US Pharm. 2006;31(9):72.

New Warnings for Dexedrine
FDA and GlaxoSmith­ Kline have announced changes to the boxed warning, warning, and precautions sections of the prescribing information for Dexedrine (dextroamphetamine sulfate), an approved treatment for attention-deficit/hyperactivity disorder and narcolepsy. Reports of sudden death in association with central nervous system stimulant treatment have been reported in children and adolescents with structural cardiac abnormalities or other serious heart problems.

FDA Warns Against Drinking High-Strength Hydrogen Peroxide
Two companies have received warning letters from FDA for illegally selling "35 Percent Food Grade Hydrogen Peroxide" products on Web sites as treatments for AIDS, cancer, emphysema, and other serious and life-threatening diseases. High-strength hydrogen peroxide products such as "35 Percent Food Grade Hydrogen Peroxide" are not FDA approved, are 10 times stronger than the solution used in OTC drugs to disinfect minor cuts, and can cause serious harm or death when ingested. FDA is warning consumers not to purchase or consume high-strength hydrogen peroxide products for medicinal purposes.

Nanotechnology Task Force Formed
FDA has formed an internal nanotechnology task force to determine regulatory approaches that encourage the continued development of innovative, safe, and effective FDA-regulated products that use nano­ technology materials. Specifically, the task force will assess the scientific knowledge pertaining to nanotechnology materials; evaluate the effectiveness of the agency's regulatory approaches and authorities to meet any unique challenges that may be presented by the use of nanotechnology materials in FDA-regulated products; explore opportunities to foster innovation using nano­ technology materials to develop safe and effective drugs, biologics, and devices, and safe foods and cosmetics; and consider appropriate vehicles for communicating with the public about the use of nanotechnology materials in FDA-regulated products. The task force will hold a public meeting to further its understanding of developments in nanotechnology materials and submit its findings and recommendations to the Acting Commissioner within nine months of the meeting.

Three Companies Warned to Stop Manufacturing
RoTech Healthcare, Inc., CCS Medical, and Reliant Pharmacy Services have been warned by FDA to stop manufacturing and distributing unapproved inhalation drugs. The three firms claim they produce the inhalation drugs for pharmacy compounding purposes.

"Compounded inhalation drugs are not reviewed by the FDA for safety and effectiveness, often are not produced according to good drug manufacturing practice, and typically are not sterile. This may expose patients to unnecessary risk," said Dr. Steven Galson, Director of the Center for Drug Evaluation and Research. "To avoid these risks, we encourage patients to use FDA-approved drugs whenever possible."

Donor Referral Services Ordered to Cease Manufacturing
Donor Referral Services, a human tissue–recovery firm, and its owner, Philip Guyett, have been warned to cease manufacturing human cells, tissues, and tissue-based products and to retain such products. FDA gave the order after an inspection revealed serious deficiencies in manufacturing practices, including donor screening and record keeping.

"Allowing the firm to continue to manufacture would present a danger to public health by increasing the risk of communicable disease transmission," said Margaret O'K Glavin, Associate Commissioner, Office of Regulatory Affairs. FDA will continue to investigate Donor Referral Services and moni­ tor recalls to account for all distributed tissue.

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