FDA adds cancer warnings to J&J foot ulcer cream

The Food and Drug Administration warned patients Friday that using large amounts of a Johnson & Johnson foot ulcer medication could heighten their risk of dying from cancer.

The FDA added its most serious warning to the company's cream medication Regranex, which is prescribed to treat severe foot and leg ulcers in diabetics. The new boxed warning states that patients who used three or more tubes of Regranex over a 20-month period were five times more likely to die of cancer.

When patients used lower amounts of the cream, the FDA said their chances of developing cancer were no higher than patients who had never used the drug.

The findings come from a long-term analysis of records from health care providers comparing 1,600 patients who took Regranex with 2,800 patients who did not, according to the FDA.

The new label, which is outlined in a black box, advises doctors to use caution when prescribing the drug to patients with malignancies.

Regranex is a man-made version of a substance produced by the human body that helps heal ulcers. Because the drug causes cells to divide more rapidly, the FDA said Johnson & Johnson closely monitored patients for reports of cancer, which spreads through uncontrolled cell division.

The FDA in March said it was reviewing the drug's links to cancer.

A spokeswoman for New Brunswick, N.J.-based Johnson and Johnson said the company cooperated with FDA on the new label and is "committed to getting the information out to physicians and patients."

About 750,000 people have used the drug since it was approved by the FDA in 1997. The drug is marketed by Ethicon Inc., a subsidiary of Johnson & Johnson.

Shares of Johnson & Johnson fell $1.20 to close at $65.76 Friday.

Source: Associated Press

Source: http://ap.google.com/

Comments: Diabetic patients are at an increased risk of developing foot ulcers, because of damaged nerve ending (diabetic neuropathy) and compromised circulation, which can delay the healing of such wound by warding off nutrients and drugs to reach to the wound site. In addition, higher levels of sugar and low Vitamin C concentration in the blood make it easier for the bacteria to flourish.

Due to much slower wound healing and other complications such as gangrene, often times diabetic patients' only option could be losing the affected limb to amputation. Regranex Gel is the FDA-approved prescription medicine that contains the platelet-derived growth factor (PDGF) claimed to help heal diabetic foot ulcers. However with this investigation the FDA has found out that people who apply this gel in the hopes of healing their foot ulcers are more likely to die of cancer.

About 750,000 people have used the drug since it was approved by the FDA in 1997. The drug is marketed by Ethicon Inc, which is a subsidiary of Johnson & Johnson. The FDA has issued agency's strongest drug warning indicating the increased risk of deaths due to cancer. Drug companies always try to get their products on the market before the competitors. However in this race to gain the market share, long-term safety data of the drug is often compromised and such studies are not done. And a "post-marketing retrospective cohort study" like in this case, brings such grave dangers to the attention of the FDA and others, and by then several lives have already been lost.

For more than a decade, Dr. Rath has been a crusader in highlighting such only profit-oriented practices of the pharmaceutical companies, which invariably compromise the health and safety of patients. In addition to that, scientists at Dr. Rath's Research Institute have also conducted diabetes clinical trials, using specific nutrient combinations in synergistic proportions and have shown significant improvements in blood sugar levels as well as reduction on diabetic complications such as foot ulcers. However pharmaceutical corporations intentionally neglect such safe and effective solutions to several diseases. Please visit us at www.drrathresearch.org and also join Dr. Rath's fight for vitamin freedom at www.drrathhealthalliance.com