More than 1 million reports of drug side effects were filed with the U.S. Food and Drug Administration in 2015, a fivefold increase since 2004, according to an analysis by the Milwaukee Journal Sentinel and MedPage Today.
Numbers aren’t final for 2016, but are expected to match that all-time high.
Drugs used to treat diseases such as rheumatoid arthritis, psoriasis, multiple sclerosis, a type of cancer and diabetes are among those with the greatest number of reports. Many of the drugs are for conditions that occur in 1% or less of the population, but several have seen increasing use in recent years.
For years, the FDA’s adverse events system has been derided because of its largely voluntary nature — only drug companies, not doctors or patients, are required to report problems. As a result, the system likely only was capturing a small percentage of cases.
In recent years, the number of reports filed has been multiplying, prompting more independent researchers and drug companies to use the data as a way to detect safety problems, the Journal Sentinel and MedPage Today found.
But experts say the information still is largely untapped and — if used more — could become an important alarm that warns of dangerous drugs after they hit the market.
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