For Consumers

FDA’s MedWatch Safety Alerts for Consumers: December 2014 – February 2015

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Once FDA-approved drugs and medical devices are on the market, we monitor them for safety and effectiveness. We encourage health care professionals and consumers to let us know about problems, for example:

  • Does a drug look unusual?
  • Does a medical device include defective parts?
  • Are instructions unclear, confusing?
  • Did the product fail to deliver the expected benefit?
  • Did you experience any unexpected or unwanted side effects?

Please report online any problems with FDA-regulated products. You can also mail, fax, or phone in your report:

FDA posted during December, January, and February following MedWatch Safety Alerts specifically for consumers:


HeartWare Recalls Ventricular Assist System and Controllers

HeartWare International urgently recalled models 1400 and 1401XX of its Ventricular Assist System, which includes the controllers, because a buildup of static may cause a sudden discharge of electricity that could stop the pump from working.

The heart pump helps deliver blood from the heart to the rest of the body. It’s used in patients who are at risk of death from heart failure and who are waiting for a heart transplant.

Risk: The recall is only for heart pumps and controllers distributed during the clinical trial period (prior to 2012). HeartWare International estimates it will affect about 120 patients in the United States. 

If the pump stops working it could cause serious harm to patients or their death.

Recommendation

  • If you have the recalled pump, contact your physician, who will assess whether you need a newer one.

For More Information

  • 2/27/2015 - FDA MedWatch Safety Alert
  • 2/27/2015 - FDA Recall Notice
  • 2/20/2015 - Firm Press Release
  • 7/29/2013 - FDA Recall Notice

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Weight Loss Pill Contains Unapproved Drugs

Do not buy or use SLIM-K Capsules. This product—which is labeled as an herbal supplement, promoted for weight loss, and sold online and in stores—has been found to contain undeclared sibutramine and phenolphthalein, which make the product an unapproved drug.

Risk: Sibutramine can raise blood pressure and increase pulse rate and may be dangerous for those with a history of irregular heartbeat, heart disease, or stroke. These products may also interact badly with medications the consumer may be taking.

Phenolphthalein may cause serious stomach problems, irregular heartbeat, and, if used a long time, cancer.

Recommendations

  • Do not buy or use SLIM-K Capsules.
  • Immediately return capsules to where they were bought.
  • If you have any questions, call Kariny Ramirez at 212-568-5330 or email customerservice@bethel30.com, Monday – Friday, 11:00 a.m – 4:00 p.m., EST.

For More Information

  • 12/19/2014 - Company Press Release - FDA
  • 12/22/2014 - MedWatch Safety Alert - FDA

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Herbal Supplement Contains Undeclared Drug

Do not consume B-Lipo Capsules, marketed as a weight loss supplement. Some of these capsules contained lorcaserin, a controlled substance. 

Risks: B-Lipo Capsules tainted with lorcaserin can cause a range of side effects, some which may be fatal if not treated: 

  • Difficulty thinking
  • Hallucinations
  • Feelings of intense excitement
  • Changes in blood sugar
  • Changes in heart rate
  • Heart damage
  • Shivering
  • Diarrhea
  • Muscle stiffness, fever, and seizures

Recommendations

  • Do not consume B-Lipo Capsules.
  • Immediately return capsules to where they were bought.
  • If you have any questions, call Kariny Ramirez at 212-568-5330 or email customerservice@bethel30.com, Monday – Friday, 11:00 a.m. – 4:00 p.m., EST.

For More Information

  • 12/22/2014 - MedWatch Safety Alert - FDA

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Happy Passengers Contains Undeclared Drug

Happy Passengers, a product promoted and sold for sexual enhancement, may be harmful. This product sold online and in stores contains sildenafil, the active ingredient in a prescription drug used to treat erectile dysfunction.

Risk: These pills 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

Do not purchase or use Happy Passengers.

For More Information

  • 1/21/2014 - Tainted Sexual Enhancement Products
  • 3/15/2011 - Beware of Fraudulent Dietary Supplements
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Warning About Simulated IV Fluid

More than 40 patients were injected with Wallcur simulated IV saline, which is for educational purposes only and should not be injected in humans or animals.

