Avandia Warning: Avandia Side Effects and Risks

GlaxoSmithKline, manufacturers of Avandia, a drug used for the treatment of type 2 diseases was given warning by Food and Drug Administration. Warning was issued as the company withheld some information on Avandia from FDA.

Roisglitazone is generic name for Avandia. It is an oral medication used for regulating sugar levels and controlling blood sugar in the patients. Avandia was once considered as one of the popular and best selling drug for the treatment of diabetes. However, according to the report published in the New England Journal of Medicine, Avandia has serious side effects on the patients suffering from cardiac problems.

According to the reports issued in May 2007, after consuming Avandia for a certain period of time, patients are exposed to the high risk of heart attacks. Long-term consumption of Avandia increases the risk of cardiac problems and may sometimes lead to death due to cardiovascular related problems. Now the regulators in the Europe and United States issued warning labels on the Avandia’s information prescribed.

Warning letter was issued by FDA against GlaxoSmithKline when it failed to report the results of ongoing clinical trials of Avandia. Avandia study was conducted for a period of six years from 2001 to 2007. FDA conducted the routine inspection of GlaxoSmithKline and drug. Because of this inspection, it was founded that some information was missing from the trials.

Avandia was introduced in the market in May 1999. Since then it has been used to benefit the patients of type 2 diabetes and Alzheimer’s. Although no. of patients taking Avandia is about 3.5 millions, there has been decline due to the negative reports issued against Avandia. Avandia has been linked to serious side effects like osteoporosis and bone fractures including heart diseases. According to researchers at the Salt Institute for Biological Studies, consumption of Avandia affects the functioning of osteoblasts and osteoclasts. These two cells renew old bone with healthy, new and strong bone.

Weight gain, swelling or fluid retention, headache, inflammation sinuses and back pain are few other side effects of Avandia. Individuals suffering from Avandia side effects can seek  advice of pharmaceutical attorney for monetary compensation.

New ‘Avandia’ Warnings Issued by GlaxoSmithKline

GlaxoSmithKline, manufacturers of Avandia issued new warning to the patients suffering from unstable angina and heart failure. These warnings were issued for the patients consuming Avandia, because of the side effects and controversies associated with the use of type 2 anti diabetic drug.

The Therapeutic Goods Administration (TGA) of Australia introduced the black box warning to Avandia in 2007. Black box warning is one of the harshest warnings issued to any drug. However, the drug was not withdrawn from the market because there was no sufficient evidence to remove it from the market.

Risks Associated with Avandia

GlaxoSmithKline introduced Avandia to the market on May 25, 1999. Since then, Avandia has been prescribed to approximately 6 million Americans. Avandia, an anti- diabetic drug controls glucose level in the patient’s body.

The New England Journal of Medicine first reported the potential side effects on patients consuming Avandia. These side effects included osteoporosis and heart failure among others. Another study conducted by Swiss researchers showed a link between early onset of osteoporosis and bone fractures.

According to Datamonitor, an analysis and research company, there will be extreme growth in the ant diabetic market in the next 10 years. Sales will rise from $18 billion in 2007 to $29 billion in 2017. However, due to the studies published on the side effects of Avandia, there has been decline in the sales of GlaxoSmithKline. Company announced that they will lay off 17 000 jobs.

Patients suffering from type 2 diabetes, who have been prescribed Avandia, if in case show any symptoms of heart failure and bone fracture should immediately consult their physician. Patients suffering from following symptoms should immediately seek the advice of the doctor:

• Sudden weight gain
• Swollen ankles or legs
• Liver disease
• Unusual tiredness
• Difficulty in breathing
• Change in vision

Patients suffering from the side effects of Avandia can also seek the advice of an experienced attorney. He will assist the victim in developing a lawsuit so that a victim may receive monetary compensation for the damages caused to him.

Consumption of Avandia Increases Risk of Bone Fracture among Women

According to the recent article published in the “Canadian Medical Association Journal”, women consuming Actos or Avandia are at a high risk of non-vertebral fractures. This study was conducted at the University of East Anglia in Norwich. There were 10 randomized clinical trials conducted on 1375 patients. According to CMAJ article it was found that large no. of women were at the high risk of bone fracture.

Study revealed that men were not at the risk of loss of bone density whereas women were at the increased risk of bone fractures.

About 4 million Americans consume thiazolidineodiones every year. It is also known as glitazones. It is used for the treatment of Type 2 diabetes .It includes pioglitazone (Actos, Competact) and rosiglitazones (Avandamet, Avandia). According to the information released by Medicines and Healthcare Products Regulatory (MHRA), a regulatory body at United Kingdom similar to United States FDA, these therapies” work by reducing insulin resistance and helping the body use the insulin it produces”.

MHRA also reported the side effects related to the consumption of such drugs including following:

• Hepatic impairment
• Hypersensitivity
• Macular Oedema
• Cardiac failure
• Bone fracture

Avandia is a commonly prescribed therapy by GlaxoSmithKline. Following are the side effects of Avandia including bone fracture:

Cold

Cardiac arrest

Inflammation of sinuses

Weight gain

Swelling, fluid retention

Headache

Back pain

Cough

Although Avandia has been always surrounded with controversy, it is easily available in the market. According to a Washing Post article, such drugs need stronger warning for their side effects. Patients suffering from Avandia side effects can file a lawsuit against the company for damages and pain and injury caused to him.