July 21, 2010

Obesity Drug Voted Down by FDA Panel

The Food and Drug Administration (FDA) holds a lot of power over drug manufacturers, and the makers of a new diet pill were disappointed Thursday, July 15. That is when an advisory panel voted 10 to 6, not to recommend a new pill that is supposed to combat obesity.

Consumer Affairs reports that the drug called Qnexa, made by Vivus, would have been available by prescription only as a weight control aid.

The FDA does not have to accept the recommendation of the advisory panel, but usually does. The experts voting against Qnexa noted the potential side effects such as psychiatric problems, birth defects, and an increased heart rate. A panel member from the University of Colorado said that no one wants to conduct a public health experiment on the population at large.

The FDA and Vivus may have dodged a bullet on that one. While obesity is a national dilemma and carries with it a host of medical problems, companies that develop weight control products, hoping to cash in on the national obsession, have found themselves at the receiving end of wrongful death and defective product lawsuits in Florida and throughout the United States.

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June 10, 2010

PediaCare Recall of Children's Medications

Four brands of children’s PediaCare medications have been recalled because they were made in the same facility as the troubled and recalled children’s Tylenol. The Food and Drug Administration (FDA) coordinated with Blacksmith Brands Inc. just before the Memorial Day holiday to issue the voluntary recall. Blacksmith doesn’t believe there are any problems with the four formulations, but “in an abundance of caution” recalled its Multi-Symptom Cold, Long Acting Cough, Decongestant, and Allergy and Cold - all 4 ounce.

Blacksmith stresses that the recall is not being undertaken on the basis of any adverse medical events. If you have any of these medications in your possession, the company says to discontinue their use. If you have the medications in your home you are advised to dispose of them in ways other than down the sink or in the toilet. The www.smartxdisposal.net has information on disposal. To find the lot number and expiration date on the product look on the label above the brand name. The lot number and expiration dates are found on the back and side label of the bottle. Blacksmith says it will offer you a free bottle when replacements are available.

Among the products recalled are:

  • PediaCare Multi-Symptom Cold 4oz. UPC #30045-0556-059

  • PediaCare Long Acting Cough 4oz. UPC# 3 0045-0465-047

  • PediaCare Decongestant 4oz. UPC# 3 0045-0554-04 8

  • PediaCare Allergy and Cold 4oz. UPC# 3 0045-0552-04

As to the reason for the recall – the Blacksmith brands of cold and allergy medications are made in the same Fort Washington, Pennsylvania plant as the recently recalled children’s Tylenol, Benadryl, Motrin, and Zyrtec products made by Johnson & Johnson subsidiary, McNeil Healthcare. The problems stem from a Food and Drug Administration April 30th inspection report that found bacterial contamination, filthy conditions, a hole in the roof and inconsistent formulations, leaving some “super potent.”

The plant remains closed and there is no word whether any of the PediaCare meds suffered from the same production mistakes, and again no illnesses were reported. This is a bigger story that indicates a systemic problem with the production of over-the-counter pediatric liquid medications. A Florida defective drug attorney may be able to help your family if you believe a family member has been sickened by liquid children medications.

June 2, 2010

Children's Tylenol on the Hot Seat

The House Committee on Oversight and Government Reform held a hearing about the recall of about 40 types of popular children and infant Tylenol products made by Johnson &Johnson subsidiary, McNeil Healthcare.

Panel members on Thursday, May 27, discussed what little authority the FDA actually has in ordering a recall. Most consumers don’t realize that the Food and Drug Administration must work with the company, in this case Johnson & Johnson, before a recall can be issued. If J & J wants to be difficult, the FDA must then obtain a court order to get a recall and defective medications off store shelves. That means a delay. It is sort of like the tail wagging the dog.

On the other hand, to work strictly through the courts would also mean a delay at the risk of consumers. Rep. Jackie Speier of California asked the FDA’s Dr. Joshua Sharfstein if having stronger enforcement powers would help the agency. As the FDA tries to be more effective in inspections and enforcement that is the 800-pound elephant in the room, said Ms. Speers.

