CDC &FDA Investigating Reports of Seizures in Young Children after Flu Vaccine

Reports of young children having seizures after receiving the flu vaccine have prompted government agencies to investigate.

The U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control (CDC) have detected an increase of febrile seizures in children younger than two years old following influenza vaccination with a vaccine called Fluzone. Data in the Vaccine Adverse Event Reporting System (VAERS), a national vaccine safety surveillance program jointly sponsored by the FDA and CDC, alerted the agencies to the potential problem.

A fever can trigger convulsions called febrile seizures in children. Symptoms of a febrile seizure may be mild or severe. Although these seizures are fairly common with about 4% of young children suffering at least one febrile seizure in their lifetime, they can be as dangerous as any seizure. Children may fall and hurt themselves, hit their head, bite their tongue or suffer lack of oxygen if their tongue obstructs the airway for example.

All children who experience a febrile seizure need immediate medical attention at the nearest hospital. The government’s Medline Plus recommends that caregivers call 911 if a child’s seizure lasts more than a few minutes or should drive the child to the emergency room if the seizure ends quickly.

There have been 36 confirmed reports of febrile seizures in children six months to two years in age within one day of vaccination with Fluzone, reports the Associated Press. In ten cases, the children required hospitalization. All 36 children recovered.

Sanofi Pasteur Inc. manufactures the Fluzone vaccine (trivalent inactivated influenza vaccine or TIV). It is the only influenza vaccine recommended for children 6-23 months old this 2010-2011 flu season.

“Further investigations are under way to assess whether there could be an association between influenza vaccination and febrile seizures, or if other factors could be involved,” the FDA said in a release.

The CDC has not changed its recommendation for influenza vaccination, recommending that all persons ages 6 months and older receive a flu vaccine each year.

“The risk of severe influenza illness is higher among young children, especially children under 2 years of age,” the FDA said. “Approximately 9 out of 10,000 children 6-23 months of age require hospitalization each season for reasons related to influenza. Flu vaccine is the best way to protect against becoming ill with the flu.”
Find out more about influenza at the U.S. Department of Health & Human Services Flu Website.

FDA Cuts Acetaminophen Dosage in Prescription Meds, Requires Black Box Warning for Liver Damage

Cases of liver failure associated with acetaminophen overdose have prompted the U.S. Food and Drug Administration (FDA) to lower the allowable amount of the drug in prescription pain relievers and require a warning about liver toxicity on the label.

Acetaminophen, also called paracetamol and APAP, is an analgesic-antipyretic drug used to relieve pain and reduce fever. It is available in an extensive number of acetaminophen products. It is available over-the-counter as a stand-alone product and combined with other medications such as cold medicines and cough syrup. It is available in higher dosages and combined with other drugs, such as opioids, in prescription medications.

In an FDA release today, the agency announced that it is asking manufacturers of prescription acetaminophen products to include no more than 325mg in each pill. This also affects combination prescription pain-reliever products such as codeine (Tylenol with Codeine), oxycodone (Percocet) and hydrocodone (Vicodin).

The new rules apply only to prescription acetaminophen products. OTC products are unaffected.

Due to continued reports of liver injury, the FDA is also requiring a black box warning, the agency’s strongest warning, added to labeling of prescription acetaminophen products to warn people of the potential risk for severe liver injury.

“FDA is taking this action to make prescription combination pain medications containing acetaminophen safer for patients to use,” said Sandra Kweder, M.D., deputy director of the Office of New Drugs in FDA’s Center for Drug Evaluation and Research (CDER). “Overdose from prescription combination products containing acetaminophen account for nearly half of all cases of acetaminophen-related liver failure in the United States; many of which result in liver transplant or death.”

Symptoms of acetaminophen overdose may include abdominal pain, appetite loss, coma, convulsions, diarrhea, irritability, jaundice (yellowing of the skin or whites of eyes), nausea, sweating, upset stomach or vomiting. These symptoms can occur 12 hours or more after ingesting the acetaminophen. Anyone who suspects they or a loved one has suffered an acetaminophen overdose must seek immediate medical attention by calling 911 or the National Poison Control Center at 1-800-222-1222.

