Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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FDA Not Seeing a Link Between Zyprexa Relprevv & Deaths of 2 Schizophrenia Patients

FDA has concluded a review of a study undertaken to determine the cause of elevated levels of the injectable schizophrenia drug Zyprexa Relprevv (olanzapine pamoate) in two patients who died. The study results were inconclusive. FDA is unable to exclude the possibility that the deaths were caused by rapid, but delayed, entry of the drug into the bloodstream following intramuscular injection. The study suggested that much of the drug level increase could have occurred after death, a finding that could explain the extremely high blood levels found in the two patients who died 3 to 4 days after receiving injections of appropriate doses of Zyprexa Relprevv. On the basis of all of the information reviewed (refer to the Drug Safety Communication for a full data summary), FDA is not recommending any changes to the current prescribing or use of Zyprexa Relprevv injection at this time. Patients should not stop receiving treatment without first talking to their health care professionals.


BACKGROUND: Treatment with Zyprexa Relprevv may help improve the symptoms of schizophrenia, which include hearing voices, seeing things that are not there, and being suspicious or withdrawn. The labeling for Zyprexa Relprevv carries a boxed warning, FDA’s most serious type of warning, for post-injection delirium sedation (PDSS). This is an update to the MedWatch safety alert issued on June 18, 2013.


RECOMMENDATION: Patients should read the Medication Guide that comes with the Zyprexa Relprevv prescription each time before they get an intramuscular injection, as there may be new information. Patients receiving Zyprexa Relprevv or their caregivers should immediately report symptoms of PDSS to a health care professional.

Pharma Guy's insight:


Interesting and suspicious that "much of the drug level increase could have occurred after death." How does that happen?

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Drug Industry Document Archive - Off-Label Marketing of Zyprexa

Drug Industry Document Archive - Off-Label Marketing of Zyprexa | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The documents in this collection are a portion of those produced in a class action court case that alleged Eli Lilly withheld data on adverse effects such as weight gain and diabetes and participated in off-label marketing of the drug. The documents were first obtained and made public in 2006 by PsychRights.org, expert consultant Dr. David Egilman, attorney Jim Gottstein, and journalists Philip Dawdy and Alex Berenson. After a legal battle over public access, the documents were un-sealed and allowed to remain in the public domain.  These documents highlight Lilly's marketing strategy of influencing key opinion leaders and its attempts to control the research, the scientific literature and regulatory product labeling to minimize information on adverse effects.

Pharma Guy's insight:


This database of documents is interesting, especially in light of FDA's new draft guidance on the distribution of off-label reprints. For more on that, read 

FDA Issues More Guidance Regarding Distribution of Reprints. Is It "Fair and Balanced?"
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