Aa
Aa
A
A
A
Close
356518 tn?1322263642

DA Posts List of Drugs Being Investigated for Safety Issues

http://www.fda.gov/cder/aers/potential_signals/potential_signals_2008Q1.htm
FDA Posts List of Drugs Being Investigated for Safety Issues
The Food and Drug Administration posted a list of 20 drugs to its website Friday that are being evaluated for potential safety issues. The agency plans to post a quarterly list—in compliance with a requirement of the Food and Drug Administration Amendments Act, which was signed into law in September 2007—of medications being investigated for such problems. Despite the agency's concerns, patients shouldn't stop taking medications on the list without first talking to their doctors, the FDA advises. Among the drugs included on the list are Oxycontin (concerns: potential misuse, abuse, and overdose), tumor necrosis factor (TNF) blockers (cancers in young adults and children), Cymbalta (urinary retention), and Heparin (anaphylactic-type reactions).



Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS) January - March 2008
Product Name: Active Ingredient (Trade)
or Product Class Potential Signal of Serious Risk/New Safety Information
Arginine Hydrochloride Injection (R-Gene 10) Pediatric overdose due to labeling / packaging confusion
Desflurane (Suprane) Cardiac arrest
Duloxetine (Cymbalta) Urinary retention
Etravirine (Intelence) Hemarthrosis
Fluorouracil Cream (Carac) and Ketoconazole Cream (Kuric) Adverse events due to name confusion
Heparin Anaphylactic-type reactions
Icodextrin (Extraneal) Hypoglycemia
Insulin  U-500 (Humulin R) Dosing confusion
Ivermectin (Stromectol) and Warfarin Drug interaction
Lapatinib (Tykerb) Hepatotoxicity
Lenalidomide (Revlimid) Stevens Johnson Syndrome
Natalizumab (Tysabri) Skin melanomas
Nitroglycerin (Nitrostat) Overdose due to labeling confusion
Octreotide Acetate Depot (Sandostatin LAR) Ileus
Oxycodone Hydrochloride Controlled-Release (Oxycontin) Drug misuse, abuse and overdose
Perflutren Lipid Microsphere (Definity) Cardiopulmonary reactions
Phenytoin Injection (Dilantin) Purple Glove Syndrome
Quetiapine (Seroquel) Overdose due to sample pack labeling confusion
Telbivudine (Tyzeka) Peripheral neuropathy
Tumor Necrosis Factor (TNF) Blockers Cancers in children and young adults

3 Responses
Sort by: Helpful Oldest Newest
356518 tn?1322263642
True jollyman069
We all pay and we all suffer because of those who want to use our meds for pleasure. I have posted repeated pleas for ways we can help the situation. The goverment is getting more involved because of the many teens that are now into taking these meds for pleasure. Parents want these meds to be unavailable to them but they are also making them unavailable to the people who need them.
Helpful - 0
518031 tn?1295575374
what is bad about this is, any drug that is abused is a safety risk. people that abuse drugs are only trhose of us that truley need and use these drugs the right way. god help us all with govt invovlmenmt we could all lose out in the end
Helpful - 0
356518 tn?1322263642
Oxycontin and cymbalta are listed here and as these are two drugs we use in our community you should be aware that these drugs are being tested for safety.
Helpful - 0
Have an Answer?

You are reading content posted in the Pain Management Community

Top Pain Answerers
Avatar universal
st. louis, MO
317787 tn?1473358451
DC
Learn About Top Answerers
Didn't find the answer you were looking for?
Ask a question
Popular Resources
Find out how beta-blocker eye drops show promising results for acute migraine relief.
Could it be something you ate? Lack of sleep? Here are 11 migraine triggers to look out for.
Find out if PRP therapy right for you.
Tips for preventing one of the most common types of knee injury.
Here are 10 ways to stop headaches before they start.
Tips and moves to ease backaches