Generic Lipitor Hits the Market - Is it the Same Medicine?

Pfizer’s cholesterol-lowering Lipitor now faces competition from generic versions of the drug for the first time since it’s U.S. patent expired Wednesday. The pharmaceutical company’s blockbuster hit the market in 1997 and generated sales of $10.7 billion last year alone. Rivalry comes from India’s largest drug manufacturer, Ranbaxy Laboratories Ltd. The new generic drug will be labeled “atorvastatin calcium,” which is the chemical name of Lipitor.


Is there a clinical difference between Lipitor and its generics? Director of Consumer Reports Health Ratings Center John Santa says that there will not be a meaningful difference. In order to gain FDA approval, generics must contain the same active ingredients and be as safe and effective.


However, a good number of patients have experienced difficulties when a generic equivalent was introduced. According to the FDA, drug approval is based on three factors:

1. Pharmaceutical Equivalency – Does the generic contain the same chemically active ingredients and are they identical is dosage form and strength?These criteria may be affected by many things such as: 
• Variations in inactive ingredients
• Manufacturing facilities in different parts of the world
• In oral drugs, capsule content is allowed to vary 7% over or 7% under the stated content, resulting in a possible 14% variation.
• Age of the patient
2. Bioavailibility – Based on the amount of drug absorbed and the speed of absorption. Some generics may be absorbed faster or slower than the brand name drug.
3. Bioequivalence – Are the generic and the brand-name drug functionally equivalent? In order to approve any generic drug, the FDA requires that the generic be effective within a 20% range of the original patented drug. This means that it could be 20% more effective OR 20% less effective than its brand-name counterpart. For prescriptions such as anti-depressants or hormone-based medications, which require precise dosages, this could be the difference as to whether the generic is effective or ineffective for you.

Another risk associated with generic drugs is that a patient could receive a different generic each time they fill their prescription. Also, the difference in inactive ingredients found in generics may react differently with medications you are already taking.

So what should you do if you have the choice between a brand-name and a generic?

• Talk to your doctor. Ask if the generic counterpart is known to be as effective and if there are side effects. Be sure your doctor know all of your current medications and dosages. 
• Listen to your own body. Have you noticed any changes after switching to a generic? How do you feel? Are you experiencing any adverse reactions? These can all be red flags as to whether that generic is the best choice for you.

By far, generic drugs are not bad things, and often they save us a lot of money, but they are not always as good as the “original.”

Good Juice, Bad Juice

Did you hear the breaking news yesterday about dangerous levels of arsenic being found in our kids’ apple and grape juices? Well, it’s serious business.

Consumer advocates are saying the FDA is allowing too much inorganic arsenic into apple and grape juice and that the government is failing to enforce protective standards. The FDA allows 23 parts per billion as a benchmark to determine whether apple juice is contaminated. Consumers Union, publisher of Consumer Reports, is calling for this level to be reduced to as low as 3 parts per billion. The EPA’s level for drinking water, set at 10 parts per billion, is much safer than the juice our little ones are currently drinking!

Consumer Reports, a product-testing organization, analyzed 88 samples of juice and found that 9 of those samples had arsenic levels exceeding federal limits set for drinking water. Of those brands sampled were:

• Apple & Eve
• Great Value
• Mott’s
• Walgreens
• Welch’s

At least one of each of these brands had a sample that exceeded the 10 parts per billion threshold. Consumer Reports also reported that 25% of all juice samples had lead levels at or above the federal limit for bottled water. Grape juice samples were actually higher than apple juice.

What are the dangers of arsenic? Well, organic arsenic is not harmful to the body and will quickly pass through. It’s the inorganic arsenic that’s the problem. Inorganic arsenic is known to cause bladder, lung, and skin cancer as well as increase the risk of heart disease and type 2 diabetes. Some reports have even suggested that arsenic exposure can affect brain development in children!

So what should you do if you have a juice-drinking toddler? All of the experts, including the government and consumer advocates, agree that the concern is over drinking large amounts of juice over a long period of time. Drinking small amounts of apple juice is not harmful. However, options to consider are:

• Limit juice intake of children under 6 to 6 ounces a day.
• Limit juice intake of children over 6 to no more than 8-12 ounces a day
• Infants under 6 months should not consume juice at all
• Dilute your child’s juice with water first
• Diversify brands of juice purchased in case one brand tends to have higher arsenic levels

Georgia Hospitals Ranked

Ever wondered how your community ranks for its health care in terms of patient satisfaction? Within the state of Georgia, the Rome area (Northwest Georgia) ranks the highest in the state. Rome area hospitals ranked 12th nationally among 295 regional hospital markets across the United States for patient satisfaction. Not bad for Romans!


