FDA NEWS

U.S. Attorney News Release: International Medical Device Maker and Four Executives Charged in Connection with Unlawful Clinical Trials

2009-07-05T00:36:00.001-07:00

U.S. Attorney News Release: International Medical Device Maker and Four Executives Charged in Connection with Unlawful Clinical Trials
U.S. Attorney news release
Source: www.fda.gov

Preventing Medical Errors: Warning on Accidental Ingestion of Benadryl Topical Gel
FDA and the Institute for Safe Medication Practices (ISMP) recently reported on several cases where people swallowed Benadryl Itch Stopping Gel, an OTC product that's supposed to be used topically. This has led to serious adverse reactions requiring...
Source: www.accessdata.fda.gov

FDA Warns Consumers Not to Eat Nestle Toll House Prepackaged, Refrigerated Cookie Dough
The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are warning consumers not to eat any varieties of Nestle Toll House Refrigerated cookie dough due to the risk of contamination with E. coli O157:H7 (a bacterium that causes food borne illness).
Source: www.fda.gov

U.S. Marshals Seize Drug Products Manufactured by Caraco Pharmaceutical Laboratories Ltd.
U.S. Marshals Seize Drug Products Manufactured by Caraco Pharmaceutical Laboratories Ltd.
Source: www.fda.gov

Fun Express Water-based Face Paints for Children

2009-07-04T05:55:00.001-07:00

Fun Express Water-based Face Paints for Children
UPDATE - Fun Express expanded its recall of face paint items to include two additional face paint colors, 85/2338 (White face paint) and 85/2339 (Yellow face paint)
Source: www.fda.gov

Simponi (golimumab)
Risk of serious fungal infections associated with TNF-α blockers, including Simponi (golimumab). Posted 05/28/2009
Source: www.fda.gov

Digoxin, USP 0.125 mg, Digoxin, USP 0.25 mg (Caraco brand)

Source: www.fda.gov

FDA Seeks Public Input on Transparency

2009-06-30T12:29:00.001-07:00

FDA Seeks Public Input on Transparency
The U.S. Food and Drug Administration will host a daylong meeting on June 24, 2009. During this meeting, the FDA will seek recommendations on how to make information on FDA activities and decision-making useful, understandable, and more accessible to the public. The meeting is scheduled for 8 a.m. to 5 p.m. EDT at the National Transportation Safety Board Conference Center, 429 L’Enfant Plaza, S.W., Washington, D.C., 20594.
Source: www.fda.gov

U.S. Attorney Press Release: Scottsdale Man Pleads Guilty to Multiple Federal Charges Related to Marketing of Sexual Enhancement Drug
Timothy Keay Isaac, 47, of Scottsdale, Ariz., pleaded guilty earlier this week to Conspiracy, Introducing Misbranded Drugs into Interstate Commerce, Making False Tax Returns, Filing False Declarations in a Bankruptcy Proceeding and Theft of Government Money.
Source: www.fda.gov

Company Recalls Various Products Due to Potential Salmonella Contamination
FDA, USDA, CDC investigating; no link to human illnesses at this time. Plainview Milk Products Cooperative, Plainview, Minn., is voluntarily recalling all instant nonfat dried milk, whey protein, fruit stabilizers, and gums (thickening agents) that it has manufactured over the past two years, because they might be contaminated with Salmonella.
Source: www.fda.gov

U.S. Marshals Seize Drug Products Manufactured by Caraco Pharmaceutical Laboratories Ltd.
U.S. Marshals Seize Drug Products Manufactured by Caraco Pharmaceutical Laboratories Ltd.
Source: www.fda.gov

Safety Concerns About Testosterone Gel

2009-06-29T17:42:00.001-07:00

Safety Concerns About Testosterone Gel
Side effects in children prompt additional warnings on testosterone gel products for adults.
Source: www.fda.gov

FDA Promotes Openness and Transparency to Public
FDA is working to make useful information about FDA activities and decision making more readily available to the public.
Source: www.fda.gov

Patients Alerted to Pacemaker Recall
FDA has alerted patients to the Class I recall of certain Medtronic Kappa and Sigma pacemakers
Source: www.fda.gov

New Labeling Required for OTC Pain and Fever Medicines
On April 28, 2009, FDA issued a final rule that requires manufacturers of over-the-counter (OTC) pain relievers and fever reducers to revise their labeling
Source: www.fda.gov

