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Patient Network

Bringing Your Voice to Drug and Device Approval and Safety

Current Patient Network Newsletter

This bi-weekly newsletter provided by the Office of Health and Constituent Affairs at the Food and Drug Administration (FDA) is intended to inform you of FDA-related information on a variety of topics, including new product approvals,significant labeling changes, safety warnings, notices of upcoming public meetings, proposed regulatory guidances and opportunity to comment, and other information of interest to patients and patient advocates. Subscribe or update your subscriber preferences.

PNN Masthead

Volume 4 | Number 13 | June 25, 2014


Product Safety Bar

Docetaxel Chemical StructureDrug Safety Communication: FDA warns that cancer drug docetaxel may cause symptoms of alcohol intoxication after treatment
FDA is warning that the intravenous chemotherapy drug docetaxel contains ethanol, also known as alcohol, which may cause patients to experience intoxication or feel drunk during and after treatment. We are revising the labels of all docetaxel drug products to warn about this risk. Health care professionals should consider the alcohol content of docetaxel when prescribing or administering the drug to patients, particularly in those whom alcohol intake should be avoided or minimized and when using it in conjunction with other medications. Patients should be aware that docetaxel may cause them to become intoxicated from the alcohol it contains. Patients should avoid driving, operating machinery, or performing other activities that are dangerous for one to two hours after the infusion of docetaxel. In addition, some medications, such as pain relievers and sleep aids, may interact with the alcohol in the docetaxel infusion and worsen the intoxicating effects. More information

Safety Communication: Mammography Problems at Big Sky Diagnostic Imaging, LLC in Butte, Montana
FDA is alerting patients who had mammograms at Big Sky Diagnostic Imaging, LLC, in Butte, Montana any time after Nov. 19, 2011, about possible problems with the quality of mammograms performed. This does not mean that the results of the examinations were inaccurate, but it does mean that patients should speak to their health care providers about whether their mammograms need to be repeated. FDA worked with the American College of Radiology (ACR) as it performed a routine review of a sample of mammograms performed by Big Sky Diagnostic Imaging, LLC that included images taken between November 20, 2011 and November 20, 2013. Results from that review included poor quality mammograms. More information

FDA adding general warning to testosterone products about potential for venous blood clots
FDA is requiring manufacturers to include a general warning in the drug labeling of all approved testosterone products about the risk of blood clots in the veins. Blood clots in the veins, also known as venous thromboembolism (VTE), include deep vein thrombosis (DVT) and pulmonary embolism (PE). The risk of venous blood clots is already included in the labeling of testosterone products as a possible consequence of polycythemia, an abnormal increase in the number of red blood cells that sometimes occurs with testosterone treatment. Because there have been postmarket reports of venous blood clots unrelated to polycythemia, FDA is requiring a change to drug labeling of all testosterone products to provide a more general warning regarding venous blood clots and to ensure this risk is described consistently in the labeling of all approved testosterone products. More information

Recall: Hospira Marcaine™ (Bupivacaine HCI Injection, USP), 0.5%, 30 ML, Single-Dose, Preservative-Free Vial - Visible Particulates
Hospira, Inc. (NYSE: HSP), announced today it will initiate a voluntary nationwide recall to the user level for one lot of 0.5% Marcaine™ (Bupivacaine HCl Injection, USP), 30 mL, Single-dose Vial – Preservative Free (NDC 0409-1560-29), Lot 33-545-DD. The recall is due to a confirmed customer report of particulate embedded in the glass vial as well as visible particulate in the solution. To date, Hospira has not received reports of any adverse events associated with this issue for this lot. Hospira has attributed the embedded particulate to a supplier’s glass defect. Hospira is working with its supplier on implementing corrective and preventive actions. More information

Recall: Doctor's Best Red Yeast Rice - Undeclared Lovastatin
Doctor’s Best is voluntarily recalling lot 3121005 (7379 bottles) of Red Yeast Rice dietary supplement, 600 mg Capsules, 120-count bottles to the retail level. Red Yeast Rice has been found to contain undeclared lovastatin, a previously approved drug indicated for the treatment of high cholesterol, making this an unapproved new drug. Consumers who use supplements found to contain lovastatin in rare cases could result in serious muscle injury; particularly if taking with prescription “statins” such as lovastatin, simvastatin, or atorvastatin. Pregnant women could theoretically put their unborn child at risk by using this product with undeclared lovastatin. Patients with pre-existing liver disease may be at an increase risk for liver injury following chronic use of statins. More information

Drug Safety Communication bannerDrug Safety Communication: Olmesartan - FDA Review Finds Cardiovascular Risks for Diabetes Not Conclusive
FDA has completed its safety review and has found no clear evidence of increased cardiovascular risks associated with use of the blood pressure medication olmesartan in diabetic patients (see previous alerts linked below). FDA believes the benefits of olmesartan in patients with high blood pressure continue to outweigh the potential risks. More information

