Pharmaceutical

Consumer group calls FDA’s unwillingness to ban latex “reckless”

Surgical and patient examination gloves that have cornstarch powder on them or are made of natural latex rubber pose a serious threat to patients and health care workers and must be banned said Public Citizen, a national, nonprofit consumer advocacy organization, in a petition filed Monday with the Food and Drug Administration (FDA).

Many people are chronically allergic to latex rubber. Health care workers can experience serious or life-threatening allergic reactions when they wear latex gloves or when they inhale the cornstarch powder bound to latex proteins that has been released from latex gloves worn by others. Inhaling the cornstarch powder can trigger acute asthma attacks and even lead to anaphylactic shock in health care workers who have been sensitized to latex.

The widespread use of latex products throughout the health care industry has led many professionals and patients who have had multiple surgical procedures to develop a sensitivity to latex through frequent exposure. Allergic reactions can range in severity from contact dermatitis (dry, itchy skin) to shock and death.

But despite these risks, latex gloves and other medical supplies containing latex are still used by physicians, nurses, nursing aides, dentists, hygienists, operating room staff, laboratory technicians, and hospital housekeeping personnel, putting them and frequent patients at risk for developing a latex allergy.

Up to 17 percent of health care workers experience some form of latex sensitivity. The use of latex is so common in the medical industry that it has forced many health care workers out of their profession and left many more to deal with the risk of an allergic reaction on a daily basis.

Surgical patients are also endangered because the cornstarch powder can be deposited in tissues inadvertently during a procedure, promoting infection, delaying healing, causing inflammation, and leading to a number of other injuries.

“The FDA’s prolonged failure to take action eliminating the dangers posed by powdered surgical and patient examination gloves demonstrates a reckless and inexcusable disregard for the health and safety of patients and health care workers,” said Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group.

“The dangers posed by powdered surgical and patient examination gloves and all latex gloves have been widely recognized throughout the medical profession and the world for many years and are indisputable. Safer, equally effective substitutes are available.”

The first time Public Citizen petitioned the FDA to ban latex gloves was on Jan. 7, 1998. The FDA rejected the petition in 1999, instead proposing regulations that would introduce special controls and warning labels for latex products, which safety advocates said was an inappropriately weak response to such an enormous health hazard. Other groups have petitioned the FDA for a latex ban without success.

Public Citizen warns that the U.S. is lagging dangerously behind other countries in removing recognized hazards from the market.

“Collectively, thousands of lives have been saved and many more injuries spared in these countries because they have placed the health of the public ahead of the concerns of manufacturers of products with no unique benefits, only unique risks,” Carome said.