FDA Adds Generic ADHD Extended-Release Tablets to Watch List
The FDA has added certain methylphenidate hydrochloride extended-release tablets (generic Concerta) to its quarterly Watch List because of reported lack of therapeutic effect, possibly related to product quality issues.
This does not mean that the FDA has concluded that the drug has the listed risk. Being added to the Watch List means that the FDA has identified a potential safety issue through the FDA Adverse Event Reporting System (FAERS) and is continuing to evaluate the issue to determine whether further action is needed. If the FDA concludes that there is a causal relationship between the drug and the related risk, it may take a variety of actions including requiring changes to the labeling of the drug, requiring development of a Risk Evaluation and Mitigation Strategy (REMS), or gathering additional data to better characterize the risk.
The FDA emphasizes that it is not suggesting that doctors should stop prescribing watch list drugs or that patients should stop taking the drugs. Patients who have questions should contact their health care provider. FDA is continuing to evaluate the watch listed drugs and will issue additional public communications as appropriate.
 FDA Surveillance "Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) between October - December 2013," 04/21/2014.
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