Thursday, May 7, 2009
Why Are Drugs Recalled?
When a drug is taken off the market, it is not unreasonable to ask why the drug was approved for sale in the first place. After all, aren't drugs supposed to be safe? Did someone make a horrible mistake somewhere along the way?
The US Food and Drug Administration's (FDA) mission is to ensure that drugs are "safe and effective". But what does this really mean? When it comes to drugs, a safe drug is one whose benefit outweighs its risks for its intended use and for the population it is intended to treat. Cancer drugs, for example, tend to be highly toxic, but they also save lives.
All drugs, in fact, have potential adverse effects. When a pharmaceutical company develops a new drug, the FDA approves the drug if the agency deems that its benefits outweigh its risks. And to make such a determination, the FDA reviews results of clinical trials and other tests that are usually conducted over several years.
But despite the rigorous and lengthy testing that a drug undergoes prior to it even being submitted for FDA approval, not all risks and adverse effects of the drug can be known before it is made available on the market. For this reason, drugs continue to be evaluated after their approval.
When the FDA receives reports of serious side effects, it assesses them for their seriousness and the probability that they were caused by the drug. The FDA then compares the efficacy and toxicity of other treatments for the same condition. A determination of whether the benefits of the drug continue to outweigh the risks for the intended condition and population is then made and, if so, the drug continues to be tested and monitored.
The US Food and Drug Administration's (FDA) mission is to ensure that drugs are "safe and effective". But what does this really mean? When it comes to drugs, a safe drug is one whose benefit outweighs its risks for its intended use and for the population it is intended to treat. Cancer drugs, for example, tend to be highly toxic, but they also save lives.
All drugs, in fact, have potential adverse effects. When a pharmaceutical company develops a new drug, the FDA approves the drug if the agency deems that its benefits outweigh its risks. And to make such a determination, the FDA reviews results of clinical trials and other tests that are usually conducted over several years.
But despite the rigorous and lengthy testing that a drug undergoes prior to it even being submitted for FDA approval, not all risks and adverse effects of the drug can be known before it is made available on the market. For this reason, drugs continue to be evaluated after their approval.
When the FDA receives reports of serious side effects, it assesses them for their seriousness and the probability that they were caused by the drug. The FDA then compares the efficacy and toxicity of other treatments for the same condition. A determination of whether the benefits of the drug continue to outweigh the risks for the intended condition and population is then made and, if so, the drug continues to be tested and monitored.
What is the FDA's Role in Drug Recalls?
Although the US Food and Drug Administration (FDA) has the authority under the Federal Food, Drug, and Cosmetic Act (1938) to "order" a recall or confiscate a product, it very rarely does so. Over the years, a cooperative effort between the FDA and the industries it regulates has been shown to be a quick and reliable approach to removing unsafe products from the market. After all, it is in the interest of both to get dangerous products out of consumers' hands as soon as possible.
I some cases, a manufacturer discovers that one of its products is unacceptably dangerous and recalls it on its own. In other cases, the FDA will share its findings with a manufacturer that a drug is more dangerous than previously thought, and may suggest or request a recall if it deems that the drug's benefits no longer outweigh its risks. In all but one case, drug manufacturers have complied. The manufacturer then keeps the FDA updated on the status of any drugs remaining on the market.
A drug recall for a drug the FDA previously certified can bring bad publicity to the agency. In part for this reason, the FDA often refrains from issuing "safety-based" recalls. If a drug continues to have a place in treatment, the FDA will instead usually work with doctors and pharmaceutical companies to change warning labels.
When a drug is recalled, however, the FDA categorizes the recall into one of three classes according to the level a hazard involved:
* Class I recalls - this is the most severe type of recall. They are issued for defective or dangerous products with a potential for serious injury or death.
* Class II recalls - these are issued for products with a lower chance of causing major health problems or death, but could also cause temporary health problems.
* Class III recalls - these are reserved for products unlikely to cause adverse health consequences, but violate manufacturing regulations or FDA labeling recommendations (or now mandates).
I some cases, a manufacturer discovers that one of its products is unacceptably dangerous and recalls it on its own. In other cases, the FDA will share its findings with a manufacturer that a drug is more dangerous than previously thought, and may suggest or request a recall if it deems that the drug's benefits no longer outweigh its risks. In all but one case, drug manufacturers have complied. The manufacturer then keeps the FDA updated on the status of any drugs remaining on the market.
A drug recall for a drug the FDA previously certified can bring bad publicity to the agency. In part for this reason, the FDA often refrains from issuing "safety-based" recalls. If a drug continues to have a place in treatment, the FDA will instead usually work with doctors and pharmaceutical companies to change warning labels.
When a drug is recalled, however, the FDA categorizes the recall into one of three classes according to the level a hazard involved:
* Class I recalls - this is the most severe type of recall. They are issued for defective or dangerous products with a potential for serious injury or death.
* Class II recalls - these are issued for products with a lower chance of causing major health problems or death, but could also cause temporary health problems.
* Class III recalls - these are reserved for products unlikely to cause adverse health consequences, but violate manufacturing regulations or FDA labeling recommendations (or now mandates).
What is a Black Box Warning?
Short of being taken off the market, a black box warning (aka. boxed warning and black label warning) is the most severe type of warning the U.S. Food and Drug Administration (FDA) issues over safety concerns about a medication. Black box warnings alert consumers and healthcare providers that a medication may cause serious side effects or poses life-threatening risks.
The warning appears on printed materials inside the drug's packaging, on materials made available to doctors who may prescribe the medication, and on print advertising such as in magazines. It is surrounded by a printed black rectangle, thus its name.
