Avastin no longer allowed for breast cancer – FDA

The U.S. Food & Drug Administration has revoked its approval of Avastin after concluding the metastatic breast cancer treatment did nothing to control tumor growth or help patients live longer, but instead increased their risk of developing severe high blood pressure, hemorrhages and other serious side effects.

“After reviewing the available studies, it is clear that women who take Avastin for metastatic breast cancer risk potentially life-threatening side effects without proof that the use of Avastin will provide a benefit, in terms of delay in tumor growth, that would justify those risks,” said FDA commissioner Margaret A. Hamburg.

The FDA’s action follows the unanimous June recommendation of an FDA advisory committee to revoke Avastin’s approval, which had been granted on a provisional basis using special procedures created in the early 1990s to quickly get new but unproven AIDS drugs greenlighted.

Avastin now holds the distinction of being one of but only a handful of medications to have been approved and subsequently revoked.

Ironically, the first clinical trial involving Avastin showed the drug had promise as a tumor growth-retardant when paired with paclitaxel (brand name: Taxol). This combination appeared to delay cancer progression for about 200 days. Trouble was, the marrying of Avastin and paclitaxel exposed patients to more side effects and failed to appreciably extend their life expectancy.

Later studies tested Avastin with other drugs. In these investigations, the delays in cancer progression were even shorter than with paclitaxel. Morever, there was no extension of life expectancy and no improvement in life quality.

Avastin is made by Genentech Co. The manufacturer announced it intends to conduct another clinical trial, with the hope that the results will help convince the FDA to r e-instate Avastin’s approval.

Even after having lost its approval as a breast cancer treatment, Avastin retains its proponents among oncologists. For example, a committee of breast-cancer specialists affiliated with the National Comprehensive Cancer Network – an organization of major cancer hospitals – asserted that the FDA should keep Avastin listed as an appropriate therapeutic option.

Meanwhile, the loss of approval for that particular use will not prevent Avastin from remaining available to treat other types of cancers. Consequently, doctors will remain free to use it for breast cancer, but only if they do so on an off-label basis.

That might not matter in the end if private insurers decide to stop paying for treatment with Avastin (as some already have done). The drug costs roughly $7,500 per month. At that price, few apart from the wealthy would be able to afford Avastin out of pocket. (The story is different for those covered under Medicare: the federally-funded payor says it intends to keep paying for Avastin as a breast cancer treatment).

CareFusion EnVe ventilator recall hit with FDA Class 1 ‘most grave’ designation

(Oct. 19, 2011) CareFusion Corp. today announced that its voluntary recall of 128 EnVe ventilators made late last year through May has received a U.S. Food & Drug Administration designation of Class 1 – meaning the government believes there is a potentially lethal injury risk to patients connected to the affected devices.

According to the San Diego, Calif., manufacturer, the ventilators were recalled for several reasons.

First was the possibility that ventilator settings might unexpectedly change on their own. The fear here was that the patient could receive too little or too much air flow, setting the stage for catastrophe.

There also was the potential that the ventilator’s connections might disengage during transportation, leaving the patient without any breathing support whatsoever.

Further, there were indications that a ventilator mask taken off the patient’s face and then put back on – even if done quickly – might trigger an air-flow failure.

CareFusion said that failure to adequately ventilate a patient can cause serious neurological injury or death from hypoxia or hypercarbia.

The FDA issues Class 1 designations when there is a reasonable probability of serious adverse health consequences or death associated with use of the defective units, the company added..

Not affected by the CareFusion recall are its other products, which include Alaris infusion pumps, Pyxis automated dispensing and patient identification systems, AVEA-, AirLife- and LTV-series ventilation and respiratory products, ChloraPrep products, MedMined services for data-mining surveillance, Nicolet neurological monitoring and diagnostic products, V. Mueller surgical instruments, and an extensive line of other interventional medicine support devices.

The voluntary recall of EnVe ventilators began with the Sept. 12 issuance by CareFusion of an urgent Medical Device Recall Notification to customers. In that notification letter, customers were provided serial numbers of affected devices (this information also is available at www.carefusion.com/customer-support/alerts-notices/medical-device-recall-enve-ventilator.aspx).

According to CareFusion, the 128 EnVe ventilators were sold to 29 customers, chiefly hospitals.

CareFusion said it is conducting a “field corrective action to update the hardware and software on affected ventilators” and that it “determined the root cause for each issue and is committed to updating each device in a timely manner with minimal disruption to customers.”

This, however, is not the first time a CareFusion voluntary recall has drawn a Class 1 designation from the FDA. In October, 2010, the agency classified the recall of approximately 17,000 CareFusion Alaris PC infusion units as a Class 1 recall.