According to a new FDA Consumer Update entitled “New Steps Aimed at Cutting Risks from Acetaminophen” released today, consumers can help reduce the risk of adverse effects from acetaminophen by

• taking opioid/acetaminophen combination products only as prescribed by a health care professional
• not taking more of an acetaminophen-containing medicine than directed
• carefully reading all labels for prescription and OTC medicines and asking the pharmacist if your prescription pain medicine contains acetaminophen
• not taking more than one product that contains acetaminophen at any given time
• not drinking alcohol when taking acetaminophen
• stopping your medicine and seeking medical help immediately if you
• experience allergic reactions such as swelling of the face, mouth, and  throat; difficulty breathing; itching; or rash
• think you have taken more acetaminophen than directed
• not taking more acetaminophen than the maximum daily dose of 4,000 milligrams (4 grams)
• not trying to calculate the total amount of acetaminophen you take each day. Instead, talk to your health care professional about all of the medications—prescription and OTC—you are taking and which include acetaminophen

“There is no immediate danger to patients who take these combination pain medications and they should continue to take them as directed by their health care provider,” said Kweder. "The risk of liver injury primarily occurs when patients take multiple products containing acetaminophen at one time and exceed the current maximum dose of 4,000 milligrams within a 24-hour period.”

Millions of Dangerous Antipsychotic Drug Prescriptions Put Patients at Risk for No Reason

Researchers in a new study have found that doctors write millions of prescriptions of antipsychotic medications for off label uses every year despite a lack of evidence of benefit for these uses and risk of serious side effects.
Physicians are prescribing the newer antipsychotic drugs known as second generation or atypical antipsychotics (AAP), developed since the 1990’s for treatment of schizophrenia, for off label uses such as bipolar disorder, depression, anxiety, attention deficit disorder, dementia and autism.

Since 1995, the number of prescriptions written for these drugs has doubled, reports Reuters.

More than half 16.7 million prescriptions written for these drugs in 2008 were for off label uses. Off label use is the prescribing of a drug for treatment of a disease or condition that the U.S. Food and Drug Administration (FDA) has not approved.

“Atypical agents were once thought to be safer and possibly more effective,” Dr. G. Caleb Alexander, lead researcher on the study, told WebMD. “And what we’ve learned over time is that they are not safer, and in the settings where there’s the best scientific evidence, they are no more effective.”

In prescribing these drugs for off label uses, physicians are placing patients at risk for serious and potentially fatal side effects without evidence the drugs even work. Patients taking typical antipsychotics can have adverse effects such as weight gain, diabetes, heart disease, hyperlipidemia and sudden death.

Atypical antipsychotics include:

• Aripiprazole (marketed as Abilify)
• Clozapine (marketed as Clozaril)
• Olanzapine (marketed as Zyprexa)
• Olanzapine/Fluoxetine (marketed as Symbyax)
• Quetiapine (marketed as Seroquel)
• Risperidone (marketed as Risperdal)
• Ziprasidone (marketed as Geodon)

The study entitled Increasing off-label use of antipsychotic medications in the United States, 1995–2008 appears in this month’s issue of Pharmacoepidemiology & Drug Safety.

“Time and time again what we see is medications that are prematurely adopted in populations that have little or nothing to gain, and this study is yet another example of how both doctors and patients may overenthusiastically or prematurely adopt medicines beyond the evidence base,” said Dr. G. Caleb Alexander to WebMD.

OSHA Warns New York Employers and Workers of Hazards of Snow Cleanup

As New York continues to recover from last week’s snowstorm and in preparation for more winter storms, the U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) warns of potential dangers of snow cleanup and urges proper worker safeguards.

“Cleaning up after a storm encompasses a variety of tasks, each of which can carry risks if performed incorrectly or without proper safeguards," said Robert Kulick, OSHA’s regional administrator in New York in an OSHA news release. "We want people to know what those risks are and what steps they can take to protect themselves against these hazards."