Prior to the Food and Drug Administration Amendments Act of 2007 (FDAAA), the FDA could only request that black box warnings be implemented. The FDA, however, can now mandate these warnings, and the economic implication of this for drug companies is significant. A drug that gets a black box warning is often prescribed about 90 percent less frequently than prior to the warning. This is in large part because doctors are more reluctant to prescribe black box labeled drugs because of the increased likelihood of a malpractice lawsuit based on practicing medicine "outside the norm".
One of the FDA's first uses of the new authority was to require a black box warning for older, conventional antipsychotics. Other examples of drugs for which a black box warning has been required under the FDA's new authority include:
* Flouroquinolone antibiotics such as ciprofloxacin (Cipro) and levofloxacin (Levaquin) for an increased risk of tendon ruptures (July 2008)
* Rosiglitazone (Avandia), a diabetes medication, for an increased chance of heart failure or heart attack in certain cases (November 2007)
* SSRI antidepressants such as sertraline (Zoloft), paroxetine (Paxil), escitalopram (Lexapro), and other antidepressants for an increased risk of suicidality in young adults ages 18 to 24 (May 2007)
The warning appears on printed materials inside the drug's packaging, on materials made available to doctors who may prescribe the medication, and on print advertising such as in magazines. It is surrounded by a printed black rectangle, thus its name.
Prior to the Food and Drug Administration Amendments Act of 2007 (FDAAA), the FDA could only request that black box warnings be implemented. The FDA, however, can now mandate these warnings, and the economic implication of this for drug companies is significant. A drug that gets a black box warning is often prescribed about 90 percent less frequently than prior to the warning. This is in large part because doctors are more reluctant to prescribe black box labeled drugs because of the increased likelihood of a malpractice lawsuit based on practicing medicine "outside the norm".
One of the FDA's first uses of the new authority was to require a black box warning for older, conventional antipsychotics. Other examples of drugs for which a black box warning has been required under the FDA's new authority include:
* Flouroquinolone antibiotics such as ciprofloxacin (Cipro) and levofloxacin (Levaquin) for an increased risk of tendon ruptures (July 2008)
* Rosiglitazone (Avandia), a diabetes medication, for an increased chance of heart failure or heart attack in certain cases (November 2007)
* SSRI antidepressants such as sertraline (Zoloft), paroxetine (Paxil), escitalopram (Lexapro), and other antidepressants for an increased risk of suicidality in young adults ages 18 to 24 (May 2007)
Drug Recalls
The pharmaceutical industry is both lucrative and cut-throat. Many companies face strong pressure to get their drugs on the market as soon as possible and to market them as broadly as they can. Pharmaceutical companies need to balance this pressure with the ethical obligation to exercise caution so that drugs are adequately tested before reaching the market. While some drug manufacturers scrupulously adhere to this ethical responsibility, others do not.
The Food and Drug Administration (FDA) is responsible for guaranteeing that drugs released on the market are safe for consumption. The process to receive FDA approval for a new drug is rigorous and can take a long time. In spite of this, it is still difficult to ascertain the long-term effects of a particular drug.
Furthermore, there are occasions when these tests are financed and carried out by the drug manufacturer's laboratories, which is clearly a conflict of interest.
When problems and harmful side effects develop in relation to an approved drug, the FDA can issue a recall. Recalls can be either voluntary or mandatory. If it is voluntary, the drug manufacturer decides to remove it from the market on its own. In mandatory recalls, the FDA orders a drug to be removed.
When a drug has the potential to cause serious or possibly fatal side effects, the FDA will issue a black box warning. It will appear either on the drug's label or in the literature accompanying the product. This is the most severe warning the FDA can issue for a drug.
Pharmaceutical drugs have contributed to more than 1,000 deaths since 1993. Some of the most serious drug recalls include:
* Fen-phen - More than six million Americans took this diet drug in the 1990's. Approximately 30% of women taking it developed heart valve abnormalities.
* Heparin - Heparin sodium is used as a blood thinner for patients who need heart surgery or kidney dialysis. Many patients who received large doses of the drug exhibited side effects including nausea, sweating, oral swelling, vomiting, and shortness of breath.
* Accutane - Accutane is an acne medication that was very successful in severe cases that did not respond well to other treatments. However, the drug can cause liver damage, birth defects, suicidal tendencies, and irritable bowel syndrome.
The Food and Drug Administration (FDA) is responsible for guaranteeing that drugs released on the market are safe for consumption. The process to receive FDA approval for a new drug is rigorous and can take a long time. In spite of this, it is still difficult to ascertain the long-term effects of a particular drug.
Furthermore, there are occasions when these tests are financed and carried out by the drug manufacturer's laboratories, which is clearly a conflict of interest.
When problems and harmful side effects develop in relation to an approved drug, the FDA can issue a recall. Recalls can be either voluntary or mandatory. If it is voluntary, the drug manufacturer decides to remove it from the market on its own. In mandatory recalls, the FDA orders a drug to be removed.
When a drug has the potential to cause serious or possibly fatal side effects, the FDA will issue a black box warning. It will appear either on the drug's label or in the literature accompanying the product. This is the most severe warning the FDA can issue for a drug.
Pharmaceutical drugs have contributed to more than 1,000 deaths since 1993. Some of the most serious drug recalls include:
* Fen-phen - More than six million Americans took this diet drug in the 1990's. Approximately 30% of women taking it developed heart valve abnormalities.
* Heparin - Heparin sodium is used as a blood thinner for patients who need heart surgery or kidney dialysis. Many patients who received large doses of the drug exhibited side effects including nausea, sweating, oral swelling, vomiting, and shortness of breath.
* Accutane - Accutane is an acne medication that was very successful in severe cases that did not respond well to other treatments. However, the drug can cause liver damage, birth defects, suicidal tendencies, and irritable bowel syndrome.
Subscribe to:
Posts (Atom)