[bunged up]

I assume that the withdrawal of a drug released to the market occurs from time to time. I also assume that the circumstances are quite like those surrounding Lotronex (I.e Many satisfied patients, and then over s hort period of time unexplained or suspicious deaths linked to the use or misuse of the medication). I am just wondering whether the same sort of process usually occurs, the devastation of satisfied patients, the grief of those who feel that a drug has caused the death of a loved one, the seeming unfeeling FDA refusing to bend to the will of those who have been helped by the medication.. and am also wondering whether there is anything to be learned from the withdrawal of the other drugs..As an aside, I was prescribed Cisapride, used it ONCE, and ended up in the ER with chest pains. This was just before the drug was withdrawn. Anyway, just wondering if this whole thing is normal when a drug is withdrawn.

 

[Kathleen M.]

Most of the time when a drug is withdrawn there are other drugs that are designed to treat the same disorder. Usually there are a few people who find that only that particular drug of the constellation of drugs available is helpful or is the only one that doesn't cause unwanted side effects.With Lotronex there isn't anything else out there that people can switch to, (there are other drugs that can be used off label for IBS that can be quite effective but most patients and doctors are not aware) thus there is a lot more noise about it.If the only disease-specific angina, ulcer, arthritis or asthma med was being pulled you'd see the same thing, but with those their are usually any number of alternatives for the vast majority of patients once the medication is pulled.K

 

[Pat B!]

When there was a worldwide push to get ozone-depleting aerosols containing CFCs off the market, it was realized that asthma medications would have to be exempted due to the fact that they are necessary for some people literally to LIVE. Under the "Montreal Protocol" it was agreed that CFC-containing asthma medications would be exempted from this ban (permitted to remain on the market) until a CFC-free asthma medication was introduced.3M had a MAJOR program underway to be first to market with a non-CFC asthma medication, and about four years ago they succeeded. At which time they asked the FDA to honor the Montreal Protocol and pull the other CFC-containing medications off the market.Well, the makers of the other products all put up a tremendous fuss - went to Congress and said "Hey - it's a lot tougher to develop a non-CFC formulation than we thought it would be! We need more time!" They put a lot of $$$ into lobbying efforts and exerted some pretty significant political clout, and FDA did an about turn on their previous position.They announced - and this was AFTER 3M had come to market with their non-CFC product - that NOW there had to be THREE non-CFC drugs with similar effectiveness before the CFC-containing formulations would be banned. So that bought the other companies more development time. Good news for them, unhappy news for 3M.That just happens to be a similar scenario that I know about.