The study was published by Kaiser Health News and several other communities in Georgia made into the top 295 rankings for the United States:

91. Columbus

145. Augusta
167. Atlanta
176. Macon
188. Savannah
243. Albany

But does this study really mean anything? Well, according to Kasier Health News, Medicare will begin taking patient satisfaction scores into account when determining what a hospital’s reimbursement amounts will be. The hospitals with the best patient scores will be paid (or reimbursed) more on Medicare bills.

According to the Georgia Hospital Association, this isn’t new to Atlanta area hospitals. They have been using patient-satisfaction scores to compete with each other for years. But connecting the scores to federal payments will be a whole new ball game.
 
All in all, this new system should provide incentives for hospitals to do more to improve patient services. This may result in improvements to quality of employees, amenities, communication between doctors and nurses and their patients, pain management, cleanliness of the facilities, quietness and night, and discharge instructions and planning.

Congratulations to the Rome area physicians and hospitals on a job well done!

How "Hip" Are You?

Do you or a loved one have a Wright CONSERVE or a Wright PROFEMUR Total Hip System or know someone with a Wright PROFEMUR Z? Have you experienced any adverse reactions or symptoms since receiving your implant? Then you need some information that may help you save pain, time and money in the near future.

The Wright Conserve Total Acetabular System is a 3 component, metal-on-metal, device consisting of a femoral stem, a femoral head, and the acetabular cup. Implantation of this system began in 2004 and is very similar in design to the recalled DePuy ASR metal-on-metal hip implant device.

Due to the shallow nature of the Wright CONSERVE cup, constant heat and friction between the metal components may result in excess metal debris being released into the surrounding soft tissue and bloodstream. This metal toxicity is more specifically caused by increased levels of cobalt and chromium ions, which may lead to a multitude of health problems or permanent injury.

The three main problems associated with Wright implants are:

1. loosening of the device

2. the development of metalosis, and

3. the inhibition of bone grafting.

Common symptoms and difficulties associated with component loosening include:

1. difficulty standing or walking

2. difficulty rising from seated positions

3. unexplained hip, thigh, and groin pain

4. popping or crunching noises

5. tissue inflammation or infection, and

6. bone fractures.

Patients are also experiencing Aseptic Lymphocytic Vasculitis Associated Lesions (“ALVAL”) from elevated levels of chromium and cobalt in the bloodstream. Some of the symptoms of this metalosis include swelling in and around the implant site, dislocation, nerve palsy, cysts, necrosis, cardiac problems, intense pain at site of hip replacement, groin or thigh, and a noticeable mass or rash. Long-term injuries from metalosis can occur as well. Lastly, excess metal ions in the bloodstream may result in stunted bone growth.

What should you do if you or someone you know has received a defective joint replacement system? The first thing that you should do is to continue your treatment regimen and consult your doctor about your concerns immediately.

It is very important that you AVOID signing a release form of any kind from your physician, surgeon or Wright. This form would enable Wright to have complete access to all your medical records and give them possession of the defective implant upon removal. Also, it may be helpful to keep a journal detailing your symptoms. This may be helpful to both your physician as well as your legal representative if you believe you may have a claim against Wright. And remember not to release any of your confidential medical information to anyone representing Wright without first contacting an experienced team of hip replacement attorneys.

For more information or to discuss whether you have a potential case, please feel free to call the injury lawyers at the Studstill Firm, LLP at (478) 745-9002.

Even though the Wright Profemur Hip System has not yet been recalled, you may still be entitled to significant compensation if you have been experiencing hip replacement problems. The injury attorneys at the Studstill Firm, LLP have years of experience in defective product cases, including medical devices that claim to be safe. We will fight for your rights against the designer, manufacturer, and seller of defective hip implants such as the Wright Profemur Hip System.

Call our office today at (478) 745-9002 to discuss your situation. Your initial consultation is free of charge – and confidential – and you pay nothing unless we win your case.

Are Bad Boy Buggies Living Up To Their "Bad" Name?

The manufacturer of Bad Boy Buggies, an off-road utility vehicle, has recently recalled 3,200 Bad Boy Buggies due to a defective steering arm assembly. Essentially, the recall was issued because the vehicles contain a defective steering arm assembly which could break during normal operation and leave the vehicle uncontrollable and result in crashes with injuries.

