32% of FDA-Approved Drugs had Post-Market Safety Problems

Researchers from Brigham and Women’s Hospital in Boston, the Mayo Clinic and Yale School of Medicine followed 222 drug therapeutics approved by the FDA from 2001-2010. Researcher found nearly one-third of the drugs had safety problems after FDA approval and required FDA action either to remove it from the market, or change safety warning labels. The median time safety issues first appear is 4.2 years after FDA approval.

Of the 222 approved drugs between 2001 and 2010, 123 post-market safety events were reported which required FDA intervention including,

  • Complete removal of 3 products from the market;
  • 61 drug products requiring upgrades to more serious safety warnings called black box warnings, the strongest FDA warning required when serious or life-threatening risks are present;
  • 59 additional FDA Safety Communication warnings

The majority of new drug trials have 1000 or fewer patient trial subjects so it’s not unexpected with that small number that more safety issues come to light once post-market use by patients increases.

The study found drugs developed to treat mental illness, and drugs “fast-tracked” through the FDA approval system, had more safety issues than other FDA-approved drugs. These findings are consistent with other studies showing fast-tracked drugs have greater numbers of Adverse Event Reports reporting problems resulting in more post-market changes and additions to safety warning labels than drugs that go through the regular approval process.

How long should a new drug therapy be tested before it is approved for the market?

The answer requires a balancing approach between the diligence in more extensive drug trial testing of a drug’s safety and effectiveness against the need to get new drug therapies to market to help people with life-threatening diseases.

It takes an average of 12 years between research development and getting a new drug approved and into the market. Only 5 out of 5000 new drugs tested gets approved for human trials, and only 1 in 5 drugs ever gets approved for use by humans.

The current administration is signaling it may reduce regulations on pharmaceuticals, and decrease drug trial approval times, thereby getting more drug therapies to needy patients, but undoubtedly also increasing the risk of additional post-market drug safety problems and adverse events.

 Researchers Not Discouraged by 32% Finding

Study authors were not discouraged to learn 32% of approved drugs had post-market safety problems arguing the high percentage shows post-market surveillance systems work. Lead author Dr. Nicholas Downing, a resident at Brigham & Women’s Hospital, said, “Everybody involved in drug development needs to commit to learning about them throughout the life cycle of the drug. Research doesn’t end at the point of FDA approval.”

Dr. Caleb Alexander, John Hopkins Center for Drug Safety and Effectiveness co-director, further explained, “All too often, patients and clinicians mistakenly view FDA approval as an indication that a product is fully safe and effective. Nothing could be further from the truth. We learn tremendous amount about a product only once it’s one the market and only after use among a broad population.”

Both the FDA and drug makers conduct post-market surveillance and monitor drugs and medical devices checking their safety and effectiveness. The FDA also monitors independent reports about drugs since the FDA reporting system is voluntary, and critics argue the system is inadequate to effectively monitor drug safety.

Can You Play a Role in Drug Safety?

Consumers can also play a vital role in providing important ongoing drug safety information. Please report any side effects or adverse reactions you suffer from any drug, supplement, or medical device, to both your prescribing healthcare provider and to the FDA. FDA reporting is done one of three ways:

Drug safety also requires being proactive with your own healthcare.

  • Tell both your healthcare provider and pharmacist about all the drugs and supplements you are taking in order to prevent dangerous drug interactions. Let them both know if you begin to have any problems with your medications.
  • Before taking any new medication, ask your healthcare provider and your pharmacist to explain the known risks and benefits, and any potential side effects of the medication so you can make the most informed decision.
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