FDA WARNINGS AND RECALLS
The U.S. Food & Drug Administration is the federal regulatory agency responsible for ensuring the safety of foods, drugs, biological products, medical devices and cosmetics. The FDA approves new drugs and medical devices, approves labeling and tracks serious adverse reactions once the drugs and devices are on the market.
The Nations Law Firm posts safety alerts and press releases on this page as a public service. We generally post alerts that are relevant to our major areas of practice, such as defective drugs and medical devices. Some of the alerts are preceded by an introductory note to summarize and to provide additional information.
If you have any comments or suggestions about this page, please contact me.
If you or someone you know has been injured by a drug or medical device, please contact our offices for a free case evaluation with one of our pharmaceutical attorneys.
FDA ALERTS
FDA DIRECTS ADHD DRUG MANUFACTURERS TO NOTIFY PATIENTS ABOUT CARDIOVASCULAR ADVERSE EVENTS AND PSYCHIATRIC ADVERSE EVENTS
February 21, 2007
The U.S. Food and Drug Administration (FDA) today directed the manufacturers of all drug products approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) to develop Patient Medication Guides to alert patients to possible cardiovascular risks and risks of adverse psychiatric symptoms associated with the medicines, and to advise them of precautions that can be taken. [more in PDF format ...]
Also see FDA Drug Information Page:
http://www.fda.gov/cder/drug/infopage/ADHD/default.htm
and FDA Safety Alert:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#ADHD
Source: U.S. Food and Drug Administration
www.fda.gov
FDA Notifies Consumers that Tomatoes in Restaurants Linked to Salmonella Typhimurium Outbreak
Current Information Suggests Outbreak is Not Ongoing
The U.S. Food and Drug Administration (FDA) today announced the results of an investigation by state and Centers for Disease Control and Prevention (CDC) investigators, which found consuming tomatoes in restaurants as the cause of illnesses in the Salmonella Typhimurium outbreak. To date, 21 states have reported 183 cases of illnesses to the CDC. [more in PDF format ...]
CDC Information on Salmonella Outbreak
http://www.cdc.gov/ncidod/dbmd/diseaseinfo/salmonellosis_2006/outbreak_notice.htm
FDA Press Release (Nov. 2, 2006)
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01503.html
ROCHE DIAGNOSTICS ANNOUNCES NATIONWIDE RECALL ON MEDICAL DEVICE USED TO DETERMINE BLOOD CLOTTING TIME
October 6, 2006
It was announced yesterday that test strips used to measure the blood clotting time of patients taking blood thinner medications can give false results. This could result in administration of the wrong treatment and could cause potentially fatal blood clots. A nationwide recall has been initiated. No injuries have been reported yet.
Full Press Release in PDF format
firmrecalls/roche10_06.pdf
FDA APPROVES THE FIRST DRUG TO TREAT IRRITABILITY ASSOCIATED WITH AUTISM, RISPERDAL
October 6, 2006
The U.S. Food and Drug Administration (FDA) today approved Risperdal (risperidone) orally disintegrating tablets, an adult antipsychotic drug, for the symptomatic treatment of irritability in autistic children and adolescents. The approval is the first for the use of a drug to treat behaviors associated with autism in children. These behaviors are included under the general heading of irritability, and include aggression, deliberate self-injury, and temper tantrums.
Full Article in PDF format:
NEWS.2006.NEW01485.Irritability.Autism.pdf
NEW RECALL OF GUIDANT DEVICES
June 27, 2006
Boston Scientific, the company that recently purchased Guidant, announced yesterday that it is recalling more heart devices. They have discovered that in certain lots, the low voltage capacitor malfunctions. A capacitor is an electrical device or circuit element used to temporarily store an electrical charge. When this component malfunctions, the heart device may not provide therapy when needed or the battery may deplete prematurely. This can be life-threatening. So far, there have been 5 confirmed reports of device malfunction. These 5 patients required surgery to replace the defective devices. No deaths have been reported so far. Boston Scientific is recommending that physicians perform a follow up exam of all patients with affected devices and that all non-implanted devices be returned to Guidant. Once again, a new group of patients are having to face the fact that the life-saving device implanted in their body may actually kill them. For some people, due to their age and/or poor health, replacement surgery is not an option and they must take their chances with the defective device.