OSHA wants workers, employers and the public in New York to be aware of the following hazards associated with snow removal and recovery work:

• Electric shock from contact with downed power lines or the use of ungrounded electrical equipment.
• Falls from snow removal on roofs, or while working in aerial lifts or on ladders.
• Being struck or crushed by trees, branches or structures that collapse under the weight of accumulated snow.
• Carbon monoxide poisoning from gasoline-powered generators in inadequately ventilated areas or idling vehicles.
• Lacerations or amputations from unguarded or improperly operated chain saws and power tools, and improperly attempting to clear jams in snow blowers.
• Slips or falls on icy or snow-covered walking surfaces.
• Being struck by motor vehicles while working in roadways.
• Hypothermia or frostbite from exposure to cold temperatures.

Ways to prevent these on the job hazards include:

• Assuming all power lines are energized, keeping a distance and coordinating with utility companies.
• Making certain that all electrically powered equipment is grounded.
• Providing and ensuring the use of effective fall protection.
• Properly using and maintaining ladders.
• Using caution around surfaces weighed down by large amounts of snow.
• Making certain all powered equipment is properly guarded and disconnected from power sources before cleaning or performing maintenance.
• Using and wearing eye, face and body protection.
• Clearing walking surfaces of snow and ice, and using salt or its equivalent where appropriate.
• Establishing and clearly marking work zones.
• Wearing reflective clothing.
• Using engineering controls, personal protective equipment and safe work practices to reduce the length and severity of exposure to the cold.

The New York Times reported today that continuing snow removal operations have hampered trash removal in New York City. A sanitation department representative told the newspaper that 50% of normal trash collection trucks would resume operation, but 50% of the trucks would still be used for snow removal operations.

Millions of Diabetes Glucose Test Strips Recalled

Abbott Diabetes Care, a division of Abbott Laboratories, is voluntarily recalling 359 million test strips used by diabetics to monitor blood glucose levels.

According to the U.S Food and Drug Administration (FDA) release, these recalled test strips may give falsely low blood glucose results. The low readings may cause the user to take action to raise the blood glucose or fail to treat high blood glucose levels.

The following brands of test strips are affected:

Precision Xtra Blood Glucose Test Strips
Precision Xceed Pro Blood Glucose Test Strips
Precision Point of Care Blood Glucose Test Strips
Medisense Optium Blood Glucose Test Strips
Relion Ultima Blood Glucose Test Strips
Optium Blood Glucose Test Strips
OptiumEZ Blood Glucose Test Strips

Consumers should check their products to the complete list of products and lot numbers.

“Patients with diabetes should be aware of the recalled glucose test strips and take steps to prevent them from affecting their health,” said Alberto Gutierrez, Ph.D., director for the Office of In-Vitro Diagnostics in FDA’s Center for Devices and Radiological Health. “FDA and Abbott are reviewing the cause of the manufacturing defect to avoid this problem in the future.”

Consumers with these test strips should stop using them and switch to an alternate testing method or purchase unaffected test strips if available. Those people who have neither should not stop testing their blood glucose, but continue to do so with these precautions:

Precaution 1: Check the amount of time it takes for your blood glucose meter to start the “countdown” after you first apply blood to the test strip. Start timing immediately after blood first makes contact with the test strip. If your meter takes longer than five (5) seconds to start the countdown that test strip is defective and the result should not be used.

Check the time for each test strip you use because all of the strips in a package may not be affected to the same degree.

Precaution 2: If any reading from a strip appears lower than you would expect or does not seem to match the way you are feeling, you should contact your health care provider.

Pay special attention to signs and symptoms of high blood sugar (hyperglycemia) and low blood sugar (hypoglycemia).

• Symptoms of high blood sugar include excessive thirst, excessive urination, blurred vision, weakness, nausea, vomiting and abdominal pain. If you are experiencing any of these symptoms or are not feeling well, contact your health care professional immediately.
• Symptoms of low blood sugar may include trembling, excessive sweating, weakness, hunger, confusion, and headache. Some individuals may have no symptoms at all before they develop unconsciousness or seizures. It is important to treat low blood sugars promptly to avoid loss of consciousness or a seizure.  If you are unable to obtain unaffected strips, you should contact your health care provider for advice on how to treat these symptoms before they occur.

