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.



http://www.medscape.com/viewarticle/737056