3 Recent Safety-Related Medication Labeling Changes
When a medication becomes FDA approved and is used in a diverse patient population, previously unreported adverse effects often emerge. This is commonly due to the fact that clinical trials are conducted in relatively small groups compared to the general population. Participants also typically fit a specific set of characteristics required for the trial period.
Based on adverse effect reports they’ve received, the FDA recently approved labeling changes for simvastatin (Zocor(R)), phenytoin (Dilantin(R)) and desloratadine (Clarinex(R)). Because it may affect the way these medications are prescribed and/or monitored in your practice, we’ve highlighted those updates here.
The previous labeling for simvastatin advised caution when prescribing doses of 20 mg or higher concomitantly with lipid-lowering doses of niacin in patients of Chinese descent. The revised labeling advises against prescribing any dose of simvastatin concomitantly with lipid-lowering doses of niacin, defined as 1 g/day or more, in patients of Chinese descent due to the increased risk of myopathy/rhabdomyolysis.
A statement was added to the labeling of phenytoin, warning that patients have experienced bradycardia and/or cardiac arrest while taking phenytoin. This has occurred in patients taking recommended dosages with therapeutic blood levels, as well as in patients with toxic levels. Cardiac arrest occurred primarily in patients with a history of heart disease.
The labeling for desloratadine previously listed seizures among the adverse effects reported in the post-marketing period, but did not indicate whether the seizures occurred only in patients with a prior seizure history or if patients without such a history were affected. The revised labeling clarifies this by noting that seizures have been reported with desloratadine use in patients with and without a prior history of seizures.
Updates like these from the FDA occur regularly as medications become more widely prescribed. For this reason, reporting suspected adverse effects to the FDA is extremely important and labeling changes should be closely monitored. All providers are highly encouraged to report suspected adverse drug effects via the FDA’s MedWatch website.
If you are a healthfinch customer and would like any modifications to your prescription renewal protocol(s) as a result of these updates, please contact your healthfinch Customer Success Manager or email@example.com.
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