Should Pradaxa Be Withdrawn From the Market?
Dabigatran etexilate marketed in the U.S. under the name of Pradaxa is an anticoagulant prescription drug. Anticoagulant medications are designated to prevent or slow down the process of blood clotting. Although blood clotting is a natural process which prevents massive blood loss in case of an external or internal injury, if the blood clots too much, the consequences can be devastating. Blood clots can block a coronary artery, leading to heart attack or if they reach the brain, they can cause a stroke. Patients who are at risk of forming blood clots are usually prescribed with anticoagulants.
Pradaxa is recommended for patients suffering from atrial fibrillation a common heart disease. The drug should be taken only with medical prescription, respecting the dosage and taking one pill every day for a longer period of time. When the active ingredient of Pradaxa reaches the bloodstream it attaches itself to the thrombin, an enzyme responsible for the clotting process. By doing so the drug affects the enzyme's capacity of clotting.
Pradaxa was first approved on the U.S. market in 2010. It was designated to be a substitute for warfarin, a more common type of anticoagulant, because the new drug needs less supervision during treatment. Considering this fact Pradaxa started to be largely used. Within the first year after its approval there were around 1 million prescriptions made.
But Pradaxa like all other medications also has a series of side effects and therefore it is not recommended to all patients. The drug can cause gastrointestinal injuries due to the presence of tartaric acid. The substance needed for the proper absorption of the active ingredient also reduces the level of gastric pH, a reason why patients can experience stomach upset and pain, indigestion, acid reflux or burning sensations. These problems can cause gastrointestinal bleeding so individuals who suffered from stomach ulcer should avoid taking Pradaxa. The drug is not recommended to pregnant women or women who are breastfeeding as its affects on newborns have not been tested.
However the most severe side effect of Pradaxa is internal bleeding. That is why patients older than 70, those who previously had any bleeding problems or individuals suffering from kidney problems should not take the medication. But the drug can cause severe internal bleeding and potentially death to theoretically all groups of patients. The manufacturing company warns its client about the symptoms of internal bleeding, like frequent nose bleeding, bleeding from the gums, unusual bruises, swelling of feet and ankles, vomiting blood, pink color urine or coughing up blood. If any of these signs become obvious or persist patients should ask for immediate medical support.
Patients are warned about all these problems in the product's label. What they are not being told is how many of them will have to deal with severe side effects. As the drug began to be massively used the number of complaints and even death reports was rising. When the number became higher than predicted the FDA believed it is time to conduct an official search. As the search is ongoing they were so far able to establish that besides the obvious risks, the drug is not as efficient as believed to be. Patients taking Pradaxa have 30% higher chances of suffering a heart attack than those treated with warfarin. While some injured patients decided to file a Pradaxa lawsuit, holding the manufacturing company responsible for their sufferings, others are thinking about whether Pradaxa should be withdrawn from the market.
There are several prescription drugs that were initially approved but when they turned out to be dangerous they were withdrawn. However in order for that to happen, consistent evidence will be needed regarding the fact that the medication is not efficient for the purposes it was designated for. Product liability laws demand for each product to be also relatively safe. But what does relatively safe mean? All prescription drugs have side effects and within certain conditions they can all cause the death of a patient. But it is hard to establish the number of acceptable deaths for every medication. Normally the stronger a medication is, they higher the chances it can also affect patients. As anticoagulants save the life of millions withdrawing them would involve a huge responsibility. We can only establish how efficient and safe a particular drug is by comparing it to other medications from the same class. In this particular case Pradaxa should be compared with other thrombin inhibitor anticoagulants. However the final decision of withdrawing Pradaxa can only be taken after the FDA's official report will be made public. Until then patients are advised to take the medication with caution, inform themselves about side effects and ask immediate medical support if they notice worrying signs.
Pradaxa is recommended for patients suffering from atrial fibrillation a common heart disease. The drug should be taken only with medical prescription, respecting the dosage and taking one pill every day for a longer period of time. When the active ingredient of Pradaxa reaches the bloodstream it attaches itself to the thrombin, an enzyme responsible for the clotting process. By doing so the drug affects the enzyme's capacity of clotting.
Pradaxa was first approved on the U.S. market in 2010. It was designated to be a substitute for warfarin, a more common type of anticoagulant, because the new drug needs less supervision during treatment. Considering this fact Pradaxa started to be largely used. Within the first year after its approval there were around 1 million prescriptions made.
But Pradaxa like all other medications also has a series of side effects and therefore it is not recommended to all patients. The drug can cause gastrointestinal injuries due to the presence of tartaric acid. The substance needed for the proper absorption of the active ingredient also reduces the level of gastric pH, a reason why patients can experience stomach upset and pain, indigestion, acid reflux or burning sensations. These problems can cause gastrointestinal bleeding so individuals who suffered from stomach ulcer should avoid taking Pradaxa. The drug is not recommended to pregnant women or women who are breastfeeding as its affects on newborns have not been tested.
However the most severe side effect of Pradaxa is internal bleeding. That is why patients older than 70, those who previously had any bleeding problems or individuals suffering from kidney problems should not take the medication. But the drug can cause severe internal bleeding and potentially death to theoretically all groups of patients. The manufacturing company warns its client about the symptoms of internal bleeding, like frequent nose bleeding, bleeding from the gums, unusual bruises, swelling of feet and ankles, vomiting blood, pink color urine or coughing up blood. If any of these signs become obvious or persist patients should ask for immediate medical support.
Patients are warned about all these problems in the product's label. What they are not being told is how many of them will have to deal with severe side effects. As the drug began to be massively used the number of complaints and even death reports was rising. When the number became higher than predicted the FDA believed it is time to conduct an official search. As the search is ongoing they were so far able to establish that besides the obvious risks, the drug is not as efficient as believed to be. Patients taking Pradaxa have 30% higher chances of suffering a heart attack than those treated with warfarin. While some injured patients decided to file a Pradaxa lawsuit, holding the manufacturing company responsible for their sufferings, others are thinking about whether Pradaxa should be withdrawn from the market.
There are several prescription drugs that were initially approved but when they turned out to be dangerous they were withdrawn. However in order for that to happen, consistent evidence will be needed regarding the fact that the medication is not efficient for the purposes it was designated for. Product liability laws demand for each product to be also relatively safe. But what does relatively safe mean? All prescription drugs have side effects and within certain conditions they can all cause the death of a patient. But it is hard to establish the number of acceptable deaths for every medication. Normally the stronger a medication is, they higher the chances it can also affect patients. As anticoagulants save the life of millions withdrawing them would involve a huge responsibility. We can only establish how efficient and safe a particular drug is by comparing it to other medications from the same class. In this particular case Pradaxa should be compared with other thrombin inhibitor anticoagulants. However the final decision of withdrawing Pradaxa can only be taken after the FDA's official report will be made public. Until then patients are advised to take the medication with caution, inform themselves about side effects and ask immediate medical support if they notice worrying signs.
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