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FDA's MedWatch Safety Alerts: December 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 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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Recall: Hydravax May Contain Undeclared Drug Ingredient

IQ Formulations is recalling all lots of its 45-capsule bottles of Hydravax—marketed as a solution to water retention—because a sample tested positive for an unlisted ingredient. FDA tested a sample from one lot of Hydravax and found it contained a diuretic. Diuretics are prescription drugs and increase urination and push water and minerals known as electrolytes from the body.
The recalled Hydravax was distributed nationwide in retail stores and by mail order. Production of the product has been suspended while the company continues its investigation into the source of the unlisted ingredient.

Risk: 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. Loss of fluid and electrolytes are the most important concern. Excessive doses of diuretics cause more severe symptoms, including low blood pressure.

Recommendations

  • Consumers who have purchased these products should stop using them immediately. All consumers who have purchased Hydravax 45 capsule bottles are urged to return them to the place of purchase for a full refund.
  • Consumers with questions may contact the company at 800-626-1022 Monday - Friday 9 a.m. – 5 p.m. ET. Or email: Recall@iqformulations.com 

For More Information

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Nipple Aspirate Test: Not an Alternative To Mammography

FDA is alerting people that a nipple aspirate test is not a replacement for mammography or other breast imaging tests, and should not be used by itself to screen for or diagnose breast cancer. A nipple aspirate device is a type of pump used to collect fluid from a woman's breast. A nipple aspirate test can determine whether the fluid collected from the breast contains any abnormal cells.

Risk: Certain manufactures are promoting the use of nipple aspirate tests as an alternative to a breast biopsy or mammography. They also claim that this test can detect pre-cancerous abnormalities and diagnose breast cancer before mammography. FDA is concerned that women will believe these misleading claims and not get mammograms and/or other needed breast imaging tests or biopsies. This may lead to serious health consequences that include false negative test results, indicating the absence of breast cancer when cancer exists, and false positive test results, indicating the presence of breast cancer when none exists.

Recommendations

  • Do not use a nipple aspirate test as a substitute for mammography or by itself for breast cancer screening or diagnosis. 

For More Information

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ADHD Medications May Cause Long-lasting Erections

FDA is warning that methylphenidate products, a type of stimulant drug used to treat attention deficit hyperactivity disorder (ADHD), may in rare instances cause prolonged and sometimes painful erections, a condition known as priapism. Based on a recent review of methylphenidate products, FDA updated drug labels and patient Medication Guides to include information about the rare but serious risk of priapism. ADHD medications with methylphenidate include Concerta, Daytrana, Focalin/Focalin XR, Metadate CD/Metadate ER, Methylin/Methylin ER, Quillivant XR, Ritalin/Ritalin LA/Ritalin SR.

Risk: If not treated right away, priapism can lead to permanent damage to the penis. Priapism can occur in males of any age and happens when blood in the penis becomes trapped, leading to an abnormally long-lasting and sometimes painful erection. Another ADHD drug, Strattera (atomoxetine), has also been associated with priapism in children, teens and adults.

Recommendations

  • Patients and caregivers should talk to their health care professionals to make sure they know the signs and symptoms of priapism. Younger males, especially those who have not yet reached puberty, may not recognize the problem or may be embarrassed to tell anyone if it occurs.
  • Patients should not stop taking a methylphenidate product without first discussing it with their health care professional.
  • Patients are encouraged to read the Medication Guide they receive with every filled prescription.

For More Information

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Recall: Burn 7 Capsules May Contain Undeclared Drug Ingredients

Burn 7 Capsules, marketed as dietary supplements, have been recalled by Deseo Rebajar Inc. The products have been found to contain sibutramine, a controlled substance that FDA previously approved for the treatment of obesity. Sibutramine was removed from the U.S. market in 2010 for safety reasons, making these dietary supplements an unapproved drug.

Risk: Products containing sibutramine pose a threat to consumers because the drug substantially increases blood pressure and pulse rate in some patients. These products may pose a significant risk to those with a history of coronary artery disease, congestive heart failure, abnormal heart rhythm or stroke. These products may also interact badly with medications being taken. The products were distributed in Puerto Rico via retail stores and nationwide online. The pills are packaged in 30-count plastic bottles with lot number #MFD: 07.18.2013.

Recommendations

  • Consumers should contact their health care professional  if they have experienced any problems that may be related to taking or using this drug product.
  • Consumers with questions should contact Deseo Rebajar Inc. at 787-961-6464 or via e-mail at sales@adipotrim.com Monday - Friday, 8:00 a.m. - 5:00 p.m. GMT.

For More Information

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Drug Safety Labeling Changes

In November 2013, FDA required safety labeling changes to be made to 27 drug products, including medicine to treat high blood pressure and a medication to treat or prevent bacterial infections. A warning was added not to use the blood pressure medicines Aliskiren and Zestril together in patients with diabetes. The antibacterial medicine, Prevpac, added warnings that include serious hypersensitivity reactions and risk of fragile bones which can fracture more easily.

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.

Jan. 23, 2014

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Page Last Updated: 01/23/2014
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