Drug Safety Communication Warning: Captomer and Captomer-250 by Thorne Research -  Potential Health Risks
FDA is warning consumers not to purchase or to use Thorne Research’s Captomer or Captomer-250, marketed as a dietary supplement for heavy metal toxicity and heavy metal chelation therapy. The products list DMSA (meso-2, 3-dimercaptosuccinic acid), as an active ingredient, which is contained in an FDA-approved prescription product indicated for the treatment of lead poisoning in children. FDA advises consumers to avoid all products offered over-the-counter (OTC) for chelation or detoxification. There are no FDA-approved OTC chelation products. More information

Recall: Advocate Redi-Code+ Blood Glucose Test Strips by Diabetic Supply of Suncoast - Labeling Error
Diabetic Supply of Suncoast, Inc. initiated a nationwide voluntary recall of all BMB-BA006A Advocate Redi-Code+ blood glucose test strip lots manufactured by BroadMaster Bio-Tech Corp due to a labeling error which could result in confusion about which meter models the Redi-Code+ BMB-BA006A blood glucose test strips are designed to be used with. In the incorrect labeling, the test strips model (BMB-BA006A) was omitted. Suncoast is recalling the test strips in an effort to avoid confusion and the possible misuse of the Advocate Redi-Code+blood glucose test strips with the Taidoc meters listed in the Firm Press Release, which could result in incorrect glucose results. More information

Public Notification: La Jiao Shou Shen Contains Hidden Drug Ingredient
FDA is advising consumers not to purchase or use La Jiao Shou Shen, a product promoted and sold for weight loss on various websites, including www.slimbeautyusa.com and in some retail stores. FDA laboratory analysis confirmed that La Jiao Shou Shen contains sibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. More information


Blue Shirt/ hand with finger pointing to rightComunicaciones de la FDA sobre la seguridad de los medicamentos en español
Descargo de responsabilidad: La FDA reconoce la necesidad de proporcionar información sobre seguridad importante en idiomas distintos al inglés. Hacemos lo mejor posible  para proporcionar  versiones en español precisas y oportunas de nuestras Comunicaciones de Seguridad de Medicamentos. Sin embargo, en caso que existiera discrepancias entre las versiones en ingles y en español, la información contenida en la versión en inglés es la que se considera como versión oficial. Si tiene alguna pregunta, por favor contáctese con Division of Drug Information en druginfo@fda.hhs.gov. Comunicaciones de la FDA


Medwatch hyperlink


Product Short and DC

Pill box with only one pillFDA recognizes the significant public health consequences that can result from drug shortages and takes tremendous efforts within its legal authority to address and prevent drug shortages. These shortages occur for many reasons, including manufacturing and quality problems, delays, and discontinuations. When issues are discovered by the company or the public and reported to FDA or are found by FDA upon inspection, FDA works closely with the firm to address risks involved to prevent harm to patients. FDA also considers the impact a shortage would have on patient care and access and works with the firm to restore supplies while also ensuring safety for patients. More information

Drug Shortages Voluntarily Reported by Manufacturers During the Past 2 Weeks:

  • Indigo Carmine Injection
  • Sodium Phosphate Injection

Blue Shirt/ hand with finger pointing to right

 

Product Approval Bar

FDA ApprovedFDA approves Sivextro to treat skin infections
FDA has approved Sivextro (tedizolid phosphate), a new antibacterial drug, to treat adults with skin infections. Sivextro is approved to treat patients with acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria, including Staphylococcus aureus (including methicillin-resistant strains (MRSA) and methicillin-susceptible strains), various Streptococcus species, and Enterococcus faecalis. Sivextro is available for intravenous and oral use. More information

FDA approves Lymphoseek to help determine the extent of head and neck cancer in the body
FDA has approved a new use for Lymphoseek (technetium 99m tilmanocept) Injection, a radioactive diagnostic imaging agent used to help doctors determine the extent a type of cancer called squamous cell carcinoma has spread in the body’s head and neck region. In 2013, Lymphoseek was approved to help identify lymph nodes closest to a primary tumor in patients with breast cancer or melanoma. Lymph nodes filter lymphatic fluid that flows from the body’s tissues. This fluid may contain cancer cells, especially if the fluid drains a part of the body containing a tumor. By surgically removing and examining the lymph nodes that drain a tumor, a procedure called a biopsy, doctors can sometimes determine if a cancer has spread. With this approval, Lymphoseek can now be used to guide testing of lymph nodes closest to a primary tumor for cancer, called a “sentinel” lymph node biopsy, in patients with cancer of the head and neck. This new indication will allow for the option of more limited lymph node surgery in patients with sentinel nodes negative for cancer. More information


For information on drug approvals or to view prescribing information and patient information, please visit Drugs@FDA or DailyMed.

