The government warned thousands of doctors Monday that a new blood thinner could leave certain surgical patients paralyzed.
The Food and Drug Administration has received more than 30 reports of patients who suffered bleeding inside the spinal column after both taking a blood thinner called Lovenox and receiving surgical anesthesia through a spinal injection.
That bleeding builds dangerous pressure inside the spinal cord. All the patients in the reports suffered at least temporary neurological damage, such as leg weakness, difficulty walking or difficulty emptying their bladders. Those not diagnosed quickly enough to repair the damage suffered permanent paralysis below the waist, said Dr. Lilia Talarico, FDA’s director of anticoagulants.
The problem appears to be combining epidural, or spinal, anesthesia with the powerful new blood thinner known as low-molecular-weight heparin. Normally, spinal injections stop bleeding quickly. These patients’ extra-thin blood cannot clot, and pools inside the spinal cord.
Lovenox, made by Rhone-Poulenc Rorer, is the biggest-selling brand of low-molecular-weight heparin, but the FDA said related brands also are risky. They include Pharmacia & Upjohn’s Fragmin; Wyeth-Ayerst Laboratories’ Normiflo; and Organon Inc.’s Orgaran.
Doctors can prevent the paralysis, the FDA said in a public health warning sent Monday to medical societies representing orthopedic surgeons, anesthesiologists and blood and pain specialists.
Surgery candidates on these anti-coagulants should be considered for general anesthesia - being put to sleep - said FDA’s Talarico.