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How Do So Many Drugs End Up Having Dangerous Side Effects After Getting FDA Approval?

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Male patient swallows a variety of pills and medicationsWhen you’re sick and you visit the doctor or take a trip to the hospital, the expectation is that your healthcare provider is looking after your health and will help you get better. Prescription drugs regularly play a major part of the healing process, and if you’ve turned on a television lately, you may have come to realize that prescription medications are big business, too. With every new drug, billions of dollars of profit are at stake for large companies, so there’s a real incentive to push drugs to market as fast as possible.

The Food and Drug Administration (FDA) is the government agency that’s supposed to be responsible for ensuring that any new drug, prescription or otherwise, is safe to use and will do more good than harm. Yet night after night, the evening news is full of stories of warnings, side effects, “black box” labels, recalls, and even deaths linked to prescription drug use. What’s going on? Why does it seem that there are so many dangerous side effects with drugs that were approved by the FDA?

Studies Show Drug Trials May Not Be Good Enough

Multiple studies have been conducted over the past decade or so to try and tackle the problem of why so many drugs are starting to show serious side effects that weren’t caught in trial. One potential issue is that companies simply may not be testing drugs as long as they should be.

According to a 2014 study, authors found that majority of pivotal trials used for FDA approval only have follow-up periods of six months, and involve fewer than a thousand patients. Further, the authors conclude that the quality of evidence that the FDA relied on between the years 2005 and 2012 “varied widely,” as did the methods that drug companies used to perform their studies. And yet over a third of drug approvals were based on just one single trial.

Another study published just this year found that of 222 new drugs (or “therapeutics”) that gained FDA approval between 2001 and 2010, 32 percent suffered from some sort of post-market safety event. This includes anything that caused the FDA to issue a safety communication, a new black-box warning label, or the removal of the drug from the market entirely. According to the author of the study, it takes an average of four years for safety risks of a new drug to become clear—yet, as the previous study mentioned, many drug companies are only performing follow-up studies for six months. With such a short span of time to test new drugs, it’s no wonder that new, undocumented side effects are popping up all over the place.

What Drugs Have Been Affected?

At least sixty-one drugs have had safety notices issued or black box warnings attached to their labels from 2001 through 2010, and the types of drugs are all across the spectrum. Some of the types of medication with safety issues during that time include:

  • Antidepressants, including SSRI drugs.
  • Antipsychotics or neuroleptics.
  • Migraine medications.
  • Medications to treat erectile dysfunction.
  • Type 2 diabetes medications.
  • Rheumatoid arthritis medication.
  • Blood thinners.

Some of the specific drugs that have been involved in post-market safety events include the following:

  • Humira
  • Pradaxa
  • Benicar
  • Raptiva
  • Zelnorm
  • Invokana
  • Paxil
  • Tramadol
  • Risperdal
  • Abilify

How Patients Are Fighting Back Against Undisclosed Side Effects

When a dangerous drug has caused serious harm to someone via an undisclosed side effect, the legal system can provide remedy to patients and their families in the form of a civil lawsuit.

When the drug company knows of the risks of a drug but fails to notify consumers of those risks, it may be alleged that the drug company was remiss in its responsibilities. Failure to notify is the basis for many actions against drug companies, as the right to be able to make an informed decision about your own health has been upheld many, many times by courts across the nation. In this type of case, a jury can award damages to the injured person, including financial compensation for hospital bills, emergency treatment, physical therapy and rehabilitation, lost time and wages, pain and suffering, and more.

Get Legal Help Today

If you or a family member has been injured by a dangerous drug, Wayne Wright LLP is here for you. Our experienced attorneys are dedicated to helping the victims and their families recover financially from negligent drug companies, and we may be able to help you, too. To contact a skilled legal professional with experience handling dangerous drug cases just like yours, call us by telephone, send an email via our contact form, or click the live chat box on this page today.


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