Healthcare facilities should also stop using these test strips and switch to unaffected lots or another testing method. If these alternatives are not available in the facility, the FDA says they should:

1. Verify any critical glucose test results (e.g., test results that may be used to adjust insulin therapy in vulnerable patient populations) generated on the Precision Xceed Pro Blood Glucose Test System using a central laboratory blood glucose method. Medical judgment should be applied when deciding whether to act on results prior to verification.
2. Verify any Precision Xceed Pro Blood Glucose Test System results that do not match a patient’s symptoms, or seem unexpected for the patient’s clinical status, using a central laboratory blood glucose method.
3. When using the Precision Xceed Pro Blood Glucose Test System, take precautions to reduce the chance of an erroneous reading. Limited evidence suggests that results may be accurate using strips from affected lots if fill time does not exceed five seconds. Monitor the amount of time it takes for the Precision Xceed Blood Glucose Meter to start the “countdown” after blood is first applied to the test strip. If the amount of time exceeds five (5) seconds, discard that test strip immediately because the blood glucose result may be erroneously low. In addition, if this occurs:
   i. Note the specific lot number of that test strip;
   ii. Notify Abbott Diabetes Care to report the observed problem with that lot by calling 1-877-529-7185;
   iii. Make sure to check fill time on each individual strip during use and do not assume if one strip in a package/lot appears to be unaffected, that all strips in that package/lot are unaffected.

Abbot will replace the recalled product free of charge. However, it may take up to two weeks for delivery.

Consumers can visit the Abbott Diabetes Care recall website or call customer service at 1-800-448-5234 (English) and 1-800-709-7010 (Español) for more information and instructions for returning the recalled test strips.

Toyota Pays Record Fine for Delay in Reporting Sudden Acceleration and Steering Defects

Toyota Motor Corporation has agreed to pay $32 million dollars in penalties, in addition to $16 million the company paid already earlier this year, for failing to report sudden acceleration and steering rod defects to the U.S government in a timely manner.

"Safety is our top priority and we take our responsibility to protect consumers seriously," said U.S. Transportation Secretary Ray LaHood said in a statement. "I am pleased that Toyota agreed to pay the maximum possible penalty and I expect Toyota to work cooperatively in the future to ensure consumers’ safety."

The fines are the result of two separate investigations into recent Toyota recalls. The first into sudden acceleration incidences first thought caused by entrapment of the floor mat, but later proved to be a defect in the design of the gas pedal. Toyota eventually recalled nearly five million Toyota vehicles between September 2007 and January 2010.

The second investigation involved a steering relay rod prone to breaking, resulting in a recall of nearly one million vehicles since 2005.

The investigations found that Toyota violated the National Traffic and Motor Vehicle Safety Act by failing to report safety defects to the National Highway Traffic Safety Administration (NHTSA) in the time specified. Under the federal law, car manufacturers must notify the NHTSA of any defect within five days and promptly conduct a recall.

"Automakers are required to report any safety defects to NHTSA swiftly, and we expect them to do so," said NHTSA Administrator David Strickland. "NHTSA acknowledges Toyota’s efforts to make improvements to its safety culture, and our agency will continue to hold all automakers accountable for defects to protect consumers’ safety."

Money from the penalties goes into the Treasury Department’s General Fund.

“Toyota is pleased to have resolved these legacy issues related to the timeliness of prior recalls dating back to 2005,” said Steve St. Angelo, Toyota’s Chief Quality Officer for North America. “These agreements are an opportunity to turn the page to an even more constructive relationship with NHTSA and focus even more on listening to our customers and meeting their high expectations for safe and reliable vehicles.”

Although Toyota agreed to pay the penalties, they refused to admit to any violation of the National Traffic and Motor Vehicle Safety Act.

