Clipping Board » Drug Poisoning ─ It is necessary to be aware of the toxic side effects before taking medication.
Updated on 2005-04-10 04:08
Source: Beijing Youth Daily
Yesterday, this newspaper published a report stating that the U.S. Food and Drug Administration (FDA) had issued updated guidelines on the use of all anti-inflammatory painkillers, releasing a statement on their proper usage. The statement noted that, based on existing research data, all non-steroidal anti-inflammatory drugs (NSAIDs) carry potential cardiovascular risks. These drugs include commonly used medications such as Voltaren, Fenbid, and Celebrex. The FDA has required manufacturers to include a black box warning in the drug labels.
Many readers inquired whether this warning means that taking these drugs will definitely lead to cardiovascular diseases or if they should no longer be used.
Reporters interviewed several pharmaceutical experts on the matter. They explained that it is common for the FDA to issue cautious usage warnings regarding potential adverse effects of drugs. This does not mean these medications should no longer be used. If the adverse effects were clearly significant and outweighed the benefits, the FDA would issue a recall or discontinuation notice. Experts reassured patients not to panic, as these drugs can still be used as usual. However, they emphasized that for over-the-counter drugs, patients must carefully read the instructions before use, while prescription drugs should be taken strictly as directed by a doctor.
■ 21 Anti-Inflammatory Painkillers Identified as Having Potential Cardiovascular Risks
Public concern about anti-inflammatory painkillers stems from the FDA's statement that "all NSAIDs carry potential cardiovascular risks." The statement listed 21 anti-inflammatory painkillers that may pose cardiovascular risks, some of which are widely used in China. The FDA has mandated that all manufacturers of these drugs revise their labels to include a black box warning, alerting patients to the potential increased risk of cardiovascular and gastrointestinal bleeding events to ensure informed and safe usage.
The FDA also requires manufacturers of over-the-counter NSAIDs to include warnings about potential skin allergic reactions in their labels. Currently, such information is already included in the labels of prescription NSAIDs.
Dr. Steven K. Galson, Director of the FDA's Center for Drug Evaluation and Research, stated, "Based on the latest scientific data, the FDA has issued public information to guide the careful and rational use of these drugs, aiming to maximize their benefits while minimizing risks."
Among the 21 anti-inflammatory painkillers listed by the FDA, some are no longer available on the market. For example, Vioxx, a leading drug for treating rheumatoid arthritis, was suspected of increasing the risk of heart attacks and strokes. Its manufacturer, Merck, voluntarily withdrew it from the global market last September.
■ Why the FDA Is Concerned About Anti-Inflammatory Painkillers
It is understood that the FDA's focus on the cardiovascular safety of anti-inflammatory painkillers originated from the withdrawal of Vioxx, a COX-2 inhibitor (a new type of anti-inflammatory painkiller), last September. In December of last year, Celebrex, produced by Pfizer—a painkiller used to treat osteoarthritis, rheumatoid arthritis, and as an adjunct in familial adenomatous polyposis—was also found to carry cardiovascular risks in long-term cancer prevention studies. However, the risks were observed in patients who took the drug continuously in high doses for an average of 33 months.
Vioxx and Celebrex, both classified as "COX-2 inhibitors," were hailed as a "milestone breakthrough" for reducing gastrointestinal damage compared to traditional anti-inflammatory painkillers.The most debated issue at the time was whether cardiovascular problems were unique to COX-2 inhibitors. Amid the uproar over cardiovascular risks, some patients reverted to traditional anti-inflammatory and pain-relief medications, despite their known gastrointestinal risks and the lack of large-scale studies proving cardiovascular safety.
To address these concerns, the FDA held a public expert hearing from February 16 to 18, 2005, comprehensively reviewing all data. The expert committee voted 31 to 1 in favor of Celebrex remaining on the market, while unanimously agreeing that cardiovascular risks might be an issue for all anti-inflammatory and pain-relief drugs, including COX-2 inhibitors. Over the next two months, the FDA reviewed and analyzed all data to ensure the objectivity and fairness of its statements.
