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
Report problems to FDA's MedWatch Adverse Event Reporting Program either online, by regular mail, by fax, or by phone.
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.
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:
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
Recommendations for People With Metal-on-Metal Hip Implants
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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.
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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.
For More Information: Super Power: Recall - Undeclared Ingredient
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 bottles .
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.
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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:
For More Information: Samsca (tolvaptan): Drug Warning - Potential Risk of Liver Injury
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.
For More Information: Recall Notice: Praxair Inc., Grab ’n Go Vantage Portable Oxygen Cylinder Units
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 Changes
This article appears on FDA's Consumer Updates page , which features the latest on all FDA-regulated products.
Feb. 26, 2013