Alerts

FDA MedWatch

Omalizumab (marketed as Xolair)
Audience: Patients, Healthcare professionals

FDA is evaluating interim safety findings from an ongoing study of Xolair (omalizumab) titled Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS) that suggests a disproportionate increase in ischemic heart disease, arrhythmias, cardiomyopathy and cardiac failure, pulmonary hypertension, cerebrovascular disorders, and embolic, thrombotic and thrombophlebitic events in patients treated with Xolair compared to the control group of patients not given the drug.  Xolair is approved for use by adults and adolescents (12 years of age and above) with moderate to severe persistent asthma who test positive for reactivity to a perennial airborne allergen, and whose symptoms are inadequately controlled with inhaled corticosteroids.

FDA is not recommending any changes to the prescribing information for Xolair and is not advising patients to stop taking Xolair at this time. Until the evaluation of the EXCELS study is completed, healthcare providers and patients should be aware of the risks and benefits described in the prescribing information, as well as the new information from the ongoing EXCELS study that may suggest a risk of cardiovascular and cerebrovascular adverse events.

Read the complete MedWatch Safety summary, including links to the FDA news release and Q&A's, Click Here.

Propoxyphene-containing Products
Audience: Pharmacists, Pain management healthcare professionals

FDA notified healthcare professionals that it is taking several actions to reduce the risk of overdose in patients using pain medications that contain propoxyphene because of data linking propoxyphene and fatal overdoses. The agency will require manufacturers of propoxyphene-containing products to strengthen the label, including the boxed warning, emphasizing the potential for overdose when using these products and to provide a medication guide to patients stressing the importance of using the drugs as directed.

Read the complete MedWatch Safety summary, including links to the FDA news release and Q&A's, Click Here.

Cefepime (marketed as Maxipime) Update of Ongoing Safety Review
Audience: Infectious disease healthcare professionals

FDA notified healthcare professionals that it has finished its analysis of a possible risk of higher death with cefepime, an antibiotic, following publication of a study that suggested a higher rate of death in patients treated with this drug, as compared to patients treated with similar drugs. FDA reviewed this study data and conducted additional analyses based on additional data, including data submitted by Bristol Meyers Squibb. FDA has determined that the data do not indicate a higher rate of death in cefepime-treated patients. Cefepime remains an appropriate therapy for its approved indications. FDA will continue to review the safety of cefepime. As part of this ongoing review, both FDA and Bristol Meyers Squib are conducting separate analyses of death potentially associated with cefepime, using hospital drug use data. The results of these analyses likely will be reported in approximately one year Read the complete MedWatch 2009 Safety Summary, including links to the Update of Ongoing Safety Review and previous 2007 and 2008 MedWatch safety alerts, Click Here.

Stimulant Medications used in Children with Attention-Deficit/Hyperactivity Disorder - Communication about an Ongoing Safety Review

Products involved include: Focalin, Focalin XR (dexmethylphenidate HCl ); Dexedrine, Dexedrine Spansules, Dextroamphetamine ER, Dextrostat (dextroamphetamine sulfate); Vyvanse (lisdexamfetamine dimesylate); Desoxyn (methamphetamine); Concerta, Daytrana, Metadate CD, Metadate ER, Methylin, Methylin ER, Ritalin, Ritalin-LA, Ritalin-SR (methylphenidate); Adderall, Adderall XR (mixed salts amphetamine); Cylert (pemoline) and generics.

Audience: Pediatricians, Neuropsychiatric healthcare professionals

FDA notified healthcare professionals that it is providing its perspective on study data published in the American Journal of Psychiatry on the potential risks of stimulant medications used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in children. This study, funded by the FDA and the National Institute of Mental Health (NIMH), compared the use of stimulant medications in 564 healthy children from across the United States who died suddenly to the use of stimulant medications in 564 children who died as passengers in a motor vehicle accident.The study authors concluded that there may be an association between the use of stimulant medications and sudden death in healthy children. Given the limitations of this study's methodology, the FDA is unable to conclude that these data affect the overall risk and benefit profile of stimulant medications used to treat ADHD in children. FDA believes that this study should not serve as a basis for parents to stop a child's stimulant medication. Parents should discuss concerns about the use of these medicines with the prescribing healthcare professional. Any child who develops cardiovascular symptoms (such as chest pain, shortness of breath or fainting) during stimulant medication treatment should immediately be seen by a doctor.

FDA is continuing its review of the strengths and limitations of this and other epidemiological studies that evaluate the risks of stimulant medications used to treat ADHD in children. FDA and the Agency for Healthcare Research and Quality are sponsoring a large epidemiological study that will provide further information about the potential risks associated with stimulant medication use in children. The data collection for this study will be complete later in 2009.

Read the complete MedWatch 2009 Safety Summary, including a link to the Communication and the FDA News Release, Click Here.

