Legal Nurse Consulting News: The Diet Pill Race
Saturday, December 04, 2010
With the U.S. obesity rates nearing 35% among adults, drug makers are struggling to get their weight loss products approved and on the market. To be approved, drugs must have at least one-third of its test patients lose 5% or more body weight in order to be considered an obesity fighting drug. Three small drug makers are racing to be granted approval for their weight-loss drugs.Vivus Inc., the manufacturer of Qxena, had high hopes for FDA approval in October 2010, but was rejected. The board stated that the drug was associated with a number of dangerous side effects, including suicidal thoughts, heart palpitations, memory lapses and birth defects. Qxena consists of two prescription drugs Phentermine and Topiramate. Phentermine has been used for years to fight obesity, but Topiramate is mainly used as an anti-convulsant such as with epilepsy patients. An official warning has been issued stating that it is very dangerous for patients to mix the medications themselves due to the release formula and correct amounts.Lorcaserin was denied earlier in the week, due to tumors seen in rats during the early stage of testing. Lorcaserin is produced by Arena Pharmaceuticals, a San Diego based company. Unlike all of the combination diet pills being developed, Lorcaserin is a single new drug being experimented with. The chemical breakdown of this drug is very similar to Fenfluramine. Fenfluramine has acquired a negative reputation from Phen-Fen. In April 2005, Phen-Fen resulted in over 50,000 product liability cases and a mass tort crisis. Wyeth set aside 21.1 billion for the settlements owed in these cases. Victims received anywhere from $5,000- $200,000. Even though Lorcaserin does not show the same heart valve problems as Fenfluramine, the FDA is requiring more detailed information on this drug.The third competitor, Orexigen Therapeutics, is the center of attention in the weight-loss drug race. Contrave is their newest product being tested. Contrave is a mixture product just like Qxena. The special unique formulation of Naltrexone and Bupropion has been proven to outdo any weight loss experienced by Bupropian alone. One would not think this combination would increase weight loss because Naltrexone is used to help fight addictions and Bupropian is used to battle depression. This formula was presented to the FDA in March 2010, but due to errors in their records, the FDA's decision will be delayed a few weeks. Once approved by the FDA, it can take up to 10 months for a product to be distributed. The weight loss drug class has a history of safety problems resulting in many mass tort cases. It is important as a Legal Nurse Consultant and/or Product Safety Specialist, to stay updated on the newest drugs that may be hitting the market. There have been numerous cases recently involving weight loss drugs. Ephedrine and Phen-Fen are only a few examples of products that resulted in payouts to consumers who were harmed by use of the products. There are even more cases you can research that resulted in million or billion dollar settlements.