Posts Tagged ‘attorney’
Multaq Heart Drug Warning from FDA
After years of close monitoring and label changes for Multaq, the Food and Drug Administration (FDA) has issued a new warning that the heart drug places some patients at an increased risk for serious cardiac events including death.
Multaq is used to treat various conditions, including patients with permanent Atrial Fibrillation (permanent AF). This is the most serious form of AF, which is an abnormal heart rhythm. The two other types are paroxysmal AF and persistent AF.
Permanent AF is a chronic condition in which sinus rhythm cannot be sustained despite treatment.
The FDA issued its Dec. 19, 2011 safety notification based on its monitoring of a 10-year study. In the communication, the FDA stated Multaq doubles the rate of cardiovascular death, stroke and heart failure in patients with permanent AF. The FDA advised healthcare professionals to:
- Not prescribe Mutlaq to patients with AF who cannot or will not be converted into normal sinus rhythm (permanent AF).
- Monitor heart rhythm by electrocardiogram at least once every three months.
- If the patient is in permanent AF, Multaq should be stopped or the patient should be cardioverted.
- Multaq is indicated to reduce hospitalization for AF in patients in sinus rhythm with a history of non-permanent AF.
- Patients prescribed Multaq should receive antithrombatic therapy.
The study the FDA acted on was called called the Permanent Atrial Fibrillation Outcome Study Using Dronedarone on Top of Standard Therapy (PALLAS). The study was stopped early in July 2011. The FDA said it will release more information as it becomes available.
Multaq Background
Dronedarone is the generic name for Multaq. It was approved by the FDA in 2009 to treat several conditions, including permanent AF. Manufactured by Sanof-Aventis, the drug has been prescribed to 500,000 people around the world.
Since 2009, Multaq has been subject to several FDA actions, including in 2010 a revised warning noting cases of worsening heart failure in some patients. In February 2011, the FDA changed the warning label to state that Multaq should be discontinued if liver damage is suspected.
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Car Accidents in Massachusetts Would Be Reduced Under Cell Phone Ban
A ban on using hand-held cell phones behind the wheel was approved by the Massachusetts Legislature’s Joint Transportation Committee this week.
On Thursday, the committee voted 8-0 to move forward the bill which advocates say will reduce car accidents, driving injuries and motor vehicle deaths. Some lawmakers did not vote on the ban, which was also discussed in 2010. That year, a new law took effect to reduce motor vehicle accidents by banning drivers under 18 from using cell phones to talk or text. All other drivers were banned from texting while driving.
Under the proposed cell phone ban, drivers would still be allowed to use hands-free cell phones with Bluetooth and other devices. Many safety advocates say hands-free cell phones are safer and this type of ban will help police better enforce the law. Right now, police say it is difficult to differentiate between drivers dialing a phone number and sending a text message.
As a result, police only wrote 1,100 tickets for texting while driving in the law’s first year, according to the Department of Transportation. This averages one for every 200 speeding tickets issued among Massachusetts’ 4.7 million drivers in the same period.
The hand-held cell phone ban will now be sent to the Massachusetts House of Representatives and Senate. The Ways and Means Committee may also consider the financial aspects of it.
If approved, Massachusetts will become the 10th state to ban any type of cell phone use while driving.
The national debate over cell phone use and car accidents has been growing stronger.
In December, the National Transportation Safety Board (NTSB) called for a nationwide ban on driver use of portable electronic devices (PEDs) while operating a motor vehicle. U.S. Secretary of Transportation Ray LaHood said he opposed including hands-free cell phones.
Click here to read more about the proposed hand-held cell phone ban in The Boston Globe.
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Actos Warning From FDA
Hundreds of thousands of diabetes patients have been re-considering their medication plans after a recent warning from the Food and Drug Administration (FDA).
On June 15, 2011, the FDA issued a safety communication reporting that use of the oral diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer.
The FDA warned that patients with active bladder cancer should not be taking pioglitazone and those with a prior history should only use it after considering the potential medical benefits against the risk for cancer recurrence.
