Original article: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm292276.htm

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On This Page:

• Parts Popping Off
• FDA Actions
• Advice to Parents, Caregivers and Consumers

When using your electric toothbrush, you don’t expect parts of the device to pop off and chip your tooth, fly into your eyes or get stuck in your throat.

But that’s exactly what has happened to some users of the battery-powered Arm & Hammer Spinbrush—or the Crest Spinbrush, as it was called before 2009.

“It’s important that consumers know how to avoid the risks associated with using the Spinbrush,” says Shumaya Ali, M.P.H., a consumer safety officer at the Food and Drug Administration. “We’ve had reports in which parts of the toothbrush broke off during use and were released into the mouth with great speed, causing broken teeth and presenting a choking hazard.”

FDA regulates toothbrushes—whether manual or electric—as medical devices that are intended to help prevent tooth decay. Safety precautions should be taken with all kinds of electric toothbrushes.

“Electric toothbrushes can be very effective in removing dental plaque, and so they can help prevent dental decay and gum disease,” says Susan Runner, D.D.S., chief of FDA’s dental devices branch. “At the same time, it’s important to supervise children when they use these brushes, and to look out for any malfunctions of the toothbrush that might cause an injury.”

Injuries reported from using the Spinbrush powered toothbrush include

• chipped or broken teeth
• cuts to the mouth and gums
• swallowing and choking on broken pieces
• injury to the face and eyes

FDA is alerting the public about the potential for injury while using the following models of Spinbrush:

• Spinbrush ProClean
• Spinbrush ProClean Recharge
• Spinbrush Pro Whitening
• Spinbrush SONIC
• Spinbrush SONIC Recharge
• Spinbrush Swirl
• Spinbrush Classic Clean
• Spinbrush For Kids
• Spinbrush Replacement Heads

Parts Popping Off

The Spinbrush handle contains batteries and a motor that operates the brushes, which are attached to a brush head. In the models of Spinbrush made for adults, the brush head is removable and can be replaced.

But the brush head should not pop off during normal use, says Ali. “In some cases, the brush head popped off to expose metal pieces underneath that can—and have—poked individuals in the cheek and areas near the eyes, causing  injuries.”

The “Spinbrush for Kids” models, which have different handle designs, such as Spiderman and Thomas & Friends, do not have removable brush heads.  Nonetheless, problems with the Spinbrush for Kids have also been reported, such as cut lips, burns from the batteries, and bristles falling off and lodging in a child’s tonsils.

“FDA’s concern is that the unexpected release of any part of this battery-powered toothbrush during use poses a risk of injury,” says Steven Silverman, director of the Office of Compliance in FDA’s Center for Devices and Radiological Health. “And the risk is higher in children or adults who may need assistance but are not supervised while using the toothbrush.”

FDA Actions

FDA’s inspection last year of Church & Dwight Co. Inc., which manufactures the Spinbrush, uncovered evidence that there had been numerous consumer complaints that had not been reported to the agency. On May 16, 2011, FDA warned the company of its violations of the Federal Food, Drug, and Cosmetic Act, including failure to report—within a reasonable time frame—serious injuries.

After further discussions with Church & Dwight about the risks of the battery-powered Spinbrush, the company has taken some actions:

• improved the labeling to caution consumers to change the brush head every three months or sooner if the brush is worn or parts are loose
• added bristles that change color with wear to give consumers a visual reminder of when to replace the brush head
• issued a safety notice about Spinbrush in television and print ads; the safety notice also appears on the Spinbrush website and the interactive voice response to consumers who call the company’s toll-free telephone numbers.

Advice to Parents, Caregivers and Consumers

• Before using the Spinbrush, inspect it for any damage or loose brush bristles. If you find any, do not use the brush. Report it to Church & Dwight, which can be reached toll-free at 1-800-352-3384 or 1-800-561-0752.
• Make sure the brush head is connected tightly to the brush handle, and test the brush outside of your mouth before using. If the connection feels loose or the brush head easily detaches from the handle, do not use the brush. Report it to Church & Dwight.
• Use care not to bite down on the brush head while brushing.  
• To prevent injuries, always supervise children and adults who may need assistance when using the Spinbrush.
• Follow the instructions and recommended replacement guidelines included with the Spinbrush.
• Report injuries or problems with the Spinbrush to MedWatch—FDA’s Safety Information and Adverse Event Reporting Program either online, by regular mail, by fax or by phone.
  • Online
  • Regular Mail: Use postage-paid, pre-addressed FDA form 3500
  • Fax: 800-FDA-0178
  • Phone: 800-332-1088

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

Feb. 16, 2012

Original article: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm291790.htm

On This Page:

• Recall: Renastart Due to Incorrectly Labeled Cans
• Potential Mix-up in Opiate Tablets
• Recall: Excedrin, NoDoz, Bufferin, Gas-X Prevention
• Recall: Hair Regrowth Products Sold on Internet
• Recall: Vagifresh Ball, Vagifresh Gel, Female One
• Tysabri and New Risk Factor for PML
• Adcetris: PML and Lung Damage
• Recall: Respironics Trilogy 100 Ventilators
• Drug Safety Labeling Changes
   

FDA encourages health care professionals and consumers to report problems with medical products, including

• unexpected and undesirable side effects
• quality problems, such as a drug with an unusual odor or color, or a device with defective parts
• unclear or confusing instructions
• failure to deliver the expected benefit

Report problems to FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail, by fax, or by phone.