According to the manufacturer, there have been 15 reported incidents of the steering arm breaking in these vehicles causing the driver to lose control. The following Bad Boy Buggy Models (pictured below) are involved in the recall: (1) Bad Boy LT; (2) Classic; (3) XT; (4) XTO, and (5) XT Safari. 

These models were manufactured at BB Buggies in Augusta, Georgia and Bad Boy Enterprises, LLC in Natchez, Mississippi and were sold nationwide.

This recall follows on the heels of an earlier recall of 9,300 Bad Boy Classic Buggies which contained defective accelerator petals that caused sudden and unintended acceleration. That recall involved Bad Boy Classic Buggies which were manufactured by Bad Boy Enterprises, LLC between 2003 and May 2010.

Owners of these vehicles should stop using them immediately and contact Bad Boy Buggies at (855) -738 3711 or visit its website at http://www.badboybuggies.com/.

Diabetes Drug Linked to Bladder Cancer

Actos is a drug that is manufactured by Takeda, a Japanese pharmaceutical company, and prescribed to treat type-2 diabetes. In September 2010, the FDA announced that Actos may be linked to urinary bladder cancer. This announcement was made by the FDA after a ten year epidemiological study revealed an increase in bladder cancer in patients taking Actos. After this study was published, Actos was removed from the market in Germany and France, but not in the U.S.

The FDA has since required Actos’ warning label to be revised to include the risk of urinary bladder cancer as a possible side effect.

Actos is currently marketed as a stand-alone drug or in combination form as Actoplus Met, Acoplus Met XR, and Duetact. Actos was designed to increase the cell’s sensitivity to insulin. It was widely prescribed in the United States as the “preferred medicine” for treating type-2 diabetes.

Unbelievably, there is strong evidence that suggests that Takeda, the Japanese manufacturer of Actos, knew of the increased risks of bladder cancer posed by Actos as early as the pre-clinical carcinogenicity studies, which showed an increase in drug-induced tumors in the bladders of rats. Despite these studies, which showed an increased risk of tumors, Takeda marketed and sold Actos without any warning whatsoever of an increased risk of bladder cancer.

In fact, it was only after the FDA required the revision to Actos’ warning label that doctors and patients were made aware of the risk of bladder cancer. Unfortunately, millions of Americans took Actos and were exposed to an increased risk of bladder cancer.

If you or a family member took Actos and have been diagnosed with bladder cancer, our Georgia injury lawyers would like to talk with you about your potential claims against Takeda.

Drug Maker Issues Correction After False Advertising

Following a meeting and warning of the FDA advisory panel, the makers of certain bisphosphonates have begun an ad campaign to correct their FALSE ADVERTISING. Genentech/Roche Group has started running an ad (which you may have seen in the Parade magazine included in your local newspaper) that begins with the following:

"AN IMPORTANT CORRECTION FROM BONIVA FOR WOMEN WITH POSTMENOPAUSAL OSTEOPOROSIS
You may have seen an ad about BONIVA for the treatment and prevention of postmenopausal osteoporosis that may have given you the wrong impression. Our ads stated that ‘After one year on BONIVA, 9 out of 10 women stopped and reversed their bone loss.’ The FDA has found that there is not enough evidence to support this statement and wants us to clear up any misunderstanding you may have had about these ads and make sure you have the correct information about BONIVA.”
And here's the part where they finally tell the truth that they had been hiding: "BONIVA has not been proven to stop and reverse bone loss in 9 out of 10 women and is not a cure for postmenopausal osteoporosis.”

It is unfortunate that pharmaceutical companies are able to propogate these sorts of half-truths and lies to the public to try to sell more of their product than their competitors. It is even more unfortunate that the product they are pushing has actually been causing harm to many women. There have been numerous reports of thigh bone fractures and necrosis (decaying) of major joints like hips and jaw bones. For more information on the problems and injuries caused by BONIVA and other bisphosphonates, please see our earlier post entitled Building Bones or Breaking Bones?.

If you would like for us to email you a copy of the ad, along with a copy of the updated medication guide, please feel free to contact us directly.

