A recent study released on July 27 found that about one in 10 severe drug side effects do not get reported to the Food and Drug Administration (FDA) within the mandated 15-day timeframe. The study also noted that manufacturers are less likely to report adverse effects of drugs when side effects include fatalities of consumers, as compared to side effects that do not result in death.
Manufacturers did not disclose about 10 percent of all adverse events within 15 days, while approximately 91 percent of nonfatal side effects were reported. This figure is slightly higher than the 88 percent of fatal side effects that were reported to the FDA within the 15-day window.
The study involved an analysis of 1.6 million reports of side effects sent to the FDA between the years of 2004 and 2014. U.S. law requires manufacturers of medications to report serious and unanticipated side effects of their drugs to the federal agency in a timely manner.
Some experts believe that the study’s findings may be reflective of complexities that take place in situations where consumers experience fatal side effects. For example, the extended report time may reflect the manufacturer’s efforts to verify that the death was as a result of the medication and not some other factor.
The impact of dangerous drugs
Negative side effects may occur for a multitude of reasons. Drugs may be improperly marketed, causing consumers to incorrectly use them, or improperly manufactured, making an entire batch of the drug dangerous for consumption. Medicine may also have serious side effects after it has been on the market and used by consumers for an extended period of time.
If you have suffered the adverse effects of a dangerous drug and would like more information on your legal options, work with an experienced San Diego personal injury attorney at Thorsnes Bartolotta McGuire LLP.