FDA Consumer

Kessler warns about drug, device promotion

Kessler warns about drug, device promotion – Food and Drug Commissioner David A. Kessler

Kessler Warns About Drug, Device Promotion

FDA Commissioner David A. Kessler, M.D., has warned that the agency will not tolerate the practice of promoting drugs and medical devices for unapproved uses.

While physicians may prescribe products for off-label uses, promotion of such uses is illegal, Kessler said last June before the House Subcommittee on Human Resources and Intergovernmental Relations Committee on Government Operations. FDA is prepared to enforce the law through legal steps such as seizure, injunction and prosecution, he said.

“We will subject not only the manufacturers, but all those involved in the manufacturer’s promotion, to the full force of the law,” Kessler said. “We also intend to identify promotional activities that are disguised as education or public relations and hold these activities to the same standards as traditional promotional techniques.”

Examples of products that have been promoted for potentially dangerous, unapproved uses are:

* Liquid silicone injections to remove wrinkles and other facial deformities. FDA has not approved silicone injection for any use. Also, because there is no standard product, the agency cannot inform consumers about the material’s composition. Swelling, reddening of the skin, lumpiness, and soft tissue tumors are some of the possible adverse effects.

* Collagen injection directly into the lip. FDA has not approved collagen for injection into the red part of the lip for purposes of enlargement. FDA has approved collagen to treat acne scars.

* Retin-A to prevent wrinkling. FDA does not have long-term safety data for chronic Retin-A use for wrinkling. Because Retin-A heightens the skin’s light sensitivity, chronic use might increase the risk of skin cancer. FDA has approved Retin-A to treat severe acne.

* Calcium channel blockers to improve survival of heart attack patients. These drugs have been promoted as a substitute for beta blockers, which have been shown to improve survival after heart attack. Patients taking calcium channel blockers, however, showed no such benefit, and a subgroup of patients taking the drug had decreased survival compared with patients given a placebo. Calcium channel blockers are approved to treat angina (chest pain) and high blood pressure.

Kessler announced a new program to inform physicians and medical students about FDA’s regulation of drug promotion and to enlist their help in reporting improper or misleading promotional campaigns. He also said an agency-wide working group will review product advertising, with special emphasis on determining how to stop inappropriate promotion of medical devices.

Latex Allergies Affect Medical Treatment

Patients who know they are sensitive to latex should inform health professionals and emergency personnel about their sensitivity before undergoing medical procedures, advises a recent FDA medical alert.

FDA has received an increasing number of reports of allergic reactions to latex-containing medical devices such as surgical and examination gloves, catheters, intubation tubes, and dental dams. The reactions range from skin rashes to breathing difficulties and shock.

One brand of latex-cuffed enema tips was recently recalled after several patients died as a result of anaphylactoid (severe allergic) reactions during barium enema procedures.

Proteins in the latex appear to be the cause of the reactions, and FDA is working with manufacturers of devices containing the material to keep the protein levels as low as possible.

FDA has asked physicians to:

* question patients about latex sensitivity when taking medical histories

* consider using devices with alternative materials, such as plastic, for patients who are sensitive

* always be alert to the possibility of allergic reaction when using latex-containing devices

* advise patients who experience an allergic reaction possibly due to latex that they may be sensitive to the material, and consider allergy testing for the patient.

Consumers should tell health professionals and emergency personnel about any known latex sensitivity before undergoing medical procedures. Those with a severe sensitivity may want to consider wearing an identification bracelet.

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