The lawyers at the Studstill Firm are interested in speaking with individuals who may have taken medications that have caused them to have injuries. While the idea of being involved in a lawsuit may not be appealing to many individuals, a consultation with us about your options is free and confidential. Please feel free to contact one of our products liability injury lawyers in Georgia by calling (478) 745-9002 (in Macon, Georgia) or (229) 686-3500 (in Nashville or Tifton, Georgia) or (229) 244-2908 (in Valdosta, Georgia) to set up an appointment or to discuss your potential case with someone over the phone.

Injury Prevention Goes High Tech

I just read about a cool new app for iPhone and Android phone users that take disaster and emergency preparedness to a new high-tech level. The Georgia Department of Public Health and the Georgia Emergency Management Agency (GEMA) launched the Ready Georgia app recently. It’s a free interactive app that provides real-time information emergency information on hazards, weather alerts and disease outbreaks in Georgia. During an emergency, the app will deliver alerts and information on what to do during different types of disasters.

During non-emergency times, the Ready Georgia app helps Georgians plan for a range of emergencies. The app can be used to create personal checklists of emergency supplies, make disaster plans for their families, and check flood-risk levels and historic tornado data for their area. The key is to take action to be prepared for different types of disasters long before they happen.

The Ready Georgia app also has “geo-location” technology to determine the app user’s location, and then show the flow of traffic on evacuation maps and the location of nearby shelters. It also provides the locations of FEMA’s disaster recovery centers.

The key to surviving a major disaster in Georgia may very well be the steps you take to be prepared well in advance. This app seems to be a great tool to help you get prepared and then stay informed when the unthinkable happens.

To download the app or for more information, check out the Ready Georgia website.

Birth Contol Pill Recalled by Manufacturer

A major pharmaceutical company, Qualitest Pharmaceuticals, has just issued a recall of multiple lots of oral contraceptives. The recall is the result of a major packaging error. The tablets within the birth control package are out of order so that women will not be effectively protected against contraception. Specifically, the “sugar pills” included in the packet during the week that a woman is to have her cycle may be dispensed during the week that a woman may ovulate and become pregnant. This results in a high risk of becoming pregnant and may be the equivalent of not using birth control at all.

The following products are subject to the recall:
• Cyclafem™ 7/7/7
• Cyclafem™ 1/35
• Emoquette™
• Gildess® FE 1.5/30
• Gildess® FE 1/20
• Orsythia™
• Previfem ®
• Tri-Previfem®
Anyone taking these birth control products should begin using another form of contraception immediately and contact their health care provider or pharmacist. Pharmacies have been directed to contact consumers who may have received affected product but this may take some time to do.
The affected lot numbers can be found at the Qualitest Pharmaceuticals web site.

Medical Information on Georgia Drivers Licenses

Georgia drivers with certain medical conditions can now choose to have their conditions listed on the back of their Georgia driver's license or state identification card. The Georgia Department of Driver Services now has 16 conditions which may be included on the license, including pacemaker, autism, hearing loss, seizures, brain injury, and diabetes. Other conditions could be added in the future according to Susan Sports, a spokeswoman with the state agency.


Having the information on a driver's license could aid emergency responders in knowing how to best treat people who may be unconscious, advocates say. The information could help law officers determine whether a medical condition, such as a brain injury, may be affecting treatment or behavior.


The information may also be especially helpful for people with hearing loss who are unable to hear instructions or communicate well with law enforcement.


The decision to give motorists the option of having the information was prompted by a state Senate bill signed into law last year that allows people with post-traumatic stress disorder to put a notation on their licenses. "It could make the difference in saving a life," said state Sen. Ronald Ramsey, D-Decatur.


Participation in the new program is voluntary. Forms are available online that need to be filled out by the applicant and submitted at the time of obtaining a license or ID card. For some (non-obvious) conditions, verification from a doctor will also be required.

Building Bones or Breaking Bones?

Dangers of Osteoporosis Medications
An advisory panel for the FDA is set to meet this Friday to determine the future for osteoporosis medications. Osteoporosis is a condition in which the bones become thin and weak and break easily. The FDA panel is expected to make recommendations on whether use of osteoporosis frugs should be limited to a few years or whether some women should temporarily stop treatment, a concept known as a drug holiday. It was originally thought that osteoporosis medications could be used indefinitely. However, problems began surfacing in the late 1990's that changed the outlook.

Fosamax (an oral bisphosphonate) is probably the most common medication that has been prescribed to both men and women as a treatment and preventative for osteoporosis. It has also been prescribed to women and men who are taking corticosteroid medications. Most commonly, women take Fosamax during and after menopause.

