by Daniel Dewberry,
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on the net: http://www.newpharmweb.com
UNITED STATES, Sep 20 — Whenever a drug is under development, the clinical trials look closely for any evidence of adverse side effects. No manufacturer wants to put a drug out on to the market with safety issues. It’s very bad PR and it can give a hit to profits if juries start awarding big damages to people injured. Even if the FDA does revise the label, it’s unlikely to say anything more than women with a risk of osteoporosis should not take Aciphex continuously for more than a year
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henever a drug is under development, the clinical trials look closely for any evidence of adverse side effects. No manufacturer wants to put a drug out on to the market with safety issues. It’s very bad PR and it can give a hit to profits if juries start awarding big damages to people injured. So, it’s the FDA’s job to shift through all the evidence generated by the trials. If it finds there are safety issues, it has the power to order more trials. The effect of this is a very expensive delay to the launch of the product. But all this is accepted as being a part of the process of protecting consumers. Even after launch, the FDA continues to monitor the performance of the drug. If too many people seem to be having problems, it can order a change to the labeling, adding clear warnings where necessary. In the worst cases, the FDA will order the drug withdrawn.
There’s a class of medication called the Proton Pump Inhibitors (PPIs). These drugs provide relief to millions of people for heart burn and a range of other stomach problems, the most serious of which is called Gastroesophageal Reflux Disease (GERD). Indeed, the agency responsible for monitoring the prescription process recently gave its summary for last year. There were 113 million prescriptions written for PPIs, but there’s also a strong over-the-counter (OTC) market for antacids. This is probably worth more than $1.5 billion a year.
About a month ago, the FDA said it was considering a change to the labels on both OTC and prescription PPIs. On its own, this is nothing to worry about. The FDA routinely reviews the safety of all classes of drugs on the market in the light of reports from hospitals and doctors. In this instance, there have been a number of research studies looking at the incidence of wrist, hip and spine fractures in older women. This is a serious problem. Post-menopausal women slowly lose bone density and this may develop into osteoporosis. Any slip or fall is more likely to result in a fracture as a hand is put down to stop the fall, or nothing slows the fall and the hip or spine itself is damaged. The researchers have detected an unusual pattern. A significant number of the women suffering fractures have been taking PPIs for one or more years.
The problem with all research is that it often throws up more questions than it answers. There may be absolutely no link between drugs like Aciphex and an increase in bone fractures. Older women with osteoporosis may just have stomach problems as well. So, to find out, the FDA is asking for more analysis of the data from these studies and indicating the possibility of asking for a formal study to discover whether this is coincidence or something stronger. Until then, there’s no need to worry about Aciphex. There’s no suggestion this drug is in any way unsafe. Even if the FDA does revise the label, it’s unlikely to say anything more than women with a risk of osteoporosis should not take Aciphex continuously for more than a year. But, just in case you see reports about this in the news media - particularly the law firm now trying to find people prepared to sue - this article is intended as reassurance.
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