FDA Advisory About Levemir Insulin
Stolen Levemir insulin has reappeared on the market; check your lot number if you use this insulin.
Source: www.fda.gov

Fun Express Water-based Face Paints for Children

2009-06-26T22:49:00.001-07:00

Fun Express Water-based Face Paints for Children
UPDATE - Fun Express expanded its recall of face paint items to include two additional face paint colors, 85/2338 (White face paint) and 85/2339 (Yellow face paint)
Source: www.fda.gov

Testosterone gel products (AndroGel 1% and Testim 1% )
Boxed warning required to inform users of risk of unintended secondary exposure of children to testosterone.
Source: www.fda.gov

New from FDA: Campaign on Using Methadone Safely
FDA and the Substance Abuse and Mental Health Services Administration (SAMHSA) have launched a campaign to increase awareness about the risks associated with using methadone and how to minimize them. Methadone has long been used to treat drug addict...
Source: www.accessdata.fda.gov

Stamina-Rx Dietary Supplement Products

2009-06-26T16:58:00.001-07:00

Stamina-Rx Dietary Supplement Products
FDA and Hi-Tech Pharmaceuticals notified patients and healthcare professionals of a nationwide recall of all product sold under the name Stamina-Rx. Hi-Tech was notified by the FDA that the lab analysis of Stamina-Rx samples found that the product contained the undeclared ingredient − benzamidenafil − a Phosphodiesterase Type 5 inhibitor.
Source: www.fda.gov

Antiepileptic Drugs

Source: www.fda.gov

U.S. Attorney News Release: Howard County Pharmacy Owner Indicted for Health Care Fraud
A federal grand jury yesterday indicted Pamela Arrey, age 48, Glenelg, Maryland, for health care fraud and aggravated identity theft, announced United States Attorney for District of Maryland Rod R. Rosenstein
Source: www.fda.gov

Cefepime (marketed as Maxipime) Update of Ongoing Safety Review
FDA finished its analysis of a possible risk of higher death with cefepime and has determined that the data do not indicate a higher rate of death in cefepime-treated patients.
Source: www.fda.gov

U.S. Attorney News Release: Former Managing Pharmacist Pleads Guilty To Conspiracy to Defraud Health Insurers
The former managing pharmacist at a Middlesex County pharmacy pleaded guilty today to conspiring to defraud health insurers, including the federal Medicaid program, by submitting phony claims for reimbursement for prescription drugs, Acting U.S. Attorney Ralph J. Marra, Jr., announced.
Source: www.fda.gov

FDA Issues Public Health Advisory Regarding Levemir Insulin (Spanish)
La Administración de Medicamentos y Alimentos de los Estados Unidos se ha enterado que algunas ampollas de insulina Levemir de acción prolongada, medicamento elaborado por Novo Nordisk Inc., que habían sido robadas, han aparecido y se encuentran a la venta en los Estados Unidos. El total de ampollas robadas es de 129,000 unidades, lo que equivale a tres lotes del producto. Cabe la posibilidad de que estas ampollas de insulina robadas no hayan sido almacenadas ni manipuladas adecuadamente, lo que puede ser peligroso para los pacientes que la usan.
Source: www.fda.gov

Stimulant Medications used in Children with Attention-Deficit/Hyperactivity Disorder - Communication about an Ongoing Safety Review
FDA provides 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 in children. The study authors concluded that there may be an association between the use of stimulant medications and sudden death in healthy children.
Source: www.fda.gov

FDA Consumer Corner: Don?t Overdo It with Acetaminophen

2009-06-25T02:11:00.001-07:00

FDA Consumer Corner: Don?t Overdo It with Acetaminophen
If you woke up with a headache this morning, you may have reached for an over-the-counter pain reliever. Millions of people do that everyday, and there's usually no problem. Over-the-counter pain relievers are effective for treating minor aches and...
Source: www.accessdata.fda.gov

FDA Issues Public Health Advisory Regarding Levemir Insulin (Spanish)
La Administración de Medicamentos y Alimentos de los Estados Unidos se ha enterado que algunas ampollas de insulina Levemir de acción prolongada, medicamento elaborado por Novo Nordisk Inc., que habían sido robadas, han aparecido y se encuentran a la venta en los Estados Unidos. El total de ampollas robadas es de 129,000 unidades, lo que equivale a tres lotes del producto. Cabe la posibilidad de que estas ampollas de insulina robadas no hayan sido almacenadas ni manipuladas adecuadamente, lo que puede ser peligroso para los pacientes que la usan.
Source: www.fda.gov

