Safety of Newly FDA Approved Drugs

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Drug Safety: Is it All Relative?

As a health care consumer, you want to be able to believe the information medical professionals tell us. You want to be to entrust your health and well-being to the health care providers you've chosen. There are numerous areas where that trust is paramount -- in diagnosis, treatment plans, therapies, surgeries and medications.

But what about those medications -- especially prescription medications? Are the drugs prescribed for the prevention and treatment of your condition safe? Will the medications cause more health problems than they relieve? And once a drug has received the U.S. Food and Drug Administration's approval, are you still a human guinea pig if you take the drug in its early years of its release?

Pharmacy 102: Drug Studies Who, What, When, Where and Why

FDA Approval Process Designed to Promote Drug safety and Efficacy

The FDA is charged by the federal government with ensuring that prescription medications both do what they claim to do and do so with relative safety.

Relative safety because all drugs, even those from natural sources, have the potential to cause side effects or adverse reactions.

Relative safety because sometimes difficult-to-treat or difficult-to-cure conditions require medications that have the potential to cause serious, sometimes even life-threatening side effects/adverse reactions, but the potential benefit to the recipient outweighs the risks.

Insights into Clinical Research in Drug Development

Simplified FDA Approval Process for New Drugs

The FDA provides an abbreviated version of the approval process for new drugs:

  1. Preclinical testing -- animal testing; if successful then,
  2. Sponsor of the proposed new medication completes an Investigational New Drug application, IND, that spells out what the sponsor proposes for human clinical testing. If the IND is approved then,
  3. Phase I clinical testing begins, usually involving 20 to 80 study participants. If all goes smoothly through this first level of human testing then,
  4. Phase II clinical testing begins, this time usually involving a few dozen to 300 study participants. If all goes smoothly through this phase of human testing, meaning the new drug formulation is proving successful in the treatment of the symptom or condition for which it is intended AND side effects/adverse reactions have been few, then
  5. Phase III clinical testing begins, this time involving several hundred to about 3,000 people. Again, if this testing phase goes well, then
  6. This is the pre-new drug application, NDA, period. It is at this time that the FDA and the drug's sponsor usually meet.
  7. Completion and submission of the NDA. This is the formal step in seeking the agency's approval to market the new drug.
  8. The FDA has 60 days to decide whether to review the NDA for filing
  9. If the FDA decides to file the NDA, a review team is assigned to evaluate the research data provided by the sponsor on safety and effectiveness of the proposed medication.
  10. The agency reviews the information provided by the drug sponsor as to the drug's professional labeling, that is, usage instructions.
  11. The proposed manufacturing site for the potential new drug is inspected by the FDA
  12. FDA reviewers will either approve the NDA or provide a complete response letter to the drug sponsor.

Each phase of testing may take from several months to multiple years.

To view this process in pictorial graphic, click here.


The Science Behind FDA Newly Approved Drugs

A new drug may spend years or even decades in the discovery and preclinical testing phase.
A new drug may spend years or even decades in the discovery and preclinical testing phase. | Source

Bumps in the Road to FDA Drug Approval

The road to market for any prescription medicine from its inception in a laboratory to approval by the FDA can be fraught with speed bumps, potholes or dead-ends.

There is no guarantee that ideas born in the laboratory will ever make it beyond the test tubes and petri dishes to begin the journey of becoming a useful drug into animal studies. There are even fewer discoveries that succeed through the animal study portion of the steps toward becoming a marketable drug, and so it goes through each step of the process.



Research Shows Clinical Research Trials, FDA Approval Process Not Infalliable

An article published in the Drug Information Journal in 2004, authored by Elane M.Gutterman, PhD, revealed the limitations of even the three-phase clinical research trials in being able to reveal side effects/adverse reactions that occur with less frequency than 1/1000th because even with the use of a few thousand participants, there are just not enough people for those adverse events to necessarily occur during the research trials.

Another factor affecting the likelihood that "real-life" situations will all be represented within the pre-approval phases of testing is that study participants are often chosen without the presence of any chronic or acute illnesses beyond the one for which the proposed drug is designed to treat. In real-life, many of the patients receiving the newly-approved drug are likely to have more than one condition or diagnosis; in real-life people are also likely to be taking a different variety of prescription and over-the-counter medications that weren't represented during the clinical trials.

