In 2019, Metformin, is a drug used to control high blood sugar in type-2 diabetes patients, was recalled by the FDA. FDA called the extended-release versions of the drug, not immediate-release versions that are more popular.
The recall was due contamination from extended release form of the drug by a carcinogenic substance but unfortunately in Middle East and gulf countries (Egyptian Drug Authority, Saudi Food and Drug Authority, United Arab Emirates FDA, etc.) it wasn’t withdrawn due to legislation and laws.
DO you guys know any drugs that are banned in US but not in Europe or other countries? And if yes, why was drug banned in USA but not in other countries?
Example: Cerivastatin is one of the drug that US banned manufactured by Bayer. Side effects of this drug include rhabdomyolysis (destruction of skeletal muscles). With this side effect, patients suffered from damage to muscles followed by kidney failure. Unfortunately, it is still available in India.
Quaalude or Methaqualone. It is a sedative and hypnotic drug. It has a lot of side effects such as dizziness, nausea, vomiting, diarrhea, abdominal cramps, fatigue, itching, rashes, sweating, dry mouth, tingling sensation in arms and legs, seizures, reduced heart rate, and slowed breathing (respiration). It can be deadly and used a lot back in the 70s usually with wine just like cocaine today. Its hole reason why its baned is that it was an abused substance with no regulation or standards but this should be the reason that it needs to be banned in my opinion. It should be banned because of its addictive nature and effects on the patient. Nevertheless, it is banned and we can be free from its negative effects.
Regulations in other countries are not as strict as the USA. It is much easier to get drugs approved that are not safe and have no benefit either. A drug that is banned in the USA but is available in other countries is pergolide (Permax), which was used in the treatment of Parkinson's disease. It was withdrawn from the US due to risks associated with heart valve damage. It was removed from the market in 2007 from the increased risk of valvular dysfunction. Unfortunately, it is saddening that other countries like the UK and Australia still use this drug for the treatment of Parkinson's disease even though it is very risky and unsafe. There is no excuse in using harmful drugs and having them approved by the law. There should be higher regulations in other countries for the safety of the people.
Pemoline is used in the treatment of attention deficit hyperactivity disorder, it is banned in the USA. It is still continued in India. It was banned in the USA because of its liver toxicity risk.
I can think of a few drugs that are banned in the US including angiotensin receptor blocker / heartburn medication Ranitidine (Zantac) was recalled in 2020 due to the presence of low levels of a contaminant NDMA and are no longer available in the US as a brand or OTC drug. The FDA is advising patients who were prescribed Zantac to stop taking this medication. The drug ranitidine is still available in Canada as an over the counter drug and prescription. Another drug banned in the US (federally) is schedule 1 narcotic cannabis yet it has been decriminalized in many states across the country and is legal in foreign jurisdictions.
Other countries including India, have certain drugs that are not banned. There drug laws and policies are different compared to the United States. Within the United States the safety and effectiveness of drugs is taken very seriously. They ensure that the benefits of the drug will outweigh the risk of negative effects with the benefit risk ratio. In other countries they typically do not have all of the resources that the United States has in terms of safety or other similar drugs that could put to use instead of those drugs that are banned in the United States.
When I thought about this question I immediately thought about the difference in drug regulation between the US and India. The US is known for having one of the most organized and regulated drugs governing bodies while India is known for not having any.
This is a journal article that goes more into detail.
http://www.ijper.org/sites/default/files/IJPER_44_1_12.pdf
This is is the Wikipedia page that outlines withdrawn drugs from countries around the world. Its a bit out of the scope of the prompt but it is very interesting to look at.
Pergolide is an ergo line-based dopamine receptor agonist used to treat Parkinson’s disease. It was approved for use in 1988. In around 2002, detrimental side effects started emerging in patients that took pergolide. Pergolide was causing serious damage to patients’ heart valves which were becoming leaky. The FDA announced a warning about the drug in 2003, and it was strengthened to a black box warning in 2006. The drug was officially taken off the market in 2007 in the US because of its serious damage to the heart valves. However, it is still on the market in other countries since every country has different regulations when it comes to drugs.
In addition to having difference in pharmaceuticals regulations Europe also has different regulations for medical device products. If anything after being in the industry for some time have came to realize the regulations of USA are a lot more lenient compared to other countries. Especially with the new MDR regulations that EU is gearing up for. For instance if you have supplier on your ASL, EU can go and audit them anytime so the company has to inspect the supplier adequately before using their products.
This is a topic that has come to my concern as well as you would think what's considered an unsafe product in one country would be consistent in others as well but that doesn't seem to be the case. For instance the FDA had to ban 6 artificial flavoring substances that were causing cancer in animals but only after a lawsuit was filed by the Center for Science in the Public Interest and other organizations. It was only banned due to the law but the FDA didn't accept that it posed any risk to public health and gave companies 2 whole years to remove the chemicals from their products instead of a more immediate resolution.
