FDA Orders Stronger Black Box Warning on Avandia

posted on:
November 15, 2007

author:
Staff

Diabetic patients consuming GlaxoSmithKline's Avandia to keep sugar levels at bay may now have to shift to some substitute drug as the US health agency has confirmed that the popular diabetes medicine may increase the risk of heart attacks in takers. However, the agency declined to pull the drug from the market. 

Putting an end to the months-long controversy, the Food and Drug Administration ruled Wednesday that GSK's blockbuster diabetes drug Avandia must now carry a "black box" label warning that says the drug could cause chest pain or heart attacks.

Avandia, also known as rosiglitazone, already carries a black box warning advising the drug could cause or exacerbate congestive heart failure in some patients. Now, the existing black box warning on Avandia would add a new language advising caution in prescribing the drug to diabetics who already have heart disease or are at high risk of suffering a heart attack.

Avandia is a drug that reduces glucose (sugar) level in the blood by increasing the level of insulin. It belongs to the antibiotic drug class called "thiazolidinediones" and is used to treat type II diabetes. Pioglitazone (Actos) is another member from this class. Avandia's drug class "thiazolidinediones" affects a gene called PPAR-gamma and helps the body to use insulin more effectively.

The safety of the drug was under consideration since May when a study conducted by researchers at the Cleveland Clinic and published in the New England Journal of Medicine revealed that Avandia can put the diabetics at higher risk of developing cardiovascular complications.

In that study, this drug, approved by the FDA on May 28, 1999, was found to have increased the risk of heart attacks by 43% and that of cardiac arrest by 64%.

However, GlaxoSmithKline, better known as GSK and Glaxo, in July won favor for its diabetes drug from FDA's safety advisory panel. The panel experts unanimously voted in favor of Avandia, even after finding that it raised the risks of heart attacks.

The U.S. government health advisers, who were gathered at the time to review the drug's safety, voted 22 to 1 that the drug should nonetheless remain on the market, saying the risk wasn't great enough to pull the drug from the market. But, they recommended adding stronger heart failure warning on the label of the drug.

Now, following the recommendations of its outside advisory panel, FDA yesterday asked the Avandia manufacturer Glaxo to add "boxed" warning on the drug label, clearly indicating that the drug is not safe for patients taking insulin or nitrate-based drugs, which are often used to treat cardiovascular disease.

The health agency also reiterated yesterday that the drug would stay in the market. "We are keeping Avandia on the market because we have concluded that there is not enough evidence to conclude that the risk for heart attack or cardiac ischemia is higher than for other type-2 diabetes drugs," the FDA's acting director of the Center for Drug Evaluation and Research, Dr. Janet Woodcock said.

Avandia is Glaxo's second-biggest seller with worldwide sales of about $3.3 billion last year. It costs $131 to $262 a month, depending on dose, compared to the three low-cost generics, metformin, glipizide and glimepiride, which range in cost from $10 to $60 a month.

Another brand-name diabetes drug- Actos (pioglitazone), made by Takeda Pharmaceutical Co., costs from $142 to $221, depending on dose, while Januvia (sitagliptin phosphate), manufactured by the Whitehouse Station, New Jersey-based pharmaceutical company Merck, costs around $200 a month.

FDA's latest decision would certainly provide a sigh of relief to London-based GlaxoSmithKline Plc that manufactures diabetes drug Avandia to treat Type 2 diabetes, a serious and debilitating disease that becomes progressively more common with age and obesity.

Diabetes is a debilitating disease where the body is unable to produce or produces too little of the hormone, insulin, which is essential for controlling the level of sugar circulating in the blood.

The World Health Organization recognizes two main forms of diabetes: type 1 and type 2. Type-1 diabetes is an autoimmune disease that leaves the body without insulin to regulate the metabolism of sugar. Type-2 diabetes is a condition, in which the islets of Langerhans that produce insulin are damaged. Poor diet and lifestyle habits could aggravate the disease, leading to kidney failure, amputation and eventually death. Both Types are incurable chronic conditions, but have been treatable since insulin became medically available in 1921.

As per the estimates of International Diabetes Federation, nearly 246 million people are currently living with diabetes. And, according to the Geneva-based WHO's forecast, 6.4% of the global population and 8.4% of the people in the developed countries could suffer diabetes in the year 2030. Between 2000 and 2030, it said the incidence could rise by 39%.

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