As it stands now, McNeil’s Pennsylvania plant that makes about 40 types of children’s cold and allergy medications is closed ever since FDA inspectors found holes in the ceiling, filthy conditions, and bacteria in the formulations. Of most concern was a lack of quality control. Some of the product was “super potent” and some had little active ingredient. This is just the tip of the iceberg for J & J.

The FDA even went out on a limb and told consumers not to purchase the McNeil/J & J brand and to instead purchase generics.

Before the plant reopens, the FDA will insist that manufacturing standards meet all requirements for health and safety, which should have been done all along of course. So far, no direct link has been established between the 40 types of medications and the 775 reported adverse events reported to the FDA, including 7 deaths.

Recalled medicines include - Motrin, Benadryl, and Zyrtec, along with Children’s Tylenol pain reliever and other mediations, in all, about 70% of the children’s over-the-market liquid medications. Jacksonville drug recalls injury attorneys will be monitoring what is noted as the largest recall of children’s medicine in the history of the FDA and the third for McNeil over the last eight months.

February 11, 2010

Merck Trying to Expand Gardasil Use

Drug maker, Merck, has given the FDA new data to win approval to market its HPV vaccine, Gardasil, to women between the ages of 27 and 45. The drug is already approved to protect girls and younger women, ages 9 through 26, from four strains of the human papillomavirus, which can lead to cervical cancer and warts. The vaccine also won approval to prevent genital warts in young males.

The drug has not been the blockbuster that Merck wanted so it has been trying for some time to win further FDA approval. In June 2008, the FDA rejected Merck’s application to expand use of the drug. And early last year, the FDA again withheld approval, asking Merck for more data on a 48-month study.

After a much heralded approval in 2006, Merck pushed and almost received approval for mandatory vaccinations for young girls. But there was a backlash when it was found that lobbyists were targeting female legislators to introduce new laws in their states. Gardasil sales slowed and now Merck faces competition from its rival, Cervarix, made by GSK.

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January 22, 2010

Floridians File Lawsuit Against Drug Makers

Two Floridians both had colonoscopies and both have kidney disease. Both have also filed Florida pharmaceutical lawsuits against the drug makers of the drugs used to cleanse the bowels. Both Floridians took drugs that contain sodium phosphate. Doctors often refer to it as the “killer of kidneys” and their lawyer argues the drugs caused their kidney damage.

The drugs are known as over-the-counter drugs Fleet Phospho-soda and OsmoPrep pills.
One of the individuals is 63 and relies on dialysis after suffering kidney failure, reports Health News Florida. The other individual is 80, is a retired airline pilot, and is not on dialysis, but he cannot enjoy a normal active lifestyle.

OsmoPrep now carries a black box warning about the possible link between the preparation and kidney damage. Fleet Phospho-soda has been taken off the market.

While a single dose of the product for bowel cleansing is considered safe, Fleet allegedly recommended a double dose without FDA approval. Publix, where Schlichting bought his product was also named in the lawsuit.

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January 18, 2010

H1N1 Strikes Jacksonville Man

Jacksonville has had its first serious drug side effect of paralysis to report, apparently a result of receiving the swine flu vaccine.

Shortly after receiving the H1N1or swine flu shot, a Jacksonville firefighter has become paralyzed with the condition called Guillain- Barre syndrome or GBS. He is in Baptist Hospital and appears to be recovering.

GBS affects the nervous system causing paralysis and it has rarely been seen in the 2009 version of the swine flu vaccine; however, in 1976, during the last round of swine flu, the vaccine created at that time was known to cause GBS as a side effect.

With millions of vaccines given across the U.S., the head of the Duval County Health Department says there are about 10 cases of GBS across the country. The Centers for Disease Control and Prevention (CDC) reports that about 3,000 to 6,000 cases of GBS are contracted in the U.S. every year with the flu vaccine, adding another one for every one million. Most people are expected to eventually recover.

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December 10, 2009

Byetta Ranks Among Worst Pills - Public Citizen

The consumer group, Public Citizen, is recommending that patients wait until at least the year 2012 before taking the prescription diabetes drug, Byetta.

