FDA Issues Multiple Safety Alerts, Updates

Family physicians should be aware that the FDA recently issued a number of warnings about various products such items as tumor necrosis factor, or TNF, blockers; hand sanitizers; body-building products that include steroids; and botulinum toxin drug products.

The FDA is requiring manufacturers of TNF blockers to update boxed warnings in the drugs' prescribing information because of an increased cancer risk in children and adolescents who use the drugs to treat immune system diseases, including juvenile idiopathic arthritis, rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, Crohn's disease and ankylosing spondylitis.

Drugs affected include infliximab (Remicade), etancercept (Enbrel), adalimumab (Humira), certolizumab pegol (Cimzia) and golimumab (Simponi).

The agency said physicians should discuss the increased risk of developing cancer with patients and their families, taking into account the clinical utility of TNF blockers, the risks and benefits of other therapies, and risks associated with untreated illness.

The FDA also is warning consumers not to use hand sanitizer and related products from Roy, Utah-based Clarcon Biological Chemistry Laboratory Inc. because these products may contain harmful bacteria.

The manufacturer voluntarily recalled the products in June after an FDA inspection. However, at the agency's request, U.S. marshals later seized all products and ingredients at the Utah facility because Clarcon did not agree to destroy them.

Affected products include Citrushield Lotion, Dermasentials DermaBarrier, Dermassentials by Clarcon Antimicrobial Hand Sanitizer, Iron Fist Barrier Hand Treatment, Skin Shield Restaurant, Skin Shield Industrial, Skin Shield Beauty Salon Lotion, Total Skin Care Beauty and Total Skin Care Work.

In addition, a July 28 public health advisory from the FDA warned consumers not to use body-building products that are represented as containing steroids or steroid-like substances. The agency said many of the products are marketed as dietary supplements but actually are unapproved and misbranded drugs.

The agency issued a warning letter on July 27 to Pacifica, Calif.-based American Cellular Laboratories Inc. for marketing and distributing products containing synthetic steroid substances.

According to the FDA, the agency has received reports of adverse events, including liver injury, stroke, kidney failure and pulmonary embolism, associated with the use of products that claim to contain steroids or steroid-like substances.

The agency said consumers should consult a physician if they suspect they are experiencing problems associated with the products.

On Aug. 3, the FDA issued an update to a previous safety alert on botulinum toxin drug products. Four such products now have boxed warnings on their labels indicating that the effects of the botulinum toxin may spread from the injection area to other parts of the body, causing symptoms similar to those of botulism.

The boxed warnings caution that symptoms -- including life-threatening swallowing and breathing difficulties -- primarily have been reported in children with cerebral palsy being treated for muscle spasticity. The FDA has not approved the drugs for this use.

Manufacturers of these products have developed medication guides for patients at the agency's behest, and the revised labels emphasize that different botox products are not interchangeable. Three of the affected products have new drug names to reduce potential for dosing errors:

A fourth product -- Dysport, or abobotulinumtoxinA -- was approved in April 2009 with an adequate boxed warning already in place and did not require name or label changes.

Physicians and consumers may report serious adverse events associated with the use of any of the above-named products online or by calling (800) FDA-1088.