FDA is warning women of childbearing age about vinpocetine supplement. Vinpocetine may cause a miscarriage or harm fetal development.

Vinpocetine is a man-made chemical resembling a substance found in the periwinkle plant Vinca minor. People use it as medicine. Vinpocetine production requires considerable laboratory work, stretching the Dietary Supplement Health and Education Act (DSHEA) definition of a dietary supplement.
Also Known as AY-27255, Cavinton, Eburnamenine-14-carboxylic acid, Ethyl Apovincaminate, Ethylapovincaminoate, Ethyl Ester, RGH-4405, TCV-3b, Vinpocetin, Vinpocetina, Vinpocétine. As well as Vinca minor extract, lesser periwinkle extract, or common periwinkle extract.

FDA Release; 

Statement on warning for women of childbearing age about possible safety risks of dietary supplements containing vinpocetine

For Immediate Release:

June 03, 2019

Statement From:

Principal Deputy Commissioner - Office of the Commissioner

Amy Abernethy MD PhD.

Deputy Commissioner for Food Policy and Response - Food and Drug Administration

Frank Yiannas

Today, the U.S. Food and Drug Administration is warning consumers about safety concerns regarding an ingredient called vinpocetine that is found in dietary supplements, specifically concerns about the use of this ingredient by women of childbearing age. According to data reviewed by the FDA, including a recent report by the National Institute of Health’s (NIH) National Toxicology Program (NTP), consumption of vinpocetine is associated with adverse reproductive effects – in other words, vinpocetine may cause a miscarriage or harm fetal development.

These findings are particularly concerning since products containing vinpocetine are widely available for use by women of childbearing age. That’s why today we’re advising pregnant women and women who could become pregnant not to take vinpocetine. We are also advising firms marketing dietary supplements containing vinpocetine to evaluate their product labeling to ensure that it provides safety warnings against use by pregnant women and women who could become pregnant.

Vinpocetine is a synthetically produced compound that is used in some products marketed as dietary supplements, either by itself or combined with other ingredients. Vinpocetine may be referred to on product labels as Vinca minor extract, lesser periwinkle extract, or common periwinkle extract. Dietary supplements containing vinpocetine are often marketed for uses that include enhanced memory, focus, or mental acuity; increased energy; and weight loss. Scientists who have studied the effects of vinpocetine on pregnant animals concluded that vinpocetine decreased fetal weight and increased the chances of a miscarriage. The blood levels of vinpocetine measured in the pregnant animals were similar to those reported in people after taking a single dose of vinpocetine, indicating that pregnant women may experience adverse effects from vinpocetine similar to those seen in the pregnant animals. 

In some countries outside of the U.S., vinpocetine is regulated as a prescription drug. When products like vinpocetine are sold as dietary supplements in the U.S., they have not been reviewed by the FDA under the safety and effectiveness standards that apply to drug products. This means that the FDA has not reviewed each vinpocetine product, or its labeling, before those products become available to consumers.

In the 1990s, the FDA received several premarket safety submissions (known as new dietary ingredient notifications) for vinpocetine as an ingredient in dietary supplements. In 2016, we requested comment from stakeholders as part of an administrative proceeding to evaluate whether vinpocetine is legal for sale as a dietary supplement. With the results in NTP’s report, it was important to issue today’s warning because the availability of dietary supplement products containing vinpocetine has grown and the labels of vinpocetine products often have no warnings about the dangers of miscarriage and harm to fetal development. For the same reasons, the FDA will expedite completion of the administrative proceeding that we began in September 2016. 

The dietary supplement market is a growing industry, with sales multiplying ten-fold over the past 25 years and more than half of all Americans taking at least one dietary supplement on a regular basis. This expansion is one reason why earlier this year, the FDA announced new efforts to strengthen the regulation of dietary supplements by modernizing our regulatory framework.

Today’s safety warning is just one of many steps the FDA is taking to adapt to the realities of the evolving dietary supplement industry. Protecting the public from unsafe dietary supplements remains a top priority for the FDA. We’ve also created a public-private partnership, the Botanical Safety Consortium, to promote scientific advances in evaluating the safety of botanical ingredients and mixtures in dietary supplements. In April, we introduced a new tool, the Dietary Supplement Ingredient Advisory List, to more quickly alert the public when we become aware of ingredients that appear to be unlawfully marketed in dietary supplements. And finally, just last month, we held a public meeting with our stakeholders to discuss responsible innovation in the dietary supplements industry.