■ "Black Box Warning" Doesn’t Mean These Drugs Can’t Be Used
Among the drugs listed in the FDA’s warning are some commonly used medications, such as ibuprofen, which can be found in many households, offices, or even handbags. This warning has caused anxiety for many: "Does this mean these drugs can’t be used anymore?" "I’ve been taking them for a long time—could I already be at risk?" "Why is this issue only being discovered now, after so many years on the market?"
Reporters posed these questions to multiple pharmaceutical experts, who unanimously agreed that such concerns were unnecessary. Experts explained that the U.S. has unique methods and channels for monitoring drug adverse effects, and the FDA frequently issues cautious usage warnings. The warning was issued because some individuals taking these 21 anti-inflammatory and pain-relief drugs developed cardiovascular diseases—but this does not mean everyone who takes these drugs will develop such conditions. There is no definitive causal relationship between these 21 drugs and cardiovascular diseases. Thus, the FDA’s warning states that "all non-steroidal anti-inflammatory drugs carry potential cardiovascular risks."
Experts believe this warning in no way means these drugs cannot be used. If a drug’s adverse effects were clearly established and its risks outweighed its benefits, the FDA would issue a discontinuation or recall notice—as was the case with Vioxx.
Additionally, it is nearly impossible to identify all potential adverse reactions of a drug at the time of its market release. The listed side effects in the drug’s instructions may only represent a portion of possible risks. Some adverse effects may only become apparent after prolonged use. For example, Longdan Xiegan Pills were found to cause kidney damage in users only after years of use (Note: This was due to the inclusion of the wrong ingredient, Aristolochia manshuriensis).
However, patients should still exercise caution when taking these medications. For over-the-counter drugs, carefully read the instructions before use. For prescription drugs, strictly follow medical advice. Some patients increase their dosage to relieve symptoms faster, which undoubtedly raises the likelihood of adverse reactions. Therefore, it is crucial to adhere to the instructions or medical guidance.
■ Domestic Companies Should Actively Report Adverse Drug Reactions
The global painkiller market turmoil that began last year and continues today also reflects the state of adverse drug reaction monitoring. It is understood that the FDA’s Adverse Event Reporting System strictly requires all pharmaceutical companies to establish a post-market surveillance department responsible for tracking drug efficacy, safety, and collecting adverse reaction reports. When the FDA raises concerns about a drug, these departments can promptly provide favorable evidence as part of their defense.Just as Pfizer could present some authoritative follow-up investigation reports after the Celebrex incident, domestic pharmaceutical companies in China currently have almost nothing in this regard. Statistics show that among the adverse reaction reports collected annually by the FDA, 60% to 70% come from pharmaceutical companies, while reports from Chinese pharmaceutical firms account for only about 15% of the total.
The stark contrast between "70% and 15%" is closely related to differences in regulations regarding adverse drug reactions. The FDA mandates that pharmaceutical companies must report adverse reactions once discovered. Failure to report on time or shifting the responsibility to patients can result in legal consequences, including fines ranging from millions to billions of dollars. Additionally, companies are required to detail adverse reactions in drug labels as comprehensively as possible, which not only helps mitigate potential legal disputes but also encourages proactive reporting.
In contrast, domestic pharmaceutical companies in China tend to downplay adverse reactions, often emphasizing positive outcomes while omitting negative ones. Many firms negotiate with experts when revising drug labels, deliberately obscuring adverse reactions. This reluctance stems from three main fears: first, the concern that reporting adverse reactions will harm future sales; second, the worry about facing compensation claims from patients' families; and third, the pressure from public opinion. Ironically, these fears have led to a vicious cycle of recurring adverse reaction incidents.
