The U.S. Food and Drug Administration (FDA) has a reputation as one of the strictest regulators in the world. According to the FDA, FDA approve drugs by evaluating their safety and efficacy in respective indications. A “drug is removed from the market when its risks outweigh its benefits. A drug is usually taken off the market because of safety issues with the drug that cannot be corrected. In fact, the FDA is considerably more lax in its oversight than drug regulators in Europe and other parts of the world, according to a 2012 study at the Temple University School of Pharmacy. The FDA has approved a number of drugs that are banned in other countries because of evidence they are ineffective and/or risky. Here is a list of some significant drugs/ointments/medications banned in USA and other countries but yet available in India.
Vicks (Used for Cough and Cold)
Vicks VapoRub is a widely used balm or cream to get relief from symptoms like common cold, cough, and congestion. Vicks VapoRub was banned in North America and many European countries as it is declared not good for health it can create Asthma, TB etc. It is declared as Toxic by WHO. Except vicks, other medicines like D’cold and vicks action-500 also banned outside India.
Vicks Action 500 Extra is a fixed dose combination of paracetamol, phenylephrine and caffeine, which was banned by the Ministry of Health in a notice issued over the weekend
Reason of Ban: According to reports, an ingredient found in Vicks has serious and dangerous side effects. Vicks action 500 was one of 344 fixed dose combination banned by Ministry of Health, including several antibiotics and analgesics.
Nandrolone Decanoate (Anabolic Steroid)
Nandrolone Decanoate is one of the most well known anabolic steroids that has become extremely popular with athletes and bodybuilders as a way to turn their extra weight into lean muscle. Nandrolone Decanoate is approved by the FDA for the treatment of anaemia due to kidney disease and osteoporosis, and several different diseases and disorders. It has been discontinued in the United States but is still used in India.
Generic Name: Nandrolone Decanoate
Dosage Form: Injection, solution
Pergolide (Drugs Acting on the Brain)
Pergolide mesylate is dopamine agonist. It works by stimulating dopamine receptors in the brain. This drug used for the treatment of Parkinson’s disease, a condition that affects the nervous system resulting in stiffness and tremors. Pergolide is one of the newer drug that replace levodopa and carbidopa. The availability of this new drugs provided hope for the patients however it had to be withdrawn and its use is restricted on USA.
Brand Name: Permax, 19 years on the market
Use: Parkinson’s disease
Manufacturer: Valeant 1988 to Mar. 29, 2007
Reason of Withdrawn: Recent studies found that this drug caused damage to heart valves. Pergolide mesylate inhibits the secretion of prolactin in humans. Pergolide causes a transient rise in serum concentrations of growth hormone and a decrease in serum concentrations of luteinizing hormone.
Cerivastatin (Cholesterol Lowering Drug) – Medications Banned in USA
Cholesterol reduction drug, manufacturer: Bayer A.G. in 1998 (3 years on the market). On Aug, 2001 the U.S. FDA announced that Bayer Pharmaceutical Division is voluntarily withdrawing Cerivastatin from the U.S. market. 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.
Brand Name: Baycol
Furazolidone (Antibacterial)
It is used in the treatment of diarrhea caused by bacteria or protozoa, alone or in combination with another drug, metronidazole. Recent studies and research found that its use has a possibility of causing cancer, and therefore it’s use is banned in several countries. In India, only its combination with loperamide + Metronidazole, And Diphenoxylate + Atropine + Furazolidone banned by Ministry of Health.
Reason of Ban: Cancer causing drug
Brand name: Furoxone and Lomofen (anti-diarrheal)
Nitrofurazone (Antibacterial)
Nitrofurazone is used in the treatment of burns and infection. It is also used to treat skin infections due to skin grafts. It works by killing bacteria or preventing their growth. It is a topically used antibacterial similar to furazolidone and therefore possibly cause cancer. This medicine is available only with your doctor’s prescription. It is banned in some countries, but yet available in India.
Brands: Furacin
Pemoline (Acting on Liver) – Medications Banned in USA
It’s used in the treatment of attention deficit hyperactivity disorder (ADHD). Pemoline (Cylert) is considered second line therapy for ADHD because of its association with life threatening hepatic failure. Several Agencies has concluded that the overall risk of liver toxicity from and pemoline (Cylert) products outweighs the benefits of this drug. Abbott chose to stop sales and marketing of Pemoline from U.S. market in Mar, 2005.
In rare cases, pemoline has caused severe liver damage resulting in death or liver transplant. It’s symptoms include high risk of liver toxicity risk and has been withdrawn in the United States. However, it is not discontinued in India.
Brand: Cylert, 30 years on the market
Use: Central nervous system stimulant to treat ADHD/ADD
Manufacturer: Abbott Laboratories 1975 to Oct. 2010
Thioridazine (Drug Acting on Brain)
Thioridazine (thioridazine hydrochloride) is an antipsychotic drug used to treat schizophrenia. This medication is used to treat certain mental disorders. This medication helps you to think more clearly, take part in everyday life, and feel less nervous.
Its side effects include eye damage, arrhythmia (abnormal heart rhythms), neuroleptic malignant syndrome where the patient suffers from high temperature and muscle rigidity. It continues to be available in India.
Common Name: Mellaril
In total, the CDSCO has issued a drug alert for 60 medicines, including anti-allergic Cetirizine, painkiller Combiflam, anti-cold D Cold Total, and drugs containing antibiotics ciprofloxacin and ofloxacin, as they failed different quality tests in March 2017, the Indian Express noted.
Among this long list of medications banned in USA, and other countries, there are some commonly used drugs like Enteroquinal, Ciza and Syspride, (acidity and constipation), and Buclizine (appetite stimulant), all of them are still being sold in Indian market. According to The Economic Times, antidepressant Droperidol has serious side effects only when given more than specific dosages.
Vicks VapoRub is NOT banned in America or by WHO, but it is important to use it as per the instructions, especially for babies. If you do not use it as per the instructions, there are certain negative effects associated with the usage of Vicks Vaporub.
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