These efforts, along with today’s announcement regarding vinpocetine, underscore how the FDA will continue to preserve access to safe, well-manufactured, and accurately labeled dietary supplements, while we protect the American public from potentially unsafe or otherwise unlawful products.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Inquiries

Media:

 Lindsay Haake

 301-796-3007

Consumer:

 888-INFO-FDA

FDA Warning : Do Not Use Devices for Diabetes Management Not Authorized for Sale in the United States.

The FDA issued the following warning / advise due to adverse effects a diabetic patient received due to an unauthorized and / or malfunctioning Insulin delivery system. Some of these devices are used for diabetes management, alone or along with authorized devices.

The FDA is concerned about a serious adverse event report about a patient used an unauthorized device that receives the electronic signal from an FDA authorized glucose sensor and converts it to a glucose value using an unauthorized algorithm. Those devices were not designed to work together and the result was the automated insulin dosing system gave too much insulin in response to repeated incorrect high glucose values sent from the continuous glucose monitoring system, resulting in an insulin overdose which required medical intervention. As of now it is unclear whether the insulin overdose resulted from inaccurate glucose values reported from the unauthorized sensor, or a software malfunction in the unauthorized automated insulin dosing system that misinterpreted the electronic signal from the unauthorized continuous glucose monitoring system.

FDA Release

FDA Warns People with Diabetes and Health Care Providers Against the Use of Devices for Diabetes Management Not Authorized for Sale in the United States: FDA Safety Communication

Date Issued: May 17, 2019

Audience:

• People with diabetes who use continuous glucose monitoring systems (CGMs), insulin pumps, or automated insulin dosing (AID) systems to manage their diabetes
• Health care providers treating or managing patients with diabetes who use continuous glucose monitoring systems, insulin pumps, or automated insulin dosing systems to manage their diabetes

Medical Specialties:

General Practice, Internal Medicine, Nursing, Endocrinology, Hematology, Cardiology, Diabetes Care Management

Devices:

People with diabetes may need medication, such as insulin, to control blood glucose and may use the glucose level obtained from certain continuous glucose monitoring systems to calculate insulin dosage.

A continuous glucose monitoring system combines a glucose sensor inserted under the skin that continuously tracks glucose levels throughout the day and night with software that translates the signal from the sensor into glucose levels that are displayed to the user.

An insulin pump is a small computerized device that delivers insulin through a catheter (a small, flexible tube) placed under a person’s skin throughout the day. People with type 1 or type 2 diabetes may need an insulin pump when they require insulin to maintain acceptable blood glucose levels.

An automated insulin dosing system is a system that is intended to automatically deliver insulin doses based on glucose measurements from a continuous glucose monitoring system.

Purpose:

The U.S. Food and Drug Administration (FDA) is warning health care providers and people with diabetes of risks associated with use of devices for diabetes management unauthorized for sale in the U.S., whether used alone or along with other devices. These unauthorized diabetes management devices have not been reviewed by the FDA to ensure they provide a reasonable assurance of safety and effectiveness for their intended use. Use of unauthorized devices could result in inaccurate glucose level readings or unsafe insulin dosing, which can lead to injury requiring medical intervention or death.

Summary of Problem and Scope:

The FDA is concerned about people with diabetes using unauthorized devices for diabetes management used alone or along with authorized devices.

The FDA received a report of a serious adverse event in which a patient used an unauthorized device that receives the electronic signal from an FDA authorized glucose sensor and converts it to a glucose value using an unauthorized algorithm. Glucose values from this unauthorized continuous glucose monitoring system were sent to an unauthorized automated insulin dosing device to drive insulin dosing. The automated insulin dosing system gave too much insulin in response to repeated incorrect high glucose values sent from the continuous glucose monitoring system. This unauthorized system resulted in an insulin overdose requiring medical intervention. These devices were not designed to be used together and were combined in a way that had not been thoroughly tested for compatibility. Based on the available information, it is unclear whether the insulin overdose resulted from inaccurate glucose values reported from the unauthorized sensor, or a software malfunction in the unauthorized automated insulin dosing system that misinterpreted the electronic signal from the unauthorized continuous glucose monitoring system.