FDA Issues Public Health Advisory Regarding Levemir Insulin
The U.S. Food and Drug Administration has learned that some stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. have reappeared and are being sold in the U.S. market. Three lots or a total of 129,000 vials of this product were stolen in all. These stolen insulin vials may not have been stored and handled properly and may be dangerous for patients to use.
Source: www.fda.gov

U.S. Attorney News Release: Business Owners Plead Guilty to Distributing Tainted Ingredient Used in Pet Food
KANSAS CITY, Mo. – Matt J. Whitworth, Acting United States Attorney for the Western District of Missouri, announced that a Nevada company and its owners pleaded guilty in federal court today to distributing a tainted ingredient used to make pet food, which resulted in a nationwide recall of pet food and the death and serious illness of countless pets across the United States in 2007.
Source: www.fda.gov

FDA Requests Labeling Change for Leukotriene Modifiers
The U.S. Food and Drug Administration today provided further updated safety information on a class of asthma drugs known as leukotriene modifiers. FDA has requested that manufacturers include a precaution in the drug prescribing information (drug labeling) regarding neuropsychiatric events (behavior, mood changes) that have been reported in some persons taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR).
Source: www.fda.gov

U.S. Attorney News Release: International Medical Device Maker and Four Executives Charged in Connection with Unlawful Clinical Trials
U.S. Attorney news release
Source: www.fda.gov

FDA Warns Consumers Not to Use Skin Products Made by Clarcon Due to Bacterial Contamination Risk
The U.S. Food and Drug Administration announced today that Clarcon Biological Chemistry Laboratory Inc. of Roy, Utah, is voluntarily recalling some skin sanitizers and skin protectants marketed under several different brand names because of high levels of disease-causing bacteria found in the product during a recent inspection. The FDA is warning consumers to not use any Clarcon products.
Source: www.fda.gov

Recalls and Safety Alerts: Recall of Medtronic Ventricular Snap Shunt Catheters
Medtronic Neurologic Technologies has recalled the company's Bioglide Ventricular Snap Shunt Catheter, which is a component of a shunt system that is used to treat hydrocephalus. The catheters may become detached from the snap base assembly, and tha...
Source: www.accessdata.fda.gov

FDA Approves Generic Prescription-Only Version of Plan B Emergency Contraceptive for Women Ages 17 and Under
The U.S. Food and Drug Administration today approved the first generic version of the emergency contraceptive Plan B (levonorgestrel) tablets, 0.75 mg. The generic product will be available by prescription only for women ages 17 and under.
Source: www.fda.gov

Cefepime (marketed as Maxipime) Update of Ongoing Safety Review

2009-06-24T16:47:00.001-07:00

Cefepime (marketed as Maxipime) Update of Ongoing Safety Review
FDA finished its analysis of a possible risk of higher death with cefepime and has determined that the data do not indicate a higher rate of death in cefepime-treated patients.
Source: www.fda.gov

Propylthiouracil
Propylthiouracil (PTU)-Induced Liver Failure
Source: www.fda.gov

Nestle Toll House Prepackaged, Refrigerated Cookie Dough
FDA and the CDC are warning consumers not to eat any varieties of prepackaged Nestle Toll House refrigerated cookie dough due to the risk of contamination with E. coli O157:H7 (a bacterium that causes food borne illness). Since March 2009 there have been 66 reports of illness across 28 states. Twenty-five persons were hospitalized; 7 with a severe complication called Hemolytic Uremic Syndrome. No one has died.E. coli O157:H7 causes abdominal cramping, vomiting and a diarrheal illness, often with bloody stools. Most healthy adults can recover completely within a week. Young children and the elderly are at highest risk for developing HUS,which can lead to serious kidney damage and even death.
Source: www.fda.gov

Recalls and Safety Alerts: Recall of Zencore Plus

2009-06-23T10:38:00.001-07:00

Recalls and Safety Alerts: Recall of Zencore Plus
Bodee LLC is recalling its supplement product called Zencore Plus after FDA laboratory analysis showed that the product contains benzamidenafil. This is a newly discovered PDE5 inhibitor that is likely to have the same pharmacologic properties as si...
Source: www.accessdata.fda.gov

