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U.S. Department of Health and Human Services

For Consumers

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FDA's MedWatch Safety Alerts: August 2011

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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.

  • 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 prompted by reports FDA has received through MedWatch.

Recall: Shoulderflex Massager Due to Risk of Strangulation

King International has recalled all of its approximately 12,000 Shoulderflex massagers that were sold between 2003 and 2011.

This personal massage device was designed for home use to provide deep tissue massage to the neck, shoulder and back. The device was sold at various stores and online retailers (including Amazon) in the U.S.

Risk: One death and one near-strangulation were reported when a necklace and clothing became caught in a piece of the device that rotates during use. Two other reports involved clothing and hair that became caught in the device.

Recommendations

  • Do not use the Shoulderflex massager.
  • Throw away the device components separately so that the massager cannot be reassembled and used.
  • If you have questions, call King International LLC at 503-524-7046.

For More Information

Photo of Shoulderflex Massager

FDA Safety Communication on Shoulderflex Massager

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Diflucan and Birth Defects

Treatment of vaginal yeast infections with long-term, high doses (400–800 mg/day) of Diflucan (fluconazole) during the first 3 months of pregnancy may be associated with rare birth defects (such as a short, broad head, cleft lip, joint deformities, and heart disease). A single dose (150 mg) of fluconazole to treat vaginal yeast infection during pregnancy does not appear to be associated with the birth defects.

Fluconazole is used to treat yeast infections of the vagina, mouth, throat, esophagus and other organs. It is also used to prevent yeast infections in patients who are likely to become infected because they are being treated with chemotherapy or radiation therapy before a bone marrow transplant. In addition, fluconazole is used to treat meningitis caused by a certain type of fungus.

The pregnancy category on the drug’s label now reflects the risk to infants when high doses are taken long-term by the mother.

Recommendation: Tell your health care professional if you are pregnant or become pregnant while taking fluconazole.

For More Information

Drug Safety Communication on Diflucan

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Celexa and Abnormal Heart Rhythms

Taking more than 40 mg per day of the antidepressant Celexa (citalopram hydrobromide) and generic forms of citalopram can cause abnormal changes in the electrical activity of the heart—called prolongation of the QT interval—which can lead to a fatal, abnormal heart rhythm.

Risk: People at particular risk for developing prolongation of the QT interval include those who have underlying heart conditions or are predisposed to low levels of potassium and magnesium in the blood.

Studies did not show a benefit in treating depression with citalopram at doses higher than 40 mg per day. The drug’s label has been revised to include the new recommended drug dosage and usage, as well as information about the potential for abnormal electrical activity and heart rhythms.

Recommendations

  • Do not stop taking citalopram or change your dose without talking to your health care professional. Stopping the drug suddenly can cause unwanted side effects.
  • If you are currently taking more than 40 mg citalopram per day, talk to your health care professional about changing your dose.
  • Get immediate care if you experience an irregular heartbeat, shortness of breath, dizziness, or fainting while taking citalopram.

For More Information

FDA Drug Safety Communication on Celexa

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Recall: Povidone Iodine Products

Multiple brands of these Povidone Iodine products have been recalled:

  • swabsticks
  • prep solutions
  • scrub solutions
  • prep gel

These products, which were distributed nationwide, are used as an antiseptic to prepare skin prior to surgery, and to prevent infection in minor cuts, scrapes and burns. The swabsticks are packaged in individual packets of 1 or 3 swabs and the other products are sold in bottles. All lot numbers (beginning with 8J-8M, 9A-9M, 0A-0M, and 1A-1C) are recalled.

Risk: Infections could occur from using these products because the manufacturer did not have proper systems in place to prevent bacterial contamination. Medical and surgical patients, including those whose immune system is weakened, have a high risk of infection from antiseptics that have been prepared, packaged, or held under insanitary conditions.

Recommendations

  • Do not use these products; return them to the place purchased.
  • If you have questions, call H&P Industries Inc. at 262-538-2907 Monday through Friday from 8:30 a.m. to 4:00 p.m. Central Time.

For More Information

H&P Industries Povidone Iodine Products

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Drug Safety Labeling Changes

In July, FDA required safety labeling changes to be made to more than 35 drug products, including Nitrostat, Seroquel, Flomax, and Truvada. 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 bad 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.

Sept. 21, 2011

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