The FDA grades prescription drugs for the public
October 21, 2008
The Federal Drug Administration has released a list of prescription drugs that could involve safety problems for patients who are taking them. There is also the possibility that patients who suddenly quit taking them because they’re on the list could suffer worse problems. Below is the first list, which was released on September 5 and is based on findings from January through March of this year.
The FDA emphasizes that no cause-and-effect relationship has been established between taking these drugs and worsening health problems. The FDA has only identified a potential risk, and patients taking these drugs should talk to their physicians about them. Further studies are needed to establish the actual risk and the most effective course of action.
One of the drugs on the list, heparin, has been taken off the market, and others may be restricted or removed as well. Some will be cleared of safety concerns.
| 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 |
