In the United States, the responsibility for the safety of both prescription and “over the counter” or nonprescription drugs rests with the Food and Drug Administration (FDA). Before any new medication can be prescribed or sold within the United States it must pass a rigorous and time-consuming set of tests and investigations before it is allowed on the market. But if this is indeed the case, how is it that we hear of drugs that are declared unsafe and ordered to be removed from the shelves at pharmacies? The answer to that question begins with how the testing of any drug is carried out by the FDA.
Drug companies spend billions of dollars on developing new drugs every year. In fact, after the expenses of research and development, testing new drugs is the most expensive part of producing a new drug. This “pre-release” testing is carried out with the patents that are most likely to benefit from the new drug and these tests are the ones watched most closely by the FDA. Careful records are kept that monitor the many factors involved in testing, with the most detailed records being devoted to what are called adverse or “unexpected” events.
Practically every medicine known to man has its share of adverse effects that can be associated with it. This is simply a fact that both the FDA and the drug companies accept and warnings about adverse events, along with known side effects of the medication, are included in the “Prescribing Information” that is packaged with every bottle of that medicine when it is produced. The problems usually begin after the medicine is approved by the FDA.
One approved, monitoring of a drug is shifted almost exclusively to the company that makes the drug. The drug company, having spent a large amount of its own money getting the drug approved, now wants to earn that money back and make a profit off that drug as well. It is therefore unlikely that the reporting of adverse events will be vigorously investigated, much less reported to the FDA.
Incidents of “under-reporting” happen far more often than one might think. Consider just a few of the more well-publicized drug recalls of the past few years:
Pondimin, aka “Fen-Phen,” a weight loss drug that had been approved in the early 1990s was ordered off the market in 1997 after it became known that the drug posed a risk of heart valve problems and a potentially fatal condition called pulmonary hypertension.
Darvocet / Darvon, a non-opioid pain medication, was withdrawn after it was found to increase the risk of heart attack and stroke.
Vioxx, a non-steroidal anti-inflammatory drug (NSAID) was withdrawn in 2004 because of increased risk of heart attack and stroke.
In each of the above-mentioned withdrawals, the drug’s manufacturer eventually negotiated a multi-billion dollar settlement to settle class action lawsuits.
A drug does not have to have been the subject of a recall to have caused an injury. Many drugs on the market have caused accidents by making someone too drowsy. Others have caused problems by the way they interacted with other drugs. Many drugs are known to have caused kidney, liver, or even heart damage.
Anyone that has been harmed by an unsuspected drug effect has the right to file a prescription drug lawsuit against the drug’s maker. Quite often someone taking a prescription drug will be unaware that the drug was the source of another problem they were having! In such cases, one should seriously consider talking with an attorney that is experienced in handling a prescription drug lawsuit. Only then can you learn what legal options are available to you.