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The 17th New Drug Safety Withdrawal Since 1992
The Health Research Group’s Seven-Year Rule You should wait at least seven years from the date of release to take any new drug unless it is one of those rare “breakthrough” drugs that offers you a documented therapeutic advantage over older proven drugs. New drugs are tested in a relatively small number of people before being released, and serious adverse effects or life-threatening drug interactions may not be detected until the new... |
The 17th New Drug Safety Withdrawal Since 1992
The Health Research Group’s Seven-Year Rule You should wait at least seven years from the date of release to take any new drug unless it is one of those rare “breakthrough” drugs that offers you a documented therapeutic advantage over older proven drugs. New drugs are tested in a relatively small number of people before being released, and serious adverse effects or life-threatening drug interactions may not be detected until the new drug has been taken by hundreds of thousands of people. A number of new drugs have been withdrawn within their first seven years after release. Also, warnings about serious new adverse reactions have been added to the labeling of a number of drugs, or new drug interactions have been detected, usually within the first seven years after a drug’s release. |
Palatin Technologies and Mallinckrodt Inc. of St. Louis, Mo., have agreed to remove the diagnostic drug technetium 99m Tc fanolesomab from the market because of potentially fatal adverse drug reactions, according to a Dec. 19, 2005 Food and Drug Administration announcement. The drug was approved for marketing in July 2004 as an imaging agent. It is administered intravenously (by injection) to help diagnose appendicitis in patients over five years old who do not demonstrate the conventional signs and symptoms of appendicitis.
This product is a monoclonal antibody attached to a radioactive element. There is no indication that the radiopharmaceutical component of the product, the technetium-99m, was related to the occurrence of these events.
The FDA had received reports of two deaths and 15 additional life-threatening adverse reactions in patients receiving technetium 99m Tc fanolesomab. These events occurred within minutes of the administration of the drug. They included shortness of breath, low blood pressure, and cardiopulmonary arrest. The affected patients required resuscitation with intravenous fluids, blood pressure support, and oxygen. Most but not all of the patients who experienced these adverse reactions had existing heart or lung conditions or both that may have placed them at higher risk for developing adverse reactions. A review of all post-marketing reports for the drug found an additional 46 patients who experienced adverse reactions that were similar but less severe. There is no evidence that patients who received the drug without incident in the past face any long-term risk.
The FDA’s decision to suspend the marketing of technetium 99m Tc fanolesomab was based on the life-threatening nature of the associated adverse events, the unpredictability of the reaction, and the availability of other means of diagnosing appendicitis that do not carry these risks.
The banning of technetium 99m Tc fanolesomab from the market makes the 17th new drug safety withdrawal in the U.S. since 1992. This is an average 1.3 new drugs being withdrawn every year since 1992 for safety reasons.
The year 1992 is significant as it marked the passage of the Prescription Drug User Fee Act (PDUFA) and the beginning of the epidemic of new drug safety withdrawals. With this law, Congress authorized the FDA to collect money from drug companies to help cover the cost of reviewing marketing applications for new drugs. Initially, these monies could only be used to speed new drug reviews and nothing else. In effect, Congress recast the FDA as the drug industry’s partner in the development of new drugs and the industry, rather than the American public, as the agency’s primary client.
The banning of technetium 99m Tc fanolesomab underscores the importance of our Seven-Year Rule. The majority of new drugs withdrawn from the market for safety reasons since 1992 were not drugs with unique therapeutic properties. Rather, they were redundant “me-too” drugs, sometimes only minor chemical modifications of drugs already on the market, in drug families that offered consumers numerous safer treatment options.
What You Can Do
By following our Seven-Year Rule which appears with this article, you and your family members can avoid potentially serious adverse drug reactions from new drugs.