Fosamax is not the only drug in this class of oral bisphosphonates. The other more common names are Reclast, Boniva, Actonel, Zometa, Aredia, Didronel and Skelid.  However, in the 16 years since the FDA approved the first oral bisphosphonate, which was Fosamax made by Merck & Co., they have all had numerous problems.

Jaw Bone Danger
The Journal of Oral and Maxillofacial Surgeons reported a link between bisphosphonates and a serious bone disease called Osteonecrosis of the Jaw (ONJ). ONJ is a disfiguring and disabling condition of the jaw bone that causes infection and rotting of the jaw bone. Typical presentation of Osteonecrosis is pain, soft-tissue swelling and infection, loosening of teeth, drainage, and exposed bone. Symptoms may occur spontaneously, or at the site of previous tooth extraction. Some cases require the complete removal of the affected jaw bone.
The FDA and the manufacturer of Fosamax issued a warning to health care professionals on September 24, 2004 of the danger of ONJ associated with the use of this drug.


Thigh Bone Danger
Unfortunately, Fosamax and other bisphosphonates (which include Reclast, Boniva, Actonel, Zometa, Aredia, Didronel and Skelid) did not only cause problems with jaw bones. In October of 2010, all manufacturers of bisphosphonates were required by the FDA to include in the warning section of their label a description of low-energy femoral shaft and subtrochanteric fractures that are associated with the use of drugs in this class.

The FDA reviewed data from an ongoing safety review of oral bisphosphonates and determined that use of the drug was related to an increased risk of thigh fractures. More specifically, it was determined that low-energy femoral shaft and subtrochanteric fractures were occurring in patients who were taking bisphosphonates like Fosamax. This means that people were suffering broken thigh bones without trauma to the leg – literally just walking down the street and all of a sudden the thigh bone would snap and break.


Other Dangers
Bisphosphonate users are also at increased risk of developing stomach ulcers if they are taking this medication with anti-inflammatory drugs. The FDA has also examined a link between these bone building drugs and irregular heartbeats. Physicians have also indicated that these drugs cause musculoskeletal pain including back pain, joint pain, intense muscle spasms and also headaches, numbness in the hands, chest pain & tightness, and persistent dizziness.


Other Bisphosphonates
Among the group of bisphosphonates approved for use in the US are Fosamax, Reclast, Boniva, Actonel, Zometa, Aredia, Didronel and Skelid.


What You Can Do
Because these bone density building drugs and medications can do more harm than good, doctors encourage patients to follow a good diet and do weight-bearing exercise in lieu of taking medications to remedy ailments such as low bone density. Talk with your doctor to determine if there are alternative ways you can build and support your bones without taking these medications.

If you know someone who has had a broken thigh bone (or subtrochanteric fracture), ask them if they are taking Fosamax or any other oral bisphosphonate (like Reclast, Boniva, Actonel, Zometa, Aredia, Didronel and Skelid). If so, tell them to contact a pharmaceutical injury lawyer immediately to determine if they have a case.

Hip Implant Not Giving You Problems?

If you have a hip implant or if you know someone who has had a hip replacement, the following information may be helpful to you regardless of whether the hip implant is causing you problems or injuries today.

Hip Implant Recall

One year ago, Johnson & Johnson recalled a hip implant it manufactures under the DePuy Orthopaedics label. It turns out the DePuy ASR hip implant system is faulty. It is a metal-on-metal (“MOM”) product that began being implanted in 2003. At first, DePuy marketed the hip as new technology that was the “Rolls Royce” of hip implants – it was designed to be implanted in a younger, more active population for long-term use.

Timeline of the Recall 

After only a couple years of use, problems with the device began to surface. The first reports of problems appeared in 2005. In 2007, DePuy began pulling some of its systems off the market in Australia due to widely-publicized problems, but it stayed on the market in the United States. In 2009, DePuy began a “silent recall” which involved decreasing sales and pulling some of its inventory from the market. On July 17, 2010, DePuy finally issued an official recall of the ASR Acetabular implants, more than 5 years after the problems began.

Problems with Design 

As it turns out, the device was very poorly designed. The shallow nature of the cup is different than other MOM devices in two primary ways that have caused problems:

1. It causes excessive heat and friction between the metal cup and the metal ball; and
2. The size, design and location of the resurfacing cup are three important factors that relate to the release of metal ions in the body. The design at issue here increases friction at multiple contact points between the femoral head and the acetabular cup. 

