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FDA's MedWatch Safety Alerts: May 2011

Posted Jun 28 2011 11:40am

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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.

Two newly published studies found that women who use birth control pills that contain the hormone drospirenone are more vulnerable to a potentially life-threatening condition.

The studies found a two to three times greater risk of venous thromboembolism events (VTE) for women who use birth control pills that contain drospirenone than for those using pills that contain the hormone levonorgestrel. Other studies have not reported an increase in risk.

Names of drospirenone-containing products include

  • Yaz (generics Gianvi and Loryna)
  • Yasmin (generics Ocella, Syeda, and Zarah)
  • Beyaz
  • Safyral
  • Drospirenone and ethinyl estradiol

Risk: VTEs include deep vein thrombosis and pulmonary embolism. Deep vein thrombosis is a rare condition in which a blood clot forms inside a vein, usually in the lower leg or thigh. If the clot breaks loose and travels to the lungs, it can block an artery, causing a life-threatening condition called a pulmonary embolism.

FDA action: FDA is currently evaluating the conflicting results from studies and other information to assess the risks and benefits of drospirenone-containing birth control pills. The agency will continue to provide new safety information to the public as it becomes available.

Recommendations

  • Call your health care professional immediately if you develop any symptoms of blood clots, including persistent leg pain, severe chest pain, or sudden shortness of breath.
  • If your birth control pill contains drospirenone, do not stop taking it without first talking to your health care professional.
  • If you smoke and are over 35 years of age, you should not take combination oral contraceptives (those that contain two types of hormones: estrogen and progestin) because they increase the risk of serious heart and blood vessel (cardiovascular) problems, including blood clots.
  • Report any problems you have with birth control pills to FDA’s MedWatch Program to help the agency evaluate the risk of deep vein thrombosis and pulmonary embolism with these drugs.

For More Information

Questions and Answers – Ongoing safety review of birth control pills containing drospirenone

Parents, caregivers, and health care professionals should not feed SimplyThick to infants born before 37 weeks gestation.

SimplyThick is a thickening agent added to breast milk and infants’ formula to help premature babies swallow their food and keep it down, without spitting up. The product can be purchased from distributors and local pharmacies throughout the U.S.

Risk: SimplyThick may cause necrotizing enterocolitis (NEC), a life-threatening condition in which tissue in the intestines becomes inflamed and dies. Since FDA first learned of this problem on May 13, the agency has received reports of more than a dozen cases of NEC, including several deaths, in premature infants.

Recommendations

  • Do not feed SimplyThick to premature infants, including those in the hospital and those sent home from the hospital within the past 30 days.
  • Call your health care professional if your baby has a bloated stomach, greenish-tinged vomiting, or bloody stools—or if you have other concerns related to using SimplyThick.

Update of 6/5/11: Simply Thick LLC recalled its thickening gel products manufactured at a food processing plant owned and operated by Thermo Pac LLC. This voluntary recall is limited to only those products manufactured at the Stone Mountain, Ga., plant. FDA had advised the company that Thermo Pac failed to file with the agency its plans to ensure that harmful bacteria of possible public health significance are destroyed during the manufacturing process.

For More Information

Photographs of SimplyThick

Consumer Update on SimplyThick

Simply Thick LLC Press Release: Recall of Products Manufactured by Thermo Pac LLC at their Stone Mountain, Ga., Food Processing Plant

New restrictions have been added to the prescribing and use of medicines that contain rosiglitazone. These medicines to treat type II diabetes are sold under the names Avandia, Avandamet, and Avandaryl. Patients will have to enroll in a special program to receive these drugs, and health care professionals cannot prescribe them without enrolling in the program.

