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FDA's MedWatch Safety Alerts: January 2014

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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 regulated 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.

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.

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Water Filtration Products Could Expose Consumers to Bacteria or Virus

Nephros is recalling its non-medical water filtration SafeSpout and SafeShower products because they may pose risks to health, potentially resulting in sickness or death. The Nephros SafeSpout and SafeShower are intended to filter water for washing and drinking. The devices are installed at the end of a standard sink faucet or shower head.

This recall involves all production lots of the following filters, manufactured between July 2011 and September 2013 and distributed between October 2011 – 2013.

  • SafeSpout 70-0233, 70-0238
  • SafeShower HH (Hand Held) 70-0237
  • SafeShower FH (Fixed Head) 70-0236

Risk: Exposure to harmful bacteria may occur when the fiber filter or the sealing compound holding the fiber in place breaks apart. If the filter breaks, consumers could be exposed to bacteria or viruses, which could result in infection or death. Reports of one death and one infection are associated with this recall.

Recommendations

  • Consumers who have purchased these products should stop using them immediately and return all filters to Nephros Inc. 41 Grand Ave., River Edge, NJ 07661-1947.
  • Consumers may contact Nephros Inc. at: 1-201-343-5202 ext.100 Monday – Friday 9:30 a.m. to 5 p.m. ET.

For More Information

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Recall: Glucose Meters Set with Incorrect Measure Level

Nipro Diagnostics is recalling a number of TRUEbalance and TRUEtrack Blood Glucose Meters because they have an incorrect factory-set unit of measure that displays the glucose result in mmol/L (millimoles per liter) rather than mg/dl (milligrams per deciliter). If a consumer did not notice the different unit of measurement, the meter would read as lower than the actual blood glucose.
There are 501 affected TRUEbalance meters and 105 affected TRUEtrack meters that were distributed in the United States from September 2008 to May 2013. Consumers should check the serial number on their product against this list disclaimer icon  to see if it is an affected meter.

Risk: Low glucose readings can cause people to consume sugar in an effort to raise their glucose levels, and could lead to hyperglycemia (high sugar levels). Having too much sugar in the blood for long periods of time can cause serious health problems. Hyperglycemia can damage the vessels that supply blood to vital organs, which can increase the risk of heart disease and stroke, kidney disease, and vision problems.

Recommendations

  • Consumers looking for more information, or to expedite a replacement should call Stericycle at 866-236-4518. 

For More Information

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Possible Harm from Exceeding Recommended Dosage of Diuretic

FDA is warning that taking more than one dose in 24 hours of over-the-counter (OTC) sodium phosphate drugs to treat constipation can cause rare but serious harm to the kidneys and heart, and even death. These products are marketed under the brand-name Fleet, as well as store brands and generics. OTC sodium phosphate drug products include oral solutions taken by mouth and enemas used rectally.

Risk: FDA has become aware of reports of severe dehydration and changes in the levels of electrolytes in the blood from taking more than the recommended dose of OTC sodium phosphate products. Possible effects of using a diuretic include an electrolyte imbalance or dehydration due to water loss. Symptoms include: excessive urination, nausea, vomiting, physical and mental weakness, fever, flushed face and hyperactive deep tendon reflexes. According to the reports, most cases of serious harm occurred with a single dose of sodium phosphate that was larger than recommended or with more than one dose in a day.

Recommendations

  • Consumers should always read the Drug Facts label for OTC sodium phosphate drugs and use these products as recommended on the label, and not exceed the labeled dose.
  • Consumers should not give the oral products to children 5 years and younger without first discussing with a health care professional.
  • The rectal form of these products should never be given to children younger than 2 years.

For More Information

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Recall: Dietary Supplements Contain Undeclared Drug Ingredients

Midwest Wholesale is recalling the following : Boost: Ultra, XZone Gold, Sexy Monkey, Triple MiracleZen Platinum, Magic for Men, "New" Extenze, and New XZen Platinum. FDA lab tests show that these products contain tadalafil and/or sildenafil, active ingredients in the FDA-approved prescription drugs Cialis and Viagra. Cialis and Viagra are used to treat erectile dysfunction.

