Soccermom - here is an answer from my source. Please don't misinterpret this as my trying to argue with you. I am merely a messenger.
“Yes, the info did come off the FDA site, but this is just a letter from Wyeth-Ayerst that the FDA posted. This is not the FDA saying anything. This is just the FDA posting the Wyeth-Ayerst letter on their (FDA) website.
We didn’t state, “… it is the same as taking Phen Pro.”
We said, “The same thing could be said about prescribing phentermine with Prozac.”
What we did is compare the Ionamin letter to the Plegine letter:
Both of these letters were posted on the FDA site.
Both of these letters were written by the manufactures
(Wyeth-Ayerst for Plegine & Mediva for Ionamin).
Both manufactures had comments about concomitant use/coadministration/monotherapy …
Wyeth-Ayerst stated –
“The safety and effectiveness of the combined use of Plegine with other anorexigens in the treatment of obesity have not been established, and there is no approved use of these products together in the treatment of obesity. Plegine is approved only as a single agent for short-term use (i.e., a few weeks).”
“Phendimetrazine is not indicated for concomitant use with any other anorexigenic drug. Wyeth-Ayerst does not recommend such concomitant use and does not know of any adequate and well-controlled studies demonstrating the safety and effectiveness of these drugs when used in combination.”
Mediva stated –
“IONAMIN Capsules are indicated as monotherapy only. There are no data to support the safety and/or efficacy of combination therapy with phentermine and any other drug products for the treatment of obesity, including serotonin reuptake inhibitors (e.g., fluoxetine, sertraline, paroxetine). The coadministration of these agents is not recommended.
Both manufacturers had something to say about long-term use …
“Phendimetrazine is not indicated for long-term use. The labeling clearly states that it is indicated only for short-term use of a few weeks.”
“At the present time, the long-term safety and efficacy of IONAMIN Capsules have not been systematically evaluated, and long-term use of IONAMIN Capsules is not recommended”.
Both manufactures had reports or were aware of their drugs being connected to a side-effect/adverse reaction …
Wyeth-Ayerst stated, “There have been reports of PPH and valvular irregularities in users of Plegine (phendimetrazine tartrate tablets).
Mediva stated, “Medeva is aware of only a few isolated case reports of PPH possibly associated with phentermine monotherapy over the last 38 years.”
In both cases the manufacturers recommend against it due to findings in studies or from some source!
In fact here it is again:
“The safety and efficacy of IONAMIN Capsules in patients with existing valvular dysfunction and/or heart murmur, in whom the influence of increased sympathomimetic activity may be undesirable, have not been established, and its use in such patients cannot be recommended.”