FDA Consumer Corner: Don?t Overdo It with Acetaminophen
If you woke up with a headache this morning, you may have reached for an over-the-counter pain reliever. Millions of people do that everyday, and there's usually no problem. Over-the-counter pain relievers are effective for treating minor aches and...
Source: www.accessdata.fda.gov

New from FDA: Campaign on Using Methadone Safely
FDA and the Substance Abuse and Mental Health Services Administration (SAMHSA) have launched a campaign to increase awareness about the risks associated with using methadone and how to minimize them. Methadone has long been used to treat drug addict...
Source: www.accessdata.fda.gov

Recalls and Safety Alerts: Recall of Medtronic Ventricular Snap Shunt Catheters
Medtronic Neurologic Technologies has recalled the company's Bioglide Ventricular Snap Shunt Catheter, which is a component of a shunt system that is used to treat hydrocephalus. The catheters may become detached from the snap base assembly, and tha...
Source: www.accessdata.fda.gov

Simponi (golimumab)
Risk of serious fungal infections associated with TNF-α blockers, including Simponi (golimumab). Posted 05/28/2009
Source: www.fda.gov

Testosterone gel products (AndroGel 1% and Testim 1% )
Boxed warning required to inform users of risk of unintended secondary exposure of children to testosterone.
Source: www.fda.gov

Nestle Toll House Prepackaged, Refrigerated Cookie Dough
FDA and the CDC are warning consumers not to eat any varieties of prepackaged Nestle Toll House refrigerated cookie dough due to the risk of contamination with E. coli O157:H7 (a bacterium that causes food borne illness). Since March 2009 there have been 66 reports of illness across 28 states. Twenty-five persons were hospitalized; 7 with a severe complication called Hemolytic Uremic Syndrome. No one has died.E. coli O157:H7 causes abdominal cramping, vomiting and a diarrheal illness, often with bloody stools. Most healthy adults can recover completely within a week. Young children and the elderly are at highest risk for developing HUS,which can lead to serious kidney damage and even death.
Source: www.fda.gov

Warnings on Three Zicam Intranasal Zinc Products

2009-06-22T15:18:00.001-07:00

Warnings on Three Zicam Intranasal Zinc Products
FDA has warned consumers not to use three Zicam intranasal products because the products may cause a loss of sense of smell.
Source: www.fda.gov

La FDA promueve la apertura y la transparencia hacia el público
La FDA está trabajando para que el público tenga un mejor acceso a toda información de utilidad sobre sus actividades y su toma de decisiones.
Source: www.fda.gov

FDA Warns Not to Eat Nestle Toll House Prepackaged, Refrigerated Cookie Dough
FDA warns consumers not to eat Nestle Toll House prepackaged, refrigerated cookie dough
Source: www.fda.gov

FDA's MedWatch Safety Alerts: June 2009
FDA has issued recent safety alerts on these medical products.
Source: www.fda.gov

Giving Medication to Children
The director of FDA's Office of Pediatric Therapeutics discusses what parents should know about medication. use in children.
Source: www.fda.gov

Warning on Hydroxycut Products
FDA is warning consumers to stop using Hydroxycut products because of serious health risks. One death due to liver failure has been reported to the agency.
Source: www.fda.gov

Recalls and Safety Alerts: Zoll AED Plus Defibrillator Recalled

2009-06-22T08:49:00.001-07:00

Recalls and Safety Alerts: Zoll AED Plus Defibrillator Recalled
The device company Zoll Medical Corporation is recalling AED Plus Defibrillators that were manufactured between May 2004 and February 2009. Some of the batteries in these devices may not work properly, and the original self-test software cannot adeq...
Source: www.accessdata.fda.gov

Recalls and Safety Alerts: Recalls of Digoxin and Propafenone Tablets
FDA has posted information about two cardiac drugs that were recently recalled because of variability in the size of the tablets: ? Caraco Pharmaceutical Laboratories, a manufacturer of generic pharmaceuticals, recalled some of their digoxin table...
Source: www.accessdata.fda.gov

Influend Cough and Cold Products
Influend Cough and Cold Products
Source: www.fda.gov

Antiepileptic Drugs

Source: www.fda.gov

Patients Alerted to Pacemaker Recall

2009-06-21T22:47:00.001-07:00

Patients Alerted to Pacemaker Recall
FDA has alerted patients to the Class I recall of certain Medtronic Kappa and Sigma pacemakers
Source: www.fda.gov