Dailymed and DrugsFDA


Comments and Guidances

Comments - yellow

 

View FDA's Comments on Current Draft Guidance page for a list of draft guidances on topics of interest for patients and caregivers.


Announcements Bar

Hand holding marijuana leafFDA and Marijuana
FDA understands that caregivers and patients are looking for treatment options for unmet medical needs. In some instances, patients or their caregivers are turning to marijuana in an attempt to treat conditions such as seizures and chemotherapy-induced nausea. Over the last few decades, there has been significant interest in the potential utility of marijuana for a variety of medical conditions, including those that already have FDA-approved therapies. More recently, several states have also passed laws that remove state restrictions on health care professionals using marijuana as a medical treatment for a variety of conditions. A number of other states are considering similar legislation regarding the use of marijuana in medical settings. More information

FDA actions have significantly reduced drug shortages but critical issues remain
At FDA, we understand that health care professionals who care for patients using drug therapies need the right drug for the right patient at the right time. We’re working hard to help enable this important tenet of health care for your patients. For instance, over the past year, we’ve seen a 60 percent decrease in new drug shortages. However, more work needs to be done. This year several critical shortages were added to the list of drugs in short supply. These include intravenous (IV) saline bags and nitroglycerin injections. More information


Jonca BullFDA Salutes World Sickle Cell Awareness Day, by Jonca Bull, M.D., Director of FDA's Office of Minority Health
June 19, 2014, was World Sickle Cell Awareness Day, an annual reminder that Sickle Cell Disease (SCD) is a major area of unmet medical need that causes serious and devastating consequences to many thousands of children and adults. It is an occasion that has been commemorated each year since 2008, when the General Assembly of the United Nations adopted a resolution recognizing SCD as a global public health concern. I am happy to have this opportunity to help raise awareness about the impact of this disease on patients and their families, and to emphasize the need for additional therapies to prevent or treat SCD and its complications.

To read the rest of this post, see FDA Voice Blog, June 19, 2014.


Picture of Thomas AbramsFDA Issues Draft Guidances for Industry on Social Media and Internet Communications About Medical Products: Designed with Patients in Mind, by Thomas Abrams, Director of FDA's Office of Prescription Drug Promotion in the Agency’s Center for Drug Evaluation and Research (CDER)
Ongoing changes in technology transform medical products – and the ways that both patients and health care providers learn about those products. In today’s world, in addition to traditional sources of medical product information, patients and health care providers regularly get information about FDA-regulated medical products through social media and other Internet sources, and those technologies continue to evolve. But regardless of the Internet source used to communicate about medical products, the public health is best served by clear, accurate, truthful and non-misleading information about them.

To read the rest of this post, see FDA Voice Blog, June 17, 2014.


Producer of tainted dietary supplements sentenced in federal court
Nikki Haskell, the owner and chief executive officer of Balanced Health Products (BHP), has been sentenced by a United States magistrate judge in Manhattan federal court to a $60,000 fine for distributing dietary supplements that contained a prescription drug. From at least November 2006 through December 2008, BHP’s primary business was the distribution across the United States of this product, called “Nikki Haskell’s StarCaps” (StarCaps). BHP advertised StarCaps as weight-loss pills containing only all-natural ingredients including, for example, papaya extract. The company failed to list on the product’s label that the pills also contained bumetanide, a powerful diuretic used clinically to treat heart failure, kidney failure, high blood pressure and swelling (edema). Bumetanide is available in the United States only by prescription from a licensed physician. In March 2014, Haskell was convicted upon a guilty plea to distributing the misbranded StarCaps from BHP’s New York City-based location. Per Haskell, the company is now defunct and has filed for bankruptcy. Agents from the FDA’s Office of Criminal Investigations, New York Field Office spearheaded this investigation, which led to the permanent removal of this tainted dietary supplement from the market. More information


Ucoming Meetings Bar

Advisory Committee Meeting at FDAFDA advisory committee meetings are free and open to the public. No prior registration is required to attend. Interested persons may present data, information, or views, orally at the meeting, or in writing, on issues pending before the committee.

Other types of meetings listed may require prior registration and fees.

 

View FDA's Calendar of Public Meetings page for a complete list of meetings and workshops.


Blue Shirt/ hand with finger pointing to rightPlease visit FDA’s Advisory Committee page to obtain advisory committee meeting agendas, briefing materials, and meeting rosters prior to the meetings. You may also visit this page after meetings to obtain transcripts, presentations, and voting results. For additional information on other agency meetings please visit Meetings, Conferences, & Workshops.