Public Citizen issued the warning in the November 2009 issue of its Worst Pills, Best Pills report.

As is true with many drugs, we don’t really know the side effects until a drug has been used on a population for at least five to seven years.

In the case of Byetta (exenatide), the Food and Drug Administration (FDA) has recently announced that additional information will be added to the drug’s label warning of a risk of kidney failure among users, including reports of acute renal failure. Reportedly 80 adverse events have been linked to Byetta concerning kidney function.

In 2007 and again in 2008, the FDA issued safety alerts about Byetta and pancreas problems, including severe hemorrhagic pancreatitis and necrotizing pancreatitis, which can be fatal.

Public Citizen launched its own independent analysis of a longer reporting period of 47 months concerning Byetta, and found a total of 181 reports of acute pancreatitis between April 2005 and March 2009, including 142 serious cases that required hospitalization.

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November 19, 2009

Yaz Yasmin Oral Contraceptives Lawsuits Growing

In 2007, a 39-year old woman from San Francisco was the happy mother of 3-year-old twins.
Doctors put her on the Yaz birth control pill. Four weeks and one day later, she suffered a stroke.

Today it’s obvious to see part of her skull has been removed. Doctors had to operate to accommodate the brain swelling following her stroke. Her IQ is 77. She has chronic pain and has no short-term memory. She can no longer drive.

The injured woman was in the hospital for six months and returned to her twins a different person. They are getting help coping with the condition of their new mother, who walks, talks and looks different, with the help of a counselor.

Her doctors told her it was Yaz that caused her stroke and she has filed suit against drug maker Bayer HealthCare.

In addition, a 34-year-old history teacher and mother of two is also suing. She developed blood clots in both lungs in 2007 after starting Yaz. That resulted in partial loss of her right lung.
Yaz and Yasmin are made by Bayer Healthcare Pharmaceuticals. Yaz is the newest sister to drug Yasmin and Yaz contains less estrogen. Ocella birth control is the generic version that is sold by Teva Pharmaceuticals.

All three oral contraceptives are among the most widely used and involve a combination of ethinyl estradiol with a new type of progestin, drospirenone. It has been linked to health problems including strokes, heart attacks, deep vein thrombosis, gallbladder disease, pulmonary embolisms, and death. The drug label says that the presence of drospirenone can increase potassium levels and may present a risk for heart problems for women who have liver or kidney problems.

Courthouse News Service reports that Bayer is facing more than 125 lawsuits over Yaz, and up to six new cases a day are being filed around the country, claiming that Bayer didn’t thoroughly research the new progesterone ingredient, drospirenone before marketing it.
Class actions are forming in New Jersey, where Bayer is headquartered, in East St. Louis, and in Pennsylvania state court.

Amazingly the drug is still on the market. Bayer may have failed to warn about side effects, but it does know how to market.

Yaz is the top-selling birth control pill in the U.S. partially due to the multimillion- dollar ad campaign by Bayer that promotes the pill as a quality-of-life treatment that improves acne and severe premenstrual depression.

The go-to drugs for women under the age of 35 generated sales of about $1.8 billion for Bayer last year.

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November 18, 2009

FDA Will Probe Medication Errors

One important element of health care reform that’s often not mentioned is the cost of medical errors and specifically errors involving prescriptions.

Medication interactions, a pharmacy mix-up, or the inability to read the doctor’s handwriting, can all lead to drug dosage errors which cost us all about $4 billion a year, not to mention lives and injuries.

Now the Food and Drug Administration (FDA) says it is trying to identify how 1.5 million prescription errors happen every year, according to the Institute of Medicine.

It is astonishing and even FDA commissioner, Margaret Hamburg, who is a doctor was stunned by the numbers. She announced a new plan called “Safe Use Initiative” by saying it “doesn’t require a new scientific discovery or a budget appropriation.”

The FDA will be holding public hearings and gathering information from the public.

Every week we hear of the adverse events from prescription medications, even when they are used as directed or prescribed. Consider Tylenol that can cause liver damage when taken in excess, and the current controversy about oral contraceptives Yaz and Yasmin, still on the market, but likely to eventually be pulled off because of the links to heart attack, strokes and blood clots.

