FDA MedWatch Safety Alerts: January 2013

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After products approved by the Food and Drug Administration (FDA) are on the market, the agency continues to monitor them for problems.
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.

Online⁴
Regular Mail: Use postage-paid, pre-addressed FDA form 3500⁵
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.

Metal-on-Metal Hip Implants: Updated Safety Recommendations

FDA is providing updated safety information and recommendations to patients and health care professionals based on the agency’s current assessment of metal-on-metal hip implants, including:

the benefits and risks
the evaluation of published literature
the results of an FDA advisory panel meeting held in June 2012

Risk: Implant components slide against each other during walking or running, which releases tiny metal particles. These particles may damage bone or soft tissue surrounding the implant and joint. Soft tissue damage could lead to pain, implant loosening, device failure and the need for revision surgery.
Some of the metal ions released will enter the bloodstream and travel to other parts of the body, where they may cause discomfort or illnesses.
Recommendations for People Considering a Metal-on-Metal Hip Implant

Be aware that every hip implant has benefits and risks.
Discuss your options for hip surgery with your orthopedic surgeon.
See a list of questions⁶ to ask your orthopedic surgeon.

Recommendations for People With Metal-on-Metal Hip Implants

If you are not having any symptoms and your orthopedic surgeon believes your implant is functioning properly, continue to follow-up routinely with the surgeon every one to two years.
If you develop new or worsening problems, such as pain, swelling, numbness, noise (popping, grinding, clicking or squeaking of your hip) or a change in your ability to walk, contact your orthopedic surgeon right away.
If you experience changes in your general health, including new or worsening symptoms outside your hip, let your doctor or other health care professional know you have a metal-on-metal hip implant.

For More Information

Lower Doses Recommended for Sleep Drugs—Especially for Women

FDA is requiring manufacturers to lower the recommended dose for sleep drugs approved for bedtime use that contain zolpidem, the most widely used active ingredient in prescription sleep medications. The products affected are sold under the brand names Ambien, Ambien CR, Edluar and Zolpimist, and also as generics.
The recommended doses of Intermezzo, a lower dose zolpidem product approved for middle-of-the-night awakenings, are not changing.
Risk: New data show that blood levels in some people who take zolpidem may be high enough the morning after use to impair activities that require alertness, including driving. This risk is highest for people who take products containing extended-release zolpidem (Ambien CR and generics). Women are especially vulnerable because zolpidem is cleared from the body more slowly in women than in men.
Recommendations

Be aware that sleep drugs can cause impaired alertness the next morning, even if you feel fully awake.
Talk to your health care professional about how to take the lowest effective dose of sleep drugs. Don’t assume that over-the-counter sleep medicines are necessarily safer alternatives to prescription drugs.

For More Information

Recall: Super Power “Dietary Supplement”

Freedom Trading has recalled one lot of its product sold as a dietary supplement under the brand name Super Power. The product is a capsule packaged in two-count blister packs. The recalled lot number is L08108, with an expiration date of 06/2015; both can be found on the back of the package.
Super Power contains trace amounts of sildenafil, which is not listed on the label. Sildenafil is an active ingredient in an FDA-approved prescription drug used to treat erectile dysfunction, making Super Power an unapproved drug. The product was sold nationwide between August 2012 and January 2013.
Risk: Sildenafil may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates.
Recommendations

Immediately stop using the recalled product.
Contact your health care professional if you have experienced any problems that may be related to taking this product. Signs of low blood pressure include dizziness, nausea, fainting, unusual thirst, blurred vision and fatigue. Sildenafil may also cause side effects such as headaches and flushing of the face.
You can return the product to the place of purchase or directly to Freedom Trading. Call the company at 866-780-6474 Monday through Friday from 9:00 a.m. to 5:00 p.m. ET for instructions on the return and refund process.

For More Information: Super Power: Recall - Undeclared Ingredient¹⁴

Recall: Rugby Natural Iron Supplement

Advance Pharmaceutical Inc. has recalled one lot of Rugby Natural Iron Supplement Ferrous Sulfate 325 mg because a pharmacist found that a bottle contained a different drug, meclizine HCl 25 mg. The lot number of the recalled Rugby supplement is 12G468 and the expiration date is 07/14. The product is packaged in 100-count bottles¹⁵.

Risk: Meclizine is an antihistamine used to treat or prevent motion sickness. Too much meclizine may lead to serious side effects, including reduced alertness, drowsiness, confusion, low blood pressure, coma and reduced breathing rate. Without treatment, meclizine toxicity could be life-threatening.
Taking meclizine HCl 25 mg while following the directions given for taking ferrous sulfate 325 mg may cause serious side effects in people who consume alcohol or other sedatives, those with a pre-existing central nervous system disorder, those with kidney or liver problems, the elderly, nursing infants of lactating mothers who received the drug, and newborns of mothers who received the drug immediately before childbirth.
Recommendations

Do not use the recalled Rugby Natural Iron Supplement Ferrous Sulfate 325 mg lot number 12G468.
Contact Advance Pharmaceutical with questions at 631-981-4600, ext. 300, Monday through Friday from 8:30 a.m. to 4:30 p.m. ET.

For More Information

Samsca Warning: Potential Risk of Liver Injury

Significant liver injury was found to be associated with the use of Samsca (tolvaptan) in a large clinical trial. Increases in liver enzymes, which could indicate serious liver damage, were found mostly during the first 18 months of taking Samsca.
Samsca is a prescription medicine used to help increase low sodium levels in the blood in adults with conditions such as heart failure, liver disease and certain hormone imbalances.
Risk: People who use Samsca may have an increased risk for irreversible and potentially fatal liver injury.
Recommendation: If you take Samsca, tell your health care professional right away if you have any symptoms that may indicate liver injury, such as:

tiredness
anorexia
discomfort in the right upper belly
dark urine
yellowing of the skin (jaundice)

For More Information: Samsca (tolvaptan): Drug Warning - Potential Risk of Liver Injury¹⁸

Risk of Fire With Grab ’n Go Vantage Portable Oxygen Cylinder Units

Praxair Inc. issued a recall of its Grab ’n Go Vantage Portable Oxygen Cylinder unit because fires may occur inside the cylinder, causing the wall of the unit to break and release oxygen. The fires, which go out by themselves, may be caused by physical force, such as dropping or knocking over the cylinder unit.
The recalled Grab ’n Go Vantage units were distributed from June 17, 2009, to Nov. 16, 2012.
Risk: If a fire occurs, users may get burned or experience a lack of oxygen (hypoxia), which may cause death.
Recommendations

Store the Grab ’n Go Vantage unit indoors in a safe area.
Never store a unit in an elevated location.
Handle the unit safely and avoid jarring or dropping it.
Send the unit to Praxair Inc. for servicing and refilling after use, according to instructions.

For More Information: Recall Notice: Praxair Inc., Grab ’n Go Vantage Portable Oxygen Cylinder Units¹⁹

Drug Safety Labeling Changes

In December 2012, FDA required safety labeling changes to be made to 42 drugs, including a number of anti-depressants.
In general, 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 Changes²⁰

This article appears on FDA's Consumer Updates page²¹, which features the latest on all FDA-regulated products.

Feb. 26, 2013