April 11, 2019
Women taking “the Pink Viagra” can now drink (with precautions)
The FDA has modified the safety warning regarding alcohol use in patients taking flibanserin (brand name Addyi®).
Flibanserin is an FDA-approved medication for the treatment of premenopausal women with acquired,
generalized hypoactive sexual desire disorder (see https://simpleandpractical.com/flibanserin-addyi/). The media has sometimes referred to it as the “Pink Viagra.”
Before the change: Cases of severe hypotension and syncope had been reported when flibanserin and alcohol were taken together. So, when flibanserin was first approved by the FDA in 2015, it carried a boxed warning stating that alcohol must be avoided by women taking flibanserin. The clinician prescribing the flibanserin was required to counsel the patient, using a Patient-Provider Agreement Form, about the increased risk of severe hypotension and syncope and about the importance of not drinking alcohol while taking flibanserin. The pharmacist was also required to counsel the patient about not drinking alcohol while taking flibanserin.
After the change: The FDA has said that the product label should be changed “to clarify that there is still a concern about consuming alcohol close in time to taking Addyi but that it does not have to be avoided completely.”
According to the FDA’s press release (linked to below), postmarketing trials showed that “the risk of severe hypotension and syncope was reduced when women who consumed up to two alcoholic drinks waited at least two hours before taking Addyi.”
The FDA’s press release notes that “women should discontinue drinking alcohol at least two hours before taking Addyi at bedtime or to skip the Addyi dose that evening. Women should not consume alcohol at least until the morning after taking Addyi at bedtime.”
March 20, 2019
First drug approved by the FDA specifically for postpartum depression
Wow! Two new drugs approved by the US Food and Drug Administration (FDA) for depressive disorders in the same month! What is even more interesting is that both of these have pharmacological effects that are different from the antidepressants that we have been prescribing for decades. On March 5, 2019, the FDA had announced the approval of esketamine (brand name Spravato). Yesterday, the FDA announced the approval of brexanolone (brand name Zulresso) injection for intravenous use for the treatment of postpartum depression.
Note that this is the first medication that has been approved by the FDA specifically for the treatment of postpartum depression.
What is so special about brexanolone? Not that it is more effective than other antidepressants but that it works very quickly–in just a couple of days–so that, if it works, the mother could potentially be back quickly with her baby and with less or no depression.
One limitation is that brexanolone will have to be given as a continuous intravenous infusion over 60 hours, that is, 2.5 days. Also, just like esketamine, brexanolone will also carry a Boxed Warning and will have to be prescribed through a special Risk Evaluation and Mitigation Strategy (REMS) program. What this means is that it will only be available at health care facilities that have been specifically certified through the brexanolone REMS program and the patient’s information will have to be registered with the REMS program before the treatment is given. Why? Why is a special REMS program needed? Because there is a concern that excessive sedation or sudden loss of consciousness can occur while the intravenous injection of brexanolone is being given. Because of this risk, patients will have to be carefully monitored during the infusion and continuous pulse oximetry monitoring will have to be done (which is easy to do, of course). Also, while the infusion is being given, the mother will have to be supervised while interacting with her children.
Other than possible sedation and loss of consciousness, other side effects reported with brexanolone were dry mouth and flushing.
Subscribers to Simple and Practical Mental Health will receive brief summaries about what brexanolone is, how it works, how well it works, and so on.
March 5, 2019
FDA approves esketamine nasal spray (brand name Spravato) for “treatment-resistant depression”
The U.S. Food and Drug Administration (FDA) announced today that it has approved esketamine nasal spray (brand name Spravato) for marketing in the US. Here are some basic details about this medication:
– What is esketamine? It is one of the two enantiomers in the medication ketamine, which has been available in the US since 1970 and is FDA-approved for use as a general anesthetic.
– Esketamine nasal spray is approved for the treatment of major depressive disorder in persons who have taken other antidepressant medications but have not benefited from them, so-called “treatment-resistant depression.”
– It is approved not for monotherapy but for adjunctive use along with an oral antidepressant medication.
– It is approved for use in adults only
– Not everyone will be able to prescribe esketamine nasal spray. Similar to medications like clozapine and flibanserin, esketamine nasal spray will only be available by prescription from clinicians registered under a Risk Evaluation and Mitigation Strategy (REMS) program. This is because serious adverse events can occur due to sedation and dissociation caused by esketamine and due to the potential for abuse.
– The manufacturer of Spravato is Janssen Pharmaceuticals, Inc., a division of Johnson & Johnson.
– Members of Simple and Practical Mental Health will receive a detailed review of this medication, the research behind, the potential risks, and so on.
The FDA’s announcement is available at the link below:
The full Prescribing Information is available at the link below:
Disclosure: Dr. Mago bought some J&J stock (less than $7000 worth) and, as in almost all his investments, has lost money on it! 🙂 He does not have any other association, financial or otherwise, with Janssen Pharmaceuticals, Inc, or its parent company, Johnson & Johnson.
Feb 13, 2019
Esketamine nasal spray on verge of being approved by the FDA
The FDA’s Psychopharmacologic Drug Advisory Committee and Drug Safety and Risk Management Advisory Committee
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