The US Food and Drug Administration (FDA) continually monitors product safety information even after the FDA has granted approval. The FDA tracks and monitors post-marketing safety information and medication errors through the Adverse Event Reporting System (AERS), which is a computerized information database designed to support the FDA's post-marketing safety surveillance program for all approved drug and biologic products. Information is compiled through voluntary reporting by health care professionals and consumers. The AERS contains over four million reports of adverse events dating back to 1969.
The FDA publishes a new report each quarter which lists medications that the FDA is monitoring based on potential signs of serious risk and/or new safety information. The latest report released on January 31, 2011 identified 13 medications that are being studied based on data submitted from July 1, 2010 through September 30, 2010. The appearance of a drug on this list does not mean that there has been a causal relationship between the drug and the listed risk. Further evaluation will be conducted by the FDA and if it is concluded that the drug is associated with the risk then additional precautions may be taken. In the past the FDA has required labeling changes, development of a Risk Evaluation and Mitigation Strategy (REMS), or requiring additional data be collected to further understand the risk.
The latest watch list contains 13 medications that are FDA approved to treat a variety of conditions. The appearance of a medication on this list does not indicate that the FDA recommends that patients stop taking these prescribed medications or that healthcare providers should stop prescribing these products. Further information regarding these potential safety issues can be found on the FDA's website.
| Medication | Potential Safety Issue |
| Benzonatate (Tessalon) | Death from accidental ingestion in children |
| Dronedarone HCl (Multaq) | Drug interaction with warfarin (increased anticoagulant effect) |
| Epoetin alfa (Epogen/Procrit) | Possible contamination with shards from glass vial |
| Gemcitabine HCl (Gemzar) | Veno-occlusive liver disease |
| Lanreotide acetate (Somatuline Depot) |
Pancreatitis, hemorrhagic and necrotizing pancreatitis |
| Lanthanum carbonate (Fosrenol) | Swallowing complications, gastrointestinal obstruction (attributed to tablet hardness) |
| Levetiracetam (Keppra) | Stevens-Johnson's syndrome, toxic epidermal necrolysis |
| Lithium citrate (Eskalith/Lithobid) | Brugada syndrome |
| Lopinavir/Ritonavir oral solution (Kaletra) | Serious adverse events in neonates |
| Immune globulin G (Octagam) | Thromboembolic adverse events |
| Pioglitazone HCl (Actos) | Rhabdomyolysis |
| Ranolazine (Ranexa) | Drug interaction with statins (rhabdomyolysis) |
| Sodium oxybate (Xyrem) | Death |