Some diabetes management devices are authorized for sale in the U.S. by the FDA only in a specific configuration, while others are authorized for use with other compatible devices, which may include automated insulin dosing systems, insulin pumps, blood glucose meters or other devices used for diabetes management.

For example, an authorized automated insulin dosing system will include a specific continuous glucose monitoring system, a specific insulin pump, and a specific algorithm. These devices are all tested and authorized together as a system.

Also, the FDA has authorized diabetes devices that have been designed to work safely with other devices, such as integrated continuous glucose monitoring systems and "automated controller enabled" insulin pumps, that comprise diabetes therapy systems. This approach allows patients to safely tailor their diabetes management. Devices are labeled to indicate which compatible devices patients can safely use together as a system.

When patients combine devices that are not intended for use with other devices, or when patients use any unauthorized devices, new risks are introduced that the FDA has not evaluated for safety or effectiveness. Patient use of unauthorized diabetes management devices, alone or along with other devices, could result in inaccurate glucose level readings or unsafe insulin dosing. These inaccuracies may lead to injuries requiring medical intervention, such as severe low blood sugar, coma, diabetic ketoacidosis (buildup of acids in blood), and death.

In addition, the FDA is aware of manufacturers marketing unauthorized diabetes management devices that use an algorithm to convert raw data from an FDA authorized glucose sensor to a glucose level displayed to the patient. The FDA has not evaluated the algorithm that these unauthorized devices use. The algorithm may return inaccurate glucose values.

Recommendations for People with Diabetes Who Use Diabetes Management Devices:

• Talk to your health care provider about diabetes management devices and how to use them correctly.
• Use diabetes management devices that the FDA authorized for sale in the U.S. and use them according to manufacturer instructions. You may ask the manufacturer or you may contact the FDA, at DICE@FDA.HHS.GOV, 800-638-2041 or 301-796-7100, if you have questions about the FDA regulatory status of any particular product.
• Be aware that the FDA has not evaluated the safety and effectiveness of unauthorized diabetes management devices or of systems that combine devices in unintended ways.
• Be aware that the use of unauthorized devices and systems may give you incorrect results and have unknown risks.
• If you experience an adverse event associated with the use of any diabetes management device, whether it is authorized or unauthorized, please report adverse events through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

Recommendations for Health Care Providers:

• Be aware that the FDA has not evaluated the safety and effectiveness of unauthorized diabetes management devices or the safety and effectiveness of systems that combine devices in unintended ways. Be aware that the use of these types of devices and systems may introduce unknown risks.
• Be aware that your patients should only use diabetes management devices the FDA has authorized for sale in the U.S. and should use them according to manufacturer instructions. You may ask the manufacturer or you may contact the FDA, at DICE@FDA.HHS.GOV, 800-638-2041 or 301-796-7100, if you have questions about the FDA regulatory status of any particular product.
• If any patients experience adverse events associated with the use of any diabetes management device, whether it is authorized or unauthorized, please report adverse events through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

Thermography Should Not Be Used in Place of Mammography to Detect, Diagnose, or Screen for Breast Cancer: FDA Safety Communication

 

FDA Warns Thermography Should Not Be Used in Place of Mammography to Detect, Diagnose, or Screen for Breast Cancer: FDA Safety Communication

Date Issued

February 25, 2019

Audience

• Women
• People recommended for breast cancer screening
• Health care providers
• Cancer treatment advocacy organizations

Medical Specialties

Radiology, Pathology, Internal Medicine, Obstetrics/Gynecology, Oncology, Nursing, General Practice, Breast Surgery, Acupuncture, Osteopathy, Chiropractic, Naturopath

Product

Thermography is a noninvasive tool that uses an infrared camera to produce images (thermograms) that show the patterns of heat and blood flow on or near the surface of the body. Thermography devices, also known as digital infrared imaging devices, have been cleared for marketing by the FDA only for use with another screening or diagnostic test like mammography, not for use as a standalone diagnostic tool.

Purpose

The FDA is alerting women, health care providers, and people getting breast cancer screening, that thermography is not an effective alternative to mammography and should not be used in place of mammography for breast cancer screening or diagnosis.