Actos is an oral drug used to treat type II diabetes, the most common form of the illness that plagues 25.8 million Americans. Actos is manufactured by Takeda Pharmaceutical Company and co-marketed by Eli Lilly and Company. It is one of the most widely used medications on the market. Over 2 million patients filled prescriptions for it in 2010.
The communication came as the FDA placed restrictions on Avandia, another popular medication, after studies showed it increased the risk of heart attacks. Both drugs belong to the thiazolidinedione class of drugs.
The warning about Actos came as the FDA made a periodic review of an ongoing 10-year Actos study into the risk for developing bladder cancer. The study reports there may be a 40 percent greater risk for developing bladder cancer among those who take Actos for more than a year.
The FDA’s warning came a new epidemiological study out of France suggested an increased risk of bladder cancer with pioglitazone use. As a result, France has suspended use of Actos and Germany has recommended new patients not be placed on the drug.
On August 4, 2011, the FDA reported it had approved new label and medication instructions for Actos. The FDA is continuing to monitor the results of Actos cancer studies.
Patients taking Actos should contact their doctors if they experience any sign of blood in the urine or a red color in the urine or other urinary pain, as these Actos complications may be signs of bladder cancer.
Click here to read the June 15, 2011 FDA Safety Communication on Actos.
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Massachusetts Considers Ban on Cell Phone Use While Driving
Massachusetts lawmakers will consider tougher laws this week to reduce car accidents associated with cell phone use.
The Legislature’s Joint Commission on Transportation will hold a hearing Tuesday to discuss several bills. One proposed measure would only allow drivers to use hands-free cell phones. Another would ban drivers from using any type of cell phone within school zones.
Just nine states and the District of Columbia prohibit all cell phone use while driving. Massachusetts joins 34 other states and the District of Columbia in banning texting while driving for all drivers.
In December, the National Transportation Safety Board (NTSB) recommended a nationwide ban on driver use of portable electronic devices (PEDs) while operating a motor vehicle. The recommendation would ban use of all non-emergency portable electronic devices and the board wants to follow the NHTSA’s model of high-visibility enforcement and focused safety communication campaigns. U.S. Secretary of Transportation Ray LaHood is opposed to including hands-free cell phones in the ban.
Texting while driving, cell phone use and other distracted driving behavior causes a large number of car accidents across the country each year. In 2009, 16 percent of fatal motor vehicle accidents involved texting while driving and other distracted behavior. Twenty percent of car accidents resulting in injury involved distracted driving.
Massachusetts’ ban on texting while driving took effect Sept. 30, 2010. But Massachusetts, like other states, has found its ban hard to enforce. The law bans texting while driving in a moving car, as well as when behind the wheel at intersections. But critics say it is often difficult to tell whether a driver is texting or dialing a number.
Another challenge is Americans are sending more text messages than in the past. In June 2011, more than 196 billion text messages were sent in this country, a 50 percent increase from June 2009, according to CTIA, the international association for the wireless telecommunications industry.
There is research which shows any type of cell phone use engages a driver enough to create a dangerous distraction. A Carnegie Mellon University study found using a cell phone behind the wheel reduces the amount of brain activity associated with driving by 37 percent. And a study from the Virginia Tech Transportation Institute (VTTI) found that headset cell phone use is not substantially safer than hand-held use.
But when drivers text behind the wheel, they are 23 times more likely to get into a car crash than normal, the VTTI study found. Sending or receiving a text takes a driver’s eyes off from the road for an average of 4.6 seconds, which is the full-length of a football field for a car traveling at 55 mph.
Read more about Massachusetts’ proposed bans on cell phone use. Read more about the NTSB’s recommendation to ban driver use of ban portable electronic devices.
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Study: Insurance Industry Pushes for ‘Hard Market,’ Rate Increases
A new study shows the property/casualty insurance industry creates periodic crises in which insurance becomes unaffordable or unavailable. It alleges the industry is currently trying to create such a crisis now to drive up profits.
