The Lynx Group

Oncology-related Updates from the US Food and Drug Administration

June 2010, Vol 1, No 2

IV Ondansetron May Be Contaminated

The FDA has alerted healthcare professionals not to use certain intravenous (IV) bags of ondansetron (an antiemetic) and metronidazole and ciprofloxacin (both antibiotics) because of potential contamination. IV bags manufactured by Claris Life - sciences Limited, Ahmeda bad, India, have generated reports of floating matter in the bags. Poten tially affected products are sold under the Claris, Sagent Pharmaceuticals, Pfizer, and West-Ward Pharma ceuticals labels. Healthcare professionals should not use and should immediately remove from their pharmacy inventories IV bags manufactured by Claris and sold under any of these labels. (May 29, 2010)

Tramadol Warning Strengthened

The FDA advised healthcare professionals of label changes to 2 tramadol products (tramadol hydrochloride, Ultram; and tramadol hydrochloride/acetaminophen, Ultracet). The opioid, indicated for the management of moderate- to moderately severe–chronic pain, now contains a stronger warning regarding the risk of suicide for patients who are addiction-prone and/or taking tranquilizers or antidepressant drugs, and also warns about the risk of overdose. (May 25, 2010)

Thyrogen Supply Limited

Due to manufacturing difficulties at one of Genzyme’s plants, the supply of Thyrogen will be temporarily limited. Thyrogen is a recombinant thyroid- stimulating hormone that is used in the treatment and follow-up diagnosis of thyroid cancer. Genzyme has entered into a consent degree with the FDA that restricts distribution of the drug to only those for whom it is medically necessary. The shortfall will last until the manufacturing issues are resolved, or operations are transferred to another facility. (May 24, 2010)

GnRH Agonists Undergoing Safety Review

The FDA has notified healthcare professionals and patients of their preliminary and ongoing review that suggests an increase in the risk of diabetes and certain cardiovascular diseases in men treated with gona - dotropin-releasing hormone (GnRH) agonists. These drugs, among them Lupron, Zoladex, Trelstar, Viadur, Vantas, Eligard, Synarel, and other generics, suppress the production of testosterone, a hormone that is involved in the growth of prostate cancer. Most of the studies reviewed by the FDA reported small, but statistically significant increased risk. The FDA’s review is ongoing and the agency has not yet made any conclusions about risks associated with GnRH agonists. (May 3, 2010)

In related news, the FDA is also conducting a safety review of Stalevo. Data from a single trial suggest that patients taking the drug may be at an increased risk for developing prostate cancer. (March 31, 2010)

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