FDA Pulls Unapproved Drugs

The U.S. Food and Drug Administration (FDA) has called for the removal of about 500 unapproved prescription drugs that are taken by mouth to treat colds, cough and allergies.

These drugs are unapproved because the FDA has not reviewed their safety, effectiveness or quality. However, many healthcare providers may be unaware that the drugs are unapproved because the labels do not explicitly state that they lack FDA approval.

In 1962, the federal government began requiring that the FDA review the safety and effectiveness of all new drugs before they enter the U.S. market. The FDA is also supposed to evaluate thousands of drugs that were already being sold.

In 2006, the FDA began its Unapproved Drugs Initiative to ensure that all drugs on the market have been evaluated and approved by the agency.

The FDA recommends that consumers contact their healthcare professionals if they are concerned that they may be taking unapproved medications.

For more information about integrative therapies for allergies or the common cold, please visit Natural Standard’s Comparative Effectiveness database.

Comments

[sherilis]

TJ, just as with recalls, scientific studies rely on patient-reported adverse effects, which is why some studies have hundreds of adverse effects reported that are not necessarily due to the drug. I stand by my statement.

[TJ]

Sherilis,

I have to go ahead and disagree with your assertion that since certain drugs have been on the market for decades, a safety concern would have arisen and the drugs would have been removed. The only way anyone is going to know if a drug has a safety concern is to conduct a scientific study, and that won't happen if we assume these older medications are safe. There could very well be a drug on the market that increases the risk of heart attacks, but if we don't scrutinize these medications properly, no one will know, and people may be harmed. All because due diligence was not done.

[sherilis]

To possibly answer RR's questions, some medications have been on the market even before some of the doctors were born. The medications do not state that they do not have FDA approval. In order to get FDA approval, certain trials are required; however, if they have been on the market for decades, I see no reason to remove them now because if there was a safety concern, the medication would have most likely been recalled already.

[Nilisha]

Good point, EJ. I feel like it would make everything more expensive because it costs money to have something approved by the FDA.

[EWF]

How did these unapproved drugs get on the market to begin with? I was always under the impression that all PRESCRIPTION medications needed to be FDA-approved before they could be sold. I thought it was only the over-the-counter medications that were not FDA-regulated. Shocking news to me.

[Denise]

Good point, RR. Shouldn’t it be the responsibility of the doctor who prescribed the medication to ensure that the drugs are approved? It seems backwards and dangerous to put the responsibility on the patient.

[Ludlum]

Some of these drugs have been on the market for decades. Instead of removing all unapproved products, case reports should be used to determine if harm has been caused by the drugs. Just because the drug has not been approved does not mean that it is not safe for use.

[MW]

For consumer safety, there really needs to be more watchfulness on issues like this. It seems like there is always news about products being pulled for some reason. The FDA has its work cut out for it to monitor so many operations.

[RR]

Are there penalties for the pharmaceutical companies for this? Also, why aren’t healthcare providers, who are writing the prescriptions, aware of whether drugs are approved or not? Perhaps drug manufacturers should be required to declare a drug’s status on the package and, before prescribing a drug, healthcare providers should confirm that it has FDA approval.

[Tom Jarvi]

I think it is important to highlight that many medications on the US market have never been evaluated for safety by FDA. Just because a drug has been sold for years and years, doesn't necessarily mean it is safe or effective, as the article points out. I agree with the FDA that these medications need to be reviewed because I do not want to put anything in my body that hasn't been thoroughly examined.

[Marissa]

Wow, shocking and scary. I agree about the benefits about FDA approval as well, but what about laws regarding label information on drugs? Usually when I have a cold, I don't have the patience to read the fine print!

[concerned]

This is scary! I didn’t realize prescription drugs could continue to be sold and prescribed without FDA approval. I realize there are difficulties regulating the supplement market, but I thought the prescription market was well-monitored at this point. How would a consumer ever know that a prescription they were regularly taking was suddenly unapproved unless they were on the alert for such a scenario?

[EJ]

PB - This recently happened with colchicine, actually. It had been generic and available by prescription for years, but the FDA removed all unapproved formulations from the market in 2010. It is still available under the brand name Colcrys, which the FDA approved in 2009.

[PB]

I never would have guessed that this could happen. I wonder if a similar situation exists with any other classes of prescription medications.

[EJ]

It's great that everything has to be FDA-approved, but this usually makes the prices go up, right?