I received in today's mail a letter for physicians from Vivus describing "important changes to the prescribing information for MUSE". The letter is dated September, 1997, no day given and is signed by Alfred P. Spivack, M.D., Director, Medical Services. Here are excerpts. I have tried to keep the same format as the letter but forgive me if it doesn't show up that way on SI.
The second paragraph says:
<<<
Our current prescribing information contains the following warning: "Because of the potential for symptomatic hypotension and syncope, which occurred in 3% and 0.4%, respectively, of patients during in-clinic dosing, MUSE titration should be carried out under medical supervision." Our Medical Services Department has received three reports of patients who were discharged from clinic after MUSE administration and had syncopal episodes shortly thereafter. We have therefore provided additional guidance in the warning section of our Package Insert:
"During post-marketing surveillance syncope occurring within one hour of administration has been reported. Patients should be cautioned to avoid activities, such as driving or hazardous tasks, where injury could result if hypotension or syncope were to occur after MUSE administration."
>>>
There is a paragraph reminding prescribing physicians that titration should be done under medical supervision. I guess that means that until the proper dose is determined the patient will have to have someone drive them home from the first few appointments. The letter goes on to say:
<<<
The revised Package Insert also mentions a potentially important drug-drug interaction (see new text in italics):
"Because there are low or undetectable (<2 picograms/mL) amounts of alprostadil found in the peripheral venous circulation following MUSE administration, systemic drug-drug interactions with MUSE are unlikely. (Italics)Although formal studies have not been conducted, the concomitant use of MUSE and anti-hypertensive medications may increase the risk of hypotension. It is therefore advised that caution be used in the administration of MUSE to individuals on anti-hypertensive medication.(End Italics-sorry, SI doesn't seem to display properly) In addition, the presence of medications in the circulation that attenuate erectile function may influence the response to MUSE"
>>>
And then two paragraphs later:
<<<
We have also added a new paragraph at the end of the "adverse reactions, home treatment" section:
"Other drug- related side effects observed during in-clinic titration and home treatments include swelling of the leg veins, leg pain, perineal pain, and rapid pulse, each occurring in <2% of patients."
>>>
This letter is addressed to health professionals and gives a number 1-888-345-6873 to call for further info. I don't know the investors' info number.
This really isn't new information. I was told much of this at the company sponsored meeting I attended in early April and heard about the rest at the AUA last spring. I posted a summary on this thread back then. My posting elicited a torrent of personal attacks so I now feel somewhat vindicated. The longs are even more in charge of the thread now, so I will post this and duck back to lurking.
By the way, I hold no position with regard to the stock. My position regarding the drug, based on my continuing clinical experience, is still that this drug works well for some patients but is a waste of time and money for at least half of patients. However, people are always hoping to find a solution and so Vivus is selling all it can produce. Until there is an alternative. |