As we know politics can become a tricky area depending on who runs the government at hand and what their values are which could lead to some discrepancies on where the level of safety lies and what products are and aren't allowed in the market. In an attempt to standardize some of these practices the EU foresees many European countries at once and I believe one day integration between the FDA and EU could lead to even more standardization and equal treatment for patients and consumers.
There are many drugs and medical devices that are manufactured and sold in other countries that are currently banned in the US or not allowed to be manufactured in the US. The main reason for this is because the FDA has deemed the products unsafe, but this can also because the FDA does not think a product follows US regulations, which are much more strict than overseas. I know that one of the products my company made was just discontinued for production in the US because the FDA came into our facility and did not like how we described how we followed our regulations. They also did not like our quality systems documents for the product. Rather then spend time trying to correct the issues, the company has decided to discontinue production of this item in the US, but we are still allowed produce it in Germany because of the lower regulations. And Germany is still allowed to sell it in the US where it is used/ While this product has not showed to be harmful when used, this situation shows how sometimes the FDA is just more cautious then other regulatory bodies which is a large reason to why some drugs are banned here and not in other countries.
A drug that was banned in the US is aprotinin. It was used to reduce bleeding during complex surgeries. However, it showed increase in deaths form 4% to 6% and studies were shown to back it up. It was removed from the market in 2008. But in 2011 the makers of the drug, Bayer, were allowed to sell and market the drug in Canada and Europe. This is due to an expert advisory panel and European Medicine Agency stated that the research against the drug were flawed.
At present, one of the leading causes of death in the U.S. is believed to be adverse drug reactions. More than 20 million patients have taken at least 1 of the 5 drugs withdrawn from the market between September 1997 and September 1998. Seven drugs that were approved in 1993 and were withdrawn shortly later have contributed to 1002 deaths. A study in 2002, showed that out of the 548 drugs that were approved in the U.S. between 1975-1999, fifty-six (10.2 %) of them required a new black box warning or were withdrawn. Thus, it is very important that the consumer, as well as the practitioner, become aware of dangerous drugs. Since 1995 the List was divided into two separate issues, one focusing on pharmaceuticals and the other on chemicals, which are published in alternate years. The pharmaceuticals are further separated into monocomponent products, combination products, and group products. In the United States of America, The Center for Drug Evaluation and Research (CDER) a part of the U.S. Food and Drug Administration (FDA) is in charge of evaluating new drugs for safety and effectiveness before they may be sold. After the drugs are on the market, CDER acts as a watchdog, monitoring for any side effects and for any unexpected health risks. Sometimes drugs have to be withdrawn from the market due to severe unwanted side effects that may be fatal. In 2005, new molecular entities (NME) such as valdecoxib, pemoline, and technetium (99m Tc) fanolesomab were all removed due to the increased risk of serious adverse effects. Valdecoxib, a COX-2 selective inhibitor was removed from the market due to the increased risk of skin reactions and cardiovascular events. Likewise, pemoline, a CNS stimulant used for the treatment of ADHD was removed because of fatal hepatoxicity. Stimulants that are banned include amphetamines, beta-2 agonists, ephedrine, pseudoephedrine, fencamfamine, cocaine, methamphetamines, mesocarb, and other substances with similar chemical structures and biological effects, including the following: Adrafinil. Adrenaline (local use allowed) Amfepramone. Some of the reasons drugs are illegal are because they cause harm. Illegal drugs such as those listed above have been proven to cause physical and psychological harm; therefore, many laws have been put in place to prevent the misuse of them. This has been done as a form of public service, as those who make the laws are looking to protect the general public.
Psilocybin is illegal in the United States. Psilocybin is a Schedule I substance under the Controlled Substances Act. Schedule I drugs, which include heroin and LSD, have a high potential for abuse and serve no legitimate medical purpose in the United States. Psilocybin, the psychoactive component in "magic" mushrooms. A number of veterans have gone to Mexico to receive this monitored treatment to help treat "breacher's syndrome" and PTSD.
The drug Aprotinin (Trasylol) has been banned in the U.S. but is still on the market in some European countries. The drug was used as a medication administered by injection to reduce bleeding during complex surgery, such as heart and liver surgery. Its main effect is the slowing down of fibrinolysis, the process that leads to the breakdown of blood clots. The aim of its use was to decrease the need for blood transfusions during surgery, as well as end-organ damage due to hypotension as a result of marked blood loss. The drug was temporarily withdrawn worldwide in 2007 after studies suggested that its use increased the risk of complications or death. This was confirmed by follow-up studies. Trasylol sales were suspended in May 2008, except for very restricted research use. In February 2012 the European Medicines Agency (EMA) scientific committee reverted its previous standpoint regarding aprotinin and has recommended that the suspension be lifted.
