U.S. Food and Drug Administration Updates for Health Professionals
Dear Colleague,
As part of our ongoing efforts to keep you informed about FDA issues, we want to make you aware of recent safety alerts, product approvals, announcements, upcoming meetings and resources. We have included a list of the issues, a brief summary of each issue, and links to detailed information on the FDA Web site.
PRODUCT SAFETY:
Orlistat (marketed as Alli and Xenical): Labeling Change (May 26)
FDA notified healthcare professionals and patients that it has approved a revised label for Xenical to include new safety information about cases of severe liver injury that have been reported rarely with the use of this medication. The agency is also adding a new warning about rare reports of severe liver injury to the OTC Drug Facts label for Alli.
Ultram (tramadol hydrochloride), Ultracet (tramadol hydrochloride/acetaminophen): Label Change (May 25)
Ortho-McNeil-Janssen and FDA notified healthcare professionals of changes to the Warnings section of the prescribing information for tramadol, a centrally acting synthetic opioid analgesic indicated for the management of moderate to moderately severe chronic pain. The strengthened Warnings information emphasizes the risk of suicide for patients who are addiction-prone, taking tranquilizers or antidepressant drugs and also warns of the risk of overdosage.
Proton Pump Inhibitors (PPI): Class Labeling Change (May 25)
FDA notified healthcare professionals and patients of revisions to the prescription and over-the-counter [OTC] labels for proton pump inhibitors, which work by reducing the amount of acid in the stomach, to include new safety information about a possible increased risk of fractures of the hip, wrist, and spine with the use of these medications. The new safety information is based on FDA's review of several epidemiological studies that found those at greatest risk for these fractures received high doses of proton pump inhibitors or used them for one year or more.
Updated Questions and Answers for Healthcare Professionals and the Public: Use an Approved Pancreatic Enzyme Product (PEP) (May 24)
This set of Questions and Answers was originally posted on April 12, 2010. It is being updated to provide additional information to healthcare professionals and the public about the safe use of approved pancreatic enzyme products.
Sagent Pharmaceuticals Initiates a Nationwide Voluntary Recall of All Lots of Metronidazole Injection, USP 500 mg/100 ml (May 17)
Sagent Pharmaceuticals, Inc. announced the voluntary nationwide recall of all lots of metronidazole injection, USP 500mg / 100mL (NDC number 25021-131-82) manufactured by Claris Lifesciences and distributed by Sagent. The lot numbers being recalled are: A090742, A090743, A090744, A090745, A090746, A090769, A090770, A090771, A090772, A090773, A090774, A090775, A090776, A090968, A091014, A000013, A000016 and A000019, which were distributed to hospitals, wholesalers and distributors nationwide from February through May 2010. Metronidazole injection, USP is an intravenous antimicrobial product used to treat infections and is supplied in a single dose plastic container.
Voluntary Recall of HYLENEX Initiated (May 17)
Baxter International Inc. (NYSE:BAX) announced today that a voluntary recall of all manufactured lots of HYLENEX recombinant (hyaluronidase human injection) has been initiated as a precautionary measure due to instances of particulate matter observed in a limited number of HYLENEX vials during routine stability testing. Baxter is working with the product's NDA-holder, Halozyme Therapeutics, to investigate the root cause of the issue and appropriately address the situation. HYLENEX recombinant is a tissue permeability modifier indicated as an adjuvant in subcutaneous fluid administration for achieving hydration; to increase the dispersion and absorption of other injected drugs; and in subcutaneous urography for improving resorption of radiopaque agents.
Rotarix Vaccine: Update to Clinicians and Public Health Professionals (May 16)
FDA has determined it is appropriate for clinicians and health care professionals to resume the use of Rotarix and to continue the use of RotaTeq. Based on a careful evaluation of laboratory results from the manufacturers and its own laboratories, a thorough review of the scientific literature, and input from scientific and public health experts, the agency is revising its recommendation to temporarily suspend use of the Rotarix vaccine. FDA has also determined that RotaTeq vaccine should remain in use.
GE Healthcare Aisys and Avance Anesthesia Systems: Recall (May 13)
GE and FDA notified healthcare professionals of a Class I Recall of specific lots of the Aisys and Avance Anesthesia Systems. The control board wiring harnesses have a defect which can cause the machine to unexpectedly shut down, terminating ventilation, anesthetic delivery, and potentially patient monitoring.
For more product safety information please visit our MedWatch website.
PRODUCT APPROVALS:
FDA Approves New Treatment for Late-Onset Pompe Disease (May 25)
FDA approved Lumizyme (alglucosidase alfa) for patients ages 8 years and older with late-onset (non-infantile) Pompe disease, a rare genetic disorder. Pompe disease occurs in an estimated 1 in every 40,000 to 300,000 births. Its primary symptom is heart and skeletal muscle weakness, progressing to respiratory weakness and death from respiratory failure.
For more information on drug approvals, please visit Drugs@FDA.
ANNOUNCEMENTS:
Healthcare professionals should be aware that the supply of Thyrogen (recombinant thyroid stimulating hormone [TSH]), a drug used in the treatment and follow-up diagnosis of thyroid cancer, will be temporarily limited.
On May 24, 2010, the U.S. Food and Drug Administration (FDA) and Genzyme entered into a legal settlement (consent decree) that is designed to permit Genzyme to produce, for the United States market, enough Thyrogen to meet the needs of patients for whom FDA considers the drug to be medically necessary. Accordingly, the consent decree restricts Genzyme's U.S. distribution of Thyrogen to customers (meaning entities that purchase Thyrogen kits directly from Genzyme, such as distributors and wholesalers) who sign a Certificate of Procedures Related to Medical Necessity. This Certificate notes the customer's agreement to distribute the product with a Dear Healthcare Provider Letter, which describes the patients for whom FDA considers Thyrogen to be medically necessary. This restriction will remain in place until Genzyme corrects manufacturing issues at their Allston Landing facility, where the fill/finish manufacturing operations for Thyrogen are performed, or transfers fill/finish manufacturing operations for Thyrogen to other manufacturing facilities operating in compliance with FDA regulations.
FDA and the National Institutes of Health (NIH) Launch Electronic Safety Reporting Portal (May 24)
FDA and NIH launched a new Web site that, when fully developed, will provide a mechanism for the reporting of pre- and post-market safety data to the federal government. Currently the Web site can be used to report safety problems related to foods, including animal feed, and animal drugs, as well as adverse events occurring on human gene transfer trials. Consumers can also use the site to report problems with pet foods and pet treats. The new site, called the Safety Reporting Portal (SRP), provides greater and easier access to online reporting.
FDA Clears First 2009 H1N1 Influenza Virus Test Previously Approved for Emergency-Use Only (May 24)
FDA announced it has cleared the Simplexa Influenza A H1N1 (2009), a test for the 2009 H1N1 Influenza Virus in patients with signs and symptoms of respiratory infection. Until this clearance, tests for 2009 H1N1 Influenza were only available through an Emergency Use Authorization (EUA), which allows the FDA, based on the evaluation of available data, to authorize the use of unapproved or uncleared medical products or unapproved or uncleared uses of approved or cleared medical products, during the time a declaration of emergency is in effect.
FDA Transparency Initiative: Draft Proposals (May 19)
FDA released a draft report on the public disclosure policies of FDA. The goal is to facilitate transparency that promotes public health and innovation.
The report proposes for public comment 21 specific draft proposals. These draft proposals reflect close review of more than 1,500 public comments and extensive consideration and discussion within FDA.