FDA Adds 13 Drugs to Watch List
The US Food and Drug Administration (FDA) has released its latest list of drugs to monitor based on potential signs of serious risks or new safety information identified in the agency's Adverse Event Reporting System (AERS).
The quarterly watch list consists of 13 medications that treat a wide range of conditions, including cough, angina, diabetes, cancer, and bipolar disorder.
The agency is studying the 13 drugs to determine whether they are causally linked to the possible risks reported through AERS from July 1, 2010, through September 30, 2010. In the meantime, the FDA considers them pharmacologically innocent until proven guilty. Physicians should not stop prescribing these drugs, therefore, nor should patients stop taking them, according to the agency.
There are some exceptions to this suspended judgment approach, however. One involves immune globulin G intravenous (human) 5% liquid preparation (Octagam, Octapharma USA), used to treat primary immunodeficiency diseases. At the FDA's request, the manufacturer withdrew all lots of the biologic from the market last September while it investigated reports of blood clots and embolisms.
Similarly, that month Amgen recalled certain lots of epoetin alfa (Epogen and Procrit), an anemia therapy, because they may have contained extremely thin glass flakes called lamellae.
Potential Signals of Serious Risks/New Safety Information Identified by AERS, Third Quarter 2010
|Product Name||Potential Signal of a Serious Risk/New Safety Information|
|Benzonatate (Tessalon, Pfizer)||Death from accidental ingestion in children|
|Dronedarone hydrochloride (Multaq, Sanofi-Aventis)||Drug interaction with warfarin (increased anticoagulant effect)|
|Epoetin alfa (Epogen/Procrit, Amgen)||Possible contamination with shards from glass vial|
|Gemcitabine hydrochloride (Gemzar, Lilly)||Veno-occlusive liver disease|
|Lanreotide acetate (Somatuline Depot, Beaufour Ipsen)||Pancreatitis, hemorrhagic and necrotizing pancreatitis|
|Lanthanum carbonate (Fosrenol, Shire)||Swallowing complications, gastrointestinal obstruction (attributed to tablet hardness)|
|Levetiracetam (Keppra, UCB Inc)||Stevens-Johnson's syndrome, toxic epidermal necrolysis|
|Lithium citrate (Eskalith and Lithobid, Noven)||Brugada syndrome|
|Lopinavir/Ritonavir oral solution (Kaletra, Abbott)||Serious adverse events in neonates|
|Immune globulin G intravenous (human) 5% liquid preparation (Octagam, Octapharma USA)||Thromboembolic adverse events|
|Pioglitazone HCl (Actos, Takeda)||Rhabdomyolysis|
|Ranolazine (Ranexa, Gilead)||Drug interaction with statins (rhabdomyolysis)|
|Sodium oxybate (Xyrem, Jazz)||Death|
The current list of drugs with potential safety issues is available on the FDA's Web site.
Also available are the AERS-generated watch lists for drugs covering previous time periods.