The study was undertaken by the Americans for Insurance Reform (AIR), a coalition of nearly 100 consumer and public interest groups which represent more than 50 million people. Casualty and property insurance is important because it provides coverage for accidents for individuals, businesses and governments. Rate hikes could stifle their ability to operate and prevent accident victims from obtaining fair compensation.
The Study
The study is called “Repeat Offenders: How the Insurance Industry Manufactures Crises and Harms Americans.” It presents data showing the typical insurance rate cycle for and the dramatic rise in insurers’ current surplus – the amount insurers set aside to pay estimated future claims. In 2010, the insurers had an all-time high $580 billion surplus on hand, more than double the amount in 1996.
The United States has been in a “soft market,” since 2006, during which insurance rates have been stable and dropped in states where no tort reform has been enacted.
But the AIR report states in early 2011, the insurance industry began pushing the country into a “hard market,” when rates skyrocket and become unaffordable. It says the insurance industry is attempting to use Hurricane Irene as another push into a hard market. The next step, AIR says, is the insurers will deny the cycle’s existence and hire lobbyists who call for tort reform legislation.
Call for Action
AIR is releasing its report to all 50 state insurance commissioners, the new Federal Insurance Office and key members of Congress. It calls for the following steps to protect property owners, car owners and business owners who carry insurance as well as accident victims:
Data Disclosure. AIR calls on the industry to provide meaningful insurance data to state insurance departments. They ask that officials be allowed to substantiate or refute allegations about the industry’s health for accident coverage and recent legal action.
State Repeal of Anti-Competitive Laws. AIR said states should enact stronger regulation and oversight of the industry, while also repealing anti-competitive laws.
Repeal Federal Anti-Trust Exemption. The AIR calls on Congress to repeal the federal anti-trust exemption under the McCarran-Ferguson Act and have the new Federal Insurance Office review the impact of the McCarran-Ferguson Act on consumers.
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Safe Driving Must Be a Priority During Holiday Season
Dangers increase for drivers in the period between Christmas Eve and New Year’s Day. There is more traffic on the road, drivers are often growing accustomed again to operating in the snow and many people are drinking and driving. These factors often lead to an increase in motor vehicle accidents.
The Boston motor vehicle accident lawyers at Breakstone, White & Gluck, urge you to drive safely and offer these tips:
For Drivers and Passengers
- The driver and all passengers should wear seat belts.
- Have a Designated Driver.
- Carry the phone number for a cab company. Call them beforehand to ask any questions so you are not reluctant to call them later.
- Consider taking public transportation, such as a bus or subway if available.
- Stop drinking a few hours before you plan to leave.
- Stay where you are until you are sober enough to drive.
- Travel slow. More drivers and pedestrians may be on the roads for the holidays.
- If possible, familiarize yourself with your driving route during daylight hours and before the holiday.
- Parents should limit the driving of teenagers on the holidays to avoid car accidents.
For Party Hosts
- Offer both alcoholic and non-alcoholic beverages.
- Have a cab company’s phone number ready.
- Stop serving alcohol early.
- In Massachusetts, you have a legal responsibility to make sure your guests do not leave your home under the influence. If you are hosting a party and serving alcohol, learn about the Massachusetts social host liability law.
Preventing Food Poisoning After Ground Beef Recall
A Northeastern grocery store chain has recalled various packages of ground beef after 14 people have been infected with an antibiotic-resistant strain of Salmonella.
Hannaford, of Scarborough, Maine, issued the voluntary recall Thursday, Dec. 15, for an undetermined amount of fresh ground beef that may be contaminated with Salmonella Typhimurium. This strain of Salmonella is resistant to treatment by many antibiotics, including drug classes such as beta-lactams and aminoglycosides. Seven of the 14 people who suffered food poisoning were hospitalized.
The United States Department of Agriculture (USDA) has classified the recall Class 1 with a high health risk. This classification means there is a reasonable probability that use of a product will cause serious, adverse health consequences or death.
The grocer recalled 10 different types of ground beef, ranging from 73 percent to 90 percent. Hannaford said most of the affected individuals had consumed 85 percent. The affected packages have the sell-by date of Dec. 17, 2011 or earlier. They were sold at Hannaford stores in Massachusetts, Maine, New Hampshire, New York and Vermont. Hannaford is offering consumers a full refund.
