The U.S. Food and Drug Administration (FDA) discovered dangerous side effects and other safety issues with nearly one third of the drugs that received approval between 2001 and 2010, according to a new study published in The Journal of the American Medical Association.
Researchers studied 222 of the drugs that received approval. They discovered that the FDA took action to deal with safety issues with 123 of these dangerous drugs, including:
- Taking three drugs off the market
- Adding warnings about serious side effects to the packaging of 61 drugs
- Including 59 drugs in communications warning doctors and consumers about new safety issues
The study revealed that the FDA was most likely to discover safety issues with drugs used to treat mental illnesses, drugs that were approved under the FDA’s accelerated approval program and medications that were approved close to the deadline for reviewing them.
There was an average of 4.2 years between FDA approval of these drugs and the discovery of safety issues.
Should The FDA Slow Its Drug-Approval Process?
The main takeaways from the study are that the FDA does not know everything about a new drug before approving it, according to lead author Nicholas Downing.
The only way to reduce the number of drugs that are found to have safety issues after approval is to require more rigorous, long-term clinical trials, says Downing.
Typically, FDA clinical trials involve fewer than 1,000 patients and there is a follow-up period of six months at the most. This makes it challenging to discover long-term side effects that can take years to develop.
However, longer and more rigorous clinical trials would increase the amount of time patients must wait to get access to new medications that could potentially improve their health.
Eventually, the FDA decides that it knows enough about the safety of a drug to put it on the market. However, the FDA does this knowing that it will continue to monitor the drug to learn more about any potential safety issues, says Downing.
Injured By A Dangerous Drug? Contact O’Connor, Acciani & Levy Today
Drug manufacturers have a legal obligation to produce safe medications and adequately warn consumers about all of the risks. When manufacturers fail in their obligations, they should be held accountable.
If you have been injured or lost a loved one because of a defective drug, you may be entitled to compensation.
The defective drug lawyers at our firm take cases involving numerous drugs that were found to have safety issues after FDA approval. We know how to build a strong case that helps give you the chance of obtaining the justice and compensation you deserve.