FDA Lists Drugs With Potential Safety Issues
Posted on Friday, 5 of September , 2008 at 7:59 pm
The U.S. Food and Drug Administration has 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 Thursday, 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.
At least five of the drugs on the list had problems that already have been publicized. These included the blood thinner heparin, recalled earlier this year, and immune-suppressing medications being studied for a link to cancer in youngsters.
Drugs under investigation by the Food and Drug Administration, what they are used for and the potential problem:
–R-Gene 10, a growth hormone, pediatric overdose due to labeling/packaging confusion
–Suprane, an anesthetic, cardiac arrest.
–Cymbalta, for depression and other conditions, urinary retention
–Intelence, an HIV medication, bleeding into joints.
–Carac and Kuric, creams for skin conditions and fungal infections, name confusion.
–Heparin, a blood-thinner, serious allergic reactions.
–Extraneal, used in kidney dialysis, low blood sugars.
–Humulin R (U-500), insulin for diabetes, dosing confusion.
–Stromectol and Warfarin, an anti-parasite drug and a blood thinner, drug interaction.
–Tykerb, for advanced breast cancer, liver damage.
–Revlimid, for multiple myeloma, severe skin blistering and bleeding.
–Tysabri, for multiple sclerosis, skin melanomas
–Nitrostat, for angina, overdose due to labeling confusion.
–Sandostatin LAR, for abnormal bone growth, bowel obstruction
–Oxycontin, a pain killer, drug misuse, abuse and overdose.
–Definity, used in cardiac imaging, cardiopulmonary reactions
–Dilantin injection, for epileptic seizures, serious skin reaction.
–Seroquel, for bipolar disorder, overdose due to sample pack labeling confusion.
–Tyzeka, for chronic hepatitis B, nerve damage.
–Tumor Necrosis Factor (TNF) Blockers, for juvenile arthritis, cancers in children and young adults.
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.”
Related links:
Web posting, “Potential Signals of Serious Risks/New Safety Information”
Fact sheet 9-5-08
Category: Consumers, Drugs, Government, Health
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