Public Citizen’s Dr. Sidney Wolfe says part of the problem is that information is missing from warning labels about 99.5 percent of the time.

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November 4, 2009

Chantix Reports of Suicide Keep Coming In

Even tobacco executives acknowledge these days that smoking is an environmental risk for cancer. According to the American Lung Association, more than 400,000 American lives are lost each year due to smoking or from secondhand smoke shared with babies and spouses.
Chantix sounded like a lifesaver when it was approved by the Food and Drug Administration in May 2006.

Also known as Varenicline Tartrate, Chantix is made by Pfizer and given to end smoking addiction. The FDA reportedly reduced its usual review time from 10 to six months.

Here’s how it works. Instead of using nicotine, which many smoking cessation therapies include, Chantix reduces cravings and decreases the pleasurable effects of smoking. But side effects reported include nausea, headaches, abnormal sleep, and Chantix dreams, vivid wild dreams.

It’s estimated about 5 million prescription have been written.

In November 2007, the FDA began investigating reports of suicidal behavior among users. 37 reports had come in of suicides and hundreds with suicidal behavior. Pfizer was forced to add a stronger warning on the drug’s label.

Pfizer has suggested that Chantix-induced psychotic episodes are actually due to nicotine withdrawal, but the FDA notes that even people who keep smoking and are taking Chantix have the same episodes.

After ABC News published the story of Carter Albrecht, who, after taking his first 1 milligram Chantix tablet, assaulted his girlfriend, and was shot and killed by a neighbor who thought he was a burglar. ABC received over 200 comments from people describing similar erratic behavior.

By November 2007, the FDA issued a release about Chantix confirming there were an increasing number of reports about radical changes in behavior and suicidal thoughts among users of Chantix. As a result the FDA recommended that healthcare workers monitor Chantix users for behavior and mood changes. Pfizer continues to say that Chantix is a real breakthrough medicine even though by February, 2008, the FDA was saying that after a continuous review of adverse event reports there was likely an association between Chantix and serious neuropsychiatric symptoms.

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October 28, 2009

Fentanyl Patch Dangers

Doctors may finally be getting the message about the dangers of Johnson & Johnson’s fentanyl patches. Sales are down worldwide 20.5 % equating to roughly $200 million dollars. The drop comes after a series of deaths and lawsuits and at least two J & J recalls in the last two years.

Just last month, the painkiller was prescribed to a 15-year-old boy who died of an overdose following a tooth extraction. The Seattle teen was autistic and for some reason was prescribed the patch usually used for chronic pain in cancer patients and is generally prescribed for people who have developed a resistance to opium-based painkillers.

Since the 15-year-old was unable to speak and communicate to caretakers, it complicated his reaction and anyone’s ability to help him.

A civil suit has been filed because the boy was given the highest dose available, says his attorney. The hospital says it erred in prescribing fentanyl to the teen patient. Wrong prescriptions of the fentanyl patch are not an uncommon problem across the country.

A Sanford, Fla., jury in October 2008 awarded $13.3 million to the family of a 34-year-old woman who died after undergoing back surgery and using the Duragesic patch (fentanyl). The jurors decided that two J & J subsidiaries, Janssen and Alza, were responsible for her death.
J & J face about 60 other lawsuits over the Duragesic patches.

Part of the problem with fentanyl, whether by J & J or generic, is that it is delivered through a patch allowing the drug to pass through the skin and entering the blood at a constant rate. When someone takes a pill, the level of drug rises and falls in the blood, giving the body somewhat of a rest.

Transdermal patches don’t give the patient’s body a rest and they may end up getting too much of the drug.

There have been five Duragesic/fentanyl recalls since 1994. Watson Pharmaceuticals issued a recall for its leaking fentanyl painkiller patch in August and the company said that exposure to fentanyl exposure may lead to respiratory depression and possible overdose.

In 2005, the FDA said that there had been 120 reports of death related to the fentanyl patch.
Most recently, in December 2008, a division of Ortho-McNeil-Janssen a company under Johnson & Johnson recalled defective fentanyl transdermal patches. The company said some patches had a slit along one side creating the possibility that the fentanyl get could leak out of the package exposing both caregivers and the patient to an overdose.

The last official move by the FDA earlier this year came in a letter sent to the six manufacturers to demonstrate that the drug’s benefits outweigh the potential risks. While the drug has a real benefit for those suffering from so-called “breakthrough pain,” especially from cancer, the FDA notes that the number of accident overdoses is increasing.

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October 22, 2009

Yaz Yasmin Lawsuits Abound

Yaz and Yasmin are two types of birth control pills manufactured by Bayer Healthcare. Both contain ethinyl estradiol which has been present in “The Pill” for more than three decades. However, what’s new about these popular forms of oral contraceptive is the presence of progestin in Yasmin and Yaz. It is called drospirenone, a so called fourth-generation synthetic progestin. Unfortunately it results in elevated potassium levels which can cause potentially life-threatening heart problems.

Approved by the FDA in 2006 and 2001, almost immediately the FDA began receiving adverse event reports including deep vein thrombosis, pulmonary embolism, and heart arrhythmia or irregular heartbeat.

Public Citizen, the consumer group, has put the two pills on its “Do Not Use” list of drugs.
As the number of complaints over the side effects of these birth control pills continues to increase, four significant lawsuits have been filed in federal court against Bayer HealthCare Pharmaceuticals and there are more to come.

Bayer will run some corrective advertising and has told the FDA it will spend $20 million on the campaign to downplay its former overstatements about the benefits of Yaz while it downplayed the risks.

The birth control pills are still sold and aggressively marketed, exposing young women to serious and potentially life-threatening risks. When you follow the money trail, you understand why.

Yaz and Yasmin account for nearly 18 percent of the birth control market last year. That translated to more than $600 million in sales for Yaz and $1.85 billion in the first quarter of 2009 and $382 million for Yasmin. With other birth control formulations on the market, there is no benefit to using Yasmin and Yaz.

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October 21, 2009

Two Girls Die of Lou Gehrig Disease Following Gardasil

Researchers believe that two separate and fatal cases of Lou Gehrig’s Disease in young girls following the Gardasil injection may be related to the vaccine. Gardasil is injected in girls beginning at age 9 through age 26, to protect against two types of virus that cause cervical cancer and two that cause genital warts. It’s estimated 7 million young girls and women have received the vaccine, delivered in a three-shot series.

In both cases the young women died of amyotrophic lateral sclerosis or ALS (Lou Gehrig’s Disease), and the disease progressed rapidly. Merck, the maker of Gardasil, does not believe that Gardasil could have caused the events.

But the two cases are very similar and researchers are suspicious that ALS in young people, affecting just one in 2-3 million, may be related to the vaccine.

Here’s what we do know. One of the girls was 14-years-old when she received Gardasil. Months after her third shot in the three-booster Gardasil series, she began tripping over easy hurdles in gym class. Soon both legs and her arms became weak, she began to limp and had trouble gripping objects and she felt pins and needles in her feet. Her muscled atrophied. Within a year she was paralyzed, a quadriplegic and used life support to help her breath before she died. The degenerative disease did not harm her mind, which Web MD reports was as sharp as ever.

The girl’ parents want people to know they are not anti-vaccine. After all, they had their daughter vaccinated with Gardasil. The girl was 15-years-old when she lost her battle with the rapidly degenerative neurological disease on March 15, 2009.

Another girl, 20-years-old had a rapid progression of ALS in a similar way within four months of her first Gardasil shot. She died 28 months later.

Our hearts go out to the parents and family and friends of these two young women.

The link between the symptoms and the shot is very suspicious to researcher Dr. Catherine Lomen-Hoerth at the ALS Center at University of California San Francisco Medical Center. First, the symptoms progressed very rapidly, more so than in a typical ALS patient. And both girls had an inflamed spinal cord she said to doctors at the American Neurological Association, which is not normally seen in ALS.