Study Finds Gastric Acid Reduction Drugs Increase Risk of Pneumonia

A new study shows that people taking acid suppression medications such as proton pump inhibitors (PPIs) and histamine-2 receptor antagonists, called H2 blockers, may encounter an increased risk of pneumonia.

Researchers at Seoul National University reviewed medical studies published between 1985 and 2009 for a link between these drugs and pneumonia. What they found was use of proton pump inhibitors increased pneumonia risk by 27 percent, while histamine receptor antagonists increased risk by 22 percent.

“Use of a proton pump inhibitor or histamine receptor antagonist may be associated with an increased risk of both community- and hospital-acquired pneumonia,” the study said. “Given these potential adverse effects, clinicians should use caution in prescribing acid-suppressive drugs for patients at risk.”

The study appears in the latest issue of the Canadian Medical Association Journal and published early online December 20, 2010.

A few common proton pump inhibitors include Prilosec (omeprazole), Nexium (esomeprazole) and Prevacid (lansoprazole).

Pepcid (famotidine), Tagament (cimetidine) and Zantac (ranitidine) are some of the available histamine-2 receptor antagonists.

These drugs are for the treatment of gastrointestinal disorders such as Dyspepsia, Peptic Ulcer Disease, Gastroesophageal Reflux Disease (GERD), Barrett’s Esophagus and Gastritis. They work by reducing the amount of acid in the stomach.

It is because these drugs reduce stomach acid that researchers believe they increase the risk of pneumonia. The lower gastric PH allows the growth and colonization of bacteria in the upper gastrointestinal tract, which could travel to the lungs. These drugs may also effect seromucinous secretions, thereby encouraging bacterial growth in the respiratory tract.

“Our results suggest that the use of acid-suppressive drugs is associated with an increased risk of pneumonia,” said study researchers. “Given that 40%–70% of patients admitted to hospital receive acid-suppressive drugs, a considerable burden of morbidity and mortality of hospital acquired pneumonia may be attributable to this type of therapy. In the context of community acquired pneumonia, the impact of these drugs could be even more serious.”

“Given the widespread use of acid-suppressive drugs, the implications of this increased risk are serious,” they said.

In May 2010, Medscape reported proton pump inhibitor use linked to Clostridium difficile (C diff) infections.

Recalls, Citations and Fines for Johnson & Johnson This Week

The Johnson & Johnson Family of Companies, the world’s largest manufacturer of healthcare products, has had a bad week, with another recall of millions of products, citations from the FDA at its manufacturing plant and a court order to pay $52 million for deceptive trade practices.

On December 9, J&J’s McNeil Consumer Healthcare issued a Rolaids recall of 13 million packages because of consumer reports of wood and metal contamination of the product that occurred at a third party manufacturing facility.

CBS news reports that J&J received dozens of consumer complaints including vomiting, unusual smell and injury to teeth and gums from people who used the Rolaids products. Another recall in a long list of J&J recalls of over the counter medicine this year for quality control issues that have resulted in the closing of a manufacturing plant and congressional investigation.

Today, Congressman Darrell Issa, exposed the third party manufacturer, Best Sweet of Mooresville, NC, as the maker of J&J’s recalled Rolaids Soft Chews. Best Sweet also makes other confectionary type health care products. He is calling for an investigation into the matter.

"I am concerned about FDA’s knowledge of Best Sweet’s contractual relationship with Johnson & Johnson in manufacturing Rolaids and whether or not the FDA is acting appropriately to determine if there are other similar public safety concerns about products manufactured by Best Sweet," Issa wrote in a letter to the U.S. Food and Drug Administration (FDA).

Reuters reported on December 15 that a report of a FDA inspection from October to December this year of the company’s Fort Washington, PA plant that has been closed since April for manufacturing problems, revealed that J&J failed to adequately handle consumer complaints, lack of proper record keeping and failure to investigate product quality discrepancies.