The supplements are packaged in three-capsule blister packs, three-pill bottles, six-pill bottles, 12 pill bottles and 30 tablet boxes. The products were promoted and sold in 20 retail locations in several states from August to October 2013. The firm has released a list of products and lot numbers included in this recall.

Risk: These undeclared ingredients may interact with nitrates found in some prescription drugs—such as nitroglycerin, used to treat chest pain—and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates.

Recommendations

  • Consumers should stop using these products immediately and throw them away.
  • Consumers who have experienced any negative side effects should consult a health care professional as soon as possible.
  • Consumers with questions regarding this recall can contact Midwest Wholesale by phone 888-514-7110, Monday – Friday, 9 a.m. – 5 p.m. CT.

For More Information

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Recall: Undeclared Drug Ingredients Found in Dietary Supplement

FDA is advising consumers not to purchase or use Pro ArthMax, a product promoted and sold as a dietary supplement for joint, muscle and arthritic pain. Pro ArthMax is labeled in English, but also promoted to the Korean-speaking community as “프로알쓰맥스.” Consumers should stop using this product immediately. The product has been found to contain undeclared active pharmaceutical ingredients (APIs), making it an unapproved new drug. FDA sample analysis tested the product to contain the following APIs: 2.4mg of Chlorzoxazone, 0.78mg of Nefopam, 2.5mg of Diclofenac, 7.7mg of Ibuprofen, 2.1mg of Naproxen, and 1.9mg of Indomethacin.

Risk:Because this product contains the undeclared drug ingredients listed above, there is a probability of negative effects that could be fatal in consumers and patients with underlying illnesses. These underlying issues include: known allergy to the hidden ingredients, cardiac, gastrointestinal, liver, and kidney conditions, and recent surgery to improve blood flow to the heart.
Consumers unaware that the product contains Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) may inadvertently overdose by taking another NSAID at the same time, increasing the risk for NSAID associated reactions, which include myocardial infarction (heart attack), stroke, congestive heart failure, kidney toxicity, and bleeding, ulceration, or a small hole in the stomach or intestines.

Recommendations

  • Consumers should contact their physician or health care professional if they have experienced any problems that may be related to taking or using this drug product.
  • Consumers should stop using the product and return it to the place of purchase.

 For More Information

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Drug Dietary Supplement Contains Undeclared Milk

Stemvida has recalled StemAlive 90 Capsules, found to contain undeclared milk. StemAlive, of Ontario, Calif., was distributed in nearly every state and in Puerto Rico.

The capsules are sold in a white plastic bottle, and the brand is StemVida International with a white and gold label. The lot numbers and expiration dates are 8419 (Exp.05/2015 and 06/2015), 8486 (Exp.07/2015), 8535 (Exp. 08/2015), 8598 (Exp. 10/2015), 8652 (Exp. 12/2015), 8863 (Exp. 01/2016 and 02/2016), 8872 (Exp. 03/2016), 8873 (Exp. 04/2016 and 05/2016), 9040 (Exp. 08/2016 and 09/2016), 9258 (Exp. 10/2016) and 9314 (Exp. 11/2016). The lot number and expiration date are printed in black ink at the bottom of the label.

Risk: People who have an allergy or severe sensitivity to milk (bovine colostrum) run the risk of serious or life-threatening allergic reaction if they consume this product. Milk allergy symptoms can range from mild to severe and can include wheezing, vomiting, hives and stomach problems

Recommendations

  • Consumers who have purchased StemAlive 90 Capsules should return it to the company for replacement or refund.
  • Consumers with questions may contact Stemvida at 888-950-8432 between the hours of 9:00 .a.m. – 8:30 p.m. PT.

For More Information

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Drug Safety Labeling Changes

In December 2013, FDA required that safety labeling changes to be made to 39 drug products, including medicine to treat leukemia, an injection to treat multiple sclerosis, and a tablet to treat heart disease. The leukemia drug, Inclusig, added warnings that include a potential blockage of blood vessels or heart failure. The MS injection, Tysabri, added warnings that include an increased risk of a viral infection of the brain that can leads to death or severe disability. The heart disease tablet, Plavix, added warnings of hypersensitivity and rashes.

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

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

Feb. 6, 2014

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Page Last Updated: 02/06/2014
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