Online: FDA Web Site Offers Virtual Treasure-Trove

For more information about The Food and Drug Administration's (FDA's) approval for drugs, medical devices and biologics, visit http://www.fda.gov/. The FDA's new mission statement says that the agency is responsible, inter alia, for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation; for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

Hot Topics on the site include: BSE (“Mad Cow Disease”), Ephedra, Imported Drugs, Counterterrorism, Bioterrorism Act, Counterfeit Drugs, and Buying Medicines Online. The information about online prescriptions contains tips and warnings for consumers. For example, purchasing online from an illegal Web site puts the purchaser at risk. He or she may receive a contaminated or counterfeit product, the wrong product, an incorrect dose, or no product at all. Additional risks include potentially dangerous drug interactions and other serious health consequences.

Click on “Drugs” and you'll find yourself at the site for the Center for Drug Evaluation and Research (CDER). News from the CDER includes two March 22 items: one from the FDA and Lilly notifying health care professionals about a revision to the WARNINGS section of labeling, describing the increased risk of hyperglycemia and diabetes in patients taking Zyprexa. There is a link to MedWatch Safety Info for further information. A second item requested a warning statement in labeling for certain antidepressants to encourage close observation for worsening depression or the emergence of suicidality. There are two March 17 items: one approving the first-time generic Desferal for Injection for the treatment of acute iron intoxication or chronic iron overload, the other approving first-time generic Naproxen Sodium and Pseudoephedrine Hydrochloride Extended-release Tablets for the temporary relief of these cold, sinus and flu symptoms: sinus pressure, minor body aches and pains, headache, fever, nasal and sinus congestion.

If you click on “Medical Devices,” you'll go to the Center for Devices and Radiological Health (CDRH). There's information on Industry Assistance, Health Topics and Device Program Areas. Key topics covered include: diabetes, LASIK, CT scanning, breast implants, cell phones and a patient safety portal. The purpose of the portal is to continuously inform and educate health care professionals on patient safety issues as related to medical devices, by providing a convenient mechanism in which to access current and emerging issues within the federal domain. You'll also find news describing the FDA's new Heart Health Online Web site. This new Web site gives you reliable information about the products used to prevent, diagnose, and treat cardiovascular disease. It includes full descriptions and patient instructions for many medications, medical devices, and diagnostic tests for cardiovascular disease.

The CDRH site also links to the FDA Patient Safety News, which can be viewed as a webcast. The March 2004 edition contains features addressing new products, protecting patients, a journal scan and what patients ask about. The new products described include a new test kit that will make it easier for laboratories to distinguish Bacillus anthracis, the organism that causes anthrax disease, from other Bacillus types. The test kit, manufactured by Tetracore, Incorporated, is called Redline Alert. It's an immunoassay that contains a monoclonal antibody which binds to a surface protein found on the anthrax bacillus. Another link advises readers that Ortho-McNeil Pharmaceuticals has revised the prescribing information for the antiepileptic drug Topamax (topiramate) to include a warning that the drug causes hyperchloremic metabolic acidosis. The “Journal Scan” talks about the dangers presented by abbreviations because they can be interpreted differently by different practitioners. The Institute for Safe Medication Practices recently published an updated list of some of the most error-prone abbreviations and dose designations. ISMP identifies dozens of dangerous abbreviations, including the prohibited abbreviations that are a part of JCAHO's National Patient Safety Goals for 2004. “Patients Are Asking” discusses women's questions about the FDA's recent decision to turn down a manufacturer's application to market silicone gel-filled breast implants. Women may want to know why the FDA did this, what the decision means in terms of safety, what kinds of implants remain available and under what circumstances, and what the future holds. The March edition of this feature answers these questions.

The FDA's News Releases Archives will take you to links with information about FDA approvals and warnings. For example, the FDA released a statement on its approval of generic oxycodone hydrochloride extended-release tablets. The FDA and the Environmental Protection Agency (EPA) announced their joint consumer advisory on methylmercury in fish and shellfish for reducing the exposure to high levels of mercury in women who may become pregnant, pregnant women, nursing mothers, and young children, unifying advice from both the FDA and the EPA and superseding the FDA's and the EPA's 2001 advisories. There are announcements of meetings of the General and Plastic Surgery Devices Panel and a public meeting on Prescription Drug Importation, as well as information on recalls, market withdrawals and safety alerts.