Injuries to Patients

The problems with the implant have required revision surgeries where the patient has to have the DePuy system removed and a new system put in. Some of the common symptoms and difficulties associated with the DePuy recalled product include:

• Difficulty standing or walking
• Crunching or popping noises
• Hip fractures or dislocation
• Inflammation and swelling
• Tissue and muscle infection and necrosis (which is tissue death)
• Cobalt and Chromium Toxicity also known as Metalosis
• Severe Pain
• Dislocation
• Loss of muscle mass

Metalosis

Metalosis is a common problem caused by metallic particles being released into surrounding tissue and into the bloodstream. The excessive heat and friction between the metal cup and the metal ball creates these metallic particles. The friction results in ions of chromium and cobalt being released into the body. As a result, patients are experiencing Aseptic Lymphocytic Vasculitis Associated Lesions (“ALVAL”) from heavy metal toxicity. Symptoms of metalosis include:

• Swelling in and around the implant site
• Spontaneous dislocation of the hip
• Nerve palsy
• Noticeable mass or rash
• Groin or thigh pain
• Fatigue
• Intense pain in the hip

The long-term injuries from metalosis include:

• Damage to the tissue and muscle surrounding the prosthesis, including necrosis
• Bone deterioration (may be progressive)
• Infection
• Possibly cancerous

No Problems Yet?

Many people who have had problems with their hips have had a hip replacement or revision surgery. However, many people who have the faulty product may not be currently experiencing problems with the device and they may not be aware that they need to act now to preserve their potential claims for a future revision surgery. Here’s why:

In these types of cases involving massive produce recalls affecting thousands of people, the manufacturer will enter into an agreement that stops the clock from running out on people who have been affected. What this does is allow people who don’t realize they are affected to be able to proceed at a later time when they realize they need to do something. Unfortunately DePuy and Johnson & Johnson have not done this and it looks like they are not going to. That means that people in Georgia (and other states that have only a 2 year statute of limitations) who have these faulty hip implants but have not yet experienced symptoms of pain or needed a hip revision surgery or who do not yet have high levels of cobalt and chromium toxicity will still be required to act no later than August of 2012 or lose their ability to pursue a claim against the manufacturer.

What You Need To Do

Because the deadline will most likely be August of 2012, anyone who has a hip implant (even if you have not had any adverse effects) needs to do the following:

1. Contact their surgeon to determine what type of implant they have
2. Get an appointment to have diagnostic testing performed to determine if your implant is injuring you
3. Do NOT sign a release from the surgeon or DePuy or Johnson & Johnson
4. Consider keeping a journal of the problems and treatment related to the hip implant
5. Contact an attorney that handles the DePuy cases for a free consultation as soon as possible

Please feel free to contact one of our hip implant recall attorneys for more information. Danny Studstill is located in South Georgia near Tifton and Valdosta. Haynes Studstill is located in Middle Georgia in Macon. We would be happy to speak with you and help you determine if you need to take action.

New Car Seat Safety Laws Aim to Protect 6 to 8 year olds in Car Accidents

A new law that goes into effect in Georgia this Friday will be a crucial step in closing the gap between Georgia law and federal guidelines when it comes to child seat safety laws and protecting children in car accidents.

Beginning July 1, the minimum age for a child to stop using a booster seat will change from 6 to 8. However, children under the age of 8 who weigh more than 40 pounds and are more than 4 feet 9 inches tall will be exempted from the law. Children who are less than 40 pounds and shorter than 57 inches tall are just too small to properly be restrained by a vehicle's seatbelt alone. They will be required to use a booster seat or 5-point harness.

Statistics show that only about 12% of children between the ages of 6 and 8 are currently using booster seats so there will be a lot of children going back into booster seats that had previously been using only the vehicle's lap and shoulder belt. But the bright side is this: statistics also show that children who are properly restrained have a much greater chance of surviving a motor vehicle collision with minor injuries or no injuries at all.

While children may reach the age where all they are required to use is a booster seat, experts agree that car seats with a 5-point harness are the best protection for children less than 100 pounds. The reason is this simple: the 5-point harness system is designed to distribute the forces of a car crash across the strongest bones of a child's body--the shoulders, chestbone and thigh bones--and minimize the strain placed on the child's neck and spine. The fact that a child has reached the minimum requirement to begin using a booster seat does not mean that it is the safest choice.

