More Drugs Added to FDA Watch List


April 21, 2014

The US Food and Drug Administration (FDA) has placed a generic drug that treats attention-deficit/hyperactivity disorder (ADHD) along with certain anticancer drugs on its latest quarterly list of products to monitor because of potential health risks, the agency announced today.

The agency received signals of these possible safety issues through its FDA Adverse Event Reporting System (FAERS) database in the last 3 months of 2013.

On the basis of the FAERS data, the FDA said certain kinase inhibitor products that thwart vascular endothelial growth factor, depriving malignant tumors of new blood vessels, may be associated with bullous skin conditions such as Stevens-Johnson syndrome and toxic epidermal necrolysis. The cancer drugs in question are lapatinib (Tykerb, GlaxoSmithKline), pazopanib (Votrient, GlaxoSmithKline), sorafenib (Nexavar, Bayer HealthCare Pharmaceuticals), and sunitinib (Sutent, Pfizer).

In the case of the ADHD drug — certain generic versions of methylphenidate hydrochloride (Concerta, Janssen Pharmaceuticals) — the issue is a possible lack of therapeutic effect, which may be linked to product quality issues, according to the FDA.

A drug's appearance on the list, which grows quarter by quarter, does not mean the FDA has concluded that the drug actually poses the health risk reported through FAERS. Instead, the agency is studying whether there is indeed a causal link. If it establishes one, the FDA then would consider a regulatory response such as gathering more information to better describe the risk, changing the drug's label, or mandating a risk evaluation and mitigation strategy.

The FDA also emphasizes that it is not suggesting that clinicians should stop prescribing watch list drugs or that patients should stop taking them while the jury is out.

Potential Signals of Serious Risks/New Safety Information Identified by FAERS, October–December 2013

Product Name: Active Ingredient (Trade) or Product Class Potential Signal of a Serious Risk/New Safety Information Additional Information (as of March 1, 2014)
Certain kinase inhibitor products with vascular endothelial growth factor–inhibiting properties: Lapatinib (Tykerb), Pazopanib (Votrient), Sorafenib (Nexavar), and Sunitinib (Sutent) Bullous skin conditions including Stevens-Johnson syndrome and toxic epidermal necrolysis The FDA is continuing to evaluate these issues to determine the need for any regulatory action.
Certain methylphenidate hydrochloride extended-release tablets (generic products for the trade name Concerta) Lack of therapeutic effect, possibly related to product quality issues The FDA is continuing to evaluate this issue to determine the need for any regulatory action.

More information on FAERS and its quarterly watch list is available on the FDA Web site.


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