Guidant's Dear Doctor Letter (June 23, 2006)
Guidant's Dear Patient Letter (June 23, 2006)
FDA Safety Alert (June 26, 2006)
http://www.fda.gov/oc/po/firmrecalls/bostonscientific06_06.html
DEFIBRILLATORS FAILING TO PROVIDE SHOCK WHEN NEEDED
RECALL NOTICE
On June 15, 2006, MRL, Inc. announced a voluntary world-wide recall of its external defibrillators. The recall was initiated after the company received 30 complaints of device failure. An automated external defibrillator (AED) is a portable device used to restore normal heart rhythm when a person suffers from cardiac arrest. An AED is applied outside the body by placing adhesive electrode pads on the chest. It automatically analyzes the patient's heart rhythm to determine whether or not shock is needed. If necessary, an AED delivers an electric shock that stuns the heart momentarily giving it a chance to start beating normally again. AED's can be found in public places and doctors sometimes recommend that cardiac patients have defibrillators at home.
In the recalled AED's, they have discovered a faulty electrical connection that may cause a delay in analyzing the patient's heart rhythm and a delay or complete failure to deliver the shock when needed. AED's are life-saving devices. When a person is suffering from cardiac arrest, they only have a few minutes to be saved. A malfunctioning AED could easily cost someone their life.
Read the FDA press release about the MCL, Inc. defibrillator recall:
http://www.fda.gov/oc/po/firmrecalls/mrl06_06.html
Learn more about automatic external defibrillators:
http://www.fda.gov/hearthealth/treatments/medicaldevices/aed.html
BLOOD PRESSURE MEDICATIONS ASSOCIATED WITH MAJOR BIRTH DEFECTS
Ace inhibitors are a form of blood pressure medication. Some of the more common ace inhibitors include Lotensin, Capotin, Vasotec, Monopril, Altace, Accupril and Mavik. A study published yesterday in the New England Journal of Medicine showed that infants who were exposed to these drugs in the first trimester of pregnancy had an increased risk of being born with major malformations of the cardiovascular system and central nervous system. The authors of the study concluded that use of ace inhibitors during the first trimester "cannot be considered safe and should be avoided". The FDA has issued safety alerts but does not plan to change the warning labels on the medications at this time.
FDA ALERT
June 8, 2006
On June 8, 2006, the New England Journal of Medicine published an article reporting that infants whose mothers had taken an angiotensin-converting enzyme inhibitor (ACE inhibitors) drug during the first trimester of pregnancy had an increased risk of major congenital malformations, compared with infants who had not undergone first trimester exposure to ACE inhibitor drugs. [more ...]
Source:
FDA website
www.fda.gov
Click here to view the abstract of the New England Journal of Medicine article.
Major Congenital Malformations after First-Trimester Exposure to ACE Inhibitors
Source:
The New England Journal of Medicine
http://content.nejm.org
June 7, 2006
Posted May 15, 2006
Note: Bausch & Lomb has decided to permanently remove their contact lens cleaning solution from the market. In April of 2006, the company issued a world-wide recall of their ReNu wtih MoistureLoc contact lens cleaning solution after receiving reports of Fusarium keratitis associated with use of the product. The Center for Disease Control and Prevention (CDC) is continuing their investigation into Fusarium keratitis outbreaks accross the country. They have 102 confirmed cases, 12 possible cases and 81 cases still being investigated from 31 U.S. states. Click here for the latest CDC update.
