Abbott Laboratories
200 Abbott Park Road
Abbott Park, Illinois 60046
May 15, 2006
Dear Healthcare Professional,
Due to circumstances outside of company control, Abbott Laboratories expects to have a shortage of our Mivacron® (mivacurium chloride) Injection (NDA 20-098) beginning in late May, 2006. Despite every effort to return this product to the market in a timely manner, it has become clear that the process timeline and competitive environment will prohibit a successful return. As a result, once current inventories are depleted, we do not anticipate availability of new inventory.
Abbott regrets any inconvenience that this product shortage may cause.
While we understand that ideal alternative therapies are limited, we would like the opportunity to help you manage through this inventory shortage. Your Abbott representative has information about another member of our NMB portfolio, Nimbex® (cisatracurium besylate) Injection, which may aid you in determining alternative therapy options for your patients. Additionally, all customers will be eligible for a 5% discount on all 5mL Nimbex purchases (direct from Abbott only) beginning June 1st through December 31st, 2006. Please contact your Abbott representative for additional details or to place an order.
If you or your colleagues have any medical questions regarding this letter, please contact us
at 1-800-633-9110.
Sincerely,
Elizabeth Holland
General Manager, Abbott Anesthesia
Please see the following for Important Safety Information.
Please see accompanying full Prescribing Information for Mivacron® (mivacurium chloride) Injection and Nimbex® (cisatracurium besylate) Injection.
Indication
Mivacron® (mivacurium chloride) Injection is a short-acting neuromuscular blocking agent indicated for inpatients and outpatients as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
Important Safety Considerations
Mivacron is not indicated for rapid sequence or emergency intubation of the trachea
The most commonly reported adverse reaction in clinical trials was flushing (16%)
- Less than 2% of flushing episodes after 0.15 mg/kg resulted in hypotension (which required no treatment)
- Less than 1% of these episodes resulted in bronchospasm (which was easily treated)
- Histamine release is related to speed and dose of administration
Less than 1% incidence of hypotension, cardiac arrhythmia, bronchospasm, wheezing, hypoxemia, urticaria, erythema, dizziness, and muscle spasm
Caution should be exercised in administering Mivacron to patients with clinically significant cardiovascular disease and patients with any history suggesting a greater sensitivity to the release of histamine or related mediators
Do not use Mivacron in patients allergic to mivacurium chloride or other benzyl-isoquinolinium agents
Use with great caution, if at all, in patients who are homozygous for the atypical plasma cholinesterase gene
Indication
NiMBex® (cisatracurium besylate) Injection is an intermediate-onset/intermediate-duration neuromuscular blocking agent indicated for inpatients and outpatients as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation in the ICU.
Important Safety Considerations
Not recommended for rapid sequence endotracheal intubation.
No adverse event was reported in ≥1% of the OR clinical trial patients treated with NiMBex.
Common adverse events in OR clinical trial patients were bradycardia (0.4%), hypotension (0.2%), flushing (0.2%), bronchospasm (0.2%), and rash (0.1%).
Use of NiMBex in the ICU for longer than 6 days has not been studied.
Adverse experiences were uncommon among the 68 ICU patients who received NiMBex in conjunction with other drugs in US and European clinical studies. One out of 68 patients experienced bronchospasm. In one study of 28 patients, there were 2 reports of prolonged recovery compared with 13 reports among 30 patients administered vecuronium.
Please see accompanying full Prescribing Information