20 Drugs the FDA is Watching
In 2007 a law was passed that required the FDA to allow consumers access to their reports on drug-related adverse reactions.
The information is gathered through a reporting program called The Adverse Event Reporting System (AERS) The Adverse Event Reporting System (AERS) collects information from doctors, hospitals, patients and drug companies about problems that may (or may not) be related to a certain drug.
If a patient complains of a side effect, has trouble (confusion) with a label or name or if any other complaints are made about a certain drug, it is reported to The Adverse Event Reporting System.
The following drugs are on the list with the potential risk stated:
| Product Name: Active Ingredient (Trade) | 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 (tingling in the extremities) |
| Tumor Necrosis Factor (TNF) Blockers | Cancers in children and young adults |
The FDA has stated that just because a drug is on the list does not mean you should stop taking the drug if it has been prescribed to you or that doctors should stop prescribing the drug. It only means that the drug and its potential risks are being investigated.
"If a drug is listed, it means we have begun an analysis to see if there is a safety problem that requires further evaluation," Gerald Dal Pan, MD, MPH, director of the FDA office of surveillance and epidemiology, said at a news conference.
Once the investigation is complete the FDA will issue further warnings, require name or label changes to eliminate any confusions or issue an all clear if the drug is deemed safe.
"This extends our commitment to keep the public and the health care community informed of what we are evaluating," Paul Seligman, MD, MPH, FDA associate director of safety policy and communication, said at the news conference.
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