Common ADHD medication Vyvanse has been recalled by the Food and Drug Administration, US, the last week. As per FDA, the lots of a prescription ADHD medication failed dissolution specification. As a result Sun Pharmaceutical Industries of New Jersey recalled bottles of lisdexamfetamine dimesylate capsules, which is a generic version of Vyvanse that was sold across the country. the recall was initiated on October 28,and was categorized under Class II risk level by the FDA on October 30. As per FDA, a Class II recall means that the recalled medication “may cause temporary or medically reversible adverse health consequences,” however, the risk of any serious health consequences is low. Which Medications Are Recalled?Here is how you can check the lot number to know whether the medication you have in your cabinet has been recalled:Sun Pharmaceutical Industries recalled the medication due to “failed dissolution specifications,” meaning the drug did not dissolve as expected in laboratory settings, which could make it less effective.What Should You Do?While there is no specific instruction for what the consumers should do as there is no official press release by the manufacturer, however, speak to your doctor before stopping your ADHD medications as an abrupt stop could lead to withdrawal symptoms. What Is A Dissolution Test?This test is conducted to determine the compliance of the drug with the dissolution requirements for dosage forms to be administrated orally.Dissolution specifications are quality control limits for drug products that define the acceptable amount of drug substance that must dissolve in a specified time under laboratory conditions. The test also ensures batch-to-batch consistency and predicts how a drug will be released in the body, providing a surrogate measure of clinical performance.The specifications are based on data from batches, which are used in clinical trials and are then guided by the drug's properties and the dosage form. They vary depending on the drug release types, which could be categorized under three kinds:Immediate Release (IR)Extended Release (ER)Delayed Release (DR)What Does FDA Say About This Recall?As per the FDA, Class I recalls are the most serious, this is where there is a reasonable probability that using or being exposed to the recalled drug could cause serious health consequences to the customer. This recall involves removing the drug from the market and are conducted at consumer level.Class II recall however could cause temporary health consequences but the probability of health issue is remove. FDA notes that "these recalls are generally conducted at the retail level, and patients and consumers can continue using the medicine unless otherwise directed by the recalling company or FDA."FDA says that for class II or class III recalls, consumers may "generally continue taking the medicine unless the recalling company provides other instructions".
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