Source Pravda.Ru

FDA to impose restrictions on Aranesp and Procrit drugs

Anemia drugs made by Amgen and Johnson & Johnson may raise the risk of death among those suffering from cancerous diseases, a new study says.

The Food and Drug Administration may therefore impose further restrictions on the use of such medications as Aranesp from Amgen and Procrit from Johnson & Johnson. The restrictions will be imposed for the use of these drugs with cancer patients.

The study showed that the medications could aggravate cancer conditions or hasten death if used too aggressively.

It is worthy of note that Aranesp is a best-seller for Amgen, although its sales decreased to $3.6 billion in 2007 from $4.1 billion in 2006.

The study was made on the base of an extensive research work conducted among 13,611 patients. It particularly showed that the above-mentioned drugs increased the risk of blood clots in veins by 57 percent.

Johnson & Johnson’s Procrit was approved for the treatment of cancer patients in 1993, and Aranesp – in 2002. The approval was made on the base of the drugs’ ability to reduce the need for blood transfusion. However, specialists disregarded the effect which the drugs showed on patients’ longevity.

In recent years, some new clinical trials showed that the use of the drugs at higher doses than indicated on the label would lead to serious complications or even death. As a result, the safety balance appeared to shift.

Amgen sent a "dear doctor" letter in January, 2007, that highlighted results from a recent anemia of cancer trial, and warned doctors to consider use in that off-label indication with caution. Amgen advised the United States FDA as to the results of the DAHANCA 10 clinical trial. The DAHANCA 10 data monitoring committee found that 3-year loco-regional control in subjects treated with Aranesp was significantly worse than for those not receiving Aranesp (p=0.01).

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