Risk: Rosiglitazone may increase the risk of a heart attack and other heart and blood vessel (cardiovascular) problems. Because of these risks, FDA is restricting the use of rosiglitazone medicines to

  • patients already being treated successfully with these medicines
  • patients whose blood sugar cannot be controlled with other antidiabetic medicines and are unable to take pioglitazone-containing medicines (Actos, Actoplus Met, Actoplus Met XR, or Duetact)

Recommendations

  • Call your health care professional as soon as possible to determine if it is appropriate for you to continue taking a rosiglitazone medicine and, if it is, how to become enrolled in the Avandia-Rosiglitazone Medicines Access Program. Your healthcare professional will need to complete and sign a patient enrollment form for you.
  • Be aware that after Nov. 18, 2011, you will no longer be able to get your rosiglitazone medicine from a retail pharmacy. You must be enrolled in the Avandia-Rosiglitazone Medicines Access Program to receive your medicine, which will only be available by mail order through certified pharmacies.
  • Read the medication guide you get along with your rosiglitazone medicine. It explains the risks linked to using the drug.
  • Talk to your health care professional about the risks and benefits associated with rosiglitazone medicines.

For More Information

FDA Drug Safety Communication on Rosiglitazone-Containing Medicines

Avandia-Rosiglitazone Medicines Access Program

One lot of 1,000-count bottles of Coumadin (warfarin sodium) Crystalline 5 mg tablets has been recalled because the company, Bristol-Myers Squibb, found a tablet to be higher in potency than expected. The lot number is 9H49374A with an expiration date of September 30, 2012.

Coumadin is prescribed to treat or prevent blood clots.

Risk: Too much active ingredient can increase the risk of bleeding. Not enough active ingredient may increase the risk of clots, which could lead to heart attack or stroke.

Recommendation: Do not stop taking Coumadin until you have talked with your pharmacist to see if your tablets are from the recalled lot. If so, contact your physician for advice.

For More Information

Photo of Coumadin 5 mg Tablet

FDA notified health care professionals that Weck Hem-o-Lok Ligating Clips should not be used to stop blood flow from the renal artery during the removal of a kidney from a living donor using minimally invasive surgery.

This V-shaped clip is made from a non-absorbable material that comes in various sizes. It is used to permanently close blood vessels or tissue structures.

Risk: The clips may become dislodged, which can lead to uncontrolled bleeding, additional surgery, or death of the donor.

Recommendations

  • If you are considering donating a kidney, talk to your health care professional about
    • potential for surgical complications
    • methods used during living-donor surgery, and the advantages and disadvantages of each method
    • risks and benefits associated with donating a kidney
  • If you have donated a kidney and have any questions or concerns about your surgical procedure, contact your doctor.

For More Information

Safety Communication About Weck Hem-o-Lok Ligating Clips

Dietary supplements distributed by two companies have been recalled because misleading packaging causes confusion in consumers who mistake them for similarly packaged antibiotics:

  • Pentrexyl Forte Natural, distributed by Phoenix Import & Distribution LLC, packaged in a green and white box, containing 30 red and white capsules. The product was sold through retail stores in Texas.
  • Certain dietary supplements  by Multi-Mex Distributor Inc. that may be labeled as antibiotic drugs, which they are not. An FDA inspection revealed the packaging resembles packages containing antibiotics readily available in Mexico and possibly familiar to Hispanic consumers. The packaging appeared to be an intentional marketing ploy. The products were distributed in Georgia, Tennessee, California, Illinois, Texas, North Carolina, South Carolina, Colorado, and Indianapolis.

Risk: Use of these products by people who are sick could delay legitimate treatment for serious illnesses. Four children were taken to a medical center due to worsening illnesses after being given the Multi-Mex dietary supplement Amoxilina, which the parents may have believed was the antibiotic amoxicillin.

Recommendations

  • Do not use Pentrexyl Forte Natural or any of the recalled products from Multi-Mex Distributor. Return them to the place where you bought them for a full refund.
  • Call 678-226-1758 if you have questions about the Multi-Mex products. Call 281-288-9838 if you have questions about the Phoenix product, Pentrexyl Forte Natural.

