Drugs Banned in other Countries But Available in India

pharmacy
Each country has its own list of banned drugs, it is worrisome that some drugs that are banned in other countries for proven adverse effects are still available in the Indian market.  Some of these drugs are available over – the – counter and people may take it without realizing the risk. A note of caution on these drugs could help patients in deciding whether they want to take the drug. Some of these drugs are:

Phenylpropanolamine
Phenylpropanolamine is commonly found in cold and cough medications in India. It was also used to treat obesity in the US where it was found to increase the risk of hemorrhagic stroke (stroke due to a bleed in the brain). It also had the potential to worsen psychiatric problems. Though the dose used in cough and cold medicines is lower than that used in obesity, people buying the medication especially over the counter should be made aware of these adverse effects. This drug has come under the scanner and may soon be banned in India.
Side Effects of Phenylpropanolamine:
an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives),seizures,unusual behavior or hallucinations,an irregular or fast heartbeat,dizziness, lightheadedness, or drowsiness, headache, insomnia, anxiety, tremor shaking or restlessness, nausea or vomiting; or sweating.
Cardiovascular:
Cardiovascular adverse effects may be associated with phenylpropanolamine. Phenylpropanolamine can cause a significant rise in heart rate. Hypertension and arrhythmias may be problematic in susceptible patients. Cardiovascular side effects have also included an increased risk of hemorrhagic stroke. Phenylpropanolamine causes vasoconstriction which usually does not result in blood pressure elevations in healthy adults given normally prescribed dosages. However, phenylpropanolamine administration may be problematic for patients with preexisting hypertension and those receiving higher dosages. In general, 75-mg of sustained-release phenylpropanolamine will not produce a significant increase in blood pressure in normotensive patients, but 150-mg of sustained-release phenylpropanolamine can.
Nervous system:
Seizures may occur in rare cases of hypertensive crisis and have been reported with normally recommended doses as well as in cases of overuse or overdose. There have been anecdotal reports of cerebrovascular hemorrhage largely associated with an uneven pattern of cerebrovascular spasm referred to as vascular beading. Vascular beading has also been reported in the absence of hemorrhage. Intracranial hemorrhage has almost always been associated with hypertension. Phenylpropanolamine produces nervous system stimulation, resulting in tremor, anxiety, insomnia, dizziness, and nervousness. Headache may also occur.
Psychiatric:
Psychiatric reactions occur infrequently but include acute mania, anxiety, paranoia, confusion, agitation, and hallucinations. These reactions may be more common in women. Psychotic reactions to phenylpropanolamine have occurred in patients receiving normally recommended doses and in cases of abuse. In a few patients, phenylpropanolamine appears to have exacerbated an underlying bipolar disorder which was previously undiagnosed.
Gastrointestinal:
Gastrointestinal adverse effects most commonly seen are anorexia and gastric irritation. Nausea and vomiting have occurred in conjunction with hypertensive episodes.
Hypersensitivity:
Hypersensitivity reactions to phenylpropanolamine may occur.
Renal:
Rarely, phenylpropanolamine may cause acute interstitial nephritis.