Experts believe that under the current circumstances, domestic pharmaceutical companies urgently need to strengthen their sense of social responsibility and corporate citizenship, setting aside their concerns to actively report adverse reactions. At the same time, the public should develop a correct understanding of adverse drug reactions—not all drugs with adverse effects should be avoided. For instance, taking Celebrex in small doses or for short periods does not pose significant risks. (Editor: Jiang)
Source: http://news. cn. yahoo. com/ 050409/ 351/ 2arhk. html
21 Painkillers Linked to Risks, 16,500 US Deaths Annually
Source: Beijing Youth Daily
Yesterday, this newspaper published a report stating that the U.S. Food and Drug Administration (FDA) had issued updated guidelines on the use of all anti-inflammatory painkillers, releasing a statement on their proper usage. The statement noted that, based on existing research data, all non-steroidal anti-inflammatory drugs (NSAIDs) carry potential cardiovascular risks. These drugs include commonly used medications such as Voltaren, Fenbid, and Celebrex. The FDA has required manufacturers to include a black box warning in the drug labels.
Many readers inquired whether this warning means that taking these drugs will definitely lead to cardiovascular diseases or if they should no longer be used.
Reporters interviewed several pharmaceutical experts on the matter. They explained that it is common for the FDA to issue cautious usage warnings regarding potential adverse effects of drugs. This does not mean these medications should no longer be used. If the adverse effects were clearly significant and outweighed the benefits, the FDA would issue a recall or discontinuation notice. Experts reassured patients not to panic, as these drugs can still be used as usual. However, they emphasized that for over-the-counter drugs, patients must carefully read the instructions before use, while prescription drugs should be taken strictly as directed by a doctor.
■ 21 Anti-Inflammatory Painkillers Identified as Having Potential Cardiovascular Risks
Public concern about anti-inflammatory painkillers stems from the FDA's statement that "all NSAIDs carry potential cardiovascular risks." The statement listed 21 anti-inflammatory painkillers that may pose cardiovascular risks, some of which are widely used in China. The FDA has mandated that all manufacturers of these drugs revise their labels to include a black box warning, alerting patients to the potential increased risk of cardiovascular and gastrointestinal bleeding events to ensure informed and safe usage.
The FDA also requires manufacturers of over-the-counter NSAIDs to include warnings about potential skin allergic reactions in their labels. Currently, such information is already included in the labels of prescription NSAIDs.
Dr. Steven K. Galson, Director of the FDA's Center for Drug Evaluation and Research, stated, "Based on the latest scientific data, the FDA has issued public information to guide the careful and rational use of these drugs, aiming to maximize their benefits while minimizing risks."
Among the 21 anti-inflammatory painkillers listed by the FDA, some are no longer available on the market. For example, Vioxx, a leading drug for treating rheumatoid arthritis, was suspected of increasing the risk of heart attacks and strokes. Its manufacturer, Merck, voluntarily withdrew it from the global market last September.
■ Why the FDA Is Concerned About Anti-Inflammatory Painkillers
It is understood that the FDA's focus on the cardiovascular safety of anti-inflammatory painkillers originated from the withdrawal of Vioxx, a COX-2 inhibitor (a new type of anti-inflammatory painkiller), last September. In December of last year, Celebrex, produced by Pfizer—a painkiller used to treat osteoarthritis, rheumatoid arthritis, and as an adjunct in familial adenomatous polyposis—was also found to carry cardiovascular risks in long-term cancer prevention studies. However, the risks were observed in patients who took the drug continuously in high doses for an average of 33 months.
Vioxx and Celebrex, both classified as "COX-2 inhibitors," were hailed as a "milestone breakthrough" for reducing gastrointestinal damage compared to traditional anti-inflammatory painkillers.The most debated issue at the time was whether cardiovascular problems were unique to COX-2 inhibitors. Amid the uproar over cardiovascular risks, some patients reverted to traditional anti-inflammatory and pain-relief medications, despite their known gastrointestinal risks and the lack of large-scale studies proving cardiovascular safety.
To address these concerns, the FDA held a public expert hearing from February 16 to 18, 2005, comprehensively reviewing all data. The expert committee voted 31 to 1 in favor of Celebrex remaining on the market, while unanimously agreeing that cardiovascular risks might be an issue for all anti-inflammatory and pain-relief drugs, including COX-2 inhibitors. Over the next two months, the FDA reviewed and analyzed all data to ensure the objectivity and fairness of its statements.
