Hi Rd389

There are many drugs that are currently banned in US and safe in other countries.
I found a weblink that tells about 35 drugs that are recalled and not considered safe in US although they were approved by FDA initially.

https://prescriptiondrugs.procon.org/view.resource.php?resourceID=005528

Hi Rd389

I found this link https://prescriptiondrugs.procon.org/view.resource.php?resourceID=005528 which tells about the drugs that are banned by FDA in US.

Hi Rd389

In addition to the list above, it should be noted, that not only is there differing regulations on pharmaceuticals, there are also differing regulations on medical devices. And it is interesting, but there are other parts of the world that are stricter on some things than the United States. As an example, I worked at a small med device company last year that worked primarily in lubricants and ultrasound couplants. Regulations in South Korea and certain Asian countries were far stricter depending on the intended use of the product. South Korea is known for being extremely strict on things like cosmetic products, which can fall under the prevue of the FDA.

I think it is fine that US is doing that and the only reason is because it is really easy to get things passed in countries like India. From experience, as long as you pay people money there, you can get bills, laws or devices pass. In addition, US is also leading medical device countries and that's most likely because of its FDA regulations.

http://www.sciencedirect.com/science/article/pii/S2452302X16300638 Many of the process needed to approve drugs in the USA made by the FDA are similar to those in Europe countries created by the EU, European Union. One main difference between the FDA and EU is that after clinical trails the FDA drugs approvals follow a centralized path but in EU approval can occur through 4 different paths. These paths in the EU depend on the nature of the drug and the preference of the manufacturer. Both the FDA and EU have it’s pros and cons when passing drugs. This link provides examples of drugs that are legal in the US but are illegal and have been removed from European market due to further research after the drug was approved. http://www.newsmax.com/Health/Headline/drugs-medications-FDA-banned/2014/05/14/id/571315/ Avandia and Actos are both diabetic mediations that are used in the USA and banned in other countries. Avandia has been proven to increase the rate of heart failure by 64% after the patient uses it for 7 years and Actos has shown an increased risk of bladder cancer. While we think that the FDA is protecting us in the USA, the FDA is actually one of the most relaxed/easy regulatory bodies in the world. Which should make us question is the FDA really has our best interested in mind or if they are being pressured/influenced by industry to make a more “lenient” regulatory process in order to get more things into market and make profit.

Other than India having drugs that allow drugs that are banned in the US, there are other drugs that the US has banned but other countries do not. For instance, flunitrazepam (Rohypnol - brand name) is also banned in the United States but there are more than 50 countries around the world that still authorize the use and distribution of this drug. It’s most common in Europe and Mexico for problems like insomnia and for general anesthesia. They also use this drug for withdrawal symptoms of drugs like cocaine. It is also available over the counter in South America. In the US, we are not allowed to sell it or prescribe it. Since this drug became a huge recreational drug, it was banned. The US also believes there are many other health risks and dangers involved with the abuse of this drug and want to keep this drug off the streets for the safety of the people. However, in most cases, there are more drugs that are banned in other countries that are not banned in the US. From a list of drugs, about 67% of those drugs were banned in the US but about 79% were banned internationally. The article states that phentermine was still being sold in the US but is banned in Sweden and the UK. Opioids is also another drug that the US still allows for pain medication but is banned in many other countries.

Link used for my post:

Analgin drug is from the group of pyrazolones. It contains an active compound called metamizole. It works by reducing the pain and fever, used in the treatment of sever pain and severe stomach pain . Analgin is just one among many such drugs—sold in India, banned elsewhere. Thioridazin continues to be available in India but also banned in US because its side effect causes eye damage,arrhythmia and neuroleptic malignant syndrome where the patient suffers from high temperature and muscle rigidity. There are many other like Disprin, Propoxyphene (Opioid Painkiller) that are available in India but banned in US.

Oxyphenbutazone is a nonsteroidal anti-inflammatory drug. It was withdrawn from markets worldwide in mid-1980 due to bone marrow suppression and Stevens-Johnson syndrome. It has been used by mouth in rheumatic disorders such as ankylosing spondylitis, osteoarthritis and rheumatoid arthritis but its use is no longer considered as there is risk of severe hematological adverse effects. Its combination with any other drug is banned in India though it is available as a single drug. Nitrofurantoin is an antibiotic used to treat bladder infection, it causes liver problems. It is banned in US but it is still sold in other countries.

One drug that was huge in the early development of modern FDA medicinal regulations was Thalidomide. This drug was popular in the 1960's and was marketed for morning sickness in pregnant women. Unbeknownst at the time, the enantiomer of the drug was extremely teratogenetic. The FDA refused this drug even though it was approved by countries in Europe. Because of the findings of birth defects linked to this drug, the FDA tightened its security regarding drugs.

Alipogene tiparvovec (Glybera) is a drug synthesized to counter Lipoprotein lipase deficiency (LPLD), a genetic disorder that is known to cause pancreatitis. It was meant to be a means of gene therapy for individuals with LPLD. This drug was approved to be used in Europe in 2012 but it was not approved for use in US. There were plans to make it approved but plans to expand the market to the US were dropped. This drug was known as the "first gene therapy" of the Western Wrold and was the most expensive medicine in the world at the time it was marketed. The cost of the drug made it very uncompetitive in the marketplace. The developer of the drug, Unicure, focused only on selling it to European countries and not the US because there were too few patients.

This is a good point. It is good that the FDA is so careful and protects us, but sometimes it may be overdone. For example, stem cell treatments. They are non FDA approved, but are legal in other countries such as Panama. Stem cells can be inserted into the spine of patient with MS or Cerebral palsy, and regrow where the dead nerve cells are. The results have been shown to be very promising.

The main reason the stem cells therapy is not FDA approved is for political reasons surrounding stem cells and pro-life movement. Also, even if the stem cells are drawn from the patients own body the FDA considers it a drug and requires advanced testing.