Consumer Update bar

Bee Pollen for Weight LossSome Bee Pollen Weight Loss Products Are a Dangerous Scam
Products labeled to contain bee pollen that promise to help you lose weight or reshape your body could actually harm you, warns the Food and Drug Administration (FDA). Some bee pollen products marketed for weight loss have been found to contain hidden and potentially dangerous ingredients that may be harmful for people who have conditions such as irregular heartbeat, high blood pressure and bipolar disorders (a brain disorder that causes unusual shifts in mood), says Coody. FDA recently warned consumers to immediately stop using one of these products—Zi Xiu Tang Bee Pollen—because it contains at least one potentially harmful ingredient that is not listed on the product’s label. More information

More Consumer Updates
For previously published Consumer Update articles that are timely and easy-to-read and cover all FDA activities and regulated products. More information

En Español
La información en esta página es para el público en general, y para profesionales y educadores de salud. Esta información puede ser distribuida y publicada sin previa autorización. En Español


Food Safety Bar

Cheese on WoodClarification on Using Wood Shelving in Artisanal Cheesemaking
Recently, you may have heard some concerns suggesting the FDA has taken steps to end the long-standing practice in the cheesemaking industry of using wooden boards to age cheese. To be clear, we have not and are not prohibiting or banning the long-standing practice of using wood shelving in artisanal cheese. Nor does the FDA Food Safety Modernization Act (FSMA) require any such action. Reports to the contrary are not accurate. The agency’s regulations do not specifically address the use of shelving made of wood in cheesemaking, nor is there any FSMA requirement in effect that addresses this issue. Moreover, the FDA has not taken any enforcement action based solely on the use of wooden shelves. More information

Center for Food Safety and Applied Nutrition
The Center for Food Safety and Applied Nutrition, known as CFSAN, carries out the mission of FDA. The Center provides services to consumers, domestic and foreign industry and other outside groups regarding field programs; agency administrative tasks; scientific analysis and support; and policy, planning and handling of critical issues related to food and cosmetics. More information

Food Facts for You
The Center for Food Safety and Applied Nutrition, known as CFSAN, issues food facts for consumers to keep you and your family safe. More information


Animal Health Bar

Safe Use of Flea and Tick Products in Pets
Fleabites may be more than an itchy annoyance to some dogs and cats. They can cause flea allergy dermatitis—an allergic reaction to proteins in flea saliva. And a pet’s constant scratching can cause permanent hair loss or other skin problems. Fleas feasting on your pet’s blood can lead to anemia and, in rare cases, death. Ticks can also harm your pet, transmitting infections such as Lyme disease. And pets can bring ticks into the home, exposing you and your family to illness from a tick bite. Hundreds of pesticides, repellents, and growth inhibitors are available to protect your pet from flea and tick bites. Some of these products are available only from a veterinarian; others can be bought over the counter. Flea and tick products range from pills given by mouth to collars, sprays, dips, shampoos, powders, and “spot-ons,” liquid products squeezed onto the dog’s or cat’s skin usually between the shoulder blades or down the back. A few spot-on products are available for flea control in ferrets, and fly and tick control in horses. More information

White cat with glassesAnimal Health Literacy
Animal Health Literacy means timely information for the benefit of all animals and their humans. With continuous communication and outreach, the Center for Veterinary Medicine (CVM) strives to enhance the public trust, promote safe and effective use of the animal health products we regulate, and share our scientific endeavors. CVM provides reliable, science-based information to promote animal and human health. More information

CVM Pet Facts
The Center for Veterinary Medicine (CVM) issues medical and feeding fact sheets to keep your pets healthy and safe. More information


Resources

Janet Woodcock
Have a question about what the Center for Drug Evaluation and Research (CDER) does? Ask Janet Woodcock, M.D., Director, CDER, FDA
FDA will select some of your questions to answer each month. Due to the volume of e-mails we receive, we won't be able to answer each question in this format. We may edit your questions for brevity or clarity. See MailBag to read questions and answers. More information

Computer and KeyboardFDA Basics
Each month, different centers and offices at FDA will host an online session where the public can ask questions to senior FDA officials about a specific topic or just listen in to learn more about FDA. More information

Educational Videos
FDA Food Safety and Modernization Act: An FDA Primer
The Rulemaking Process: An FDA Primer
What is Regulatory Science
Taking Acetaminophen Safely

healthfinder.govhealthfinder.gov
Welcome to healthfinder.gov, a government Web site where you will find information and tools to help you and those you care about stay healthy. More information

Tobacco Products Resources for You
Federal resources to help you quit using tobacco products and to help you learn more about youth tobacco prevention, effective treatment for nicotine addiction, and tobacco research and statistics.
More information

FDA E-list
Sign up for one of the FDA disease specific e-mail list that delivers updates, including product approvals, safety warnings, notices of upcoming meetings, and notices on proposed regulatory guidances.



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