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Published: July, 2007; Vol 4, Num 2

 

FDA Adds Stern Warning to Diabetes Meds

In a dramatic announcement amid a chorus of criticism, the Food and Drug Administration (FDA) announced June 5th that it would henceforth require its toughest safety warning – the so-called “black box” warning – on two widely used Type 2 diabetes medications:  Avandia and Actos.

Type 2 diabetes has reached epidemic proportions in the U.S. and Canada, increasing by 80 percent over the last decade. It is a serious disease that can result in the amputation of limbs and shortens life by an average of five or ten years. It also increases the risk of heart disease or stroke and the likelihood of complications from flu or pneumonia. Symptoms develop slowly over many years, and, unfortunately, about a third of all people with the disease are not aware of their condition. A simple blood test to check blood sugar levels can assess the situation. Those with high levels should consult their health care providers. 

For most people, good nutrition and proper exercise can prevent onset of the disease or help manage it successfully when it develops. For some people, however, medical help is required. Initial studies indicated that two thiazolidinediones – rosiglitazone (Avandia) and pioglitazone (Actos) – could help, but experience has since shown that they also increase the risk of heart attack. The American Diabetes Association (ADA), in a media release on its website, now recommends that patients using the drugs consult with their physicians. In the meantime, the ADA urges them to continue their prescribed treatment, as it is dangerous to drop any prescribed medication without monitoring or an alternative medical plan.

Although Caucasians with diabetes outnumber diabetic African-Americans by about 13.1 million to 3.2 million in the U.S., the rate of diabetes is twice as high among African-Americans. This disparity led GlaxoSmithKline, the manufacturer of Avandia, to hire jazz singer and actress Della Reese – herself, a Type 2 diabetic – to serve as Avandia’s spokeswoman. Last year, the company spent $25.7 million marketing the medication to patients and their doctors. Thus, African-American Laborers and their families with diabetes should be especially sure to check their medications and consult with their health care providers.

Avandia is also widely prescribed among Caucasians, as is Actos, manufactured by the Japanese company Takeda Pharmaceuticals. The two drugs share equal portions of the total diabetes drug market.

The FDA announcement followed a series of recent articles in The New England Journal of Medicine that questioned the safety of the two medications. More ominously, the announcement also followed a parting shot of criticism from outgoing FDA drug safety supervisor Dr. Rosemary Johann-Liang who, more than a year ago, approved the black box warning only to be reversed and reprimanded by FDA Commissioner Andrew C. von Eschenbach.

The controversy has again tarnished the FDA’s image, with critics suggesting that the agency has placed speeding approval of new drugs ahead of monitoring their actual safety performance. The agency was roundly criticized in 2003 for failing to note the rising trend of suicides among children using antidepressant drugs. In 2005, it was forced to add stronger warnings to COX-2 pain inhibitors after studies showed that their use doubled the risk of stroke and heart attacks. And in 2006, the agency was pressured to take action on an antibiotic, Ketek, after FDA insiders leaked information about its danger to outside media. In each case, a new drug had been approved after accelerated trials funded by the drug’s manufacturer proved its benefits. However, the agency lacked the resources or will to monitor the actual impact of the drug once it went into wide public usage. Then, despite broad concerns raised by doctors and patients, the FDA sustained its initial approval without review until pressured by mounting media reports of problems.

Whatever the merits of criticisms of the FDA, the key message for Laborers and their families is the need to take an active interest in their own health and health care. A healthy diet, regular exercise and an annual check-up at the doctor are the foundation of sound health management.

[Steve Clark]