FDA Postpones Decision On Safety Of Controversial Cannabinoid Blocking Agent

US regulatory authorities announced that an independent Food and Drug Administration (FDA) advisory committee will hear testimony in June regarding whether the controversial cannabinoid receptor antagonist SR 141716A/Rimonabant is safe for human consumption. The agency had previously announced that it would decide by April 26, 2007, whether to grant US market approval for Rimonabant as a weight-loss drug.

Neither the FDA nor the drug's manufacturer, Sanofi-Aventis Pharmaceuticals, gave a reason for the postponement.

Under the FDA's revised timeline, the agency's Endocrinologic and Metabolic Drugs Advisory Committee will hear testimony regarding the drug's safety and efficacy on June 13, 2007. The FDA has previously denied Sanofi-Aventis Pharmaceuticals permission to market the drug in the US.

Rimonabant, marketed under the trade name Acomplia, recently received regulatory approval for sale in Europe as a prescription dietary aid. It is the first cannabinoid antagonist ever to be approved for human consumption.

Rimonabant blocks the natural binding of endogenous cannabinoids (as well as exogenous cannabinoids such as delta-9-THC, the psychoactive component of marijuana) to the neuronal CB1 receptors, causing users to lose their appetites. However, because the endocannabinoid receptor system is intricately involved in the regulation of a broad range of primary biological functions *-- including appetite, body temperature, mood regulation, blood pressure, bone density, reproduction, learning capacity, and motor coordination --* some experts are concerned that the long-term use of Rimonabant or similar drugs may eventually contribute to a host of significant adverse health effects.

In preclinical trials, newborn mice injected with Rimonabant refuse feeding and often die days after birth. Mice genetically bred to lack the CB1 receptor also suffer from numerous health defects such as cognitive decline, hypoalgesia, decreased locomotor activity, and increased mortality compared to healthy controls.

At least one published case study reports that daily use of the drug may have triggered neurological symptoms of multiple sclerosis in a volunteer with no known history of the disease. Mental health side effects, such as depression, are also commonly reported among volunteers administered Rimonabant.

In human trials, daily administration of Rimonabant is associated with lower blood sugar levels and weight loss compared to placebo. Sanofi is seeking to market the drug in the US under the trade name Zimulti.

Marijuana Health Effects and Workplace Issues

Marijuana Health Effects:

Emphysema-like conditions

One joint of marijuana contains cancer-causing substances equal to 1/2 pack of cigarettes.

One joint causes the heart to race and overwork. People with heart conditions are at risk.

Marijuana is commonly contaminated with the fungus aspergillus, which can cause serious respiratory tract and sinus infections.

Marijuana lowers the body's immune system response making users more susceptible to infection.

Chronic Marijuana smoking causes changes in brain cells and brain waves. The brain does not work as efficiently or effectively. Long-term brain damage may occur.

Tetrahydrocannabinol (THC) and 60 other chemicals in marijuana concentrate in the ovaries and testes.

Chronic smoking of marijuana in males causes a decrease in testosterone and an increase in estrogen, the female hormone. Therefore, the sperm count is reduced, leading to temporary sterility.

Chronic smoking of marijuana in females causes a decrease in fertility.

A higher than normal incidence of stillborn births, early termination of pregnancy, and higher infant mortality rate during the first few days of life are common in pregnant marijuana smokers.

THC causes birth defects including brain damage, spinal cord, forelimbs, liver, and water on the brain and spine in test animals.

Prenatal exposure may cause underweight newborns.

Fetal exposure may decrease visual functioning.

User's mental function can display the following effects:

  • delayed decision making
  • diminished concentration
  • impaired short-term memory
  • impaired signal detection
  • impaired tracking
  • erratic cognitive function
  • distortion of time estimation

Marijuana Workplace Issues

THC is stored in body fat and slowly released.

Marijuana smoking has long-term effects on performance.

Increased THC potency in modern marijuana increases the impairment.

Combining alcohol or other depressant drugs with marijuana increases impairment.

Aerosol home drug test: Detect Now Marijuana (THC) Test

Detect Now Marijuana Test is aerosol drug test for detection & identification of THC. Using special drug wipes, you simply wipe or touch the suspected surface or substance, then spray the drug wipes. You'll receive very accurate results in seconds.

Each Detect Now Marijuana Test kit includes:

  • a spray kit,
  • 10 separate test papers,
  • complete directions, FAQ, "What to do", and a resource list.

This drug test is very accurate and there's no lab required. This is the same drug test, which is used by law enforcement agencies. And the best thing is that you have the advantage of testing with or without the knowledge of the person being tested.

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