Product News and Recalls

Concerns about FDA fast-track process

A story in The Scientist magazine says some medical professionals are concerned about health risks attendant with the U.S. Food and Drug Administration’s heavy reliance on the fast-track review process for new medications.

The Scientist cites an article in the Journal of the American Medical Association, which states that the FDA fast-tracked nearly half of all the 35 drugs it reviewed in 2011.

Among them was the blood thinner dabigatran, sold under brand name Pradaxa, which was approved for lowering the risk of stroke in patients with irregular heart beat.

Within less than a year, however: “Pradaxa accounted for more serious adverse drug events reported to the FDA during the second quarter of 2011 than any other regularly monitored drug.” The most common problem was increased risk of uncontrolled bleeding in older patients.

The FDA’s fast-track approval process for medical devices has also generated a good deal of safety concerns recently. Under the FDA’s 510(k) process, medical devices can be approved based on their supposed similarity to products that have already been approved.

Consumer health advocates say the 510(k) process has served as a loophole under which medical products companies use to sell unsafe devices that make it onto the market without clinical testing in humans.

For example, thousands of patients have filed lawsuit over two devices approved under the 510(k) process – an all-metal artificial hip manufactured by Johnson & Johnson’s DePuy Orthopaedics division, and a transvaginal mesh implant used to treat pelvic organ prolapse and urinary incontinence.

The DePuy hip was recalled after studies indicated that nearly half of the devices had to be replaced within six years, and numerous reports surfaced of toxic metal debris breaking off and getting into patients’ soft tissues.

The mesh implants generated widespread complaints of problems including infection, organ perforation and chronic, debilitating pain.

You should consult with a doctor before changing medication, or if you have any ongoing symptoms or health concerns from a medical implant. If you have significant injuries, you should also consult with a lawyer familiar with the Pradaxa, DePuy hip implant or transvaginal mesh case to discuss your legal rights.

See the story here: