FDA MedWatch – Nzu, Traditional Remedy for Morning Sickness

The Texas Department of State Health Services and FDA notified healthcare professionals and consumers, especially pregnant or breastfeeding women, to avoid consuming a product called “Nzu”, taken as a traditional remedy for morning sickness,because of the potential health risks from high levels of lead and arsenic, noted on laboratory analysis by Texas DSHS. Exposure to lead can result in a number of harmful effects, and a developing child is particularly at risk of effects on the brain and nervous system. Arsenic is a carcinogen, and excessive long-term exposure to it has been associated with a range of adverse health effects, including cancers of the urinary bladder, lung and skin. Nzu, which is sold at African specialty stores is also called Calabash clay, Calabar stone, Mabele, Argile and La Craie. It generally resembles balls of clay or mud and is usually sold in small plastic bags with a handwritten label identifying it as “Nzu” or “Salted Nzu.” Anyone who has been ingesting the product should contact their health care provider.

CLICK HERE to read the complete MedWatch 2009 Safety summary, including a link to the Texas State Health Services press release.

FDA MedWatch – Tylenol Arthritis Pain Caplet 100 count (Recall)

McNeil Consumer Healthcare and FDA notified consumers that it is expanding a voluntary recall to include all available product lots of TYLENOL Arthritis Pain Caplet 100 count bottles, with the distinctive red EZ-OPEN CAP (Full list of lot numbers provided in press release at link below). In November 2009, 5 lots of this product were recalled due to consumer reports of an unusual moldy, musty, or mildew-like odor that was associated with nausea, stomach pain, vomiting and diarrhea. The odor is caused by the presence of a chemical 2,4,6-tribromoanisole, believed to be the breakdown of a chemical used to treat wooden pallets that transport and store packaging materials. The health effects of this compound have not been well studied, and to date all of the observed events reported to McNeil were temporary and non-serious. Consumers who purchased TYLENOL Arthritis Pain Caplet 100 count bottles with the distinctive red EZ-OPEN CAP from the lots included in this recall should stop using the product and contact McNeil for instructions on a refund or replacement.

CLICK HERE to read the complete MedWatch 2009 Safety summary, including a link to the firm’s press release.

FDA MedWatch – Thermoflect Blankets and product line (Recall)

Encompass Group and FDA notified healthcare professionals of the voluntary recall of the Thermoflect product line for relabeling regarding its use in the MR (Magnetic Resonance) environment. FDA has recommended that the Thermoflect blankets and other products not be used in MR conditional or MR compatible environments. Encompass is in the process of sending labels to customers to be attached per instructions to remind hospitals that the product line should not be used in the MR environment. A complete list of Thermoflect products and additional information can be found at www.thermoflect.com.

CLICK HERE to read the complete MedWatch 2009 Safety summary, including a link to the firm press release.

FDA MedWatch – Cleviprex (clevidipine butyrate): Recall

The Medicines Company and FDA notified healthcare professionals of a nationwide recall of eleven lots of Cleviprex (clevidipine butyrate) injectable emulsion, indicated for treatment of hypertension, due to the potential presence of particulate matter found to be inert stainless steel particles. If the particles were to aggregate, or if larger particles were present, then they could theoretically reduce blood flow in capillaries, cause mechanical damage to some tissues, or initiate acute or chronic inflammatory reactions. Reduced blood supply to tissues may lead to ischemia or organ insufficiency in the brain, kidney, liver, heart or lungs.

CLICK HERE to read the full report and to find a link to the company press release for information on specific lots affected by this recall.

FDA MedWatch – November 2009 Drug Safety Labeling Changes

The MedWatch November 2009 Drug Safety Labeling Changes posting includes 44 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.

The “Summary Page” provides a listing of drug names and safety labeling sections revised: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm191946.htm

Clicking on a drug product name in the Summary View will take you to the “detailed view” page, which identifies safety labeling sections and subsections revised, along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections.

The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and WARNINGS sections:
• Actiq (fentanyl citrate)
• Adenocard (adenosine)
• Adenoscan (adenosine)
• Avandaryl (rosiglitazone maleate and glimepiride)
• Byetta (exenatide)
• Cimzia (certolizumab pegol)
• Cleocin HCL (clindamycin hydrochloride)
• Enbrel (etanercept)
• Humira (adalimumab)
• Lotensin (benazepril hydrochloride)
• Lotensin HCT (benazepril/hydrochlorothiazide)
• Lopressor (metoprolol tartrate)
• Norvir (ritonavir) capsule and solution
• Parnate (tranylcypromine sulfate)
• Plavix (clopidogrel bisulfate)
• Qualaquin (quinine sulfate)
• Rebetol (ribavirin), Soma (carisoprodol)
• Remicade (infliximab)
• Simponi (golimumab)
• Soma Compound (carisoprodol 200 mg and aspirin 325 mg)
• Soma Compound with Codeine (carisoprodol 200 mg, aspirin 325 mg and codeine phosphate 16 mg)
• Tekturna (aliskiren)

FDA MedWatch – Atlas Operations, Inc. Sexual Enhancement Products – Recall

Atlas Operations, Inc. and FDA notified consumers of a nationwide recall of the company’s dietary supplements for sexual enhancement. These products are currently being sold as dietary supplements throughout the United States. FDA lab analyses found that the products tested from certain batches contain Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used as treatment for male erectile dysfunction, making these products unapproved drugs. The active drug ingredient is not listed on the product labels.

