Weight-loss Pill Manufactures Still Attempting to Gain FDA Approval - allvoices

Three different weight-loss pills rejected by FDA but manufactures still try to gain approval

Manufactures of pills face tough challenges when attempting to receive FDA approval and at times they get rejected but this does not keep them from trying.

Vivus Inc., Orexigen Therapeutics and Arena Pharmaceuticals all manufactures of weight-loss pills are once again trying to receive the FDA approval even though they have received rejections.

Vivus Inc developed an oral combination of phentermine and topiramate labeled Qnexa.

The company is planning to submit a revised application for their product next month.

This weigh-loss pill had received FDA rejection upon the agency identifying an increased risk for psychiatric issues, cardiovascular effects and birth defects if used by women during pregnancy. It is believed that the part of the pill called topiramate is the main cause of issues even though phentermine is a recognized risk as well for psychosis.

The company had revealed their new development plan which calls for a starting application which would list "child bearing potential' as a contravention of the pill in obese women. Currently they are conducting a retrospective examination consisting of electronic health records of around 2,500 children who had been conceived while the mother took topiramate during pregnancy.

The manufactures of Orexigen had been informed by the FDA in January, they needed to conduct a randomized double-blind, and placebo controlled trial of acceptable size and time length in order to demonstrate that the drugs benefit out weighs the risk of major adverse cardiovascular events in overweight and obese participants.

The company in June had stated that a trial of this type would be uncommon and would produce remarkably greater data than is beneficial. They also made their grievance known for the FDA refusal to even examining the product for approval to a restricted populace without needing the added cardiovascular event safety data.

Arena Pharmaceuticals mishap occurred when information demonstrating an increase of mammary tumors in rats paired with clinical effectiveness outcomes demonstrating an average weight-loss of only five percent, this being the lowest of all the mentioned products.

On 2004, the diet pill Ephedra had banned by the FDA. The agency's final ruling prohibited the sale of any dietary supplements containing ephedra due to the fact it had posed unnecessary risks of illness and injuries.

In April of this year the consumers watchdog group Public Citizen's had issued a petition to the agency to ban Xenical and Alli.

The group had cited the drugs had posed the possibility of remarkable damage to numerous critical organs.

Based on scientific studies the average weight loss achieved is 12.4 to 13.4 pounds when taken six months to one year. Proper diet and exercise is still required. Most studies do show weight loss with these prescription pills however, they do show most people regain the weight once they stop taking the pills.

There are natural alternative that can promote weight loss a few of these are:

Green Tea

Clinical studies have advocated that green tea could boost the metabolism and burn fat.

Ginseng

There have been studies demonstrating the ginseng may be helpful in weight loss. It boosts the body's metabolism, burns fat and appears to suppress appetite of over eaters.

Glucomannan

There have been numerous placebo controlled studies that have shown to have moderate but remarked weight loss.

Remember before using any supplement or herb check with your practitioner first for possible side effects and drug interactions.

18 Sep, 2011

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