Interim data from a randomized, multi-center study indicate that darbepoetin alfa (Aranesp®, Amgen) is beneficial in correcting anemia in cancer patients who are not undergoing chemotherapy. The results were presented at the 45th annual meeting of the American Society of Hematology, from December 6-9, 2003 (Abstract No. 1816).

The hemoglobin counts at the baseline examination were 10.1 g/dl in the Aranesp® group and 10.4 g/dl in the control group. After 12 weeks of treatment, the mean change in hemoglobin was 1.9 g/dl for the Aranesp® group and 0.2 g/dl in the controls, who received standard care.
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Methylphenidate (Ritalin®, Novartis) has been the most popular drug for treating attention-deficit problems for more than 50 years, but a small study has linked its use with a higher risk of cancer.

Texas researchers found that after only three months, 12 treated children had a three-fold increase in chromosome abnormalities associated with increased cancer risk.

Novartis has emphasized the safety record of the drug, which has shown no clinical evidence of a link to the development of cancer in humans. A mild central nervous system stimulant, it is the most widely prescribed drug for treating attention deficit/hyperactivity disorder (ADHD).

In 1996, two-year animal studies that showed that high levels of methyl-phenidate caused liver tumors in male and female mice; studies of rats, however, did not show these results. The FDA concluded those findings were not sufficient to have children discontinue therapy.

Canada recently pulled the amphetamine/mixed salts medication Adderall® XR from the market after Shire provided information about 20 patient deaths, and the FDA has linked atomoxetine (Strat-tera®, Eli Lilly), a nonstimulant ADHD medication, with liver damage.

Medical experts say that until more is known, parents should not be overly frightened of giving methylphenidate to their children. Larger studies are needed to confirm these findings.

The FDA has approved raloxifene HCl (Evista, Eli Lilly) for reducing the risk of invasive breast cancer in post-menopausal women with osteoporosis and in postmenopausal women at high risk for invasive breast cancer. As a selective estrogen receptor modulator (SERM), raloxifene may act by blocking estrogen receptors in the breast.

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The FDA has approved revised boxed warnings and safety-related product labeling changes for erythropoiesis-stimulating agents (ESAs), which treat certain types of anemia. ESAs are a bio-engineered version of a protein made in the kidneys that stimulates bone marrow to produce more red blood cells.

A sampling of the new statements addresses the following:

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Merck’s Gardasil vaccine is now indicated for the prevention of genital warts (condyloma acuminata) caused by human papillomavirus (HPV) types 6 and 11 in boys and men 9 through 26 years of age. Gardasil is currently approved for use in girls and women 9 through 26 years of age for preventing cervical, vulvar, and vaginal cancer caused by HPV types 16 and 18; precancerous lesions caused by types 6, 11, 16, and 18; and genital warts caused by types and 11.

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