FDA's MedWatch Safety Alerts: March 2014
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.
- Regular Mail: Use postage-paid, pre-addressed FDA forms 3500 (voluntary reporting), 3500A (mandatory reporting) and 3500B (consumer friendly)
- 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.
Recall: Homeopathic Drug Contains Penicillin
Terra-Medica, Inc. has recalled 56 lots of Pleo-FORT, Pleo-QUENT, Pleo-NOT, Pleo-STOLO, Pleo-NOTA-QUENT, and Pleo-EX homeopathic drug products in liquid, tablet, capsule, ointment and suppository forms. (The practice of homeopathy is based on the belief that disease symptoms can be cured by small doses of substances that produce similar symptoms in healthy people.) FDA has determined that these Terra-Medica products—marketed for a variety of purposes—could potentially contain penicillin or derivatives of penicillin, which may be produced during a fermentation process.
Pleo homeopathic drugs have a label stating “Distributed by SANUM USA Corp.” The affected products were distributed nationwide. Click here for a complete listing of products affected by this recall.
Risk: For consumers who are allergic to antibiotics, even at low levels, the exposure to penicillin can result in a range of reactions, from mild rashes to severe and life-threatening allergic reactions that could cause death.
- Consumers should stop using the products and return them to the point of purchase.
- Consumers with questions regarding this recall can contact Terra-Medica’s Customer Service Department at 888-415-0535, ext. 1, Monday-Friday 8 a.m. to 5 p.m. PT.
For More Information
Recall: Undeclared Drugs Found in Pain Relief Pills
Pain Free By Nature announced a recall of Reumofan Plus for pain management. The pills have been found to contain the active pharmaceutical ingredients methocarbamol and diclofenac, making it an unapproved drug. Reumofan Plus is marketed as a treatment for muscle pain, arthritis, osteoporosis, bone cancer and other conditions. The product comes in 30 tablet containers and is packaged in a green and gold box.
Risk: Methocarbamol and diclofenac may cause unexpected side effects or an allergic reaction because the ingredients are not listed on the product. Methocarbamol can impair the ability to perform physical tasks like driving a car and side effects include flu symptoms, slow heart rate, feeling like you might pass out, or seizures.
Diclofenac, is a nonsteroidal anti-inflammatory drug (NSAID) and may cause an increased risk of heart attack and stroke, ulcers, bleeding, or holes in the stomach or intestine. These problems can develop without symptoms and can cause death. One illness has been reported in connection with this problem.
In 2012, FDA issued several warnings about Reumofan Plus because of the undeclared active ingredients found in prescription drugs. The agency had received reports of serious, and sometimes, fatal reactions.
- Consumers who have purchased these products should stop using them immediately and contact a health care professional.
- Consumers are urged to return all unopened bottles to Pain Free By Nature, LLC, Attn: Nilsen, 211 West 11th Street, Harper, Kan., 67058.
- Consumers with questions may contact the company at 719-235-8864, Monday – Friday 10:00 a.m. to 2:00 p.m. MT.
For More Information
Glucose Meter May Produce Mistakenly Low Results
Abbott has determined that the FreeStyle Blood Glucose Meter and the FreeStyle Flash Blood Glucose Meter, when used with Abbott FreeStyle test strips, may produce a mistakenly low blood glucose result. This problem also exists with the OmniPod Insulin Management System with the built-in FreeStyle Blood Glucose Meter. FreeStyle and FreeStyle Flash Blood Glucose Meters have not been made since 2010.
Risk: Patients with diabetes must monitor their blood glucose (sugar) levels. A false, abnormally low blood glucose reading could lead to an insulin dosing error that could endanger their health. Patients with diabetes should be aware of symptoms of low blood sugar (hypoglycemia) and high blood sugar (hyperglycemia). For hypoglycemia these include shakiness, sweating, rapid heartbeat, confusion and nausea. For hyperglycemia they include frequent urination and increased thirst.
- Consumers should immediately contact Abbott Diabetes Care at 888-345-5364 to obtain a replacement meter.
- Consumers who have access to an alternative glucose meter should immediately discontinue use of the affected meter and take the necessary steps to continue to monitor their blood sugar with the alternative meter.
- Consumers who use the OmniPod Insulin Management System with the built-in FreeStyle Blood Glucose Meter should refer to the Abbott recommended actionshere .
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Weight-Loss Product Recalled Due to Tampering
GlaxoSmithKline (GSK) Consumer Healthcare has recalled all Alli weight loss products from U.S. retailers, as the company believes that some packages of the product were tampered with and may contain product that is not authentic Alli.
GSK received inquiries from consumers in seven states about bottles of Alli that contained tablets and capsules that were not the weight loss product. A range of tablets and capsules of various shapes and colors were reported to have been found inside bottles. Additionally, some bottles inside the outer carton were missing labels and had tamper-evident seals that were not authentic. These tampered products were purchased in retail stores.
Alli is a turquoise blue capsule with a dark blue band imprinted with the text “60 Orlistat.” It is packaged in a labeled bottle that has an inner foil seal imprinted with the words: “Sealed for Your Protection.”
Risk: Taking unknown pills can have a wide range of effects on the body. Always check for the proper capsules inside these bottles and ensure the foil seal is present. Taking a product that has been tampered with or replaced with another pill can be fatal.
- If consumers who have Alli are unsure or concerned about its safety and quality, they should not use it. Instead, they should call GSK at 800-671-2554, and a representative will provide further instructions.
- Consumers who have consumed a questionable product should contact their health care professional.
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Drug Safety Labeling Changes
In February 2014, FDA required safety labeling changes to be made to 35 drug products, including an anti-fungal medication, a medicine to treat high cholesterol, and a medication for a blood disorder.
The anti-fungal medicine, Nizoral, added warnings that include additional medicines that interact badly with the drug and can have serious affects. The cholesterol drug, Mevacor, added warnings that include negative interactions with certain HIV drugs. The blood disorder medication, Agrylin, added warnings of an increased heart rate.
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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This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.
April 11, 2014