FDA STATEMENT
On Thursday, May 11, 2006 a team from Bausch & Lomb met with Food & Drug Administration (FDA) officials to share information resulting from the company's internal investigation into cases of Fusarium keratitis associated with ReNu with MoistureLoc.
Bausch & Lomb has proposed that unique characteristics of the formulation of the ReNu with MoistureLoc product in certain unusual circumstances can increase the risk of Fusarium infection.
Based on this scientific and epidemiological data suggesting that ReNu with MoistureLoc may increase susceptibility to Fusarium , Bausch & Lomb has decided to permanently remove the ReNu with MoistureLoc product worldwide. FDA supports this decision. [more...]
Source: FDA website
http://www.fda.gov
Note:
The Colleague Infusion Pumps manufactured by Baxter Healthcare were first recalled last summer. Baxter has been working to correct the problems. Today the FDA issued a Preliminary Public Health Notification about the continued dangers of using these pumps. Infusion pumps inject fluids, medications or nutrients directly into a patient's circulatory system at selected intervals. Most fluids are infused intravenously (directly into the vein), but subcutaneous, arterial or epidural infusions are occasionally used. The infusion pump is set up to inject the specified amount of fluid at pre-selected intervals or it can be patient-controlled. The infusion pump has many more options than the well-known drip IV because you control the amount and timing of each injection, whereas a drip IV just drips at a regular interval until the bag is empty. Clearly, a mal-functioning infusion pump can have life-threatening consequences, i.e. overdosing or undermedicating. On July 21, 2005, the FDA announced a world-wide Class I recall of all models of the Colleague Infusion Pumps. At that time, there were six serious injuries and three deaths reported as a result of the pumps shutting down during use. In September and December of 2005, the FDA expanded the recalls and warned of the discovery of additional problems with the pumps. Baxter Healthcare has issued proposed corrections and replacement units for the defective pumps. Today the FDA issued a Preliminary Public Health Notification with further warnings about using the Colleague Infusion Pumps. The FDA has not yet approved Baxter's corrections or replacement units and cannot assure their safety. See the FDA notification below.
FDA Preliminary Public Health Notification*: Important Safety Recommendations for Baxter’s COLLEAGUE Infusion Pumps
April 28, 2006
Dear Health Care Provider or Biomedical Engineer:
The FDA is recommending that you take important safety steps, in addition to those recommended by the manufacturer, when using the COLLEAGUE Volumetric Infusion Pump manufactured by Baxter Healthcare Corporation.
The COLLEAGUE pump has exhibited a variety of problems, including under-infusion, battery failures, false alarms and failure to alarm. Over the past year, Baxter has issued four urgent safety notices and recalls for COLLEAGUE infusion pumps. These notices, which are listed below, identify the specific problems and steps that you should take to address them. [more...]
Source: U.S. Food & Drug Administration
http://www.fda.gov
Safety Alert Warning - FDA:
Today the FDA issued a Safety Alert warning healthcare providers and patients not to use promethazine HCI in children less than two years of age. Promethazine is an antihistamine, antiemetic and sedative approved by the FDA in 1951. It is commonly used to treat colds, allergies and vomiting in children. Since the 1950's, serious, often life-threatening adverse events have been reported in children using promethazine. The reports include respiratory depression, oversedation, agitation, dystonic reactions, seizures and hallucinations. In late 2004, a black box warning was added to the promethazine label to reflect a contraindication in children less than two years old and to warn of the risks involved with older pediatric patients. The fact that the FDA is issuing a safety alert now shows that promethazine is still being used in children under two and it is causing injuries and deaths. Pharmaceutical companies have an obligation to provide adequate warnings of the risks involved in using their drugs. Some drugs are considered unreasonably dangerous and must be recalled from the market in order to protect the public. Our firm will be monitoring this situation and will post new updates as information becomes available.
