Concerta Placed on FDA’s Watch List

Concerta Placed on FDA’s Watch List
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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
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.

ADHD Meds Linked to Priapism

FDA Warning & Label Change
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Methylphenidate, also marketed as Ritalin, has been noted to cause tics, heart problems, weight loss, and sleep problems. It has now been linked to a rare risk for priapism in males taking the stimulant for the treatment of ADHD according to the US Food and Drug Administration (FDA).

The FDA disclosed in a press release that the stimulant may in rare instances cause prolonged and sometimes painful erections (priapism). In light of this, the FDA has updated drug labels to alert the public to this rare but serious side effect which may lead to permanent penis damage. The FDA warns (similar to Viagra) that patients who take methylphenidate and develop erections lasting longer than 4 hours should seek immediate medical treatment to prevent long-term problems with the penis.

The FDA also warns that nonstimulant ADHD drugs like atomoxetine (Strattera) have also been associated with priapism in young children, teenagers, and adults. Priapism appears to be more common in patients taking atomoxetine than in patients taking methylphenidate, so one has to cautiously consider atomoxetine products as alternatives to Ritalin.