• Online
• Regular Mail: Use postage-paid, pre-addressed FDA form 3500
• Fax: 800-FDA-0178
• Phone: 800-332-1088

MedWatch reports can signal a safety problem and may lead to FDA action to protect the public from harm, serious illness or death.

Here are some of the most recent safety alerts and ongoing safety reviews prompted by reports FDA has received through MedWatch.

Recall: Renastart Due to Incorrectly Labeled Cans

A powdered medical food for children has been recalled because it was incorrectly labeled.

The recall applies to Renastart 14.11 oz (400g) cans, batch number 12832, shipped throughout the U.S. from Dec. 29, 2011, through Jan. 26, 2012. Following a customer complaint about the way the product was dissolving, the distributor, Vitaflo USA, determined that a small number of cans of a different product may have been wrongly labeled as Renastart.

Renastart is used in children one year and older for the dietary management of kidney disease.

Risk: Using the incorrectly labeled product may result in high levels of potassium or sodium in the blood. Symptoms may be hard to detect, but can result in health problems that are potentially fatal.

Recommendations

• Immediately stop using Renastart 14.11 oz (400g) cans, batch number 12832 (found on the bottom of the can).
• If your child has consumed any Renastart from this batch, contact your child’s health care professional immediately to determine what to do next and how else you can help your child get the nutrition that he or she needs.
• Contact Vitaflo USA toll-free at 888-848-2356 for answers to your questions or arrange to return the recalled product at Vitaflo’s expense. 

For More Information

Photo of Renastart

Vitaflo USA Renastart: Recall – Possible Health Risk Due to Incorrectly Labeled Cans

Potential Mix-up in Opiate Tablets

Tablets from one opiate medicine may have ended up in the bottle of another one due to problems that occurred during packaging and labeling. The products affected are manufactured and packaged for Endo Pharmaceuticals by Novartis Consumer Health Inc. and include:

• Opana ER (oxymorphone hydrochloride) Extended-Release Tablets CII
• Opana (oxymorphone hydrochloride) Tablets CII
• Oxymorphone hydrochloride Tablets CII
• Percocet (oxycodone hydrochloride and acetaminophen, USP) Tablets CII
• Percodan (oxycodone hydrochloride and aspirin, USP) Tablets CII
• Endocet (oxycodone hydrochloride and acetaminophen, USP) Tablets CII
• Endodan (oxycodone hydrochloride and aspirin, USP) Tablets CII
• Morphine Sulfate Extended-Release Tablets CII
• Zydone (hydrocodone bitartrate/acetaminophen tablets, USP) CIII

Opiates are strong medications used to alleviate pain and are available only by prescription. Endo Pharmaceuticals reports that they are aware of only three mix-ups involving these products since 2009; all three were detected by pharmacists before they were dispensed to consumers.

In the coming weeks, FDA expects there will be shortages of these medications while the manufacturing issues are resolved. The agency is working with Endo Pharmaceuticals and Novartis to minimize the impact to consumers. The extent of the shortage will depend upon how quickly safeguards can be put in place to prevent this mix-up from happening again and then how soon manufacturing can be restarted.

Recommendations

• Examine all opiate medicines made by Endo Pharmaceuticals to ensure that all the tablets are the same and match the pictures of tablets in the visual guide.
• Bring your medicine bottle to your pharmacist and do not take any of the tablets if:
  • one or more tablets in your bottle look different from the others
  • there are tablets that are different in shape, color or size, or the markings are different
• If you have questions about your medicine, call your pharmacist or health care professional, or call Endo Pharmaceuticals at 800-462-3636.
• Dispose of any unused opiate tablets according to FDA’s recommendations.

For More Information

FDA Public Health Advisory on Certain Opiate Products Made for Endo Pharmaceuticals

A Guide to Safe Use of Pain Medicine

Lock it Up: Medicine Safety in Your Home (video)

FDA Acts to Reduce Harm from Opioid Drugs

Recall: Excedrin, NoDoz, Bufferin, Gas-X Prevention

The following over-the-counter products have been recalled:

• Excedrin – all lots with expiration dates of December 20, 2014, or earlier
• Bufferin – all lots with expiration dates of December 20, 2013, or earlier
• Gas-X Prevention – all lots with expiration dates of December 20, 2013, or earlier
• NoDoz – all lots with expiration dates of December 20, 2014, or earlier

Reports of chipped and broken pills and inconsistent packaging practices at Novartis Consumer Health’s Lincoln, Neb., facility could result in pill bottles containing the wrong tablets, caplets or capsules.

Risk: Mixing different products in the same bottle could result in overdose, interaction with other medications you may be taking, or a bad reaction if you are allergic to an unintended ingredient.

Recommendations

• If you have a recalled product, do not use it. Contact Novartis at 888-477-2403 (available Monday–Friday 9 a.m. to 8 p.m. ET) for information on how to return the product for a full refund.
• If you find a pill in any medicine bottle that is different in shape, size, color or markings than the other pills in the bottle, do not use the medicine. Take the medicine bottle to your pharmacist. 

For More Information

Novartis Consumer Health Over-The-Counter Products: Recall

Recall: Hair Regrowth Products Sold on Internet

All topical hair regrowth products made by Perfect Image Solutions LLC have been recalled because they are “unapproved new drugs” under FDA regulations and may be hazardous to your health.