There is no valid scientific data to demonstrate that thermography devices, when used on their own or with another diagnostic test, are an effective screening tool for any medical condition including the early detection of breast cancer or other diseases and health conditions.

Mammography (taking X-ray pictures of the breasts) is the most effective breast cancer screening method and the only method proven to increase the chance of survival through earlier detection.

Summary of Problem and Scope

The FDA is aware that health spas, homeopathic clinics, mobile health units, and other health care facilities are using thermography inappropriately as a standalone tool for breast cancer screening or diagnosis.

The FDA has received reports that these types of facilities provide false information that can mislead patients into believing that thermography is an alternative or better option than mammography. Some facilities make inaccurate, unsupported, and misleading claims, such as thermography can find breast cancer years before it would be detected through other methods or thermography improves detection of cancer in dense breasts.

None of these claims are true or have any valid scientific evidence to support them. In addition, the Society for Breast Imaging notes a lack of evidence that thermography has any effective role in breast cancer screening.  Mammography is the most safe and effective tool for screening and diagnosis of breast cancer, and the only method proven to increase the chance of survival through earlier detection.

The FDA is concerned that people will believe the misleading claims about thermography and not get mammograms to screen for breast cancer.  People who choose thermography instead of mammograms may miss the chance to detect cancer at its earliest and most treatable stages. The agency is taking steps to stop the false advertising of thermography—see the FDA Actions section below for more information.

Recommendations for People Getting Breast Cancer Screening  

• Be aware that thermography is not a substitute for regular mammograms and should not be used in place of mammography for breast cancer screening or diagnosis.
• Have regular mammograms according to screening guidelines or as recommended by your health care provider.
  • You can learn more about what to expect during a mammogram on the FDA's Mammograms webpage.
• Follow your health care provider's recommendations for additional steps to diagnose breast cancer such as a clinical breast exam, other breast imaging (for example, breast ultrasound or MRI), or breast tissue biopsy.

Recommendations for Health Care Providers

• Educate patients about the limitations of thermography. For example, the high false negative and false positive rates of thermography can provide misleading information that could result in a delayed diagnosis or unnecessary medical follow up.
• Discourage the use of thermography to diagnose or screen for breast cancer.
• Talk to patients or caregivers about safe and effective ways to screen for breast cancer including the benefits and risks of available testing options.

FDA Actions

On February 22, 2019, the FDA issued a Warning Letter to Total Thermal Imaging, Inc., in La Mesa, California, for marketing and promoting thermography devices for uses that have not received marketing clearance or approval.

The FDA has also issued Warning Letters to the following facilities:

• Warning Letter to Thermogram Assessment Services (November 10, 2016)
• Warning Letter to Nature's Treasures (April 17, 2017)
• Warning Letter to Meditherm, Inc (April 4, 2011)
• Warning Letter to Dr. Joseph Mercola, Dr. Mercola's Natural Health Center (March 22, 2011)
• Warning Letter to Central Coast Thermography (January 6, 2011)

In these Warning Letters, the FDA instructed the providers to immediately stop making inappropriate claims about thermography devices.

The FDA is closely monitoring adverse event reports associated with thermography and will take additional steps necessary to address the risks associated with use of these products. We are committed to protecting and promoting access to safe and effective breast screening devices. 

FDA warns compounders not to use glutathione from Letco Medical, Decatur, Alabama.

FDA warns compounders not to use glutathione from Letco Medical to compound sterile drugs

Agency is aware of adverse events related to compounded glutathione injection

[2/1/2019] FDA is warning compounders not to use glutathione-L-reduced powder distributed by Letco Medical, Decatur, Alabama, to compound sterile injectable drugs for patients. Based on reported adverse events, the agency has concerns with use of the Letco distributed glutathione to compound injectable drugs due to potential endotoxins.

Letco supplied this glutathione powder to about 100 compounders in 30 states. FDA urges compounders that use glutathione to make sterile injectable drugs to ensure the glutathione powder is appropriate for compounding sterile drugs, including checking with their supplier.

