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(pentobarbital sodium injection, USP) in the executio - Lundbeck

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<strong>Lundbeck</strong>'s position regard<strong>in</strong>g misuse of Nembutal® CII Sodium Solution(<strong>pentobarbital</strong> <strong>sodium</strong> <strong><strong>in</strong>jection</strong>, <strong>USP</strong>) <strong>in</strong> <strong>the</strong> <strong>executio</strong>n of prisonersThe company is opposed to <strong>the</strong> use of its products for <strong>the</strong> purpose of capitalpunishment. Use of our products to end lives contradicts everyth<strong>in</strong>g we’re <strong>in</strong>bus<strong>in</strong>ess to do – provide <strong>the</strong>rapies that help improve people’s lives.<strong>Lundbeck</strong> makes <strong>pentobarbital</strong> available solely for its approved uses, one ofwhich <strong>in</strong>cludes status epilepticus. This serious and life threaten<strong>in</strong>g emergencyepilepsy causes approximately 42,000 deaths a year <strong>in</strong> <strong>the</strong> U.S. – a conditionthat can be helped with treatments such as <strong>pentobarbital</strong>. Clearly, use of thisproduct to carry out <strong>the</strong> death penalty <strong>in</strong> US prisons falls outside its <strong>in</strong>tended use.We have vetted a broad range of remedies - many suggested dur<strong>in</strong>g ongo<strong>in</strong>gdialogue with external experts, government officials, and human rightsadvocates. After much consideration, we have determ<strong>in</strong>ed that a restricteddistribution system is <strong>the</strong> most mean<strong>in</strong>gful means through which we can restrict<strong>the</strong> misuse of Nembutal. As such, <strong>the</strong> company announced on July 1, 2011 thatNembutal will be supplied exclusively through a specialty pharmacy drop shipprogram that will deny distribution of <strong>the</strong> product to prisons <strong>in</strong> U.S. statescurrently active <strong>in</strong> carry<strong>in</strong>g out <strong>the</strong> death penalty by lethal <strong><strong>in</strong>jection</strong>. The companynotified its distributors of <strong>the</strong> plan <strong>in</strong> late June.The new distribution program ensures that hospitals and treatment centers willcont<strong>in</strong>ue to have access to Nembutal for <strong>the</strong>rapeutic purposes. Under <strong>the</strong>program, <strong>Lundbeck</strong> will review all Nembutal orders before provid<strong>in</strong>g clearance forshipp<strong>in</strong>g <strong>the</strong> product and deny orders from prisons located <strong>in</strong> states currentlyactive <strong>in</strong> carry<strong>in</strong>g out death penalty sentences.Prior to receiv<strong>in</strong>g Nembutal, <strong>the</strong> purchaser must sign a form stat<strong>in</strong>g that <strong>the</strong>purchase of Nembutal is for its own use and that it will not redistribute anypurchased product without express written authorization from <strong>Lundbeck</strong>. Bysign<strong>in</strong>g <strong>the</strong> form, <strong>the</strong> purchaser agrees that <strong>the</strong> product will not be madeavailable for use <strong>in</strong> capital punishment.We will cont<strong>in</strong>ue to urge states <strong>in</strong> <strong>the</strong> U.S. to refra<strong>in</strong> from us<strong>in</strong>g <strong>pentobarbital</strong> for<strong>the</strong> <strong>executio</strong>n of prisoners as it contradicts everyth<strong>in</strong>g we stand for as acompany.


Important Safety Information NEMBUTAL is contra<strong>in</strong>dicated <strong>in</strong> patients with aknown hypersensitivity to any barbiturate, manifest or latent porphyria.Barbiturates <strong>in</strong>clud<strong>in</strong>g NEMBUTAL may be habit form<strong>in</strong>g. Abrupt discont<strong>in</strong>uationmay result <strong>in</strong> withdrawal symptoms, <strong>in</strong>clud<strong>in</strong>g delirium, convulsions and possiblydeath. Too rapid of an <strong>in</strong>travenous adm<strong>in</strong>istration may cause respiratorydepression, apnea, laryngospasm, or vasodilation with fall <strong>in</strong> blood pressure.Concomitant use of alcohol or o<strong>the</strong>r CNS depressants may produce additiveCNS depressant effects. Barbiturates should be adm<strong>in</strong>istered with caution, if atall, to patients who are mentally depressed, have suicidal tendencies, chronic oracute pa<strong>in</strong>. Barbiturates can cause fetal damage and <strong>in</strong>fants may havewithdrawal symptoms if mo<strong>the</strong>rs receive barbiturates. Withdrawal symptomsoccur <strong>in</strong> <strong>in</strong>fants born to mo<strong>the</strong>rs who receive barbiturates dur<strong>in</strong>g <strong>the</strong> last trimesterof pregnancy. Prolonged treatment with barbiturates should be monitored.The most commonly reported adverse event (>1 <strong>in</strong> 100 patients) is somnolence.For more <strong>in</strong>formation, please see Full Prescrib<strong>in</strong>g Information available atwww.<strong>Lundbeck</strong><strong>in</strong>c.com or www.<strong>Lundbeck</strong>SHARE.com.

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