The recalled products, which are distributed nationwide through the Internet, include

• Men’s Minoxidil 15% Azelaic 5% Hair regrowth topical, 60mL
• Men’s Minoxidil 10% Azelaic 5% Hair regrowth topical, 60mL
• Men’s Minoxidil 5% Azelaic 5% Hair regrowth topical, 60mL
• Women’s Minoxidil 3% Azelaic 5% Hair regrowth topical, 60mL
• Hair regrowth shampoo enhanced with Ketoconazole and salicylic acid, 180mL

Risk: Minoxidil 15% and 10% could cause low blood pressure, a rapid or irregular heartbeat, and other heart-related symptoms. Azelaic acid can make the skin where it is applied more sensitive to sunburn. Ketoconazole contained in the shampoo product could cause hair discoloration and abnormal hair texture, removal of the curl from permanently waved hair, itching, rash, skin irritation and dry skin. Salicylic acid contained in the shampoo could cause mild, temporary burning, itching, irritation or stinging.

These products are used by men and women to slow or stop hair loss and to help hair regrow. They are packaged in glass-dropper containers or plastic shampoo bottles and sold in single units.

Recommendations

• If you have any of these recalled products, throw them out.
• Contact Perfect Image Solutions LLC with any questions at 916-791-3230 Monday–Friday from 9 a.m. to 5 p.m. PST or email dave@perfectimagesolutions.com.
• Contact your health care professional if you have had any problems that you think may be related to using these products. 

Recall: Vagifresh Ball, Vagifresh Gel, Female One

Vaginal products sold as cosmetics have been recalled because they contain a drug ingredient or harmful bacteria.

FDA’s analysis found that Vagifresh Gel contains benzocaine—an active ingredient in many anesthetic drug products—and Vagifresh Ball is contaminated with bacteria. FDA also determined that marketing material for these products contains unproven treatment claims related to various gynecologic conditions. These claims could have caused women who use these products from getting proper medical care for potentially serious conditions.

Vagifresh Gel and Vagifresh Ball were sold in herbal stores, beauty shops, drug stores and by Internet and mail order. The two products were also sold together with Vagifresh Liquid in a package named Female One. (The Vagifresh Liquid product has not been recalled.)

Recommendations

• Stop using these products immediately and contact your health care professional if you have any problems that you think may be related to using them.
• Return unused products to the place of purchase for a refund.
• Call the product distributor, USA Far Ocean Group Inc., with any questions at 626-560-2435 Monday–Sunday between 9 a.m. and 5 p.m. PST. 

For More Information

Vagifresh Product Photos

Tysabri and New Risk Factor for PML

Testing positive for anti-JC virus (JCV) antibodies has been identified as a risk factor for developing progressive multifocal leukoencephalopathy (PML). This rare but serious brain infection that can result in death is associated with the use of Tysabri (natalizumab) to treat multiple sclerosis or Crohn’s disease. FDA has updated the drug label for Tysabri to include this information.

In January, FDA approved the first test to detect anti-JCV antibodies, helping doctors determine if people with multiple sclerosis or Crohn’s disease who use Tysabri are at an increased risk for developing PML.

Recommendation: You and your health care professional should consider the risks and benefits of using Tysabri if you have one or more of the three known risk factors for PML:

• presence of anti-JCV antibodies
• longer duration of Tysabri treatment, especially beyond two years
• prior treatment with a medication that suppresses the immune system, such as mitoxantrone, azathioprine, methotrexate, cyclophosphamide or mycophenolate mofetil

For More Information

FDA Drug Safety Communication: New risk factor for PML associated with Tysabri

Adcetris: PML and Lung Damage

Two additional cases of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection that can result in death, have been reported in patients using the lymphoma drug Adcetris (brentuximab vedotin). At the time of Adcetris’ approval in August 2011, one case of PML was described in the drug label.

A new boxed warning highlighting this risk has been added to the drug label, as well as a warning against using Adcetris with the cancer drug bleomycin due to an increased risk of lung damage.

Recommendations

• Contact your health care professional immediately if you develop any signs or symptoms of PML. These may include:
  • changes in mood or usual behavior
  • confusion, thinking problems, loss of memory
  • changes in vision, speech or walking
  • decreased strength or weakness on one side of the body
• If you take Adcetris in combination with bleomycin, talk to your health care professional about stopping this combination of medications.  

For More Information

FDA Drug Safety Communication: New Boxed Warning and Contraindication for Adcetris

Recall: Respironics Trilogy 100 Ventilators

The Respironics Trilogy 100 ventilator manufactured from Feb. 1, 2011, to April 30, 2011, has been recalled because of a manufacturing problem that can cause the product to stop helping a patient breathe.

Risk: Part of the blower that circulates air and other gases through the ventilator may move out of position, stop working, and cause the device’s alarm to sound. Failure of a caregiver to respond could potentially harm or cause the death of a patient dependent on the ventilator.

The Trilogy 100 ventilator is intended for continuous or intermittent breathing support for the care of infants weighing at least 11 pounds, through adult patients who require mechanical ventilation.

Recommendations

• Check the list of serial numbers to see if your Respironics Trilogy 100 ventilator has been recalled.
• Arrange for the return or repair of your recalled ventilator by contacting Respironics Customer Service toll-free at 877-387-3311.

