FDA Starts Reporting Drugs Under Safety Investigation

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Main Category: Regulatory Affairs / Drug Approvals
Article Date: 08 Sep 2008 - 1:00 PDT

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On Friday 5th September, in line with new legislation introduced last year, the US Food and Drug Administration (FDA) posted the first of its quarterly reports on the drugs it is investigating for safety reasons because of post marketing adverse events reports it has received from patients and doctors.

The drugs appear on a page on the FDA website that is titled "Potential Signals of Serious Risks/New Safety Information." The first posting is for drugs identified in January to March 2008.

Patients, health care professionals and drug companies can report potential drug safety issues to the FDA via its Adverse Event Reporting System (AERS). The FDA decides if and when to investigate a drug based on the AERS data. This is not new and the agency has been doing this for some time.

What is new is the public transparency aspect of this, where under the provisions of the Food and Drug Administration Amendments Act, which became law on 27th September 2007, the agency has to inform the public every quarter of new drug safety information or any potential or serious risks it is investigating because of AERS information.

The first quarterly list shows 20 drugs along with the potential safety issue that has arisen from the AERS data and which the FDA is investigating further.

The agency is keen to point out that if a drug appears on such a list it does not mean that the FDA has found the drug to be unsafe, or that there is a direct causal link between the drug and the risk shown on the list. The drug is only on the list because of a potential safety issue, said the FDA, and doctors and patients should not intepret this as a reason to stop prescribing or taking the drug.

If patients have questions or concerns because their drug appears on the list they should talk to their doctor, as director of FDA's Center for Drug Evaluation and Research, Dr Janet Woodcock explained:

"My message to patients is this: Don't stop taking your medicine."

"If your doctor has prescribed a drug that appears on this list, you should continue taking it unless your doctor advises you differently," she added.

The AERS database contains millions of adverse event reports from drug manufacturers, health care professionals and patients. FDA reviewers examine at the data and decide whether to look at the drug more closely, depending on the number of AERS reports and the alleged seriousness of the adverse events they contain. The ones they decide to investigate further are put on the potential risk list, which is being shown to the public for the first time.

If the FDA investigation leads to a conclusion that the drug is linked to the potential risk, the agency can require that the drug company change the labelling, develop a Risk Evaluation and Mitigation Strategy (REMS), or it may set in motion more research about the risk.

The list will be new every quarter; it will not show any drugs that appeared on previous lists that are still under investigation.

Woodcock said:

"Over the past two years, FDA has become much more proactive in our communication about possible safety problems."

She said that patients and healthcare professionals have said they want know about potential safety problems much earlier, before the FDA has concluded whether there is a safety issue or not. Congress took this into account when the new legislation was drawn up.

It is not clear how the FDA will alert the public of when an investigation "clears" a drug that appeared on the list. According to the Washington Post, FDA officials said they had not decided what to do about this yet.

Some AERS reports turn out to be things like using the wrong drug because it has a similar name to the correct one. The Post gives an example of where the FDA is investigating a cream called Carac for treating precancerous skin conditions which was confused with another cream called Kuric which is used for fungal infections.

Click here to view the Potential Signals of Serious Risks/New Safety Information identified from the FDA's AERS for January to March 2008.

Sources: FDA, Washington Post.

Written by: Catharine Paddock, PhD
Copyright: Medical News Today
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