Risk: FDA and the Centers for Disease Control and Prevention (CDC) are assessing the risks. Side effects—including fever, chills, tremors, and headaches—have been reported in seven states (FL, GA, ID, LA, NC, NY, CO). Some patients were hospitalized and one person died, though it isn’t known if the product caused the person’s death.

Recommendations

  • Contact your health care provider immediately if you believe you’ve received an injection of the product.
  • Before being injected with a fluid, ask your doctor or nurse to inspect it and ensure it is for human use.
  • Ask your health care provider NOT to administer fluid with the following labels: “Wallcur,” “Practi-products,” “For clinical simulation,” “Not for use in human or animal patients.”

For More Information

  • 1/14/2015 - CDER Statement - FDA
  • 1/10/2015 - MedWatch Safety Alert

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Warnings About Bone Graft Substitutes

Like substances found in the body, bone graft substitutes replace or repair bone. FDA has not approved bone graft substitutes containing recombinant proteins or synthetic peptides for use in patients under age 18 because their bones may still be growing and using these types of bone graft substitutes may cause serious injuries. Therefore, health care providers are urged to consider them a treatment of last resort for pediatric patients. Bone graft alternatives that do not contain recombinant proteins or synthetic peptides exist for patients under age 18.

Risk: Reported side effects from these products include fluid accumulation, swelling near the graft site, and inhibited or excessive bone growth. Patients aged 18 or younger are particularly vulnerable to serious reactions.

Recommendations

  • Ask your health care provider to explain the benefits and risks of treatments for bone defects.
  • Ask your health care provider about his or her experience performing treatments for bone defects.
  • Ask if recommended treatment is FDA-approved, FDA-cleared, and appropriate for the procedure you or your child is undergoing.
  • Ask how often bone healing should be monitored after treatment with these products.
  • Report to your health care provider any bad effects from these products, such as fever, swelling, rash, pain, or physical changes near the surgical site.

For More Information

  • 01/21/2015 - Safety Communication - FDA

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Psychiatric Drug May Cause Serious Side Effects

Ziprasidone (also marketed as Geodon and as generics) may cause a serious, progressive condition known as DRESS, which begins as a skin reaction and can spread to all parts of the body. It can include rash, fever, swollen lymph nodes and inflammation of organs, such as liver, kidney, lungs, and pancreas.

This drug, which is used to treat schizophrenia and bipolar I disorder, can decrease hallucinations, delusions, other psychotic symptoms, and mania. To work properly, ziprasidone should be taken every day as prescribed. Patients should not stop taking their medicine or change their dose without first talking to their health care provider.

Risk: The Geodon label includes a new warning that the drug is associated with DRESS, a progressive skin condition.

Recommendation

  • Seek immediate medical care if you develop a rash or swollen glands.

For More Information

  • 12/11/2014 - Drug Safety Communication

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Cancer Drug Recalled

Hospira Inc. recalled ten lots of Mitoxantrone, used to treat multiple sclerosis and some cancers, because they may be impure and less potent. (This alert applies to veterinary use also.)

Risk: If the drug is ineffective and more doses are administered, then impurities can build up in the body and lead to a medical problem.

Recommendation

  • Do not use affected lots.
  • Contact your health care provider immediately if you believe you (or your pet) received an injection of the product.

For More Information

  • 12/23/2014 - Press Release

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FDA Reviewed Risks of Using Pain Meds While Pregnant

FDA reviewed the medical literature for information about whether or not it is safe for pregnant women to use prescription—and over-the-counter pain medications, but the studies were too limited for FDA to make any recommendations.

Recommendations

  • Before taking any medication while pregnant, consult with your health care provider and carefully weigh the benefits and risks of using prescription and over-the-counter pain medicines during pregnancy.
  • Follow directions on drug labels about using pain medications while pregnant.

For More Information

  • 01/09/2015 - Drug Safety Communication - FDA

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April 22, 2015

     

Page Last Updated: 04/22/2015
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