Drug Safety Labeling Changes

In December 2011, FDA required safety labeling changes to be made to 40 drug products, including Dilantin (phenytoin), Relenza (zanamivir), Heparin, Plavix (clopidogrel bisulfate) and Singulair (montelukast sodium).

Changes were made to the prescribing information for health care professionals and, in some cases, to the information that is provided to patients when they receive the drug to warn about potential harmful reactions, tell who shouldn’t take the drug, or give other safety information.

For More Information

Monthly Safety Labeling Changes

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

Feb. 15, 2012

Original article: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm290879.htm

Original article: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm291872.htm

Original article: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm291741.htm

On This Page:

• Liquid Acetaminophen for Infants: Avoid Dosing Mistakes
• Recall: Eclectic Institute Dietary Supplements
• Death After Taking Gilenya for Multiple Sclerosis
• Multaq: Increased Risk of Serious Heart Problems and Death
• ADHD Drugs: No Increased Risk of Heart Problems in Adults
• Expansion of Recall: CooperVision’s Avaira Brand Contact Lenses
• Pradaxa: Risk of Serious Bleeding Events
• Drug Safety Labeling Changes

FDA encourages health care professionals and consumers to report problems with medical products, including

• unexpected and undesirable side effects
• quality problems, such as a drug with an unusual odor or color, or a device with defective parts
• unclear or confusing instructions
• failure to deliver the expected benefit

Report problems to FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail, by fax, or by phone.

• Online
• Regular Mail: Use postage-paid, pre-addressed FDA form 3500
• Fax: 800-FDA-0178
• Phone: 800-332-1088

MedWatch reports can signal a safety problem and may lead to FDA action to protect the public from harm, serious illness or death.

Here are some of the most recent safety alerts and ongoing safety reviews prompted by reports FDA has received through MedWatch.

Liquid Acetaminophen for Infants: Avoid Dosing Mistakes

An additional, less concentrated form of over-the-counter liquid acetaminophen marketed for infants (160 mg/5 mL) is now available. Until now, liquid acetaminophen for infants was only available in the higher concentrations of 80 mg/0.8 mL or 80 mg per 1 mL. This change in the concentration affects the amount of liquid that should be given to an infant. The newer product may also be packaged with an oral syringe instead of a dropper.

Risk: If a parent or caregiver confuses the different concentrations of acetaminophen, the wrong dose could be given. If too little medicine is given, it may not work. If too much is given, it can cause serious side effects and possibly death.

Acetaminophen is marketed under brand names such as Tylenol, Little Fevers Fever/Pain Reliever, Pedia Care Fever Reducer Pain Reliever, Triaminic Infants’ Syrup Fever Reducer Pain Reliever, and store brands such as Rite Aid, CVS and Walgreens.

Recommendations

• Read the Drug Facts label on the package to identify the concentration of the liquid acetaminophen, the correct dosage, and the directions for use.
• Do not depend on a banner claiming that the product is “new.” Some medicines with the old concentration also have this headline on their packaging.
• Use only the dosing device provided with the product in order to correctly measure the right amount of liquid acetaminophen.
• Contact your pediatrician before giving this medication and make sure you’re both talking about the same concentration.

For More Information

Consumer Update: Know Concentration Before Giving Acetaminophen to Infants

Recall: Eclectic Institute Dietary Supplements

Eclectic Institute is recalling specific lots of its freeze-dried capsules containing Gotu Kola (Centella asiatica) and Bladderwrack (Fucus vesiculosus) because of potential Salmonella contamination. The supplements are used as herbal remedies for a variety of medical conditions.  

Risk: The Salmonella organism can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy people infected with Salmonella often experience fever, diarrhea, nausea, vomiting and stomach pain. In rare circumstances, Salmonella infection can result in more severe illnesses such as arthritis and inflamed lining and valves in the heart (endocarditis).

The products were sold to retailers, individuals and health practitioners throughout the U.S. The affected lots of Gotu Kola products were sold from Sept. 14, 2011, to Dec. 14, 2011. The affected lots of Bladderwrack products were sold from July 14, 2011, to Dec. 14, 2011. See the list of the recalled lots.

Recommendations

• Do not use these products. Return them for a full refund to Eclectic Institute, 36350 SE Industrial Way, Sandy, OR 97055.
• If you have questions, call Eclectic Institute at 800-332-4372, Monday through Friday from 7:30 a.m. to 4:30 p.m. PST.

Death After Taking Gilenya for Multiple Sclerosis

FDA received a report of a person with multiple sclerosis (MS) who died within 24 hours of taking the first dose of Gilenya (fingolimod). At this time, FDA cannot conclude whether the drug was related to the death. The agency continues to investigate the case and will communicate any new information it finds.

Gilenya is an oral medicine for the treatment of relapsing forms of MS in adults.

Recommendations

• Do not stop taking Gilenya without talking to your health care professional. FDA continues to believe that Gilenya provides an important health benefit when used as directed.
• Call your health care professional and get immediate care if you take Gilenya and develop any signs or symptoms of a slow heart rate, such as
  • dizziness
  • tiredness
  • slow or irregular heart beat or palpitations

For More Information

FDA Drug Safety Communication: Safety review of a reported death after the first dose of multiple sclerosis drug Gilenya (fingolimod)

Multaq: Increased Risk of Serious Heart Problems and Death

FDA has completed a safety review of the antiarrhythmic drug Multaq (dronedarone). The review showed an increased risk of serious heart and blood vessel (cardiovascular) problems, including stroke, heart failure and death, when used by people in permanent atrial fibrillation (AF).