According to an ABC News story today, a Pennsylvania court has ordered Johnson & Johnson to pay $52 million in damages and penalties for deceptive trade practices. The court found that J&J falsely reported drug prices to manipulate a drug pricing benchmark used by state agencies to calculate drug reimbursements, resulting in great expense to Medicaid and PACE prescription drug program for seniors.

New Govt. Crib Safety Rules will make Nearly Every Crib in Use Today Illegal

In a U.S. Consumer Product Safety Commission (CPSC) public meeting today, the agency voted unanimously to approve new regulations that set mandatory requirements for strength and durability of crib slats, mattress supports and hardware. Most cribs currently in use will not meet new crib safety regulations established by the government.

The CPSC used data from its Early Warning System (EWS), a pilot project to monitor incident reports related to cribs and other infant sleep products, in developing the new regulations. EWS data showed 3,584 incidents involving cribs. At least 35 fatalities have been attributable to structural problems with cribs and more than half of those caused by drop side failures.

Since 2007, the CPSC has issued 46 recalls affecting more than 11 million cribs.

The new regulations would take effect in June 2011, allowing time for crib manufacturers to produce products that comply. After that date, it will be illegal for not only manufacturers and retailers to sell non-conforming cribs, but also anyone selling used non-conforming cribs at venues such as garage sales and thrift stores.

Within two years, childcare facilities and public places of accommodations such as inns and hotels that use cribs must replace non-conforming cribs. The CPSC estimates as many as 935,000 cribs in these businesses fail to meet new regulations and require replacement. In explanation for allowing these facilities longer time to comply, the CPSC cited financial burden on the facilities and estimated costs of replacing these cribs at about $460 million.

Because 2.4 million cribs are sold each year in the United States, the CPSC also feared manufacturers could not manufacture enough new cribs in a year’s time to meet the increased demand.

“The nature of this rule making is unprecedented at the CPSC. As Congress mandated, we promulgating a rule containing a mandatory performance standard that also applies to users or providers of a product in an occupational setting,” said CPSC chairperson Inez M. Tenenbaum. “While manufacturers and retailers are accustomed to meeting a performance standard, many of the estimated 59,000 child care facilities and family childcare homes and an estimated 53,000 places of public accommodation that are also required by this rule to purchase new full size or non full size cribs are not accustomed to meeting such requirements and are not likely to be well aware of this rules consequences.”

One member of the CPSC singled out the efforts of Michele Witte, whose son Tyler died due to a drop side crib in 1997, who has worked tirelessly with the CPSC to make this happen.

“It’s been a long 13 years," Witte told the Associated Press. "I feel like it’s a celebratory time because things are finally being done about the issue.”

J&J Recalls Rolaids Products due to Foreign Material such as Metal and Wood

McNeil Consumer Healthcare, a Division of McNEIL-PPC, Inc. and part of the Johnson & Johnson Family of Companies, has announced a recall of Rolaids products due to reports of foreign materials, including pieces of metal and wood.

Consumers use Rolaids products for the relief of heartburn, acid indigestion, sour stomach and gas.

According to an FDA release by the U.S. Food and Drug Administration, McNeil initiated the recall after consumer complaints of foreign materials in the products. An investigation by McNeil found that introduction of the foreign materials may have occurred during the manufacturing process at a third party manufacturer.

Affected by this recall are all lots of Rolaids Extra Strength Softchews, Rolaids Extra Strength plus Gas Softchews, and Rolaids Multi-Symptom plus Anti-Gas Softchews distributed nationwide.

Consumers can determine if their Rolaids products is under recall by using this full list of recalled Rolaids.

McNeil advises that consumers should stop using these products immediately. Anyone with medical concerns regarding these products should seek medical care and report any adverse effects to the FDA’s MedWatch Program at www. Fda.gov/MedWatch/report.htm or by calling 1-800-332-1088.

Consumers may call 1-888-222-6036 with questions or for refund instructions.

Manufacturing of these recalled Rolaids products has been halted until McNeil implements corrective actions to prevent this occurring in the future.

J&J’s McNeil has recalled millions of products in the past year due to quality control issues in manufacturing.