FDA is aware of seven patients who experienced various adverse events ranging from nausea and vomiting to difficulty breathing, which required one patient to be hospitalized immediately after receiving glutathione 200mg/mL intravenous injection. FDA believes high levels of endotoxin may have contributed to these adverse events. Following these reports, FDA has received varying third-party test results on the levels of endotoxin that may be present in Letco’s glutathione powder. FDA testing is underway.

Letco repackaged the glutathione into five sizes – 25gm, 50gm, 100gm, 500gm and 1kg – and distributed 13 lots with an expiration date of 6/17/2020:

• 1808030041
• 1808030042
• 1808030043
• 1808030044
• 1808030045
• 1808290090
• 1808290091
• 1808290092
• 1808290093
• 1810150048
• 1810150049
• 1810150050
• 1810150051

Health care professionals should check with their compounders regarding the source of the glutathione used to make sterile drugs for their patients. Patients who have concerns should talk to their health care professionals.

FDA is investigating this incident and will provide additional information as it becomes available.

FDA Drug Safety Communication Regarding Biogen Idec's Tecfidera (dimethyl fumarate)

Tecfidera (dimethyl fumarate) by Biogen Idec: Drug Safety Communication - Case of Rare Brain Infection PML Reported

[Posted 11/25/2014]
AUDIENCE: Neurology
ISSUE: FDA is warning that a patient with multiple sclerosis (MS) who was being treated with Tecfidera (dimethyl fumarate) developed a rare and serious brain infection called progressive multifocal leukoencephalopathy (PML), and later died. The patient who died was not taking any other drugs that affect the immune system or drugs that are thought to be associated with PML. As a result, information describing this case of PML is being added to the Tecfidera drug label.
PML is a rare and serious brain infection caused by the John Cunningham (JC) virus. The JC virus is a common virus that is harmless in most people but can cause PML in some patients who have weakened immune systems.
See the FDA Drug Safety Communication for additional clinical information about this case.

• Tecfidera is a drug used to treat relapsing forms of multiple sclerosis (MS), a brain and spinal cord disease in which patients experience multiple episodes of weakness, numbness, and other nervous system signs and symptoms that partially or completely resolve overs weeks or months. Patients may develop persistent symptoms and disability over time.
• Approximately 4,000 patients have taken Tecfidera in MS clinical trials, including 1,000 patients treated for at least 4 years. Biogen reports that more than 100,000 patients with MS worldwide have taken Tecfidera since FDA approved it in 2013.

Philadelphia Jury Find GlaxoSmithKline Guilty In Paxil-Birth Defects Lawsuit

Philadelphia jury has found GlaxoSmithKline guilty of negligence, but not guilty of outrageous conduct. It Awarded 2.5 million. The verdict is the first of about 600 similar Paxil lawsuits filed across the United States according to the Associated Press
Drug maker GlaxoSmithKline plans to appeal a $2.5 million verdict in a lawsuit that alleged the company's antidepressant drug Paxil caused birth defects.
This lawsuit was launched by a Philadelphia family whose son was born four years ago with a number of heart defects.
In 2005, the U.S. Food and Drug Administration (FDA) issued warnings that Paxil may be associated with birth defects, the AP reported.

The first study illustrates the potential risk of relapsed depression after stopping antidepressant medication during pregnancy. The authors followed pregnant women who in the past had major depression. During their pregnancy, some of these women were not feeling depressed and stopped taking their antidepressant medicines. Others stayed on their antidepressant medicines while pregnant. The women who stopped their medicine were five times more likely to have a relapse of depression during their pregnancy than were the women who continued to take their antidepressant medicine while pregnant. This study, by Lee Cohen and other authors, was published February 1, 2006 in the Journal of the American Medical Association (JAMA).

A second study suggests there may be additional, though rare, risks of SSRI medications during pregnancy. This study focused on newborn babies with persistent pulmonary hypertension (PPHN), which is a serious and life-threatening lung condition that occurs soon after birth of the newborn. Babies with PPHN have high pressure in their lung blood vessels and are not able to get enough oxygen into their bloodstream. About 1 to 2 babies per 1000 babies born in the U.S. develop PPHN shortly after birth, and often they need intensive medical care. In this study PPHN was six times more common in babies whose mothers took an SSRI antidepressant after the 20th week of the pregnancy compared to babies whose mothers did not take an antidepressant. The study was too small to compare the risk in one drug compared to another, and this risk has not so far been investigated by other researchers. The study, by Christina Chambers and others, was published on February 9, 2006 in The New England Journal of Medicine.

