FDA's MedWatch Safety Alerts: June 2009
- Children’s Face Paints Recalled
- Safety Concerns About Testosterone Gel
- Warning on Hydroxycut Products
- Recall of ACCU-CHEK Spirit Insulin Pumps
- Boxed Warning Required for Botulinum Toxin Products
After the Food and Drug Administration (FDA) approves a product and it is on the market, FDA continues to monitor unexpected and undesirable side effects (adverse events) of that product.
Health care professionals and consumers may report any problems with the use of medical products to FDA's MedWatch Adverse Event Reporting program either online, by regular mail, by fax, or by phone.
- Regular Mail: Use postage-paid FDA form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
- Fax: 1-800-FDA-0178
- Phone: 1-800-332-1088
MedWatch reports can signal a safety problem and lead to an FDA action to protect the public from harm, serious illness, or even death.
Here are a few of the most recent safety alerts prompted by reports received by FDA from health care professionals and their patients. Others can be found at 2009 MedWatch Safety Alerts.
FDA advises consumers to stop using certain cosmetic “Face Paints” labeled as distributed by Oriental Trading Co., Omaha, Neb., due to reports of skin reactions in children. These items were distributed nationwide.
Adverse events: Rashes, itchiness, burning sensation, and swelling where the face paints were applied have been reported.
People at risk: Children or others exposed to various colors of the recalled face paints are at risk. Fun Express Inc., a subsidiary of Oriental Trading Co., is recalling the following face paints:
|Item Number||Product Description|
Blue Face Paint
Purple Face Paint
Red Face Paint
Orange Face Paint
Black Face Paint
Green Face Paint
White face paint
Yellow face paint
FDA actions: FDA tested samples of the face paints in a laboratory and found them to be contaminated.
- Stop using any of the recalled face paints; throw them out or return them to the place of purchase.
- Report any side effects from face paints to FDA through MedWatch as well as to state and local health authorities.
For more information:
FDA has received reports of serious side effects in children who were exposed to testosterone by accident through contact with another person being treated with AndroGel 1% or Testim 1%.
These two products are prescription testosterone gels applied to the skin. They are approved for use in men who either no longer produce the male sex hormone testosterone or produce it in very low amounts. Both products are applied once daily, to the shoulders or upper arms. Only AndroGel 1% is approved to apply to the abdomen.
AndroGel 1% is manufactured by Solvay Pharmaceuticals in Marietta, Ga. Testim 1% is made by Auxilium Pharmaceuticals in Malvern, Pa.
Adverse events: Since Dec. 1, 2008, FDA has received reports of eight cases of accidental exposure to testosterone in children ages 9 months to 5 years. In most of the cases, users of the gels failed to follow the instructions for appropriate use, resulting in direct contact between the treated skin and the child. Side effects reported in children include
- inappropriate enlargement of the external sexual organs (penis or clitoris)
- premature development of pubic hair
- advanced bone age
- increased self-stimulation
- aggressive behavior
In most cases, the signs and symptoms lessened when the child was no longer exposed to the product.
People at risk: Children and women who come in contact with areas of skin where men have applied testosterone gel.
FDA actions: FDA is requiring the manufacturers of these products to
- make product label changes that will provide additional information about the risk of accidental exposure and the steps that should be taken to reduce this risk
- develop a Medication Guide to be given to people each time they receive these products from a pharmacy
- carry out a plan to ensure that the benefits of these products continue to outweigh their potential risks
Recommendations: If you use testosterone gels, you should
wash your hands with soap and warm water each time you apply the gel
cover the area where you have applied the gel with clothing after the gel has dried
wash the area where you apply the gel thoroughly with soap and warm water before any situation where skin-to-skin contact with another person may occur
- avoid using any similar, but unapproved, products from the marketplace—including the Internet—because they can result in the same serious side effects
- contact your child's health care professional if you see any signs of the child's exposure to testosterone gels
- report serious side effects or product quality problems with the use of these gels to FDA's MedWatch
For more information:
FDA is warning consumers to immediately stop using Hydroxycut products because of reports of serious liver injuries. Hydroxycut products are distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y. Iovate has agreed to recall Hydroxycut products from the market.
Hydroxycut products are dietary supplements that are marketed for weight loss, as fat burners, as energy-enhancers, as low-carb diet aids, and for water loss under the Iovate and MuscleTech brand names.