Levemir Insulin (Novo Nordisk)

Audience: Patients, pharmacists, diabetes healthcare professionals

FDA notified patients and healthcare professionals that some stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. are being sold in the U.S. market, may not have been stored and handled properly, and may be dangerous for patients to use. The agency is advising patients who use Levemir insulin to:

Check your personal supply of insulin to determine if you have Levemir insulin from one of the following lots: XZF0036, XZF0037, and XZF0038.
Do not use your Levemir insulin if it is from one of these lots.
Always visually inspect your insulin before using it. Levemir is a clear and colorless solution.
Contact the Novo Nordisk Customer Care Center at 1-800-727-6500 for what to do with vials from these lots or if you have any other questions.
Read the complete MedWatch 2009 Safety Summary, including a link to the FDA News Release, Click Here.

Sirolimus (marketed as Rapamune)

Audience: Transplantation healthcare professionals

FDA notified healthcare professionals of clinical trial data that suggest increased mortality in stable liver transplant patients after conversion from a calcineurin inhibitor (CNI)-based immunosuppressive regimen to sirolimus (Rapamune). The trial was conducted by sirolimus manufacturer, Wyeth. The Agency will continue to examine the data on mortality and other adverse events in this study, and will make further recommendations, as appropriate. The FDA is determining whether a labeling change for sirolimus is needed. In the interim, physicians should continue to use the drug's professional labeling as a guide to therapy. See the FDA Healthcare Professional Information sheet for current FDA recommendations.

Read the complete MedWatch 2009 Safety summary, including a link to the FDA Healthcare Professional Information Sheet, Click Here.

Recalls

For the latest recall information from the FDA Click Here.

Individual Recall Notices: 2009

June Recalls:

Recall: 2009-004 (Word - 1.2MB) - Zicam Cold Remedy Adult Swabs and Zicam Cold Remedy Nasal Gel manufactured by Matrixx Initiatives are being voluntarily removed from the market based on an FDA warning that products may produce possible, temporary loss of smell (Anosmia). The recall extends to the retail level.

Recall: 2009-039A (Word - 47k) - Klonopin (clonazepam) Wafers ODT are manufactured by Roche Laboratories. Roche Laboratories, in a follow-up to the voluntary drug recall of Lot U5011, determined the sub-potent wafers did not present a safety risk to the patient. The recall is classified by the FDA as Class II and it extends to the retail level.

Recall: 2009-078 (Word - 1.3MB) - Fluocinonide Cream manufactured by Taro Pharmaceuticals is being voluntarily recalled due to out of specification tube uniformity values observed at 18 and 34 months stability intervals. This recall extends to the retail level.

Recall: 2009-081 (Word - 1.1MB) - Klonopin (clonazepam) Wafers ODT are manufactured by Roche Laboratories. Several lot #'s are being recalled due to the potential of assay results which fall below the labeled claim (sub-potent wafers). The recall was classified by the FDA as a Class II and extends to the retail level.

Recall: 2009-083 (Word - 1MB) - Cyclosporine Capsules are manufactured by Apotex Corporation. Lot # HM4156 is being voluntarily recalled from the market because it was determined that capsules had a level of related compound (Maximum Unknown) marginally in excess of the specification limit. This recall extends to the retail level.

Recall: 2009-084 (Word - 1.2MB) - Citalopran Tablets are manufactured by Caraco Pharmaceuticals. Lot # 82577A is being recalled because it was determined that the product may contain tablets of varying size. This recall extends to the retail level.

Recall: 2009-088A (Word - 1.6MB) - Cefdinir Oral Supspension are manufactured by TEVA Pharmaceuticals. Several lot #'s are being recalled because it was determined that the product has incorrect pediatric dosing information on the label outsert. This recall extends to the retail level.

Recall: 2009-089 (Word - 980k) - Ciprofloxacian Injection SDV are manufactured by Hospira, INC.. Several lot #'s are being recalled because it was determined that the Routine stability testing has identified discoloration of the product. This recall extends to the retail level.

May Recalls:

Recall: 2009-066 (Word - 372k) - Furosemide Tablets are manufactured by Sandoz. Lot # P-13418 is being recalled due to the presence of tablets that have high assay values out of specification. This recall extends to the retail level.

Recall: 2009-067 (Word - 413k) - Furosemide Tablets, UPS are manufactured by Sandoz. Lot # 180974 is being voluntarily recalled due to the presence of tablets that have high assay values out of specification. This recall extends to the retail level.

Recall: 2009-071 (Word - 324k) - Soluclenz RX Gel manufactured by Obagi Medical Products is being withdrawn from the market based on a business decision by OMP to discontinue the manufacture, marketing and sale of product. This recall extends to the retail level.

