Concerta Placed on FDA’s Watch List

Concerta Placed on FDA’s Watch List
Read More: http://www.medscape.com/viewarticle/823917

Medscape reports that on April 21, 2014 the US Food and Drug Administration (FDA) has placed a generic drug that treats attention-deficit/hyperactivity disorder (ADHD) on its latest quarterly list of products to monitor because of potential health risks, the agency announced today.

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.

More Drugs Added to FDA Watch List
www.medscape.com
Members of a certain class of cancer drugs, as well as a drug treating ADHD, made the list on the basis of potential signals of health risks.