FDA Requests Labeling Change for Leukotriene Modifiers

2009-06-21T11:41:00.001-07:00

FDA Requests Labeling Change for Leukotriene Modifiers
The U.S. Food and Drug Administration today provided further updated safety information on a class of asthma drugs known as leukotriene modifiers. FDA has requested that manufacturers include a precaution in the drug prescribing information (drug labeling) regarding neuropsychiatric events (behavior, mood changes) that have been reported in some persons taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR).
Source: www.fda.gov

FDA Warns Web Sites against Marketing Fraudulent H1N1 Flu Virus Claims
The U.S. Food and Drug Administration is enforcing the laws that protect consumers from illegal products marketed through the Internet that claim to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 flu virus.
Source: www.fda.gov

November 2008
MedWatch November 2008 Drug Safety Labeling Changes
Source: www.fda.gov

Sirolimus (marketed as Rapamune)
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.
Source: www.fda.gov

Nestle Toll House Prepackaged, Refrigerated Cookie Dough
FDA and the CDC are warning consumers not to eat any varieties of prepackaged Nestle Toll House refrigerated cookie dough due to the risk of contamination with E. coli O157:H7 (a bacterium that causes food borne illness). Since March 2009 there have been 66 reports of illness across 28 states. Twenty-five persons were hospitalized; 7 with a severe complication called Hemolytic Uremic Syndrome. No one has died.E. coli O157:H7 causes abdominal cramping, vomiting and a diarrheal illness, often with bloody stools. Most healthy adults can recover completely within a week. Young children and the elderly are at highest risk for developing HUS,which can lead to serious kidney damage and even death.
Source: www.fda.gov

Levemir Insulin (Novo Nordisk)
Patients advised to check personal supply of insulin to identify possible stolen and dangerous product.
Source: www.fda.gov

Digoxin, USP 0.125 mg, Digoxin, USP 0.25 mg (Caraco brand)

Source: www.fda.gov

Recalls and Safety Alerts: Recall of Zencore Plus

2009-06-21T00:45:00.001-07:00

Warning on Hydroxycut Products

2009-06-20T12:51:00.001-07:00

Warning on Hydroxycut Products
FDA is warning consumers to stop using Hydroxycut products because of serious health risks. One death due to liver failure has been reported to the agency.
Source: www.fda.gov

Are You Taking Medication as Prescribed?
Strategies for improving medication adherence.
Source: www.fda.gov

Patients Alerted to Pacemaker Recall
FDA has alerted patients to the Class I recall of certain Medtronic Kappa and Sigma pacemakers
Source: www.fda.gov

Recalls and Safety Alerts: Recall of Zencore Plus
Bodee LLC is recalling its supplement product called Zencore Plus after FDA laboratory analysis showed that the product contains benzamidenafil. This is a newly discovered PDE5 inhibitor that is likely to have the same pharmacologic properties as si...
Source: www.accessdata.fda.gov

FDA's MedWatch Safety Alerts: June 2009
FDA has issued recent safety alerts on these medical products.
Source: www.fda.gov

Ensuring Safe Use of Contact Lens Solution

2009-06-19T23:29:00.001-07:00

Ensuring Safe Use of Contact Lens Solution
Advice from FDA for using contact lens solution
Source: www.fda.gov

Recalls and Safety Alerts: Recalls of Digoxin and Propafenone Tablets
FDA has posted information about two cardiac drugs that were recently recalled because of variability in the size of the tablets: ? Caraco Pharmaceutical Laboratories, a manufacturer of generic pharmaceuticals, recalled some of their digoxin table...
Source: www.accessdata.fda.gov

Safety Concerns About Testosterone Gel

2009-06-19T12:53:00.001-07:00

Safety Concerns About Testosterone Gel
Side effects in children prompt additional warnings on testosterone gel products for adults.
Source: www.fda.gov

La FDA promueve la apertura y la transparencia hacia el público
La FDA está trabajando para que el público tenga un mejor acceso a toda información de utilidad sobre sus actividades y su toma de decisiones.
Source: www.fda.gov

Ensuring Safe Use of Contact Lens Solution
Advice from FDA for using contact lens solution
Source: www.fda.gov