■ "Black Box Warning" Doesn’t Mean These Drugs Can’t Be Used
Among the drugs listed in the FDA’s warning are some commonly used medications, such as ibuprofen, which can be found in many households, offices, or even handbags. This warning has caused anxiety for many: "Does this mean these drugs can’t be used anymore?" "I’ve been taking them for a long time—could I already be at risk?" "Why is this issue only being discovered now, after so many years on the market?"
Reporters posed these questions to multiple pharmaceutical experts, who unanimously agreed that such concerns were unnecessary. Experts explained that the U.S. has unique methods and channels for monitoring drug adverse effects, and the FDA frequently issues cautious usage warnings. The warning was issued because some individuals taking these 21 anti-inflammatory and pain-relief drugs developed cardiovascular diseases—but this does not mean everyone who takes these drugs will develop such conditions. There is no definitive causal relationship between these 21 drugs and cardiovascular diseases. Thus, the FDA’s warning states that "all non-steroidal anti-inflammatory drugs carry potential cardiovascular risks."
Experts believe this warning in no way means these drugs cannot be used. If a drug’s adverse effects were clearly established and its risks outweighed its benefits, the FDA would issue a discontinuation or recall notice—as was the case with Vioxx.
Additionally, it is nearly impossible to identify all potential adverse reactions of a drug at the time of its market release. The listed side effects in the drug’s instructions may only represent a portion of possible risks. Some adverse effects may only become apparent after prolonged use. For example, Longdan Xiegan Pills were found to cause kidney damage in users only after years of use (Note: This was due to the inclusion of the wrong ingredient, Aristolochia manshuriensis).
However, patients should still exercise caution when taking these medications. For over-the-counter drugs, carefully read the instructions before use. For prescription drugs, strictly follow medical advice. Some patients increase their dosage to relieve symptoms faster, which undoubtedly raises the likelihood of adverse reactions. Therefore, it is crucial to adhere to the instructions or medical guidance.
■ Domestic Companies Should Actively Report Adverse Drug Reactions
The global painkiller market turmoil that began last year and continues today also reflects the state of adverse drug reaction monitoring. It is understood that the FDA’s Adverse Event Reporting System strictly requires all pharmaceutical companies to establish a post-market surveillance department responsible for tracking drug efficacy, safety, and collecting adverse reaction reports. When the FDA raises concerns about a drug, these departments can promptly provide favorable evidence as part of their defense.Just as Pfizer could present some authoritative follow-up investigation reports after the Celebrex incident, domestic pharmaceutical companies in China currently have almost nothing in this regard. Statistics show that among the adverse reaction reports collected annually by the FDA, 60% to 70% come from pharmaceutical companies, while reports from Chinese pharmaceutical firms account for only about 15% of the total.
The stark contrast between "70% and 15%" is closely related to differences in regulations regarding adverse drug reactions. The FDA mandates that pharmaceutical companies must report adverse reactions once discovered. Failure to report on time or shifting the responsibility to patients can result in legal consequences, including fines ranging from millions to billions of dollars. Additionally, companies are required to detail adverse reactions in drug labels as comprehensively as possible, which not only helps mitigate potential legal disputes but also encourages proactive reporting.
In contrast, domestic pharmaceutical companies in China tend to downplay adverse reactions, often emphasizing positive outcomes while omitting negative ones. Many firms negotiate with experts when revising drug labels, deliberately obscuring adverse reactions. This reluctance stems from three main fears: first, the concern that reporting adverse reactions will harm future sales; second, the worry about facing compensation claims from patients' families; and third, the pressure from public opinion. Ironically, these fears have led to a vicious cycle of recurring adverse reaction incidents.
Experts believe that under the current circumstances, domestic pharmaceutical companies urgently need to strengthen their sense of social responsibility and corporate citizenship, setting aside their concerns to actively report adverse reactions. At the same time, the public should develop a correct understanding of adverse drug reactions—not all drugs with adverse effects should be avoided. For instance, taking Celebrex in small doses or for short periods does not pose significant risks. (Editor: Jiang)
Source: http://news. cn. yahoo. com/ 050409/ 351/ 2arhk. html