The recalled products include
- Hydroxycut Regular Rapid Release Caplets
- Hydroxycut Caffeine-Free Rapid Release Caplets
- Hydroxycut Hardcore Liquid Caplets
- Hydroxycut Max Liquid Caplets
- Hydroxycut Regular Drink Packets
- Hydroxycut Caffeine-Free Drink Packets
- Hydroxycut Hardcore Drink Packets (Ignition Stix)
- Hydroxycut Max Drink Packets
- Hydroxycut Liquid Shots
- Hydroxycut Hardcore RTDs (Ready-to-Drink)
- Hydroxycut Max Aqua Shed
- Hydroxycut 24
- Hydroxycut Carb Control
- Hydroxycut Natural
Hydroxycut Cleanse and Hoodia products are not affected by the recall.
Adverse events: FDA has received 23 reports of serious health problems ranging from jaundice (yellowing of the skin or whites of the eyes) and elevated liver enzymes (an indicator of potential liver injury), to liver damage requiring a liver transplant and one death due to liver failure.
Other health problems reported include seizures, cardiovascular problems, and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.
People at risk: Anyone who has taken any of the recalled Hydroxycut products, even if they haven’t exceeded the doses recommended on the bottle.
Stop using the recalled products and return them to the place of purchase.
Watch for symptoms of liver injury including jaundice and brown urine. Other symptoms include nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching, and loss of appetite.
Call your health care professional if you have symptoms possibly associated with these products.
FDA actions: FDA continues to investigate the potential relationship between Hydroxycut dietary supplements and liver injury or other potentially serious side effects.
For more information:
Disetronic Medical Systems Inc. announced a recall of some of its ACCU-CHEK® Spirit insulin pumps due to a potential defect in the “up” and “down” buttons on the pumps.
The buttons may not work all the time, meaning that users may not be able to change any programmed setting on the pump.
Adverse events: The user may not get the proper amount of insulin.
People at risk: Users of an ACCU-CHEK Spirit insulin pump with “up” or “down” buttons that are not working. The recall applies to all ACCU-CHEK Spirit insulin pumps with serial numbers from SN02119552 through SN10006093. Pumps with serial numbers of SN10006094 and above are not affected.
- If the vibration or confirmation signal does not occur on your pump, disconnect the pump and switch to a backup pump or another method of insulin delivery.
- If your pump has this defect, immediately contact ACCU-CHEK Spirit hotline for a replacement pump or for further information at 1-800-778-5095, available 24 hours a day, 7 days a week.
For more information:
Prompted by reports of serious side effects, FDA announced on April 30, 2009, that all botulinum toxin products require a boxed warning on the label and a strategy to ensure the benefits continue to outweigh the risks for these products.
A boxed warning is the agency’s strictest warning that can be put on a product label.
Adverse events: FDA has received reports of symptoms similar to those of botulism, including
- muscle weakness or loss of strength
- hoarseness or trouble talking
- trouble saying words clearly
- loss of bladder control
- trouble breathing
- trouble swallowing
- double vision, blurred vision and drooping eyelids
These symptoms indicate that the effects of botulinum toxin may spread from the injection area to other areas of the body. The symptoms have mostly been reported in children with cerebral palsy being treated with the products for muscle spasticity, which is not an approved use of these drugs. The doses used to treat muscle spasticity are often much higher than the doses described in the labels of FDA-approved botulinum toxin products.
Symptoms have also been reported in adults treated both for approved and unapproved uses. The symptoms have been reported as early as several hours and as late as several weeks after treatment.
Products affected: The products required to add the boxed warning are
- Botox and Botox Cosmetic (botulinum toxin type A), marketed by Allergan
- Myobloc (botulinum toxin type B), marketed by Solstice Neurosciences
- Dysport (abobotulinumtoxinA), marketed by Ipsen Biopharm Ltd., and newly approved by FDA
The FDA-approved uses of these products are as follows:
- Botox, Myobloc, and Dysport to treat cervical dystonia, a condition that affects the muscles in the neck that control the position of the head
- Botox also to treat severe underarm sweating (primary axillary hyperhidrosis), crossed eyes (strabismus), and abnormal tics and twitches of the eyelids (blepharospasm)
- Botox Cosmetic and Dysport to temporarily improve the appearance of frown lines between the eyebrows (glabellar lines)
- Call your healthcare professional immediately if you or your family members have used these products and develop any of the symptoms listed above.
- You may report serious side effects or product quality problems with the use of these products to FDA's MedWatch Adverse Event Reporting program listed at the beginning of this update.
For more information:
This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.
Date Posted: June 5, 2009