FDA Adds 13 Drugs to Watch List


February 08, 2011

February 8, 2011 — 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.


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