The ground beef involved in the food poisoning outbreak was sold under the brand names of Hannaford, Taste of Inspirations and Nature’s Place.
The USDA is reminding consumers to check their freezers as well as refrigerators as it continues to investigate.
The USDA said Hannaford kept limited records regarding the source of the ground beef and it is unable to determine the responsible supplier. The government agency said it will pursue rulemaking to address this problem in the future.
Salmonella is one of the most common bacterial foodborne illnesses. It can be life-threatening in individuals with weak immune systems, such as the elderly. Common symptoms include diarrhea, abdominal cramps, fever, headache, chills, nausea and vomiting. The food poisoning symptoms can start within 12 to 72 hours of food consumption and last up to seven days.
Preventing Salmonella
The USDA advises consumers to take special care in handling ground beef to avoid Salmonella.
Wash Your Hands. Consumers are urged to wash their hands with warm, soapy water for at least 20 seconds before and after handling food.
Separate. Keep raw meat, fish and poultry away from other foods that will not be cooked. Use separate cutting boards for different meats and egg products.
Cook Properly. Cook meat to safe internal temperatures. The safe internal temperature for beef and pork is 160 degrees Fahrenheit and 165 degrees for poultry. Use a food thermometer to check.
Refrigerate Immediately. Refrigerate raw meat and poultry within two hours of purchase or one hour if kept in temperatures of 90 degrees or greater.
Click here to read the full USDA notice on the Hannaford Ground Beef Recall.
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Carbon Monoxide Poisoning a Risk in Winter
With the official start of winter just days away, it is a good time to get your home and automobile ready. While some types of home heating equipment require little preparation, it is best to review yours before the snowfall.
Winter home heating carries the risk for fires and carbon monoxide poisoning, which can result from a build-up of the invisible, poisoning gas. Each year, half of all home fires occur in the three months from December to February, when home heating equipment is most used. Some 1,500 Americans die each year from carbon monoxide poisoning, while more than 10,000 suffer carbon monoxide injuries, according to Children’s Hospital Boston.
Smoke and Carbon Monoxide Detectors
Make sure your smoke detectors and carbon monoxide alarms are working and properly placed. Massachusetts requires smoke alarms be installed on every habitable level of a residence as well as in basements. Carbon monoxide detectors are also required on every habitable level of the home. Additional units are recommended outside of bedrooms and sleeping areas.
Chimneys
Get your chimney professionally cleaned once a year. Report any cracks or water leaking. Fall is the best time for a cleaning. Creosote can build up in the chimney over time, lead to blockages and produce carbon monoxide. Creosote is created when firewood does not burn correctly, when wet or soft wood is placed in the fireplace and by closing the fireplace before the wood is fully burned.
Fireplaces
Open the fireplace damper before lighting and keep it open until the ashes are cool. Never close the damper before going to bed if the ashes are still warm. An open damper may prevent the build-up of poisoning gases. Light your fire with matches. Never use gasoline, charcoal lighter or another fuel because the vapors can explode. Make sure you have no flammable materials near open flames.
Furnace Vents
Your heating system will likely have a vent on your home’s exterior. The vent will have two pipes, one of which lets air in and one of which sends air back out. Make sure both of these pipes are kept clear of snow to avoid carbon monoxide from building up in your home.
Cars
Check your snow tires and decide whether you need new ones. Check your tires’ air pressure using a gauge, which you can purchase at an auto parts store. Put an emergency kit inside your car and make sure it includes a neon-glow vest, snacks, a flash light and other essential supplies. Click for a full list of emergency safety supplies.
If you have a garage, make sure you do not warm up your car inside it with a closed door. Pull your car out and heat it in the driveway to prevent carbon monoxide poisoning.
For more information about winter safety, visit these sites:
Home Safety Tips for a Safe and Healthy Winter, Home Safety Council.
