Safety is always vital
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. 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 In the worst cases, the FDA will order the drug withdrawn.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. Read more…