AF is an abnormal heart rhythm that occurs when rapid, disorganized electrical signals cause the heart’s two upper chambers (atria) to contract very fast and irregularly. People in permanent AF have hearts that cannot be returned to a normal rhythm.

The safety review was based on data from two clinical trials. The Multaq drug label has been revised to include this new information. FDA believes that Multaq provides a benefit for patients who have AF that is temporary or intermittent.

Recommendations

• Do not stop taking the drug without consulting your health care professional.
• If you take Multaq for non-permanent AF, talk to your health care professional about whether you should continue to take it.

For More Information

FDA Drug Safety Communication: Multaq (dronedarone) - Increased Risk of Death or Serious Cardiovascular Events

ADHD Drugs: No Increased Risk of Heart Problems in Adults

Recently completed studies have not shown an increased risk of serious cardiovascular events—such as stroke, heart attack and sudden cardiac death—in adults treated with medications for attention deficit hyperactivity disorder (ADHD).

And earlier studies—which FDA announced in November 2011—showed no evidence that ADHD drugs are associated with an increased risk of cardiovascular events in children and young adults (age 2–24 years).

The studies were sponsored by FDA and the Agency for Healthcare Research and Quality, another agency of the U.S. Department of Health and Human Services.

Stimulant products and Strattera (atomoxetine) for treating ADHD should generally not be used in people with serious heart problems or in those for whom an increase in blood pressure or heart rate would present a health problem.

Recommendations

• Continue your own or your child’s ADHD treatment as prescribed by a health care professional.
• Immediately see a health care professional if you or the person you are caring for develops chest pain, shortness of breath or fainting while taking medication to treat ADHD.
• See your health care professional for periodic monitoring for changes in heart rate or blood pressure.

For More Information

Stimulant Medications Used in Adults with Attention-Deficit/Hyperactivity Disorder – Communication About an Ongoing Safety Review

Consumer Update: How Do You Know If Your Child Has ADHD?

Expansion of Recall: CooperVision’s Avaira Brand Contact Lenses

Additional lots of Avaira Sphere contact lenses have been added to CooperVision’s earlier recall of Avaira Toric and Sphere contact lenses because of a silicone oil residue on them.

Risk: Symptoms of people wearing these lenses include blurry vision, eye pain and eye injuries requiring medical treatment.

Recommendations

• If you wear Avaira Toric or Avaira Sphere contact lenses and experience any symptoms, stop wearing them immediately and contact your eye care professional for advice.
• If you wear either of these contact lenses and do not have symptoms
  • go to the CooperVision recall website and enter the lot number on your lens package or blister label to determine whether your lenses have been recalled, or
  • contact CooperVision on its toll-free hotline at 1-855-526-6737
• If your lenses have been recalled, immediately remove them and return them to the place where you bought them.

For More Information

CooperVision AVAIRA Toric and Sphere Soft Contact Lenses Recall 

Consumer Update: Decorative Contact Lenses: Is Your Vision Worth It? (article and video)

Consumer Update: Focusing on Contact Lens Safety

Pradaxa: Risk of Serious Bleeding Events

FDA is evaluating reports of serious bleeding in people taking the blood thinner Pradaxa (dabigatran etexilate mesylate) after it became available on the market. The drug was approved in October 2011 to prevent stroke and blood clots in people with non-valvular atrial fibrillation, the most common type of heart rhythm abnormality. The Pradaxa drug label contains a warning about significant and sometimes fatal bleeding, a well-recognized complication of all blood thinners.

A large clinical trial involving 18,000 patients compared Pradaxa and Coumadin (warfarin), another blood thinner approved more than 50 years ago. Major bleeding occurred at similar rates with the two drugs. FDA is working to determine whether the reports of bleeding in people taking Pradaxa since the drug has been on the market are occurring more commonly than would be expected based on the clinical trial.

At this time, FDA continues to believe that Pradaxa provides an important health benefit when used as directed.

Recommendations

• Do not stop taking Pradaxa without talking to your health care professional. Stopping use of your blood thinner suddenly can put you at risk for a stroke, which can lead to permanent disability and death.
• Be aware that while taking Pradaxa you may bruise more easily and it may take longer for any bleeding to stop.
• Call your health care professional and get immediate care if you develop any signs or symptoms of bleeding such as
  • unusual bleeding from the gums
  • nose bleeding that happens often
  • menstrual or vaginal bleeding that is heavier than normal
  • bleeding that is severe or you cannot control
  • pink or brown urine
  • red or black stools (look like tar)
  • bruises that happen without a known cause or that get larger
  • coughing up blood or blood clots
  • vomiting blood or vomit that looks like coffee grounds

For More Information

FDA Drug Safety Communication: Safety review of post-market reports of serious bleeding events with the anticoagulant Pradaxa 

Drug Safety Labeling Changes

In November 2011, FDA required safety labeling changes to be made to 48 drug products, including Amoxil (amoxicillin), Prinivil (lisinopril), Lamictal (lamotrigine) and AndroGel (testosterone gel).