Metamizole (Analgin)
Analgin is a painkiller. It has been banned in some countries since it carries the risk of agranulocytosis (condition where the bone marrow does not produce certain types of white blood cells). Beside, safer painkillers that are equally effective are easily available and there is no need to take such as serious risk. Analgin itself is not banned in India but the combination of analgin with any other drug is banned.
side effects Metamizole :
it is known to cause minimal side effects in most people given it; serious side effects include agranulocytosisaplastic anaemia, hypersensitivity reactions (like anaphylaxis and bronchospasm), toxic epidermal necrolysis and it may provoke acute attacks ofporphyria, as it is chemically related to sulfonamides. The relative risk for agranulocytosis appears to greatly vary according to the country of estimates on said rate
Contraindications: Previous hypersensitivity (such as agranulocytosis or anaphylaxis) to metamizole or any of the excipients (e.g. lactose) in the preparation used, acute porphyria, impaired haematopoiesis (such as due to treatment with chemotherapy agents), third trimester of pregnancy (potential for adverse effects in the newborn), lactation, children with a body weight below 16 kg, history of aspirin-induced asthma and other hypersensitivity reactions to analgesics.
Drug(s)Interaction/reason for theoretical potential for interaction
CiclosporinDecreased serum levels of ciclosporin.
ChlorpromazineAdditive hypothermia (low body temperature) may result.
MethotrexateAdditive risk for haematologic (blood) toxicity.
Oral anticoagulants (blood thinners), lithiumcaptopriltriamterene and antihypertensives may also interact with metamizole, as other pyrazolones are known to interact adversely with these substances.
Overdose: It is considered fairly safe on overdose, but in these cases supportive measures are usually advised as well as measures to limit absorption (such as activated charcoal) and accelerate excretion (such as haemodialysis)
Oxyphenbutazone
Oxyphenbutazone is a painkiller belonging to the same class of drugs as analgin. It has been banned in many countries since it causes bone marrow depression and other side effects. Its combination with any other drug is banned in India.
Side effects of Oxyphenbutazone:
The severe or irreversible adverse effects of Oxyphenbutazone, which give rise to further complications include Allergic reactions, Abdominal pain, Blurred vision. The symptomatic adverse reactions produced by Oxyphenbutazone are more or less tolerable and if they become severe, they can be treated symptomatically, these include Weakness, Headache, Drowsiness,Irritability, Diarrhea, Heart burn, Bruising, Weight loss, Loss of appetite.
Nimesulide
Nimesulide is a painkiller that was not introduced in the American, UK or Australian market but is widely used in India. It has been found to cause liver failure and hence has been banned in some countries.  Children with viral infection could be particularly susceptible. However, the ban has not been implemented even in children in India.
Side effects of nimesulide:
The use of nimesulide in children under the age of 12 is contraindicated. Continuous use of nimesulide (more than 15 days) can cause side effects like Diarrhea,Vomiting,Skin rash, Pruritus ,Dizziness,Bitterness in mouth. Women should use the drug with caution during lactation and it is contraindicated during pregnancy.

Cisapride
Cisapride is a drug that increases the motility of the gastrointestinal tract. It is used to treat acidity and constipation. It may cause arrhythmia when used in high doses or when combined with other drugs like erythromycin and ketoconazole, hence it is banned in some countries. Its use in India is under the scanner and it may soon face a ban.
Side effects of Cisapride:
Cisapride is generally well tolerated. The most common side affects include headache, diarrhea, nausea, abdominal pain, and constipation. Rarely, seizures, abnormal liver tests, fast heart rates have been reported. But the relationship of cisapride to these events were not clear.
Furazolidone and Nitrofurazone
Furazolidone acts against some bacteria and protozoa that cause diarrhea. It is used alone as well as with other drugs such as metronidazole. It has been banned in some countries since it belongs to a class of drugs that could cause cancer. The combination of loperamide with furazolidone is banned in India.
Side effects of Furazolidone: Furazolidone is no longer available in the US. Though an effective antibiotic when all others fail, against extremely drug resistant infections, it has many side effects, and as with other nitrofurans generally, minimum inhibitory concentrations also produce systemic toxicity (tremors, convulsions, peripheral neuritis, gastrointestinal disturbances, depression of spermatogenesis.) Nitrofurans are recognized by FDA as mutagens/carcinogens, and can no longer be used since 1991.

Nitrofurazone is an antibacterial cream that belongs to the same class of drugs as furazolidone, thus there is a chance that it could also cause cancer. Hence it is banned in some countries.
Some side effects of nitrofurazone: nitrofurazone topical may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.nitrofurazone is applied topicaly as topical cream, topical ointment, topical solution Along with its needed effects, nitrofurazone topical may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.less common Side effects are Itching, rash, swelling.

Cerivastatin

Cerivastatin in a cholesterol lowering drug similar to atorvastatin. It was withdrawn since it caused several cases of rhabdomyolysis (damage to muscles) following which patients suffer from kidney failure. Unfortunately, it is still available in India.

