The Food and Drug Administration approved them, your doctor prescribes them, and you see them advertised on TV-so your medications must be safe, right? Then why is Consumers Union bothering to publish alerts about drug hazards?
More than half of all prescription drugs cause adverse effects—some serious or fatal—that aren't detected until after the FDA approves them, sometimes many years later. Such delayed detection contributes to the high number of drug-related injuries in the U.S. In 2008 alone, the FDA received more than 100,000 reports of serious injuries related to adverse drug events, an increase of about 25 percent over the previous year, according to the Institute for Safe Medication Practices.
Some of the delay is inevitable: It's simply not possible to detect every risk before doctors start prescribing a drug. Doing so would require clinical trials that would be prohibitively large, long, and costly.
In addition, the U.S. system for identifying drug risks before approval is flawed—and the one for spotting them afterward is even worse. The 2007 FDA Amendments Act promised many changes in the drug-safety system, but whether they will be sufficient, even if the agency uses its new powers effectively, remains to be seen.
Here's a closer look at why you face these unexpected dangers, and what you can do to protect yourself.
Clinical trials submitted to the Food and Drug Administration before approval have several limitations, some of them unavoidable. They can't adequately assess safety because they're:
In the real world, patients may receive lax care that exposes them to greater risks; moreover, doctors are allowed to prescribe approved drugs for unapproved purposes, sometimes for patients at considerably higher risk than the trial volunteers. The trials also tend to include few women and minority-group members.
And they often use clinical lab results—for example blood cholesterol levels—to determine how well a drug works rather that measuring how often it helps a person avoid having a heart attack or if it helps them to actually live longer. Such measures may represent a misleading picture of a drug's risks and benefits.
In addition, the FDA may approve some new drugs more quickly that others. The time devoted to preapproval review, particularly for drugs deemed "priority," has dropped substantially since 1992. Congress passed a law designed to speed up the FDA approval process for some drugs to get them to the market faster. But doing so may have come at a significant cost. A 2003 survey of FDA reviewers indicated that they generally felt rushed and, in some cases, pressured by their supervisors to approve medications. Some studies—though not all—have found that the faster the review, the greater the chance of hazards emerging after a drug's approval.
Because all hazards can't be reliably detected before approval, some are discovered afterward. Unfortunately, the system for detecting risks after approval has been the weakest link in the drug-safety system, for several reasons:
Despite all those problems, pharmaceutical companies typically start advertising a drug within a year of approval, long before anyone knows whether its benefits outweigh its risks. And the companies may minimize the known risks, often by running distracting or reassuring images while mentioning adverse effects.
The FDA has lacked the resources and authority to regulate drug ads effectively. Months can go by before it catches up with misrepresentations, exaggerated claims, or inaccuracies. While the 2007 law authorized more FDA staffing to scrutinize ads and more power to regulate them, companies still don't need the agency's go-ahead before running their promotions in most cases, though some do so voluntarily.
Even if the FDA reforms are fully implemented, taking prescription drugs, especially new ones, still requires caution. To protect yourself, take these steps: