Originally posted by barondla Singular, Belviq, Zantac, Xeljanz, etc. All still in litigation.
Thanks,,
barondla
These are all different types of issues. The ranitidine issue had to do with NDMA contamination. It isn't clear to me if this is a manufacture issue (several other medications were withdrawn for contamination with NDMA in 2020) or a metablizing issue. The medication was completely taken off the market when the issue was identified.
Singulair is a medication that is relatively safe. It actually isn't used frequently (probably more so, now that it is generic), but is often added to antihistamines/inhaled corticosteroids for difficult to treat asthma. Personally, I am glad that it is still on the market -- I think the point of the warnings was not to use the medication for mild cases and that doctors warn patients about possible side effects, as these resolve rapidly with discontinuation.
The Belviq situation was a difficult one. A five year trial showed slight increase risk of cancers (7.7 percent in Belviq group versus 7.1 percent in placebo group). This is the sort of thing that requires large trials for extended periods of time to identify and it is not surprising that it took time to ferret it out. Once the data was in, the FDA acted quickly and pulled the medication.
I actually think the FDA does a pretty good job of approving medications and doing post hoc analysis and adding warning labels to medications as issues come up. Medications with serious side effects should still be allowed on the market, if they are there for life threatening diseases. On the other hand, they shouldn't be used for mild, self-limited diseases.
If the FDA falls down, it is in monitoring off shore generic makers. They currently do inspections every five years and a lot can happen in that time. This is probably not frequently enough to identify issues with generics, but it is the level of funding that they get.
---------- Post added 08-19-21 at 05:57 AM ----------
Originally posted by barondla This is bigger than Covid. People see lots of FDA approved drugs recalled. It is easy to see why many don't trust the FDA. Many feel they should have caught most of these problems before approval. Everyone isn't a doctor or scientist and aren't going to research all these drugs. But, they will see the TV commercials.
The CDC, and other world health organizations have similar problems. Their recommendations have been all over the map. People have a difficult time placing a lot of confidence in them. The science may be great - the presentation has been very sloppy.
Thanks,
barondla
COVID has been a really tough situation. Recommendations now versus a year and a half ago have changed due to studies showing what things have worked and what haven't. Early on, the CDC didn't recommend wearing masks unless you felt sick and then you were really supposed to be in isolation. This was because they didn't think there was much asymptomatic spread and there was a shortage of personal protective equipment for health care workers. Later, it turned out that probably at least 50 percent of the spread of COVID is done by presymptomatic and asymptomatic individuals and there was no longer a mask shortage and they changed their recommendations.
I think the CDC is ready to recommend that people get COVID vaccine boosters at 8 months. The WHO thinks that they aren't needed yet and it will decrease world supply of vaccine. The issue is that we are seeing more breakthrough infections with COVID, but for the most part they are relatively mild disease, not requiring hospitalization. Whether this truly warrants a booster or if we should wait a little longer probably depends on your perspective.
As far as medications, it takes a lot of post-hoc analysis and monitoring to identify some of the issues in them. It would be nice, I suppose, to have trials lasting ten years that involved a million patients. The reality is that no one could afford such a trial and it would take too long to get medications to the people who need them. What ends up happening is a few thousand people are in the Phase 3 trial for 2 to 3 years. This is enough to identify most major, common side effects, but there are still plenty of things that can crop up down the line.