FDA to Post Quarterly Report of Potential Safety Issues

The U.S. Food and Drug AdministrationThe U.S. Food and Drug Administration announced that it has posted on its Web site its first quarterly report that lists certain drugs that are being evaluated for potential safety issues. The drugs have been identified based on a review of reports in FDA's Adverse Event Reporting System (AERS).

The information is being provided under provisions of the Food and Drug Administration Amendments Act, signed into law Sept. 27, 2007. The law requires that FDA inform the public each quarter of new safety information or potential signals of serious risk, based on the agency's review of adverse event reports contained in AERS.

The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk, or that FDA has identified a causal relationship between the drug and the listed risk. It is on the list only because FDA has identified a potential safety issue.

"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," said Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research.

Drugs that appear on the agency's new AERS-based table, titled "Potential Signals of Serious Risks/New Safety Information," are identified by FDA reviewers based on reports from the FDA's AERS database, which contains millions of reports of adverse events submitted to FDA by drug manufacturers, health care professionals and patients. For a drug to appear on this report, an FDA reviewer will have determined there is a reason to examine a drug more closely based on either the seriousness or number of AERS reports associated with the drug. The drugs for which issues have been identified are under evaluation for the listed potential risk.

This first quarterly report, posted to FDA's Web site, lists 20 drugs along with the potential safety issue associated with each drug. Each quarter, a new report will be posted to FDA's Web site listing additional drugs for which new safety information or potential signals of serious risks have been identified through AERS. The quarterly reports will not be cumulative; they will list only drugs for which new safety information or potential signals of serious risks have been identified through AERS during the previous quarter.

A new quarterly report listing additional drugs for which new safety information or potential signals of serious risks have been identified through AERS will be posted to the FDA's Web site every three months.

"Over the past two years, FDA has become much more proactive in our communication about possible safety problems," Woodcock said. "Patients and health care professionals have told us that they want to be informed about possible safety problems sooner. They want to know when FDA is in the early stages of looking into a potential safety problem. Congress took note of this when it directed us to post this quarterly report of potential safety issues."

For further information, please visit:
http://www.fda.gov

Most Popular Now

New target for COVID-19 vaccines identified

Next generation vaccines for COVID-19 should aim to induce an immune response against 'replication proteins', essential for the very earliest stages of the viral cycle, c...

Safety concerns raised for neuroblastoma candidate…

St. Jude Children's Research Hospital scientists looking for drugs to improve survival of children with high-risk neuroblastoma found a promising candidate in CX-5461. Th...

Johnson & Johnson COVID-19 vaccine named one o…

The editors of Time announced that the Johnson & Johnson COVID-19 vaccine has been selected as one of Time's Best Inventions of 2021. The vaccine, for which Johnson & ...

Pfizer's novel COVID-19 oral antiviral treatment c…

Pfizer Inc. (NYSE: PFE) today announced its investigational novel COVID-19 oral antiviral candidate,PAXLOVID™, significantly reduced hospitalization and death, based on a...

Researchers reveal a strategy for next-generation …

A study led by the Garvan Institute of Medical Research has revealed a guide to developing COVID-19 vaccines that both prevent the coronavirus from infecting human cells ...

A commonly found parasite could treat certain type…

Scientists have discovered that a deadly parasite, known to cause ill health in pregnant women and immunocompromised patients, could potentially be used to treat various ...

'Dancing molecules' successfully repair severe spi…

Northwestern University researchers have developed a new injectable therapy that harnesses “dancing molecules” to reverse paralysis and repair tissue after severe spinal ...

A target for potential cancer drugs may, in fact, …

In recent years, much scientific effort and funding has focused on developing drugs that target an enzyme with the unwieldy name of Src homology 2-containing protein tyro...

Abbott launches new initiative to drive diversity …

Abbott (NYSE: ABT) today announced the launch of a new initiative designed to help create a more inclusive clinical trial ecosystem through new approaches to training, ed...

Needle-free COVID-19 vaccine shows promise

A needle-free COVID-19 vaccination could be possible, with University of Queensland scientists successfully protecting mice from the virus by administering a US-developed...

Cleveland Clinic launches first-of-its kind preven…

Cleveland Clinic researchers have opened a novel study for a vaccine aimed at eventually preventing triple-negative breast cancer, the most aggressive and lethal form of ...

Novartis to sell its Roche stake in a bilateral tr…

Novartis has agreed to sell 53.3 million (approximately 33%) Roche bearer shares in a bilateral transaction to Roche for a total consideration of USD 20.7 billion. Vas...