FDA Promotes Openness and Transparency to Public
FDA is working to make useful information about FDA activities and decision making more readily available to the public.
Source: www.fda.gov

FDA Advisory About Levemir Insulin
Stolen Levemir insulin has reappeared on the market; check your lot number if you use this insulin.
Source: www.fda.gov

H1N1 Flu: FDA Responds Quickly to Protect the Public's Health
FDA is addressing the H1N1 flu outbreak with a team-based incident management approach
Source: www.fda.gov

FDA's MedWatch Safety Alerts: June 2009
FDA has issued recent safety alerts on these medical products.
Source: www.fda.gov

New Labeling Required for OTC Pain and Fever Medicines
On April 28, 2009, FDA issued a final rule that requires manufacturers of over-the-counter (OTC) pain relievers and fever reducers to revise their labeling
Source: www.fda.gov

Warning on Hydroxycut Products
FDA is warning consumers to stop using Hydroxycut products because of serious health risks. One death due to liver failure has been reported to the agency.
Source: www.fda.gov

Safety Concerns About Testosterone Gel

2009-06-19T00:54:00.001-07:00

Safety Concerns About Testosterone Gel
Side effects in children prompt additional warnings on testosterone gel products for adults.
Source: www.fda.gov

The Scoop on Whole Grains
What are whole grains and how much should you eat?
Source: www.fda.gov

New Labeling Required for OTC Pain and Fever Medicines
On April 28, 2009, FDA issued a final rule that requires manufacturers of over-the-counter (OTC) pain relievers and fever reducers to revise their labeling
Source: www.fda.gov

Ensuring Safe Use of Contact Lens Solution
Advice from FDA for using contact lens solution
Source: www.fda.gov

Ceftriaxone (marketed as Rocephin and generics)
Ceftriaxone (marketed as Rocephin and generics)
Source: www.fda.gov

Dietary Supplements Distributed by Universal ABC Beauty Supply International, Inc.

2009-06-18T17:46:00.001-07:00

Dietary Supplements Distributed by Universal ABC Beauty Supply International, Inc.

Source: www.fda.gov

Recalls and Safety Alerts: Recall of Zencore Plus

2009-06-18T13:35:00.001-07:00

Recalls and Safety Alerts: Recall of Zencore Plus
Bodee LLC is recalling its supplement product called Zencore Plus after FDA laboratory analysis showed that the product contains benzamidenafil. This is a newly discovered PDE5 inhibitor that is likely to have the same pharmacologic properties as si...
Source: www.accessdata.fda.gov

FDA Issues Safety Communication about an Ongoing Review of Stimulant Medications Used in Children with ADHD
There may be an association between the use of stimulant medications for attention- deficit hyperactivity disorder, known as ADHD, and sudden cardiac death in healthy children, according to a study published in the American Journal of Psychiatry. But the U.S. Food and Drug Administration says that, because of the study’s limitations, parents should not stop a child’s stimulant medication based on the study. The FDA recommends that parents should discuss concerns about the use of these medications with the prescribing health care professional.
Source: www.fda.gov

U.S. Attorney News Release: International Medical Device Maker and Four Executives Charged in Connection with Unlawful Clinical Trials
U.S. Attorney news release
Source: www.fda.gov

FDA Promotes Openness and Transparency to Public
FDA is working to make useful information about FDA activities and decision making more readily available to the public.
Source: www.fda.gov

FDA Advises Consumers Not To Use Certain Zicam Cold Remedies
The U.S. Food and Drug Administration today advised consumers to stop using three products marketed over-the-counter as cold remedies because they are associated with the loss of sense of smell (anosmia). Anosmia may be long-lasting or permanent.
Source: www.fda.gov

FDA Approves Injectable Form of Ibuprofen
The U.S. Food and Drug Administration today approved Caldolor, the first injectable dosage form of the common pain medication ibuprofen, to treat pain and fever.
Source: www.fda.gov

U.S. Attorney News Release: Business Owners Plead Guilty to Distributing Tainted Ingredient Used in Pet Food
KANSAS CITY, Mo. – Matt J. Whitworth, Acting United States Attorney for the Western District of Missouri, announced that a Nevada company and its owners pleaded guilty in federal court today to distributing a tainted ingredient used to make pet food, which resulted in a nationwide recall of pet food and the death and serious illness of countless pets across the United States in 2007.
Source: www.fda.gov