For more information on children's safety in cars, please see our September 30, 2010 post about car seats. We posted great videos that demonstrate what a difference a 5-point harness can make in a car crash.

Understanding Sunscreen Labels: FDA Helps Reduce Confusion and Permanent Injury

The U.S. Food and Drug Administration (FDA) announced Tuesday that sunscreen products meeting modern standards for effectiveness may be labeled with new information to help consumers find products that, when used with other sun protection measures, reduce the risk of skin cancer and early skin aging, as well as help prevent sunburn.

The final regulation allows sunscreen products that pass the FDA’s test for protection against both ultraviolet A (UVA) and ultraviolet B (UVB) rays to be labeled as “Broad Spectrum.” Both UVB and UVA radiation contribute to sunburn, skin cancer, and premature skin aging. Sunburn is primarily caused by UVB radiation.

Under the new labeling, sunscreens labeled as both Broad Spectrum and SPF 15 (or higher), if used regularly, as directed, and in combination with other sun protection measures will help prevent sunburn, reduce the risk of skin cancer, and reduce the risk of early skin aging.

Here's the key: Products that have SPF values between 2 and 14 may be labeled as Broad Spectrum if they pass the required test, but only products that are labeled both as Broad Spectrum with SPF values of 15 or higher may state that they reduce the risk of skin cancer and early skin aging, when used as directed.

Any product that is not Broad Spectrum, or that is Broad Spectrum but has an SPF between 2 to 14, will be required to have a warning stating that the product has not been shown to help prevent skin cancer or early skin aging.

In addition to the final rule for sunscreen labeling, the FDA also released a Proposed Rule that would limit the maximum SPF value on sunscreen labels to “50 +”, because there is not sufficient data to show that products with SPF values higher than 50 provide greater protection for users than products with SPF values of 50.

The new regulations will become effective for most manufacturers in one year.

Cholesterol-Lowering Drug Warning

The Food and Drug Administration warned Wednesday that a popular cholesterol-lowering drug should no longer be prescribed at its highest dosage to new patients because of concerns that it can cause muscle damage.

The drug is simvastatin and the unsafe dosage level is 80 milligrams. This dosage level can increase the risk for myopathy, which is a form of muscle damage.

Simvastatin is sold under the brand name Zocor, in addition to being sold as a generic product. It is also sold in combination with other drugs under the brand names Vytorin and Simcor.

The FDA recommendation is that doctors only continue prescribing the 80 mg dose to patients who have been taking it for at least a year without experiencing problems.

Additionally, simvastatin should not be taken with some other drugs, including some antibiotics, HIV drugs and anti-fungal medications, according to the FDA and Merck, which makes the drug.

In 2010, about 2.1 million patients in the United States were prescribed a product containing simvastatin at that dose, the agency said. About 12 percent of simvastatin users take that dose, according to Merck.

Teething Baby? Think Twice About Oral Medications

The FDA recently issued a warning concerning the use of Benzocaine, a local anesthetic used to relieve pain in the mouth and gums. The product is commonly used for pain associated with teething, canker sores, and irritation of the mouth and gums.

The FDA became concerned about products containing benzocaine because they may cause a rare but serious and possibly fatal condition where oxygen in the blood stream is greatly reduced. This condition is called methemoglobinemia. In the most serious cases, this condition can result in death.

Benzocaine products do not currently carry any warnings regarding methemoglobinemia, therefore, the FDA is concerned that consumers might not be aware of the danger or know what to look for when using these products. Signs and symptoms of methemoglobinemia include pale, gray or blue colored skin, lips and nail beds, shortness of breath, fatigue, confusion, headache, lightheadedness, and rapid heart rate.

The FDA is particularly concerned about the use of benzocaine products in children under two years of age. There have been 21 reported cases of methemoglobinemia after using benzocaine gels and liquids. Eleven of the 21 cases occurred in children under age two.

If while using benzocaine products any of the symptoms of methemoglobinemia appear, persons should stop using the product immediately and call 911. If left untreated, serious cases may lead to permanent injury to the brain and body tissues, and even death. Parents are cautioned not to use this product on children less than two years of age unless it is given under the advice and supervision of a healthcare professional. These products should always be kept out of reach of children.

The American Academy of Pediatrics recommends that for teething problems in children, safer alternatives such as chilled teething rings or gentle massage to the gums using a cloth or your finger are preferred over benzocaine products. For a list of products containing benzocaine, visit the FDA’s website.