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Ken Margolin
Ken Margolin
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New Pharmaceutical Worries

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A British study reported last week in the Journal of the American Medical Association, reported a significantly higher risk of hip fractures in patients over 50 years of age, taking popular heartburn drugs, such as Nexium, Prevacid, or Prilosec, for more than a year. The drugs, as any television watcher or magazine reader, knows, have been heavily advertised. The drugs that showed the highest risk of hip fracture in older individuals are members of a class of drugs known as proton pump inhibitors. Other popular anti-heartburn drugs, in the H-2 blocker class, such as Tagamet and Pepcid, also appeared to increase the risk of hip fracture, but not as dramatically as the proton pump inhibitors.

Several points must be kept in mind. The study is a single study only, and must be replicated before governments or the pharmaceutical industry are likely to take any action with regard to the drugs. While the study spoke of an increased risk of hip fracture in anti-heart burn pill takers over 50 years old, the average age of the person in the study, was 77 years of age. It is too early to say whether there were other factors, not controlled for, that may have influenced the results.

Whatever the limitations of the study, the results were alarming. Patients amongst the 145,000 whose records were studied, who took the drugs for more than a year showed increases in their hip fracture risk ranging from 44% to as much as 2 ½ times as great as those who did not take the drugs. It appeared that the longer the drugs were taken, the higher the hip fracture risk.

Nexium alone had global sales in 2005, of $5.7 billion. The study implicitly raises the question of whether drug companies will exercise due caution and patience in seeking approval for their drugs, when billions of dollars are at stake in the highly competitive pharmaceutical industry. Drug-related injuries affect millions of Americans each year. Pharmaceutical company cover-ups can cause tragedies. Sooner or later, older patients who suffer devastating hip fractures after taking anti-heart burn drugs for a lengthy period of time, will bring claims against the manufacturers, and attempt to find out if the drug companies knew of the hip fracture risk, and if so, what they knew and when they knew it.