Medical Device Recall for CooperVision Contact Lenses
Consumers are advised to stop using a second type of CooperVision’s Avaira contact lenses due to a defect that may result in blurry vision and other eye injuries.
On Nov. 16, an unknown quantity of CooperVision Avaira (enfilcon A) Sphere contact lenses were recalled due to the unintended presence of a silicone oil residue.
CooperVision, a Fairport, NY-company, recalled the lenses in cooperation with the Food and Drug Administration (FDA), which states that the silicone oil residue can result in a wide range of symptoms, including eye discomfort, hazy and blurry vision and eye injuries requiring medical treatment. The FDA regulates contact lenses as a medical device.
The recalled lenses were manufactured from Feb. 1, 2011 to Aug. 24, 2011 and distributed from March 2, 2011 to Nov. 15, 2011.
The contact lenses were used to correct myopia and hyperopia and non-aphakic individuals with non-diseased eyes. The lenses may be worn by individuals who have astigmatism of 2.00 diopters or less that do not interfere with visual acuity.
Lens wearers have been instructed to stop using the lenses immediately and contact their eye care professional. They can visit the CooperVision recall website and enter the defective medical device package numbers to determine if their lenses have been recalled.
The medical device recall expanded another in August 2011 for limited lots of Avaira Toric contact lenses. CooperVision said the product defect on that line has been corrected through its quality system process.
Contact lens injuries are prevalent, due to product defect or improper use. They are most common among children and adolescents. In a study published in the July 2010 Pediatrics, FDA researchers reported 23 percent of total medical device injuries in 2004 and 2005 in the U.S. involved children and contact lenses. Children ages 11 and over were the most affected.
Common personal injuries include corneal contusions and abrasions, hemorrhage and conjunctivitis.
Click to read the FDA notice about the CooperVision recall.
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Motor Vehicle Accidents at Massachusetts Police Details
Massachusetts police officers assigned to protect public safety at roadside construction details are increasingly becoming the victims of car accidents themselves.
On Dec. 5, a Peabody police officer was struck by a 1991 Chevrolet pick-up truck while working on a Rte. 1 construction detail. He was thrown over the truck’s hood and transported to Massachusetts General Hospital with serious personal injuries. An initial police investigation found the driver was speeding, but it remains ongoing.
In recent years, negligent drivers have struck police officers on several construction details in Massachusetts and caused life-threatening personal injuries. In June 2010, state police Sgt. Douglas Weddleton was killed while working on a construction detail on Interstate 95 in Mansfield. The driver was charged with operating under the influence as well as other driving infractions.
Police officers are not the only ones vulnerable in construction site accidents. Construction workers as well as pedestrians, homeowners and others nearby are also at risk for injury, especially during night construction.
Drivers have a responsibility to operate with care in construction areas. Here are a few ways to make your travel safer:
Avoid Construction Zones If Possible. When you find a construction project on your daily commute, see if you can find an alternate route until work is complete. For projects in your local community, pay attention to your town’s government website and contact the police department’s business line if you have questions.
Identify Who Is In Charge of Traffic. Detail police officers typically direct traffic on many sites, but other work sites utilize civilian flaggers. The civilian flaggers should be dressed in fluorescent clothing and carrying traffic direction signs.
Give Other Drivers Space. Do not travel too closely behind other vehicles. It can be difficult to anticipate when another vehicle may stop short.
Slow Down. We all want to reach our destinations on time, but once you are stuck in construction traffic, it is best to take a deep breath and be as patient as possible to avoid a car accident.
Keep Your Eye on the Traffic. When there is a lot of activity going on at a construction site, there is a natural tendency to look at the crew and different machinery. But it is important to keep your eyes on the road.
Do Not Stop to Talk to the Detail Officer. Even if traffic volume is low, do not stop and ask the detail officer for help or directions. You are putting the officer at risk and confusing other drivers.
Avoid Construction Work Zones At Night. A large number of car accidents occur during night construction work because drivers are speeding, fatigued, operating under the influence or poor lighting.
Pedestrians and Cyclists. Like cars, it is also important for pedestrians and cyclists to follow the detail officer’s instructions for when to pass.
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