U.S. Attorney News Release: California Man Sentenced for Prescription Drug Diversion
CONCORD, NEW HAMPSHIRE: Thomas Lavery, of Irvine, CA, was sentenced to 52 months of incarceration to be followed by three years of supervised release for illegally distributing large quantities of Serostim, an HIV drug, which were illegally purchased from illegitimate sources and then illegally sold to wholesale distributors in various parts of the country, using falsified paperwork. Judge McAuliffe also entered an order of forfeiture against Lavery for the sum of $1,009,460.
Source: www.fda.gov

Recalls and Safety Alerts: Raptiva Withdrawn from the Market
Genentech is conducting a phased market withdrawal of the psoriasis drug Raptiva (efalizumab). The company is doing this because taking the drug carries the risk of developing progressive multifocal leukoencephalopathy (PML). PML, which is caused by...
Source: www.accessdata.fda.gov

Safety Concerns About Testosterone Gel
Side effects in children prompt additional warnings on testosterone gel products for adults.
Source: www.fda.gov

FDA Warns Consumers to Stop Using Hydroxycut Products

2009-06-17T17:11:00.001-07:00

FDA Warns Consumers to Stop Using Hydroxycut Products
The U.S. Food and Drug Administration is warning consumers to immediately stop using Hydroxycut products by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y. Some Hydroxycut products are associated with a number of serious liver injuries. Iovate has agreed to recall Hydroxycut products from the market.
Source: www.fda.gov

Warning on Hydroxycut Products
FDA is warning consumers to stop using Hydroxycut products because of serious health risks. One death due to liver failure has been reported to the agency.
Source: www.fda.gov

Treating Cushing's Disease in Dogs
Medications, including a recently approved drug, can help manage this disease that most commonly occurs in middle-aged and older dogs.
Source: www.fda.gov

Consumers Warned Not to Use Clarcon Skin Products
The U.S. Food and Drug Administration announced today that Clarcon Biological Chemistry Laboratory Inc. of Roy, Utah, is voluntarily recalling some skin sanitizers and skin protectants marketed under several different brand names because of high levels of disease-causing bacteria found in the product during a recent inspection. The FDA is warning consumers to not use any Clarcon products.
Source: www.fda.gov

FDA Advises Consumers Not To Use Certain Zicam Cold Remedies
The U.S. Food and Drug Administration today advised consumers to stop using three products marketed over-the-counter as cold remedies because they are associated with the loss of sense of smell (anosmia). Anosmia may be long-lasting or permanent.
Source: www.fda.gov

FDA Alerts Patients to Medtronic Pacemaker Recall
The U.S. Food and Drug Administration is alerting patients to the Class I recall of certain Medtronic Kappa and Sigma pacemakers. These devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery.
Source: www.fda.gov

Testosterone gel products (AndroGel 1% and Testim 1% )

2009-06-17T12:41:00.001-07:00

Testosterone gel products (AndroGel 1% and Testim 1% )
Boxed warning required to inform users of risk of unintended secondary exposure of children to testosterone.
Source: www.fda.gov

Tarceva (erlotinib) May 2009
Dear Healthcare Professional letter issued to warn about GI perforation, exfoliative skin conditions and corneal perforation/ulceration.
Source: www.fda.gov

Skin Products Made by Clarcon
FDA notified consumers and healthcare professionals that Clarcon Biological Chemistry Laboratory is recalling some skin sanitizers and skin protectants because of high levels of disease-causing bacteria found in the product. During an FDA inspection, analyses of samples of several of these products revealed high levels of various bacteria, including some associated with unsanitary conditions. Some of these bacteria can cause opportunistic infections of the skin and underlying tissues. Such infections may need medical or surgical attention, and may result in permanent damage. These findings are particularly concerning because the products are promoted as antimicrobial agents that claim to treat open wounds, damaged skin, and protect against various infectious diseases. FDA is warning consumers to not use any Clarcon products and should throw these products away in household refuse.
Source: www.fda.gov

Sirolimus (marketed as Rapamune)
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.
Source: www.fda.gov

Fun Express Water-based Face Paints for Children
UPDATE - Fun Express expanded its recall of face paint items to include two additional face paint colors, 85/2338 (White face paint) and 85/2339 (Yellow face paint)
Source: www.fda.gov