Two products sold as dietary supplements contain drugs that are not declared on the label:

  • Slim Xtreme Herbal Slimming Capsule, sold 30 capsules per bottle, distributed by Globe All Wellness. All lots are recalled. The product was marketed for weight loss and sold nationwide through the Internet and at the company’s headquarters in Hollywood, Fla.
  • Regenerect, by Ethos Environmental Inc., lot number 100521 (blue capsule sold individually in foil packets, expires 5/2012) and lot number 112850 (clear capsule sold individually in foil packets, expires 11/2013). Regenerect was sold in the U.S. and Puerto Rico through the Internet.

Slim Xtreme Herbal Slimming Capsule contains the controlled substance sibutramine, which was withdrawn from the U.S. market in October 2010 for safety reasons. Regenerect contains a compound (sulfoaildenafil) of an active ingredient in an FDA-approved drug used to treat erectile dysfunction.

Risk: Sibutramine (found in Slim Xtreme) is known to substantially increase blood pressure or pulse rate in some people—especially those with a history of heart disease or stroke. This product may also interact in life-threatening ways with other medications a person may be taking. Sulfoaildenafil (found in Regenerect) may interact with prescription drugs known as nitrates, including nitroglycerin, and cause dangerously low blood pressure. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

Recommendations

  • Do not use Slim Xtreme, or Regenerect lot numbers 100521 and 112850.
  • If you have used either of these products and have any negative side effects, call your health care professional as soon as possible.
  • If you have questions about Slim Xtreme or need instructions for returning the product, call 954-922-1133 Monday through Friday from 9 a.m. to 4 p.m. Eastern Standard Time.
  • If you have questions about Regenerect or need instructions for returning the product, call 866-925-9553 Monday through Friday from 6 a.m. to 6 p.m. Pacific Time.

For More Information

Photos of Slim Extreme

Tainted Weight Loss Products

Hidden Risks of Erectile Dysfunction "Treatments" Sold Online

Automated external defibrillators (AEDs) model DDU-100 series with software version 2.004 or earlier, sold under the brand names Lifeline and ReviveR, are recalled. AEDs are used on victims of sudden cardiac arrest who are unconscious, unresponsive, and not breathing.

Risk: The software version 2.004 or earlier may cause the device to cancel shock during the charging process, which may result in failure to resuscitate the patient.

Recommendations

  • Defibtech will give customers a free software upgrade. Full instructions and recommendations are being mailed to affected customers.
  • Customers should keep their AEDs in service during the software upgrade process.

For More Information

Recall Notice on Lifeline and ReviveR AEDs

Defibtech AED Serial Number Verification

Triad Povidone Iodine Prep Pads contained in Atwater Carey first aid kits have been recalled because the prep pads may be contaminated. The first aid kits are distributed by Wisconsin Pharmacal Company.

In March, H&P Industries recalled all Povidone Iodine Prep Pads sold in individual packets and in a box of 100 packets. The pads may be sold under the brand names of

  • Triad
  • Triad Plus
  • Cardinal Health
  • Medical Specialties
  • VHA
  • North Safety
  • Total Resources

Povidone Iodine Prep Pads are used to prevent infection in minor cuts, scrapes, and burns.

Risk: Testing showed the presence on the pads of the bacterium Elizabethkingia meningoseptica, which could lead to life-threatening infections. Treatment options are limited for infections caused by this bacterium.

Recommendations

  • Throw away the Povidone Iodine Prep Pads included in Atwater Carey first aid kits.
  • Do not use Triad Povidone Iodine Prep Pads sold separately.

For More Information

Photos of Atwater Carey First Aid Kits

Photos of Povidone Iodine Prep Pads

Press Release: Important Information for Atwater Carey First Aid Kit Consumers Regarding Triad’s Povidone Iodine Prep Pads

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

June 28, 2011

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