March 3, 2001 - Voluntary Market Withdrawal - Adverse Drug Reaction
Re: RAPLON (rapacuronium bromide) for Injection
NDC 0052-0490-15 (100 mg)
NDC 0052-0495-16 (200 mg)
NDC 0052-0490-86 (100 mg sample)
In light of the recent safety issues raised, regarding RAPLON and its possible association with the occurrence of bronchospasm, we are voluntarily withdrawing the product. We feel a strong responsibility to the clinicians that not only use our products, but also entrust the lives of their patients on the reliability of these products. Our primary concern and goal in this endeavor is to ensure the safety of each patient. The Food and Drug Administration (FDA) was notified immediately of this decision and the planned market withdrawal of all unused product.
The RAPLON package insert lists bronchospasm as an adverse event which occurred in 3.2% of patients in premarketing clinical trials. We have now received reports of several serious adverse bronchospasm events including a few unexplained fatalities. In each of these cases the cause is unknown, as there were multiple drugs administered and other conditions present. From our surveillance of postmarketing spontaneous reporting, it appears that the incidence is within labeling, however, the severity of these events, up to and including mortality that has been reported postmarketing, was not seen in clinical trials. These reports are made voluntarily from a population of unknown size and the exact frequency can not be determined.
Please examine your stock immediately to determine if you have any RAPLON in your inventory. If so, discontinue using the material and have your hospital pharmacy or wholesaler promptly return via parcel post to our West Orange facility: Attn: RETURN MARKET WITHDRAWAL.
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