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