Changes were made to the prescribing information and, in some cases, to the patient package inserts and medication guides (paper handouts for patients that come with many prescription medicines) to warn about potential harmful reactions, tell who shouldn’t take the drug, or give other safety information.

For More Information

Monthly Safety Labeling Changes

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

Jan. 25, 2012

Original article: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm288002.htm

From morning until night—styling our hair for work to showering before bed—Americans depend upon personal care products. Most are safe, but some may cause problems, and that’s when FDA gets involved.

FDA collects information about consumers’ bad reactions to products it regulates. If you have a reaction to a beauty, personal hygiene, or makeup product, FDA wants to hear from you.

In this 30-minute webinar, learn:

• how FDA regulates cosmetics and monitors their safety
• steps consumers can take to minimize their chances of having a bad reaction to a cosmetic
• how to report a bad reaction to a cosmetic
• how this information helps FDA in its public health mission.  

An opportunity to ask questions will follow the presentation.

When: Wednesday, Jan. 18, 2:00 p.m. ET

Length: 30 minutes

Where: To join the webinar, see the instructions here. Webinar slides are posted here also.

Host: FDA’s Office of Cosmetics and Colors

Featured speakers: Interdisciplinary Scientist Wendy Good, Ph.D., and Policy Fellow Jon Hicks, M.P.P, both from FDA’s Office of Cosmetics and Colors

This webinar is part of a series of online sessions hosted by different FDA centers and offices. The series is part of FDA Basics, a Web-based resource aimed at helping the public better understand what the agency does.

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

Jan. 12, 2012

Original article: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm287405.htm

Stem cell therapies offer the potential to treat diseases or conditions for which few treatments exist.

Stem cells, sometimes called the body’s “master cells,” are the precursor cells that develop into blood, brain, bones and all of your organs. Their promise in medical treatments is that they have the potential to repair, restore, replace and regenerate cells that could then be used to treat many medical conditions and diseases.

But the Food and Drug Administration (FDA) is concerned that the hope that patients have for cures not yet available may leave them vulnerable to unscrupulous providers of stem cell treatments that are illegal and potentially harmful.

FDA cautions consumers to make sure that any stem cell treatment they are considering has been approved by FDA or is being studied under a clinical investigation that has been submitted to and allowed to proceed by FDA.

FDA has approved only one stem cell product, Hemacord, a cord blood-derived product manufactured by the New York Blood Center and used for specified indications in patients with disorders affecting the body’s blood-forming system.

Regulation of Stem Cells

FDA regulates stem cells in the U.S. to ensure that they are safe and effective for their intended use.

“Stem cells can come from many different sources and under the right conditions can give rise to many different cell types,” says Stephanie Simek, Ph.D., deputy director of FDA’s Office of Cellular, Tissue and Gene Therapies.

Stem cells that come from bone marrow or blood are routinely used in transplant procedures to treat patients with cancer and other disorders of the blood and immune system.

Umbilical cord blood is collected from a placenta with the birth mother’s consent. Cord blood cells are then isolated, processed, and frozen and stored in a cord blood bank for future use. Cord blood is regulated by FDA and cord blood banks must follow regulatory requirements.

But there are many other stem cell products, including other cord blood-derived products, that have been reviewed by FDA for use in investigational studies, says Simek.  Investigational products undergo a thorough review process as the sponsor prepares to study the safety and effectiveness of the product in adequate and well-controlled human studies (clinical trials).

As part of this review, the sponsor must show how the product will be manufactured so that FDA can make certain that appropriate steps are being taken to help assure the product’s safety, purity and potency. FDA also requires that there be sufficient data generated from animal studies to aid in evaluating any potential risks associated with the use of these products.

Consumers need to be aware that at present–other than cord blood for certain specified indications–there are no approved stem cell products.

Advice for Consumers

• If you are considering stem cell treatment in the U.S., ask your physician if the necessary FDA approval has been obtained or if you will be part of an FDA-regulated clinical study. This also applies if the stem cells are your own. Even if the cells are yours, there are safety risks, including risks introduced when the cells are manipulated after removal.

  There is a potential safety risk when you put cells in an area where they are not performing the same biological function as they were when in their original location in the body,” says Simek. Cells in a different environment may multiply, form tumors, or may leave the site you put them in and migrate somewhere else.
   

• If you are considering having stem cell treatment in another country, learn all you can about regulations covering the products in that country. Exercise caution before undergoing treatment with a stem cell-based product in a country that—unlike the U.S.—may not require clinical studies designed to demonstrate that the product is safe and effective. FDA does not regulate stem cell treatments used in solely in countries other than the United States and typically has little information about foreign establishments or their stem cell products.

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

Jan. 6, 2012

Original article: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm286155.htm

Pamela Scott’s Story (MP3)

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Some medical devices are reused many times in common surgical and diagnostic procedures, and have been for years. They include instruments used in surgery (like clamps and forceps), and endoscopes (like bronchoscopes and colonoscopes) used to visualize areas inside the body.

And the Food and Drug Administration (FDA) wants to ensure that they are safely reused.

The agency is working with healthcare providers, manufacturers, organizations that set standards, and other government agencies to reduce the risk of infection from the inadequate “reprocessing” of these durable devices designed for repeated use. Reprocessing means cleaning and high-level disinfection or sterilization.

FDA has received reports of patients being exposed to microscopic amounts of blood, body fluids and tissue from other patients that may have occurred because the reusable devices were inadequately reprocessed and these contaminants were not removed. Transmission of infection was extremely rare, but the potential for becoming infected by an inadequately processed device was there.