Simponi (golimumab)
Risk of serious fungal infections associated with TNF-α blockers, including Simponi (golimumab). Posted 05/28/2009
Source: www.fda.gov

Recalls and Safety Alerts: Recall of Zencore Plus
Bodee LLC is recalling its supplement product called Zencore Plus after FDA laboratory analysis showed that the product contains benzamidenafil. This is a newly discovered PDE5 inhibitor that is likely to have the same pharmacologic properties as si...
Source: www.accessdata.fda.gov

Stimulant Medications used in Children with Attention-Deficit/Hyperactivity Disorder - Communication about an Ongoing Safety Review
FDA provides 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 in children. The study authors concluded that there may be an association between the use of stimulant medications and sudden death in healthy children.
Source: www.fda.gov

Antiepileptic Drugs

Source: www.fda.gov

U.S. Attorney News Release: Robert McFadden Palms Springs Attorney Sentenced for Prescription Drug Diversion

2009-06-16T23:00:00.001-07:00

U.S. Attorney News Release: Robert McFadden Palms Springs Attorney Sentenced for Prescription Drug Diversion
This press release is not being maintained on the FDA site. View the PDF version of this press announcement now.
Source: www.fda.gov

Digoxin, USP 0.125 mg, Digoxin, USP 0.25 mg (Caraco brand)

2009-06-16T16:34:00.001-07:00

Digoxin, USP 0.125 mg, Digoxin, USP 0.25 mg (Caraco brand)

Source: www.fda.gov

Medtronic Kappa Series 600/700/900, Sigma Series 100/200/300 Pacemakers
Class I recall of certain Kappa and Sigma Series pacemakers, because these devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components.
Source: www.fda.gov

November 2008
MedWatch November 2008 Drug Safety Labeling Changes
Source: www.fda.gov

January 2009

2009-06-16T13:05:00.001-07:00

January 2009
January 2009 Drug Safety Labeling Changes
Source: www.fda.gov

Medtronic Kappa Series 600/700/900, Sigma Series 100/200/300 Pacemakers
Class I recall of certain Kappa and Sigma Series pacemakers, because these devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components.
Source: www.fda.gov

Ceftriaxone (marketed as Rocephin and generics)
Ceftriaxone (marketed as Rocephin and generics)
Source: www.fda.gov

Tri-State Hospital Supply Corporation, Centurion Brand Trays and Kits
Tri-State Hospital Supply Corporation, Centurion Brand Trays and Kits
Source: www.fda.gov

Antiepileptic Drugs

Source: www.fda.gov

Recalls and Safety Alerts: Zoll AED Plus Defibrillator Recalled
The device company Zoll Medical Corporation is recalling AED Plus Defibrillators that were manufactured between May 2004 and February 2009. Some of the batteries in these devices may not work properly, and the original self-test software cannot adeq...
Source: www.accessdata.fda.gov

Advice for Patients: Help Patients Use Acetaminophen Safely
Acetaminophen toxicity is a leading cause of acute liver failure, resulting in an estimated 400 deaths in this country each year. Many of these events are happening because patients are unknowingly taking too much of the drug. Several factors co...
Source: www.accessdata.fda.gov

Leukotriene Inhibitors: Montelukast (marketed as Singulair), Zafirlukast (marketed as Accolate), and Zileuton (marketed as Zyflo and Zyflo CR)
FDA provided healthcare professionals with updated information on the original March 2008 early communication and January 2009 follow-up communcation about the ongoing safety review for the Leukotriene inhibitors, montelukast, zafirlukast and zileuton. Neuropsychiatric events have been reported in some patients taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR). FDA has requested that manufacturers include a precaution in the drug prescribing information (drug labeling). The reported neuropsychiatric events include postmarket cases of agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor.
Source: www.fda.gov

Recalls and Safety Alerts: Recalls of Digoxin and Propafenone Tablets
FDA has posted information about two cardiac drugs that were recently recalled because of variability in the size of the tablets: ? Caraco Pharmaceutical Laboratories, a manufacturer of generic pharmaceuticals, recalled some of their digoxin table...
Source: www.accessdata.fda.gov

FDA Consumer Corner: Don?t Overdo It with Acetaminophen
If you woke up with a headache this morning, you may have reached for an over-the-counter pain reliever. Millions of people do that everyday, and there's usually no problem. Over-the-counter pain relievers are effective for treating minor aches and...
Source: www.accessdata.fda.gov