FDA Drug Safety Newsletter

FDA Drug Safety Newsletter - Dec 2009: Newsletter for healthcare professionals with selected postmarketing drug safety reviews, product labeling changes, and recent drug safety communications


Postmarket Reviews
In this issue, we highlight two drug safety-related issues involving children. The first topic describes a risk associated with topical testosterone gel products. FDA has received postmarket reports of inappropriate development of early sex characteristics (i.e., enlargement of genitalia, advanced bone age, increased growth velocity, aggressive behavior) in children exposed to testosterone through contact with a person using these products. To mitigate this risk and increase awareness of this adverse event, FDA required a Boxed Warning on the product’s prescribing information, as well as a Medication Guide.

The second topic describes reports of deaths of newborns and young infants associated with concomitant use of intravenous ceftriaxone (third-generation cephalosporin) and calcium-containing solutions. FDA has changed ceftriaxone’s prescribing information based on these findings.

Our third topic is on reports of loss of sense of smell (anosmia) with Zicam zinc-containing intranasal products. These products were sold over-the-counter and used to reduce the duration and severity of cold symptoms. FDA has taken regulatory action to stop the marketing these products without FDA review and approval.
Topical Testosterone Gel Products
Reports of secondary exposure of children to testosterone gel products (marketed as AndroGel 1% and Testim 1%)

Intravenous Ceftriaxone and Calcium Drug-Drug Interaction
Reports of serious cardiopulmonary adverse events in neonates associated with precipitation of ceftriaxone (marketed as Rocephin and generics) and calcium salt in the body

Zinc-Containing Intranasal Cold Products
Reports of loss of sense of smell associated with the use of zinc-containing intranasal cold products (marketed as Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs, Kids Size)

http://www.fda.gov/Drugs/DrugSafety/DrugSafetyNewsletter/ucm189806.htm