FDA ALERT
FDA ALERT [April 2006]: Medications containing promethazine hydrochloride (HCl) should not be used for children less than two years of age because of the potential for fatal respiratory depression. This includes promethazine HCl in any form: syrups, suppositories, tablets, or injectables. Cases of respiratory depression including fatalities have been reported with use of promethazine HCl in children less than two years of age. Caution should also be exercised when administering promethazine HCl in any form to pediatric patients two years of age and older. The labeling on all products, brand name and generic, has been changed to reflect these strengthened warnings. One manufacturer of suppositories and tablets has notified healthcare professionals of the changed label. The FDA is issuing this safety alert to make sure that healthcare professionals, other caregivers, and patients realize that the warnings apply to promethazine HCl syrups as well. [more...]
Source: U.S. Food & Drug Administration
http://www.fda.gov
Posted April 25, 2006
DISETRONIC MEDICAL SYSTEMS, INC. ANNOUNCES A VOLUNTARY NATIONWIDE RECALL OF ALL ACCU-CHEK™ ULTRAFLEX INFUSION SETS
Posted April 3, 2006
Contact:
Joel Reuter
317-521-7431
FOR IMMEDIATE RELEASE -- Fishers, IN -- April 3, 2006 -- Disetronic Medical Systems, Inc, (Disetronic) of Fishers, Ind. announced today a voluntary nationwide recall of all ACCU-CHEK™ Ultraflex Infusion Sets, because of a potential that tubing could fully or partially separate at the luer lock-tubing connection. In the event that a full or partial separation occurs, it is possible that insulin could leak from the infusion set tubing causing an interruption of insulin delivery, which can cause hyperglycemia.
The symptoms of hyperglycemia include nausea/vomiting, blurred vision, excessive thirst or hunger, frequent urination, fatigue/tiredness/sleepiness, headache, fruity acetone breath and abdominal pain. Patients experiencing these symptoms are advised to check their blood glucose to ensure that the blood glucose level is within an acceptable range as defined by the patient's healthcare team and follow the medical advice given by the healthcare professional or contact their physician. [more...]
Source:
U.S.Food & Drug Administration
www.fda.gov
ADHD BLACK BOX WARNING ON PSYCHIATRIC/CARDIAC EVENTS IS UNNECESSARY, PEDIATRIC COMMITTEE SAYS
March 23, 2006
Potential episodes of psychosis, aggression and cardiac events with attention deficit drugs in children do not warrant a black box warning, FDA's Pediatric Advisory Committee said March 22.
In February, FDA's Drug Safety & Risk Management Advisory Committee suggested that a black box warning be added to ADHD drugs for cardiovascular risks in adults.
The committee felt that the cardiovascular events were not of a similar risk in ADHD children as adults, except for those with cardiovascular abnormalities. The committee also declined to endorse a black box for psychiatric events, including aggression, and suicidality.
Source:
U.S. Food & Drug Administration
http://www.fdaadvisorycommittee.com
H-E-B ISSUES BABY FOOD RECALL
March 15, 2006
FOR IMMEDIATE RELEASE -- San Antonio, TX -- March 15, 2006 -- H-E-B announced today that it has issued a recall of its entire H-E-B Baby Food and Mom's Organic Choice product lines. As of this afternoon, all H-E-B baby food and Mom's Organic Choice product lines was removed from shelves due to a few customer reports of pieces of glass being found inside the baby food jars of H-E-B peas, carrots and applesauce.
According to Winell Herron, H-E-B Group Vice-President of Public Affairs, there have been no reports of injuries associated with the incidents, however the company is taking the issue very seriously and taking all necessary precautions.
"Though these reports have been isolated to just a few products in the H-E-B baby food and Mom's Organic Choice line, as a company, we are committed to absolute and complete food safety. As a result of that commitment, coupled with the fact that we are dealing with a children's product, we have made the decision to pull all of our H-E-B baby food and Mom's Organic Choice products from our shelves," said Winell Herron, H-E-B Group Vice-President of Public Affairs.