So if you’re scheduled to have a medical procedure, how worried should you be about this?

Not worried enough to cancel or delay your plans, says FDA.

The risk of acquiring an infection from a reprocessed medical device is low, says William Maisel, MD, deputy director for science at the FDA’s Center for Devices and Radiological Health. The benefits of these procedures in diagnosing and treating medical conditions far outweigh any risk, he says.

That said, there are questions you can ask your healthcare providers.

Frank Nemec, MD, a Las Vegas gastroenterologist and patient advocate who spoke at an FDA-sponsored workshop in June, advises his patients to ask this question: What precautions are in place to ensure that the procedure will be done safely?

One person who did ask that question is Pamela D. Scott, a biomedical engineer who has been working on this issue at FDA.

Earlier this year, Scott’s mother, Ophelia, was about to have a colonoscopy. Scott called the gastro-intestinal clinic and asked to speak to the person in charge of reprocessing medical devices. In this case, it was the head nurse.

Scott asked if the clinic staff was aware of news reports about problems with the reprocessing of endoscopes. And, if they were aware, how did these reports affect how they clean and disinfect these tools?

The nurse replied that clinic had recently assessed its reprocessing procedures and called in the manufacturer to make sure staff members are properly cleaning and disinfecting or sterilizing the devices.

“Just to know that they took steps, that they had procedures, that helped me,” Scott says.

So ask questions, just as Nemec recommends and Scott did on her mother’s behalf. Before having any medical procedure, it’s a good idea to learn more about the procedure and steps the healthcare facility takes to keep patients safe.

Health care providers are one source of this information. Many professional organizations, including the American Academy of Family Physicians, offer advice on how to ask such questions of your healthcare provider.

FDA is working with manufacturers and healthcare providers to:

• Make sure that the makers of these devices are providing reprocessing instructions that are clear and scientifically validated.
• Make sure that staff at hospitals and other healthcare facilities understand and are following the manufacturers’ instructions.
• Identify device designs that facilitate optimal cleaning, disinfecting and sterilization. 

And FDA has created a new website (www.fda.gov/reprocessingreusabledevices) with information about these medical tools. To report a problem, the site also provides a link to MedWatch, the FDA Safety Information and Adverse Event Reporting Program.

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

Posted December 28, 2011 

Original article: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm284636.htm

On This Page:

• Warning: Do Not Use ShoulderFlex Massager
• Cholesterol-Lowering Trilipix May Not Lower Other Risks
• No Evidence of Increased Risk of Heart Problems With ADHD Drugs
• Update: TNF Blockers and Cancer Risk
• Recall: Unapproved Drug Sold as ‘Sexual Enhancer’
• Drug Safety Labeling Changes

FDA encourages health care professionals and consumers to report problems with medical products, including

• unexpected and undesirable side effects
• quality problems, such as a drug with an unusual odor or color, or a device with defective parts
• unclear or confusing instructions
• failure to deliver the expected benefit

Report problems to FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail, by fax, or by phone.

• Online
• Regular Mail: Use postage-paid, pre-addressed FDA form 3500
• Fax: 800-FDA-0178
• Phone: 800-332-1088

MedWatch reports can signal a safety problem and may lead to FDA action to protect the public from harm, serious illness or death.

Here are some of the most recent safety alerts and ongoing safety reviews prompted by reports FDA has received through MedWatch.

Warning: Do Not Use ShoulderFlex Massager

FDA has warned consumers to stop using the ShoulderFlex Massager because it can cause serious injury or death.

This personal massage device was designed for home use to provide deep tissue massage to the neck, shoulders and back while the user is lying down. The device was sold in various stores and through catalogs and online retailers (including Amazon) in the U.S.

On Aug. 31, King International recalled all of its nearly 12,000 ShoulderFlex massagers that it has distributed since Oct. 18, 2003. However, FDA has found that the company went out of business and did not follow through with recall procedures, leaving many companies that sell this device unaware of the recall.

Risk: One death and one near-strangulation were reported when a necklace and clothing became caught in a piece of the device that rotates during use. Two other reports involved clothing and hair that became caught in the device.

Recommendations

• Do not use the ShoulderFlex massager.
• Throw away the device components separately so that the massager cannot be reassembled and used. (Remove the massage fingers and dispose of them separately. Dispose of the power supply separately as well.)

For More Information

Photo of ShoulderFlex Massager

FDA Safety Communication: Update on Life-Threatening Injuries Associated With the ShoulderFlex Massager

Cholesterol-Lowering Trilipix May Not Lower Other Risks

A study showed that the medicine Trilipix (fenofibric acid)—while lowering cholesterol—may not lower a person’s risk of having a heart attack or stroke. Data from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Lipid trial show no significant difference in the risk of experiencing a major heart-related event between a group treated with Trilipix plus the statin Zocor (simvastatin) and a group treated with Zocor alone.

Information from the study has been added to the Trilipix physician label and to the patient medication guide (paper handout of safety information that comes with many prescription drugs).

FDA is requiring the manufacturer of Trilipix to conduct a study to evaluate the heart and blood vessel (cardiovascular) effects of Trilipix in people at high risk for cardiovascular disease who are already taking statins.

