A paid subscription is required for full access. Additional Information. Number of all FDA drug product recall enforcement reports issued Medical Technology. Distribution of major causes for medical device recalls in U. Pharmaceutical industry financial penalties in the U.
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This statistic is not included in your account. Skip to main content Try our corporate solution for free! Single Accounts Corporate Solutions Universities. Premium statistics. Read more. This statistic depicts a list of selected FDA-approved prescription drugs, which were later pulled from the U. The reason for the recall was serious toxicity to the heart: between and there were over 2, deaths reported connected to that drug.
According to the Food and Drug Adminitration FDA , 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, such as when it is discovered that the drug can cause serious side effects that were not known at the time of approval. You need a Single Account for unlimited access.
Full access to 1m statistics Incl. Single Account. Up to , suffered from heart attacks or strokes after taking Vioxx. Bextra, like Vioxx, was a pain reliever meant to treat arthritis and other inflammation in the body. Its manufacturer, Pfizer, recalled the drug in after being on the market for one year. Also like Vioxx, but not as widely or heavily publicized, Bextra was recalled due to increased risk of heart attack and stroke in some patients, but it was also found to cause a fatal skin condition.
It is one of the largest criminal fines imposed on a U. Baycol, made by Bayer, was recalled after being on the market for four years. In , Bayer recalled Baycol, a drug for patients with high cholesterol, after it was reported to be the cause of more than , deaths and connected to a muscle disorder called rhabdomyolysis, a condition that caused the kidneys to clog with protein from dying or dead muscle tissue.
In May , Able Laboratories unexpectedly recalled and removed all their generic prescription drugs from the market due to questions about the quality of their manufacturing process. Some of the drugs were scrutinized for being too strong, and others were not effective enough.
Able Laboratories went out of business after this recall. The Los Angeles Times gave the first insight into the way Rezulin was recalled in after one year on the market. Rezulin, an anti-diabetic drug manufactured by Warner-Lambert, was recalled after links with hepatitis and liver failure were discovered. Or can we? This new study adds to our concerns.
With the politics in our nation being under the control of the pro-market neoliberals and conservatives, the pharmaceutical industry and insurance companies have been given a most favored status under the belief that markets will serve the public better if not constrained by supposedly excessive government oversight.
In the case of pharmaceuticals, the public can experience the benefits earlier of the new blockbuster miracle drugs if the government FDA will just get out of the way, or so they say. More recent laws and regulations have allowed pharmaceutical firms to pay fees to enter an accelerated process for new drug approval like buying their way to the front of the queue. This accelerated process has been expanded to include most new drugs, ignoring the fact that there may be a conflict of interest when firms can buy off government regulators to expedite approval of their products.
To be sure that the information evaluated truly represents the value of the new drugs, pharmaceutical firms have agreed to register all studies in advance and not just the studies with favorable results. But research studies with adverse results are still being filed away without public oversight, explaining some of the reason that drugs on the market do not have the same benefits and safety margin as the pre-marketing studies submitted to the FDA show.
Also the firms have promised close post-marketing surveillance, but that seems to disappear once the drug is approved.
Also the firms are not required to compare new drugs with existing drugs even though many turn out to be inferior. Yet with our lax rules on direct-to-consumer advertising, a demand can be created for these new drugs in spite of their typically outrageous prices. This problem is serious. The study by Saluia et al. About , people die each year from drug reactions, and this is particularly tragic when it is from a drug that never should have been on the market in the first place.
The stewards of a well designed single payer system would demand much better performance from the pharmaceutical industry — drugs and other biomedical products that are effective, that are an improvement over existing treatments, that are reasonably safe, and that are priced appropriately based on legitimate costs and a fair profit margin.
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