Protect Yourself Against Possible Drug Safety Concerns

Being pro-active in your health care is a great way to protect and arm yourself as an active participant in your health care, whether its about the medications you take or the diagnosis you're given. Read as much as you can about your medications, from the label on the drug bottle to the product insert to information you can find on the Internet.

Talk to your health care provider; talk to your pharmacist; talk to the nurses -- all of these people are resources for any questions or concerns you may have. If you don't get the answers you're seeking, consider getting a second opinion. You have a right to have your questions and concerns taken seriously by these health care professionals.

If you and your doctor determine that a newly FDA-approved drug is an appropriate treatment for your condition, be sure to notify your doctor at once if you begin to experience symptoms that may indicate medication side effects.

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Comments 10 comments

visionandfocus profile image

visionandfocus 3 years ago from North York, Canada

The FDA has approved and then recalled so many dangerous drugs that its credibility, as far as I'm concerned, is zero. It is laughable to think that it is supposed to be a champion of public health, because it is not. The FDA has vested interests in industry (primarily pharmaceutical and device manufacturing industries which contribute heavily to re-election campaigns of members of Congress). When you have a government that is not free of the influence of vested interests, democracy itself is on shaky ground.

Thanks for bringing this topic to our attention. It's one that more people need to be aware of. Thanks for sharing. Voted up.


L.L. Woodard profile image

L.L. Woodard 3 years ago from Oklahoma City Author

VisionandFocus, you've raised valid concerns about the FDA and its vested interests. Unfortunately, it is all we have in the United States. It is valuable info, though, to check out what the EU and Canada studies and authorities have said about a drug newly approved by the FDA.

Appreciate the read and thoughtful comment.


Gail Meyers profile image

Gail Meyers 3 years ago from United States

I completely agree with visionandfocus who already made the point I was going to make. It even seems at times the FDA has allegedly fought cheaper, healthier natural alternatives in favor of prescription alternatives. Voted up and useful.


L.L. Woodard profile image

L.L. Woodard 3 years ago from Oklahoma City Author

Hi Gail, You and visionandfocus are both correct in your opinions. It's unfortunate that the FDA is another one of those things that works great in theory, but falters when put into practice by people who have interests other than the safety and health of the people they are meant to protect.

Thank you for the read, comment and vote.


RTalloni profile image

RTalloni 3 years ago from the short journey

A good practical look at giving careful consideration of FDA approved drugs before taking them. The tip about checking on EU and Canadian reports is invaluable.


rebeccamealey profile image

rebeccamealey 3 years ago from Northeastern Georgia, USA

I often hear ads on the radio for participants in 'investigative medicine "projects. Scary! I, for one, do not want to be a pharmaceutical company's guinea pig. Voted very, very useful and shared. Thanks!


L.L. Woodard profile image

L.L. Woodard 3 years ago from Oklahoma City Author

RTalloni, I appreciate your taking the time to read and comment. Probably the most suspect newly-approved drugs are the ones that have been pushed through the system the most quickly. Generally speaking, these are drugs referred to as "orphan drugs," because only a small subset of the population has a condition for which the drugs are developed. One would hope that medical practitioners prescribing these new drugs would take extra care to check for potential side effects and adverse reactions.


L.L. Woodard profile image

L.L. Woodard 3 years ago from Oklahoma City Author

Rebecca, I am not certain I'd like to take part in any clinical studies of newly developed drugs, either. For some people who have life-threatening illnesses and have exhausted all known treatments, participation in such research may be their only hope.

Some people might argue that whether we participate in the research before a new medication receives approval or if we are simply some of the first people to be prescribed the new medication, we are still human guinea pigs of a sort. It's not a reassuring thought.

Thank you for your comments, voting and Sharing.


Deborah-Diane profile image

Deborah-Diane 3 years ago from Orange County, California

I agree with Rebecca. When I listen to the ads that cite all the possible side effects, I wonder why I would ever want to try any of these drugs! Very thought provoking article.


L.L. Woodard profile image

L.L. Woodard 3 years ago from Oklahoma City Author

Deborah-Diane, I believe the U.S. is only one of two countries in the world that allow commercials for prescription drugs; guess we can chalk that up to capitalism. The possible side effects can be frightening, but we have a false sense of security about medications that have been around for a long time. There are potential side effects and adverse reactions for almost anything we put into our bodies.

I appreciate your read and comment; thanks for stopping by.

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