Recommendations

• Do not stop taking Trilipix medicine without first talking to your health care professional.
• Discuss the benefits and risks of taking Trilipix with your health care professional.
• Read the medication guide that you get along with your Trilipix prescription.

For More Information

FDA Drug Safety Communication: Review Update of Trilipix and the ACCORD Lipid Trial

FDA Consumer Update: Limit Use of 80 mg Simvastatin

No Evidence of Increased Risk of Heart Problems With ADHD Drugs

A large, recently completed study showed no evidence that drugs used to treat attention deficit hyperactivity disorder (ADHD) are associated with an increased risk of cardiovascular events (such as stroke, heart attack, and sudden cardiac death) in children and young adults (age 2–24 years). The medications studied include the following:

Stimulants

• methylphenidate (Concerta, Daytrana, Metadate CD, Metadate ER, Methylin, Methylin ER, Ritalin, Ritalin LA, Ritalin-SR)
• dexmethylphenidate HCl (Focalin, Focalin XR)
• dextroamphetamine sulfate (Dexedrine, Dexedrine Spansules, Dextroamphetamine ER, Dextrostat)
• lisdexamfetamine dimesylate (Vyvanse)
• amphetamine, mixed salts (Adderall, Adderall XR)
• methamphetamine (Desoxyn)

Non-stimulants

• pemoline (Cylert—no longer marketed)
• atomoxetine (Strattera)

The study was sponsored by FDA and the Agency for Healthcare Research and Quality, another agency of the U.S. Department of Health and Human Services.

Stimulant products and Strattera should generally not be used in people with serious heart problems or in those for whom an increase in blood pressure or heart rate would present a health problem.

Recommendations

• Continue your child’s or your own ADHD treatment as prescribed by a health care professional.
• Immediately see a health care professional if you or the person you are caring for develops chest pain, shortness of breath or fainting while taking medication to treat ADHD.
• Talk to your health care professional about any questions you may have about ADHD medications.

For More Information

FDA Drug Safety Communication: Safety Review Update of Medications to Treat ADHD in Children and Young Adults

Consumer Update: How Do You Know If Your Child Has ADHD?

Update: TNF Blockers and Cancer Risk

FDA is continuing its safety review of a type of drug used to treat Crohn’s disease, rheumatoid arthritis, ulcerative colitis and other conditions that has been linked to reports of a rare cancer in children, adolescents and adults age 30 and younger. The agency is requiring manufacturers of these tumor necrosis factor (TNF) blocker drugs to conduct in-depth follow-up of reports of cancer cases and expedite them to FDA. Other data FDA is requiring of manufacturers will allow the agency to more completely analyze all reported cancers.

In April, FDA communicated that it continues to receive reports of a rare cancer of white blood cells (known as Hepatosplenic T-Cell Lymphoma, or HSTCL), occurring mainly in adolescents and young adults being treated for Crohn’s disease and ulcerative colitis with the following medicines:

• TNF blockers, including Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol), and Simponi (golimumab)
• Imuran (azathioprine)
• Purinethol (mercaptopurine)

Risk: HSTCL is a fast-growing cancer that is usually fatal. Most of the cases reported have been in people being treated for Crohn’s disease or ulcerative colitis, but also included a person treated for psoriasis and two people treated for rheumatoid arthritis.

Although most reported cases of HSTCL occurred in people treated with a combination of medicines known to suppress the immune system—including TNF blockers, azathioprine, and mercaptopurine—there have been cases reported in people receiving azathioprine or mercaptopurine alone.

Recommendations

• Do not stop taking TNF blockers, azathioprine or mercaptopurine without talking to your health care professional.
• Read the medication guide that comes with your prescription for TNF blockers.
• If you use a TNF blocker or azathioprine or mercaptopurine and you develop any serious infections or cancer, ask your health care professional if he or she has reported the issue to FDA and, if not, urge him or her to do so. You may also report it to FDA yourself through MedWatch.

For More Information

FDA Drug Safety Communication: Update on TNF Blockers and Risk for Pediatric Malignancy

Recall: Unapproved Drug Sold as ‘Sexual Enhancer’

One lot of Virility Max—a product sold as a dietary supplement—has been recalled because it contains an active drug ingredient that is not listed on the label, making it an unapproved drug.

Virility Max is marketed for sexual enhancement. It is distributed in 10-count, white plastic bottles to retail customers in the South Florida area. Only lot 10090571 is included in this recall.

Risk: The product contains a substance similar to sildenafil, which is an active ingredient in an FDA-approved drug for erectile dysfunction. This substance may interact with prescription drugs known as nitrates, including nitroglycerin, and cause dangerously low blood pressure. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

Recommendations

• Stop using this product immediately and contact your health care professional if you have had any problems that you think may be related to taking this product.
• Return any unused product to the place of purchase or contact the distributor, Keime Inc., at 561-368-2070 Monday through Friday, 9 a.m. to 5 p.m. EDT.

Drug Safety Labeling Changes

In October, FDA required safety labeling changes to be made to more than 45 drug products, including Premarin, Lithobid, Norvasc, Lotrel, Vytorin and Zocor. Changes were made to the prescribing information and, in some cases, to the patient package inserts and medication guides to warn about potential harmful reactions, tell who shouldn’t take the drug, or give other safety information.

For More Information

Monthly Safety Labeling Changes

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

Dec. 27, 2011

Original article: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm283962.htm