FDA's MedWatch Safety Alerts: July 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 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 and ongoing safety reviews prompted by reports FDA has received through MedWatch.
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Beware of Illegally Sold Products Claiming to Treat Diabetes

FDA is taking action to remove from the market illegal products that claim to mitigate, treat, cure or prevent diabetes and related complications. The agency issued letters warning 15 companies that the sale of their illegally marketed diabetes products violates federal law. These products include:

Products sold as “natural” treatments for diabetes, but containing undeclared active pharmaceutical ingredients;
Dietary supplements and ayurvedic products (medicine of the healing arts that originated in India) with claims to treat, cure, and/or prevent diabetes;
Unapproved drugs sold over-the-counter (OTC), including some homeopathic products, intended to treat complications associated with diabetes; and
Prescription drugs for diabetes sold by online pharmacies without a prescription.

Risk: These products may contain harmful ingredients or may be otherwise unsafe, or may improperly be marketed as OTC products when they should be marketed as prescription products. They carry an additional risk if they cause consumers to delay or discontinue effective treatments for diabetes. Without proper disease management, people with diabetes are at a greater risk for developing serious health complications.
Recommendations

If patients notice anything unusual during the priming process (crucial for consistent insulin delivery), such as the insulin continuing to drip when priming has been completed, this may indicate that the connector vents are not working properly. If this occurs, do not insert the infusion set and immediately call the HelpLine at 888-204-7616 for assistance.

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Infusion Set Could Deliver Too Much or Too Little Insulin

The medical technology company Medtronic sent an urgent safety notification to health care professionals to inform them of the potential for over or under delivery of insulin from their Medtronic MiniMed Paradigm Insulin Infusion Sets. Infusion sets are used by patients with diabetes, who need insulin to maintain acceptable blood glucose levels. The sets work with a pump to deliver insulin under the skin.
Risk: If insulin or other fluids come in contact with the inside of the infusion set’s tubing connectors it can temporarily block the vents that allow the pump to properly prime. This can result in too much or too little insulin being delivered, resulting in hypoglycemia or hyperglycemia, which can be severe and lead to serious illness.
The recall notice lists affected models. They were manufactured from October 2001 to June 2013 and distributed from December 2001 to June 2013.
Recommendations

If patients notice anything unusual during the priming process (crucial for consistent insulin delivery), such as the insulin continuing to drip when priming has been completed, this may indicate that the connector vents are not working properly. If this occurs, do not insert the infusion set and immediately call the HelpLine at 888-204-7616 for assistance.

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Medtronic MiniMed Paradigm Insulin Infusion Sets: Class 1 Recall - Potential for Over or Under Delivery of Insulin

Placebo Tablet Found in Birth Control Pill Pack

Sandoz is recalling one lot of its Estarylla (norgestimate and ethinyl estradiol), tablets after a customer reported the presence of a placebo tablet in a row of active tablets. Estarylla is used for the prevention of pregnancy.
Risk: Sandoz is not aware of any reports of problems caused by taking the placebo. The company’s medical assessment concluded the packaging flaw is easily visible and the risk of pregnancy occurring after missing a dose of the medicine is low. The recalled lot number is LF01213A, with an expiration date of 02/2014. The NDC (National Drug Code) is 00781-4058-15. The product comes in cartons containing three blister cards of 28 tablets each. This lot was distributed to the U.S. market only.
Recommendations

If a consumer has a problem with this medication, she should contact her health care professional and the Sandoz Drug Information Direct Line at 800-525-2492.

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Estarylla: Recall - Report of Placebo Tablet Present in Row of Active Tablets

Blood Pressure Medicine Expands Warnings to Include Intestinal Problems

FDA issued an approved change to the warning labels of the blood pressure drug olmesartan medoxomil. The drug is used to keep the blood vessels from contracting, lowering blood pressure and easing the strain on the heart.
Risk: The drug, marketed as Benicar, Benicar HCT, Azor, Tribenzor, and generics can cause intestinal problems known as “sprue-like enteropathy.” Symptoms of this include severe chronic diarrhea with substantial weight loss. Olmesartan is the only blood pressure drug of its kind—known as angiotensin II receptor blockers—in which these intestinal problems have been detected. FDA will continue to evaluate the safety of olmesartan-containing products and will communicate again if additional information becomes available.
Recommendations

Patients should contact their health care professional right away if they take an olmesartan-containing product and experience severe diarrhea, diarrhea that does not go away, or significant weight loss.

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FDA Safety Communication

Male Enhancement Drug Contains Undeclared Ingredients

Volcano Company is recalling all lots of Volcano Male Enhancement Liquid and Volcano Male Enhancement Capsules because the products have been found to contain undeclared ingredients. The capsules contain desmethyl carbodenafil and dapoxetine. The liquid contains the same undeclared ingredients as well as dimethylsildenafil. Desmethyl carbodenafil and dimethylsilsildenafil are drugs used to treat male erectile dysfunction, making these products unapproved new drugs.
Risk: Desmthyl carbodenafil and dimethylsidenafil may interact with nitrates found in some prescription drugs and may lower blood pressure to dangerous levels that can be life threatening. Patients with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Additionally, dapoxetine has not been approved by FDA and therefore its safety or effectiveness has not been established. Dapoxetine is a type of drug used to treat depression. The liquid drugs were packaged in a 2 oz. Bottle, UPC (Universal Product Code) 609613859960, Lot 301, and were distributed from January to July 2013. Volcano Male Enhancement Capsules are packaged in a black or white round plastic pop top container with 1 capsule inside, UPC 609613859977, Lot 7455, distributed from January 1, 2013 to July 2013.
Recommendations

Customers, distributors and retailers who have Volcano Male Enhancement Liquid and/or Volcano Male Enhancement Capsules should stop using the product and return it to the place of purchase or directly to Volcano Company P.O. Box 90277, Long Beach CA, 90809.

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FDA Safety Communication

Appetite Supplement Tested Positive for Undeclared Drug Ingredients

FDA is alerting the public to a recall of Herbal Give Care LLC’s Esbelin siloutte te and Esbelin siloutte Herbal Blend with L-Carnitine capsules because they contain unapproved drugs. The Esbelin siloutte Herbal Blend with L-Carnitine is marketed as a treatment to help normalize a nervous appetite, preventing fat accumulation and fluid retention. Esbelin siloutte Te is promoted as a fat burner, in addition to aiding the proper functioning of the digestive system.
Risk: The products contain undeclared sibutramine, n-desmethylsibutramine, and n-di-desmethylsibutramine. FDA has identified these products as posing a threat to consumers because the drugs substantially increase 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.
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 with questions regarding this recall can contact Herbal Give Care LLC by calling to 972-602-6850 or email to hgc-usa@hotmail.com Monday- Friday from 9:00 am to 6:00 pm CT.

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FDA Safety Communication

Drug Safety Labeling Changes

In June 2013, FDA required safety labeling changes to be made to 44 drug products, including a number of medications used to treat attention deficit hyperactivity disorder (ADHD) that could cause circulation problems in fingers and toes.
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.
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