FDA Warns Against Body-building Supplements Claiming To Be Steroids

The FDA is notifying the public about new safety information concerning products marketed for body building and increasing muscle mass. The FDA has sent a Warning Letter to a manufacturer of body building supplements that claim to contain steroid-like ingredients, but in fact contain synthetic steroids. The products named in the Warning Letter are marketed by American Cellular Laboratories, Inc., and include “TREN-Xtreme,” “MASS Xtreme,” “ESTRO Xtreme,” “AH-89-Xtreme,” “HMG Xtreme,” “MMA-3 Xtreme,” “VNS-9 Xtreme,” and “TT-40-Xtreme.”

The FDA has received reports of serious adverse events associated with the use of these products and other similar products. Products like these are frequently marketed as alternatives to anabolic steroids for increasing muscle mass and strength and are sold both online and in retail stores. They are often promoted to athletes to improve sports performance and to aid in recovery from training and sporting events. Although products containing synthetic steroids are frequently marketed as dietary supplements, they are NOT dietary supplements, but instead are unapproved new drugs that have not been reviewed by the FDA for safety and effectiveness.

Adverse event reports received by the FDA for body building products that are labeled to contain steroids or steroid alternatives involve men (ages 22-55) and include cases of serious liver injury, stroke, kidney failure and pulmonary embolism (blockage of an artery in the lung).

Due to the potentially serious health risks associated with using these types of products, the FDA recommends that consumers immediately stop using all body building products that claim to contain steroids or steroid-like substances. Consumers should consult their health care professional if they are experiencing symptoms possibly associated with these products, particularly nausea, weakness or fatigue, fever, abdominal pain, chest pain, shortness of breath, jaundice (yellowing of the skin or whites of the eyes) or brown/discolored urine. The FDA also recommends that consumers talk with their health care professional about any body building supplements they are taking or planning to take, particularly if they are uncertain about a product’s ingredients.

Health care professionals are advised to ask their patients about any over-the-counter products they may be using, including products marketed as dietary supplements. Additionally, health care professionals should be alert to patients presenting with the warning signs that may be associated with the use of steroids or steroid-like substances, including liver injury, kidney failure, stroke, and hormone-associated adverse effects, such as blood clots, including pulmonary embolism and deep vein thrombosis.

Health care professionals and consumers are encouraged to report any adverse events related to the use of these products to FDA's MedWatch Adverse Event Reporting program, either online, by regular mail or by fax, using the contact information at the bottom of this page.

For more details about these products see FDA’s Consumer Information piece (Consumer Update)Warning on Body Building Products Marketed as Containing Steroids or Steroid-Like Substances.

Tags: TREN-Xtreme, MASS Xtreme, ESTRO Xtreme, fda warning

Do Not Eat Certain Mussel Products from Bantry Bay Seafood, FDA

FOR IMMEDIATE RELEASE
August 15, 2008


Media Inquiries:
Michael Herndon, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

FDA Warns Consumers Not to Eat Certain Mussel Products from Bantry Bay Seafood

The U.S. Food and Drug Administration (FDA) is warning consumers against eating certain frozen cooked mussel products made by Bantry Bay Seafoods, imported from Ireland, because they may be contaminated with azaspiracid toxins, a group of naturally occurring marine toxins known to cause nausea, vomiting, diarrhea, and stomach cramps.

Azaspiracid toxins are odorless, tasteless, and cannot be destroyed or neutralized by freezing or cooking, including boiling. Individuals who have experienced gastrointestinal symptoms such as those noted above after eating any of the products listed below should consult their health care professional. Symptoms typically occur within hours of consumption and persist for two to three days.

In July, two people in Washington state became ill after eating the company's "Mussels in a Garlic Butter Sauce." FDA tested unopened product from the same production lot and found that it contained the azaspiracid toxins.

