FDA Asks Purdue Pharma to Withdraw Palladone for Safety Reasons
After acquiring new information that serious and potentially fatal adverse reactions can occur when Palladone (hydromorphone hydrochloride) extended release capsules are taken together with alcohol, the U.S. Food and Drug Administration has asked Purdue Pharma L.P., the makers of the drug, to withdraw it from the market.
Palladone is a once-a-day pain management drug containing a very potent narcotic. New data gathered from a company-sponsored study testing the potential effects of alcohol use shows that when Palladone is taken with alcohol the extended release mechanism is harmed which can lead to dose-dumping. Dose-dumping is a term that describes the rapid release of the active ingredient from an extended release product into the blood stream. The consequences of dose dumping at the lowest marketed dose (12 mg.) of Palladone could lead to serious, or even fatal, adverse events in some patients and the risk is even greater for the higher strengths of the product. As a result of this potential serious safety risk, the FDA has asked Purdue Pharma, and they have agreed, to suspend all sales and marketing of Palladone in the U.S. pending further discussions with the agency.
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Suicidality in Adults Being Treated with Antidepressant Medications
Public Health Advisory: Suicidality in Adults Being Treated with Antidepressant Medications
Audience: Neuropsychiatric healthcare professionals and consumers
[UPDATE 07/08/2005] FDA notified healthcare professionals about the availability of updated Healthcare Professional and Patient Information Sheets for antidepressant medications that were the subject of a June 30, 2005 Public Health Advisory issued about the risk of suicidality (suicidal thinking or behavior) in adults being treated with antidepressant medications.
[Posted 07/01/2005] In response to recent scientific publications that report the possibility of increased risk of suicidal behavior in adults treated with antidepressants, the FDA has issued a Public Health Advisory to update patients and healthcare providers with the latest information on this subject. Even before the publication of these recent reports, FDA had already begun the process of reviewing available data to determine whether there is an increased risk of suicidal behavior in adults taking antidepressants. The Agency has asked manufacturers to provide information from their trials using an approach similar to that used in the evaluation of the risk of suicidal behavior in the pediatric population taking antidepressants. This effort will involve hundreds of clinical trials and may take more than a year to complete.
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Liqiang 4 Dietary Supplement Capsules
Liqiang 4 Dietary Supplement Capsules
Audience: Consumers and Healthcare professionals
[Posted 07/05/2005] FDA notified consumers and healthcare professionals about the risks of taking Liqiang 4 Dietary Supplement Capsules because they contain glyburide – a drug that could have serious, life-threatening consequences in some people. The product is manufactured by Liqiang Research Institute, China, and marketed throughout the United States in herbal stores and through mail order by Bugle International of Northridge CA. Glyburide is a drug used to lower blood sugar, and is safe and effective when used as labeled in FDA-approved medications. People who have low blood sugar or those with diabetes can receive dangerously high amounts of glyburide by consuming Liqiang 4. Consumers should immediately stop using these products and seek medical attention, especially if they are currently being treated with diabetes drugs or if they have symptoms of fatigue, excessive hunger, profuse sweating, or numbness of the extremities.
FDA Issues Nationwide Alert for “Liqiang 4″ Due to Potential Health Risk
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Cialis, Levitra, Viagra
Cialis (Tadalafil)
Levitra (Vardenafil hydrochloride)
Viagra (Sildenafil citrate)
Audience: Urologists, Ophthalmologists and other healthcare professionals
[Posted 07/08/2005] FDA notified healthcare professionals of updated labeling for Cialis, Levitra and Viagra to reflect a small number of post-marketing reports of sudden vision loss, attributed to NAION (non arteritic ischemic optic neuropathy), a condition where blood flow is blocked to the optic nerve. FDA advises patients to stop taking these medicines, and call a doctor or healthcare provider right away if they experience sudden or decreased vision loss in one or both eyes. Patients taking or considering taking these products should inform their health care professionals if they have ever had severe loss of vision, which might reflect a prior episode of NAION. Such patients are at an increased risk of developing NAION again. At this time, it is not possible to determine whether these oral medicines for erectile dysfunction were the cause of the loss of eyesight or whether the problem is related to other factors such as high blood pressure or diabetes, or to a combination of these problems. The new labeling information is available along with additional information for healthcare providers and consumers at:
Cialis (http://www.fda.gov/cder/drug/infopage/cialis/default.htm)
Levitra (http://www.fda.gov/cder/drug/infopage/vardenafil/default.htm)
Viagra (http://www.fda.gov/cder/consumerinfo/viagra/viagra.htm)
Duragesic (fentanyl transdermal system)
Duragesic (fentanyl transdermal system)
Audience: Pain Specialists, Oncologists and other healtcare professionals
[Posted 07/08/2005] Janssen and FDA notified healthcare professionals of changes to the BOXED WARNING/WARNINGS, CONTRAINDICATIONS, PRECAUTIONS, and DOSAGE AND ADMINISTRATION sections of the prescribing information for Duragesic. These changes include important safety information in the following areas of the labeling: Use Only in Opioid-Tolerant Patients, Misuse, Abuse and Diversion, Hypoventilation (Respiratory Depression), Interactions with CYP3A4 Inhibitors, Damaged or Cut Patches, Accidental Exposure to Fentanyl, Chronic Pulmonary Disease, Head Injuries and Intracranial Pressure, Interactions with Other CNS Depressants, and Interactions with Alcohol and Drugs of Abuse.
Guidant Corporation Initiates Physician Communications
Guidant Initiates Worldwide Physician Communications Regarding Important Safety Information and Corrective Action about Implantable Cardiac Defibrillators
Contact:
Guidant Corporation
1-866-GUIDANT (1-866-484-3268)
FOR IMMEDIATE RELEASE — Indianapolis, Ind. — June 24, 2005 — Guidant Corporation (NYSE: GDT) said today it is voluntarily advising physicians about important safety information regarding certain devices. Guidant apprised FDA of this action, and FDA may classify this action as a recall. At this time, Guidant is in the very early stages of a diligent evaluation of the component failure described below. Guidant will continue its evaluation and communicate further as more information is learned. As a precautionary measure, physicians should discontinue implants of these devices pending further notice. This communication advises physicians and their patients of safety information and is intended to limit adverse events. Physicians should use this information to decide how best to treat their patients.
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New legal requirements recommended for sensitive data
FTC Testifies on Data Security and Identity Theft
The FTC today told Congress it should consider extending security protections for sensitive consumer data and requiring that companies that possess such data notify consumers when they are victims of security breaches that could result in identity theft. In testimony on data breaches and identity theft to the Senate Committee on Commerce, Science and Transportation, FTC Chairman Deborah Platt Majoras said that recent security breaches of data brokers and other companies that collect or maintain sensitive personal information are prompting the Commission and Congress to assess the need for new legal requirements for those who possess sensitive data.
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Labeling won’t reduce spam
FTC Issues Report to Congress
Requiring “ADV” Labeling for Commercial E-Mail Won’t Reduce Spam
In a report to Congress required by the Controlling the Assault of Non-Solicited Pornography and Marketing Act of 2003 (“CAN-SPAM Act”), the Federal Trade Commission says it does not recommend requiring unsolicited commercial e-mail to include a label in the subject line as a means to reduce spam.
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New FTC Publication Helps New Grads Become Wise Consumers
Graduation from high school or college is an exciting time when students focus on the future and the new responsibilities and opportunities it brings. The Federal Trade Commission has issued a new consumer alert, “How to Be the Class ‘Value-dictorian,’” that gives students and graduates tips to avoid scams, keep their personal information safe, and hold on to their hard-earned money.
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