Side effects of Cerivastatin: Cerivastatin generally is well-tolerated, and side effects are rare. Minor side effects include constipationdiarrhea, fatigue, gas, heartburn, nasal congestion, and headache. Cerivastatin should be used with caution in patients with alcoholic or other liver diseases. Persistently abnormal liver tests during treatment are rare but may require discontinuation of the medication. Rare cases of muscle damage due to inflammation (myositis) have been reported with other drugs in the same class as cerivastatin, and is presumed also to occur with cerivastatin as well. (Muscle inflammation causes the release of muscle protein, myoglobin, into the blood where it is carried to the kidneys and leads to kidney failure.)
Phenolphthalein
Phenolphthalein is a stimulant purgative. It produced cancers when tested in mice as well as damage to genes. Hence it has been banned in some countries.
Side effects of Phenolphthalein : Feel Like Throwing Up, Burping, Diarrhea , Stomach Cramps, Inflammation of Skin caused by an Allergy, Rash, Abnormal Urine Color, Reaction due to an Allergy.
Quiniodochlor
Quiniodochlor is an amoebicidal drug effective against diarrhea caused by amoebae.  It caused a serious side effect called subacute myelo – optic neuropathy, initially seen in Japanese, a condition that caused nerve damage and loss of sight.
Side effects of Quiniodochlor  : Nausea, transient loose and green stools, pruritus, goiter.
Relatively prolonged and uninterrupted treatment with halogenated hydroxyquinoline derivatives used in high dosage for more than 14 days has been reported to cause peripheral neuritis and damage to optic nerves in isolated cases.
Tegaserod
Tegaserod is a drug that is used to treat patients with irritable bowel syndrome with predominantly constipation. It was withdrawn from the market since patients taking this drug showed increased incidence of heart attack and stroke.
Side effects Tegaserod  :
More common:Diarrhea, stomach pain
Less common:Dizziness, feeling of warmth, itching skin, redness of the face, neck, arms and occasionally, upper chest, swelling or puffiness of face, Black or tarry stools, bloody diarrhea, bloody stools, constipation ,fainting, indigestion, nausea ,new or worsening abdominal pain ,rectal bleeding , severe stomach pain with nausea and vomiting, vomiting.
Symptoms of overdose: Bloated, full feeling, chills, cold sweats,confusion, dizziness, faintness, or lightheadedness when getting up from lying or sitting position,excess air or gas in stomach or intestines, headache,passing gas
Less common or rare: Back pain, disease or abnormality of the joint, headache, severe and throbbing, leg pain

Human Placental extract
Human placental extract is used in the cosmetic industry in the form of lotion, gel and injection. It is not permitted in some countries since it can transmit diseases to the user. It is under the scanner and may be banned in the future.

Thioridazine
Thioridazine is an antipsychotic drug. It causes adverse effects like arrhythmia (abnormal heart rhythm), eye damage, and a condition called neuroleptic malignant syndrome.
Side effects of Thioridazine:
  • fast or pounding heartbeat;
  • twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;
  • tremor (uncontrolled shaking), drooling, trouble swallowing, problems with balance or walking;
  • feeling restless, jittery, or agitated;
  • very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, feeling like you might pass out;
  • seizure (convulsions);
  • decreased night vision, tunnel vision, watery eyes, increased sensitivity to light;
  • pale skin, easy bruising or bleeding, sore throat, flu symptoms;
  • urinating less than usual or not at all;
  • nausea and stomach pain, skin rash, and jaundice (yellowing of the skin or eyes);
  • joint pain or swelling with fever, swollen glands, muscle aches, chest pain, vomiting, unusual thoughts or behavior, and patchy skin color; or
  • slow heart rate, weak pulse, fainting, slow breathing (breathing may stop).
Less serious side effects may include:
  • dizziness, drowsiness, anxiety;
  • dry mouth, stuffy nose, constipation;
  • blurred vision, headache;
  • breast swelling or discharge;
  • changes in your menstrual periods;
  • weight gain, swelling in your hands or feet;
  • impotence, trouble having an orgasm;
  • increased or decreased interest in sex;
  • sleep problems (insomnia), strange dreams; or
  • mild itching or skin rash.
Pergolide
Pergolide is a drug used for the treatment of Parkinson’s disease. It has been withdrawn from some countries since it causes damage to heart valves.
Side effects of :
More common side effects: Anxiety, bloody or cloudy urine, confusion, difficult or painful urination, frequent urge to urinate, hallucinations (seeing, hearing, or feeling things that are not there), uncontrolled movements of the body, such as the face, tongue, arms, hands, head, and upper body
Rare side effects: Chest pain (severe), convulsions (seizures), difficulty in breathing, fainting,fast heartbeat or irregular pulse,headache (severe or continuing), high fever ,high or low (irregular) blood pressure, increased sweating, loss of bladder control, nausea and vomiting (continuing or severe), nervousness, severe muscle stiffness, sudden weakness, unexplained shortness of breath, unusual tiredness or weakness, unusually pale skin, vision changes, such as blurred vision or temporary blindness
Less common side effects: Dizziness, headache, swelling in hands and legs. Some side effects of pergolide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine.

-Written by Devesh Chaudhari
:)  Thank you for reading :)

Reference:
Disclaimer - The contents of this Article is for informational & educational purposes only. Always seek the advice of a qualified physician or health provider for medical diagnosis and treatment.

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