The undeclared ingredient may pose a threat to the consumer because the interaction of the analogue with some prescription drugs (such as nitroglycerin) may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take other prescription drugs. Erectile Dysfunction is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance. Read the company Press Release for a complete list of product names and lot numbers.

The FDA advises consumers who have experienced any adverse events from sexual enhancement products to consult a health care professional.

CLICK HERE to read the complete MedWatch 2009 Safety summary, including a link to the firm press release.

FDA MedWatch – Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels – Incorrect Packaging

Bayer Consumer Care and FDA notified Consumers of a recall of a single product lot of the combination package of Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels. The labeling on the foil blister card of certain packages within the lot were printed with the label reversed. The label for the green Night product appears under some of the blue Day product and vice versa. Consumers using the affected product lot may not be aware of the warnings of an antihistamine in the product that could cause drowsiness.

The affected Alka-Seltzer Plus product lot number can be found on both the interior blister package (in black text adjacent to the expiration date) as well as on the exterior carton containing the blister packaging (embossed on the side panel under the Bayer logo). This product was sold only in the U.S. at retail outlets nationwide.

• Package size: 20 liquid filled capsules per carton (12 day formulation capsules and 8 night formulation capsules)
• UPC#: 016500537779
• Lot #: 296939L
• Expiration: 5/11

Consumers who purchased combination packages of Alka-Seltzer Plus Day and Night Cold Formula Liquid Gels from the lot included in this recall should stop using the product and contact Bayer with any questions or for instructions on a refund or replacement. See the company Press Release for contact information.

CLICK HERE to read the MedWatch safety summary, including a link to the Bayer Consumer Care Press Release.

FDA MedWatch – Voltaren Gel (diclofenac sodium topical gel) 1% – Hepatic Effects Labeling Changes

Endo, Novartis and FDA notified healthcare professionals of revisions to the Hepatic Effects section of the Prescribing Information to add new warnings and precautions about the potential for elevation in liver function tests during treatment with all products containing diclofenac sodium.

In postmarketing reports, cases of drug-induced hepatotoxicity have been reported in the first month but can occur at any time during treatment with diclofenac. Postmarketing surveillance has reported cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Some of these reported cases resulted in fatalities or liver transplantation.

Physicians should measure transaminases periodically in patients receiving long-term therapy with diclofenac. The optimum times for making the first and subsequent transaminase measurement are not known. Based on clinical trial data and postmarketing experiences, transaminases should be monitored within 4 to 8 weeks after initiating treatment with diclofenac.

CLICK HERE to read the complete MedWatch 2009 Safety summary, including links to the Dear Healthcare Professional letter and revised Prescribing Information.

FDA MedWatch – Steris System 1 Processor: FDA Notice and Recommendations

FDA notified healthcare facility administrators and infection control healthcare professionals of important information regarding the regulatory status of the STERIS System 1 Processor (SS1) used in surgical and endoscopy suites for reprocessing, i.e., sterilizing or disinfecting, medical devices.

STERIS has significantly modified the SS1 and FDA has not approved or cleared this modified product. Thus, FDA has not determined whether the SS1 is safe or effective for its labeled claims, including claims that it sterilizes medical devices. Use of a device that is promoted to sterilize or disinfect a medical or surgical device, but that does not properly perform these functions, poses risks to patients and users. Improperly disinfected or sterilized instruments may transmit pathogens to patients and healthcare staff, or expose them to hazardous chemicals. Improper sterilization or disinfection may also adversely affect the quality and functionality of reprocessed instruments. FDA has received some reports of malfunctions of the SS1 that had the potential to cause or contribute to serious injuries to patients, such as infections. There have also been reports of injuries, mostly burns from exposure to the sterilant solution, to healthcare facility staff operating the device.

FDA recommends that if a facility has an acceptable alternative to the SS1 to meet sterilization and disinfection needs, the facility should transition to that alternative as soon as possible to ensure continued patient safety. If an acceptable alternative to the SS1 is not available, the facility should promptly assess its patient-care needs and sterilization and disinfection requirements and take steps to obtain legally-marketed substitutes for the SS1.

CLICK HERE to read the complete MedWatch 2009 Safety summary, including a link to the FDA letter to healthcare facilities.

FDA MedWatch – Valproate Sodium and related products (valproic acid and divalproex sodium): Risk of Birth Defects

The FDA notified health care professionals and patients about the increased risk of neural tube defects and other major birth defects, such as craniofacial defects and cardiovascular malformations, in babies exposed to valproate sodium and related products (valproic acid and divalproex sodium) during pregnancy. Healthcare practitioners should inform women of childbearing potential about these risks, and consider alternative therapies, especially if using valproate to treat migraines or other conditions not usually considered life-threatening.

Women of childbearing potential should only use valproate if it is essential to manage their medical condition. Those who are not actively planning a pregnancy should use effective contraception, as birth defect risks are particularly high during the first trimester, before many women know they are pregnant. A valproate Medication Guide, provided with each outpatient prescription, will explain the benefits and risks of valproate and encourage patients to discuss options with their healthcare professional.

Pregnant women using valproate or other AEDs should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry (1-888-233-2334; www.aedpregnancyregistry.org).

CLICK HERE to read the complete MedWatch 2009 Safety summary, including a link to the Information for Health Professionals sheet.