Healthcare News & Insights

Are those common drugs still safe 20 years later?

pharmaceutical-gamble

Drugs approved for chronic conditions can have major side effects that aren’t discovered until years or decades after they’re approved. Is there a better way to protect patients?

Two recent incidents involving commonly prescribed drugs have health professionals asking if there’s a better way to monitor complications, side effects and adverse reactions that may not be identifiable until after years of use.

The questions have new relevance after the diabetes drug, Avandia, was found to increase heart risks in patients; and bisphosphonates used to prevent bone fractures in patients with osteoporosis were found to increase the risk of one type of fracture as well as jaw bone degeneration.

Both types of drugs were evaluated and cleared by the FDA with no indication of these problems. Many experts say the problem is that premarket evaluation looks at relatively short-term studies — but our aging population is taking more medications for chronic diseases.

Put simply: There’s no efficient way to test the risks a drug may pose when it’s taken for decades.

A better system?

Health care professionals face a dilemma when it comes to testing drugs that patients may be on for life: Clinical trials typically last only a few years. Extending them would be difficult, costly and would deny patients faster access to drugs they need.

Some experts have recommended continuing clinical trials after a drug gets approved for the market. But that requires prescribing physicians to agree to randomly assign patients to one treatment vs. another. And the length of time required for the study would make it harder to track those patients’ results.

Another option that’s been suggested is creating a national electronic database that would make it easier to track complications from prescriptions.

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