Compelling information about Avandia side effects
When it comes to diabetes, food is not the enemy. It’s just sugar waiting to enter our body cells in order to function, and insulin becomes the door key. Sometimes there is resistance to that key, and that’s where Avandia - among other sugar lowering agents - fit in.
Since its approval in 1999, several attempts have been done to study Avandia’s side effects. As early as September 2005, Avandia has been suspected of causing macular edema, which causes partial blindness in various spots of the angle of vision. While blindness is also a possible effect of diabetes, which Avandia is intended to prevent, an article in the Canadian Journal CMAJ has documented several occurences and recommended discontinuation at the first sign of vision problems.
A press release by GlaxoSmithKline in February 2007 noted that there is a greater incidence of fractures of the upper arms, hands and feet in female diabetics given Avandia compared with those given metformin or glyburide. The information was based on data from the ADOPT trial.
A meta-analysis reported in May 2007 that the use of Avandia was associated with significantly increased risk of heart attack, and an even higher risk of death from all cardiovascular diseases. The US Food and Drug Administration (FDA) issued an alert on May 21, 2007. On July 30 of the same year, and advisory Committee of the FDA concluded that the use of Avandia for the treatment of type 2 diabetes was associated with a greater risk of myocardial ischemic events including heart attacks, than placebo.
In 2009, the RECORD study, an open label trial published in the Lancet, found that there was no increase in cardiovascular hospitalization or death with Avandia compared to metformin plus sulfonylurea, but the rate of heart failure causing admission to hospital or death was significantly increased.
Endocrine side effects have included the resumption of ovulation in premenopausal anovulatory women with insulin resistance . These patients may be at risk for pregnancy if adequate contraception is not used.
Metabolic side effects have included increase in total cholesterol, LDL, HDL and decrease in free fatty acids. These changes were statistically different from placebo or glyburide controls. Dose related weight gain has been reported in patients treated with Avandia alone and in combination with other hypoglycemic agents.
Avandia is structurally related to troglitazone , a similar member of the same therapeutic family no longer marketed in the united states, which was associated with toxicity to the liver and rarely caused liver failure and death during use. It is recommended that liver enzymes to be checked in all patients prior to initiation of therapy, and every two months for the first 12 months and periodically thereafter.
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