to treat attention deficits.

Treatment of a bipolar patient during a depressed phase with an antidepressant can in 8 to 15% of individuals, cause a severe reaction. The reaction can include increased irritability, low frustration tolerance, hyperactivity, anger, aggression, suicidal behavior, and even violence. In some cases, a depressed person will become extremely manic.

Manic symptoms are high energy and accelerated states. Giving people an antidepressant (a type of stimulant) can trigger in some people a manic episode on top of a depressed mood. The rapid onset of a mixed phase of depression and mania can cause people to lose control and become very impulsive, reckless, self-destructive or dangerous. Their behavior can be very unstable and reactive.

Pure manic episodes are rare. They can last hours or many weeks. There is seldom a set pattern. The severity and duration is never the same.

Symptoms of a Manic Episode

  • Increased energy, activity and restlessness
  • Racing thoughts and rapid speech
  • Denial that anything is wrong
  • High risk behavior
  • Impulsiveness or reckless behavior
  • Excessive “high” or moderately positive feelings
  • Poor sleep or decreased sleep
  • Unrealistic beliefs in one’s ability
  • Poor judgment
  • A sustained period of behavior that is different from usual behavior
  • Increased sexual drive
  • Abuse of drugs and alcohol
  • Provocative, intrusive, or aggressive behavior