FDA NEWS

Recalls and Safety Alerts: Higher Mortality for Certain Elderly Patients with Innohep
Celgene is alerting healthcare professionals of an increased mortality risk among certain elderly patients treated with Innohep (tinzaparin sodium injection). Innohep is a low-molecular weight heparin that is used along with warfarin to treat acute ...
Source: www.accessdata.fda.gov

Patients Are Asking: Caution Using Topical Anesthetics Prior to Mammography
FDA is alerting patients and healthcare professionals about the potential danger of using topical anesthetics to relieve pain before having mammography or other medical procedures. The concern is that patients may apply these drugs improperly, which...
Source: www.accessdata.fda.gov

FDA Warns About Risk of Wearing Medicated Patches During MRIs
Certain adhesive patches that deliver medication through the skin have been found to be a risk to patient safety. The patches, if worn while undergoing magnetic resonance imaging scans or MRIs, can cause skin burns, says the U.S. Food and Drug Administration today.
Source: www.fda.gov

Patients Are Asking: Potentially Fatal Salmonella Infections from Pet Turtles
Turtles may look like cute pets, but it is estimated that they are responsible for over 70,000 cases of Salmonella infections every year in this country. Some of these infections can be serious or even fatal. In one case, a four week-old infant d...
Source: www.accessdata.fda.gov

FDA Shuts Down a Flour Tortilla Manufacturer for Repeated Violations
The U.S. Food and Drug Administration (FDA) today announced that Del Rey Tortilleria Inc., Chicago, Ill., its president, and two general managers have entered into a consent decree of permanent injunction that prevents Del Rey Tortilleria from manufacturing and distributing soft-shell flour tortillas until the company obtains FDA approval.
Source: www.fda.gov

FDA Takes Action Against KV Pharmaceutical Company
The FDA announced a Consent Decree of permanent injunction filed March 2, 2009, enjoining KV Pharmaceutical Company, its subsidiaries ETHEX Corporation and Ther-Rx Corporation, and its principal officers from making and distributing adulterated and unapproved drugs. The injunction against KV and the other defendants, once entered by the court, will prevent them from manufacturing and shipping drugs until the firm obtains FDA approval. It will remain in place until the defendants sustain continuous compliance with FDA's current Good Manufacturing Practice (cGMP) and new drug approval requirements for five years.
Source: www.fda.gov

Preventing Medical Errors: Preventing Dosing Errors with Alteplase
In a recent report, the Institute for Safe Medication Practices warned about the possibility of prescribing and administering the wrong dose of alteplase when the indication for the drug is not specified. ISMP described a case of a patient in an i...
Source: www.accessdata.fda.gov

FDA Requires Boxed Warning and Risk Mitigation Strategy for Metoclopramide-Containing Drugs
The U.S. Food and Drug Administration announced today that manufacturers of metoclopramide, a drug used to treat gastrointestinal disorders, must add a boxed warning to their drug labels about the risk of its long-term or high-dose use. Chronic use of metoclopramide has been linked to tardive dyskinesia, which may include involuntary and repetitive movements of the body, even after the drugs are no longer taken.
Source: www.fda.gov