For more information about The Food and Drug Administration's (FDA's) approval for drugs, medical devices and biologics, visit http://www.fda.gov/. The FDA's new mission statement says that the agency is responsible, inter alia, for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation; for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

Hot Topics on the site include: BSE (“Mad Cow Disease”), Ephedra, Imported Drugs, Counterterrorism, Bioterrorism Act, Counterfeit Drugs, and Buying Medicines Online. The information about online prescriptions contains tips and warnings for consumers. For example, purchasing online from an illegal Web site puts the purchaser at risk. He or she may receive a contaminated or counterfeit product, the wrong product, an incorrect dose, or no product at all. Additional risks include potentially dangerous drug interactions and other serious health consequences.

Click on “Drugs” and you'll find yourself at the site for the Center for Drug Evaluation and Research (CDER). News from the CDER includes two March 22 items: one from the FDA and Lilly notifying health care professionals about a revision to the WARNINGS section of labeling, describing the increased risk of hyperglycemia and diabetes in patients taking Zyprexa. There is a link to MedWatch Safety Info for further information. A second item requested a warning statement in labeling for certain antidepressants to encourage close observation for worsening depression or the emergence of suicidality. There are two March 17 items: one approving the first-time generic Desferal for Injection for the treatment of acute iron intoxication or chronic iron overload, the other approving first-time generic Naproxen Sodium and Pseudoephedrine Hydrochloride Extended-release Tablets for the temporary relief of these cold, sinus and flu symptoms: sinus pressure, minor body aches and pains, headache, fever, nasal and sinus congestion.

If you click on “Medical Devices,” you'll go to the Center for Devices and Radiological Health (CDRH). There's information on Industry Assistance, Health Topics and Device Program Areas. Key topics covered include: diabetes, LASIK, CT scanning, breast implants, cell phones and a patient safety portal. The purpose of the portal is to continuously inform and educate health care professionals on patient safety issues as related to medical devices, by providing a convenient mechanism in which to access current and emerging issues within the federal domain. You'll also find news describing the FDA's new Heart Health Online Web site. This new Web site gives you reliable information about the products used to prevent, diagnose, and treat cardiovascular disease. It includes full descriptions and patient instructions for many medications, medical devices, and diagnostic tests for cardiovascular disease.

The CDRH site also links to the FDA Patient Safety News, which can be viewed as a webcast. The March 2004 edition contains features addressing new products, protecting patients, a journal scan and what patients ask about. The new products described include a new test kit that will make it easier for laboratories to distinguish Bacillus anthracis, the organism that causes anthrax disease, from other Bacillus types. The test kit, manufactured by Tetracore, Incorporated, is called Redline Alert. It's an immunoassay that contains a monoclonal antibody which binds to a surface protein found on the anthrax bacillus. Another link advises readers that Ortho-McNeil Pharmaceuticals has revised the prescribing information for the antiepileptic drug Topamax (topiramate) to include a warning that the drug causes hyperchloremic metabolic acidosis. The “Journal Scan” talks about the dangers presented by abbreviations because they can be interpreted differently by different practitioners. The Institute for Safe Medication Practices recently published an updated list of some of the most error-prone abbreviations and dose designations. ISMP identifies dozens of dangerous abbreviations, including the prohibited abbreviations that are a part of JCAHO's National Patient Safety Goals for 2004. “Patients Are Asking” discusses women's questions about the FDA's recent decision to turn down a manufacturer's application to market silicone gel-filled breast implants. Women may want to know why the FDA did this, what the decision means in terms of safety, what kinds of implants remain available and under what circumstances, and what the future holds. The March edition of this feature answers these questions.

The FDA's News Releases Archives will take you to links with information about FDA approvals and warnings. For example, the FDA released a statement on its approval of generic oxycodone hydrochloride extended-release tablets. The FDA and the Environmental Protection Agency (EPA) announced their joint consumer advisory on methylmercury in fish and shellfish for reducing the exposure to high levels of mercury in women who may become pregnant, pregnant women, nursing mothers, and young children, unifying advice from both the FDA and the EPA and superseding the FDA's and the EPA's 2001 advisories. There are announcements of meetings of the General and Plastic Surgery Devices Panel and a public meeting on Prescription Drug Importation, as well as information on recalls, market withdrawals and safety alerts.