Recall: 2009-072 (Word - 469k) - Morphine Sul Tablets, Hydromorph Tablets, and Roxicodone Tablets (all lots by various manufacturers) will no longer be available based on a warning dated 3-30-09 by the FDA directing certain companies to stop making and distributing specific narcotic products in certain dosage forms that lack the FDA Approval. This extends to the retail level.

Recall: 2009-073 (Word - 1.1MB) - Nitrofurantoin Monohydrate/Macrocrystals Capsules USP manufactured by Ranbaxy Pharmaceuticals Inc., are being voluntarily recalled (all lots) based on product testing results which showed certain lots of the product were non-conforming to the approved laboratory specification for dissolution. The recall extends to the retail level.

Recall: 2009-075 (Word - 1MB) - Sulfazine EC Tablets aremanufactured by Vintage Pharmaceuticals. Lot #CO200108A is being recalled due to failing dissolution at the 12-month stability time point. The recall extends to the retail level.

Recall: 2009-076 (Word - 452k) - Hydrocod +AB Tablets are manufactured by Vintage Pharmaceuticals. Lot #'s T068A09 & T069A09 are being recalled because some bottles may have an incorrect package outsert reflecting an incorrect strength. The recall extends to the retail level.

April Recalls:

Recall: 2009-041A (Word - 1.8MB) - Digoxin Tablets are manufactured by Caraco Pharmaceuticals. Several lots are being recalled because they may contain tablets of varying sizes. The tablets may differ from the labeled level of active ingredient. This recall extends to the consumer level.

Recall: 2009-049A (Word - 49k) - Ciclopirox Olamine Cream USP is manufactured by Taro Pharmaceuticals. Several lots are being voluntarily recalled until sufficient data is obtained to support the expiration period. The recall extends to the retail level.

Recall: 2009-052 (Word - 1.5MB) - Senna-Gen Tablets and Senna-S Tablets are manufactured by Time Cap Labs, Inc. Several lots are being voluntarily recalled because they contain small amounts of undeclared (not on label) anhydrous lactose and tartaric acid. This recall extends to the retail level.

Recall: 2009-053A (Word - 1.2MB) - Dok Plus Tablets and Senna Tablets are manufactured by Time Cap Labs Inc. Several lots are being recalled due to undeclared inactive ingredients (anhydrous lactose and tartaric acid). This recall extends to the retail level.

Recall: 2009-054A (Word - 878k) - Metoprol Tartrate Tablets, Metoprol Tartrate and Clonazepam Tablets are manufactured by Caraco Pharmaceuticals. Several lots are being recalled since products may contain tablets of varying size and may differ from the labeled level of active ingredient. The recall extends to the retail level.

Recall: 2009-058 (Word - 43k) - B-Vex Suspension, B-Vex D Suspension, B-Vex PD Suspension, Ben-Tann Suspension, D-Tann AT Suspension, D-Tann CD Suspension, D-Tann CT Suspension, D-Tann CT Tablets, D-Tann DM, D-Tann Suspension, L-All 12 NF Suspension, and RY Tann Tablets are manufactured by Midlothian Laboratories. Several lots are being voluntarily recalled because the FDA recently announced that it obtained a permanent injunction barring NeilGen Pharmaceuticals, Inc., and Advent Pharmaceuticals, Inc., from manufacturing and distributing any unapproved, adulterated or misbranded drugs. There are no safety issues associated with this recall. This recall extends to the Retail Level.

March Recalls:

Recall: 2009-018A (Word - 1.2MB) - Dextroamphetamine Tablets, Morphine Sulfate ER Tablets, Morphine IR Tablets, Propafenone Tablets and Isosorbide Mononitrate ER Tablets are manufactured by Ethex Corporation. Several lots are being voluntarily recalled (listed lots and package sizes) because they potentially were manufactured under conditions that did not fully comply with cGMP's. This recall extends to the retail level.

Recall: 2009-034A (Word - 1MB) - Fluocinonide Topical Solution USP is manufactured by Taro Pharmaceuticals. Taro Pharmaceuticals is recalling additional lots (original recall issued 12-18-08) because the product does not meet Taro's stability requirements. This recall extends to the retail level.

Recall: 2009-038 (Word - 910k) - Leukine Sargramostim Liquid is manufactured by Bayer Healthcare Pharmaceuticals. Bayer Healthcare Pharmaceuticals, in consultation with the FDA, decided to recall Commercial lot B13958 because it did not meet an established parameter of ongoing product stability monitoring. This recall extends to the retail level.

Recall: 2009-040 (Word - 1.3MB) - Fluocinon Ointment is manufactured by Nycomed US Inc. Several lots are being voluntarily recalled due to out-of-specification stability test results (for a degradant product at the 15-month stability time point). This recall extends to the retail level. Further use and distribution of this product should cease.

Archived Recalls