Herron went on to say that H-E-B will launch a full investigation into the incidents and work closely with its H-E-B baby food suppliers to ensure all safety measures are being taken when manufacturing the product.
H-E-B is encouraging anyone who has any H-E-B baby food and/or Mom's Organic Choice product in their pantries to remove it and take it to their nearest H-E-B store for a full refund.
Customers with any questions or concerns can call H-E-B customer service at 1-800-432-3113.
H-E-B PRESS RELEASE
Source:
http://www.fda.gov/oc/po/firmrecalls/heb03_06.html
FDA ALERT
Gatifloxin (marketed as Tequin) Information
March 7, 2006
On February 15, 2006, Bristol Myers Squibb (BMS) issued a Dear Healthcare Professional (DHCP) letter to U.S. physicians announcing an update to the U.S. labeling for Tequin (gatifloxacin) Tablets and Injection. The update includes labeling changes to strengthen the existing WARNING on hypoglycemia and hyperglycemia and adds a CONTRAINDICATION for use in diabetic patients. Serious reports of hypoglycemia and hyperglycemia continue to occur in patients both with and without a history of diabetes. These events can occur throughout the course of Tequin therapy. The labeling has also been updated to identify other risk factors for developing hypoglycemia and hyperglycemia, (i.e., older age, abnormal kidney function, and other blood glucose altering medications being used at the same time) while taking Tequin (gatifloxacin), and includes a recommendation for close medical monitoring.
FDA will review all available data and determine whether additional changes to labeling, or other regulatory actions, are warranted.
This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.
This information reflects FDA's preliminary analysis of data concerning this drug. FDA is considering, but has not reached a final conclusion about, this information. FDA intends to update this sheet when additional information or analyses become available.
Source:
http://www.fda.gov/cder/drug/infopage/gatifloxacin/default.htm
FDA Press Release
Classic Delight Initiates Nationwide Recall of Egg Salad on Vienna Bread Sandwiches Because of a Possible Health Risk
March 6, 2006
FOR IMMEDIATE RELEASE -- St. Marys, OH -- March 6, 2006 -- Classic Delight, Inc. of St. Marys, Ohio is recalling "Egg Salad on Vienna Bread, Pilot good to go" sandwiches because the product has the potential to be contaminated with Listeria monocytogenes, an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headaches, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women. No illnesses resulting from the consumption of this product have been reported to date. [more...]
FDA NEWS
FDA Approves Emsam (Selegiline) as First Drug Patch for Depression
Lowest Dose can be used without Restrictions Required of MAOI Class of Depression Drugs
February 28, 2006
The Food and Drug Administration today approved Emsam (selegiline), the first skin (transdermal) patch for use in treating major depression. The once a day patch works by delivering selegiline, a monoamine oxidase inhibitor or MAOI, through the skin and into the bloodstream. [more...]
Posted on FDA Advisory Committee website
http://www.fdaadvisorycommittee.com
FDA PRESS RELEASE
FDA Announces New Prescription Drug Information Format to Improve Patient Safety
January 18, 2006
The U.S. Food and Drug Administration (FDA) today unveiled a major revision to the format of prescription drug information, commonly called the package insert, to give healthcare professionals clear and concise prescribing information. In an effort to manage the risks of medication use and reduce medical errors, the newly designed package insert will provide the most up-to-date information in an easy-to-read format that draws physician and patient attention to the most important pieces of drug information before a product is prescribed. The new format will also make prescription information more accessible for use with electronic prescribing tools and other electronic information resources. [more...]
FDA Alert [9/2005]: Suicidal Thinking in Children and Adolescents
The Food and Drug Administration (FDA) directed Eli Lilly (Lilly) to revise the labeling for Strattera to include a boxed warning and additional warning statements regarding an increased risk of suicidal thinking in children and adolescents being treated with this drug. [more ...]
Source:
U.S. Food & Drug Administration
www.fda.gov
Posted September 2005
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