Consumers should throw out the following Bantry Bay Seafood frozen cooked products with "Best before end" dates ranging from January 23, 2009, to November 15, 2009:

* Mussels in a Garlic Butter Sauce
* Mussels in White Wine Sauce
* Mussels in Tomato and Garlic Sauce

The "Best before end" dates are displayed on the side of the box in the following format: MM:DD:YY. Products to be thrown out are marked with dates 01:23:09 through 11:15:09.

These products are sold frozen in 1 pound cardboard packages in stores throughout the United States.

The FDA also recommends that retailers and foodservice operators remove these products, and any food in which these products were used as an ingredient, from sale or service.

Azaspiracid toxins were an unknown marine toxin until 1995, when they were identified and linked to an outbreak of foodborne illnesses associated with consumption of Irish shellfish. The toxins have since been identified in other shellfish from the west coast of Europe. They have never been detected in shellfish harvested from U.S. waters.

Tags: Bantry Bay Seafood, azaspiracid toxins

FDA Warns Consumers About Medicine Shoppe Pharmacies As They May Have Received Drugs That Were Either Expired Or Suspected Counterfeit.

FOR IMMEDIATE RELEASE August 8, 2008

Media Inquiries: Rita Chappelle, 240-753-8603 Consumer Inquiries: 888-INFO-FDA

FDA Warns Consumers About Potential Problems at Two Baltimore Pharmacies
Expired and suspected counterfeit prescription drugs found at pharmacies

The U.S. Food and Drug Administration is warning consumers who filled prescriptions at The Medicine Shoppe pharmacies located at 8035A Liberty Road and 5900 Reisterstown Road in Baltimore that they may have received drugs that were either expired or suspected counterfeit. The FDA is particularly concerned because a number of the drugs are for serious diseases and could have an adverse effect on treatment.

The products in question include:

• Lisinopril (20 milligrams)
• Guaifenesin/Dextromethorphan (600 mg and 1000 mg)
• Gabapentin (100 mg, 300 mg and 400 mg)
• Metoprolol (50 mg)
• Nifedipine (30 mg)
• Diclofenac Sodium (30 mg)
• Glucophage (500 mg Extended Release)
• Glucovance (125 mg and 500 mg)
• Glipizide/Metformin (2.50 mg/250 mg)
• Furosemide (20 mg)
• Tamoxifen Citrate (10 mg)
• Metformin HCl ER (500 mg)
• Calcitrol (0.25 micrograms)

The FDA has no evidence that any other Medicine Shoppe pharmacies outside of the 8035A Liberty Road and 5900 Reisterstown Road facilities are involved.

Because the safety and efficacy of the listed drugs has not been established, the FDA is strongly advising consumers who filled prescriptions for these drugs at these two pharmacies to contact their prescribing physician immediately for new prescriptions. Additionally, consumers in possession of the above listed prescription drugs from these pharmacies should call FDA at 800-521-5783 for further information on how to dispose of the drugs.

Consumers and health care professionals can report adverse events to the FDA's MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, Md 20852-9787, or online at www.fda.gov/medwatch/report.htm.

Tags: fda warning, counterfeit drugs, Medicine Shoppe pharmacies

Life-threatening Complications Associated with Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion

Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion

Audience: Orthopedic surgeons, neurosurgeons, hospital risk managers, surgical service staff
[Posted 07/02/2008] FDA informed healthcare professionals of reports of life-threatening complications associated with recombinant human Bone Morphogenetic Protein (rhBMP) when used in the cervical spine. The safety and effectiveness of rhBMP in the cervical spine have not been demonstrated and these products are not approved by FDA for this use. There have been at least 38 reports of complications during the last 4 years with the use of rhBMP in cervical spine fusion. These complications were associated with swelling of neck and throat tissue, which resulted in compression of the airway and/or neurological structures in the neck. Some reports describe difficulty swallowing, breathing or speaking. FDA recommends that practitioners either use approved alternative treatments or consider enrolling as investigators in approved clinical studies.

FDA requires hospitals and other user facilities to report deaths and serious injuries associated with the use of medical devices. If you suspect that a reportable adverse event was related to the use of rhBMP, you should follow the reporting procedure established by your facility. Reporting adverse events is everyone’s responsibility, even if the event involves off-label use of medical devices.

[July 01, 2008 - Public Health Notification - FDA]

Tags: fda warning, recombinant human Bone Morphogenetic Protein, rhBMP, cervical spine fusion