And one doctor, Yadollah Harati, a neurologist at Baylor College of Medicine in Houston, says he will now ask his young ALS patients if they received the Gardasil vaccine. He didn’t think to ask before, he tells Web MD. The parents of the 14-year-old are asking anyone who visits their Web site in their daughter’s honor, Jenny’s Journey, to forward any cases of muscle paralysis following a Gardasil injection to their Web site so they can make sure that it is registered on the federal VAERS (Vaccine Adverse Events Reporting System). They fear other cases may not be reported since VAERS is not generally known to the public and there are no requirements to post adverse events, though hospitals and doctors are encouraged to do so.

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October 7, 2009

Tylenol Recall

The makers of Children's Tylenol have announced a voluntary recall of more than 20 children's and infants' liquid products.

The products were made between April and June 2008 and the recall involves 57 lots of children’s products.

The full list and lot numbers of the products are contained on the Web site. Among those recalled:
Varieties of Children’s Tylenol have been voluntarily recalled. The brands include Children’s Tylenol Suspension 4 ounce Strawberry, Children’s Tylenol Pediatric Suspension 1 ounce Cherry, and Infant’s Tylenol Suspension Drops ½ ounce Grape.

The company says one of the inactive ingredients tested positive for a gram-negative bacteria, Burkholderia cepacia or B. cepacia. However none of the bacteria was found in the finished product and that the chance of a serious medical event is unlikely.

The bacterium is responsible for some antibiotic resistant hospital infections.

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October 2, 2009

Grandmother Says Gardasil Killed Her Granddaughter

A 17-year-old was about to graduate from high school when the cheerleader and softball pitcher received the first of the three-shot series of Gardasil, the Merck drug that is supposed to protect young girls from the human papillomavirus, or HPV, that causes two types of cervical cancer and two types of warts.

That was 19 months ago.

"I just didn't know what to think because she was so healthy. I just could not understand why she was dead. No one seemed to know why she was dead,” says her grandmother.

The teen had no health problems, but after the second shot in September 2007 she started to get bad headaches, as well as muscle aches, and joint pain, said her grandmother. The doctor thought it was stress. Her third shot was February 20, 2008. By February 22 she was dead.

Her grandmother said that after the final shot, her granddaughter said she had a headache and went to bed. That next morning her mother found her on the bathroom floor. "Without a shadow of a doubt, I know that Gardasil is what killed her," says her grandmother.
An autopsy was inconclusive.

The grandmother says she is angry with the CDC and the FDA because even today they encourage girls to get the vaccine, even though there have been about 14,000 adverse events reported to the government, including Guillian-Barre Syndrome, where the muscles become paralyzed, in addition to headaches, fainting and even death.

In fact, the CDC says it has either investigated or is currently looking at 43 reports of deaths of those who received the vaccine. Read the reports on the Web site, Judicial Watch, that had to file a FOIA to get the death reports from the government.

"The FDA adverse event reports on the HPV vaccine read like a catalog of horrors. Any state or local government now beset by Merck’s lobbying campaigns to mandate this HPV vaccine for young girls ought to take a look at these adverse health reports."
-Tom Fitton, Judicial Watch

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September 30, 2009

The Many Dangers of Avandia: Study Reveals Heightened Risk for the Elderly

After it was revealed in an analysis of 42 clinical trials in May 2007 that patients taking Avandia to treat Type 2 diabetes faced a 43% greater risk of having a heart attack, concern spread relating to the failure of manufacturers GlaxoSmithKline and the FDA to properly warn consumers about its cardiac risks. Based on a recent report, Avandia is now considered to pose more risk than Actos and a study revealed that senior citizens are the group most at risk of suffering from heart failure and death as a result of using Avandia. According to the article, in analyzing almost 40,000 records of patients 66-years-old and above, Sunnybrook Health Sciences Centre researchers in Toronto found that for every 93 patients given Avandia as opposed to Actos, there would be one additional cardiovascular event or death each year.

Even though new warning stating the specific risks of myocardial ischemia was added to Avandia’s boxed warning information in November 2007, other serious risks have been brought to the surface, such as liver failure. A Consumer advocacy group, Public Citizen, published the research that revealed Avandia’s risk of liver toxicity and noted that its risks “far outweigh its benefits.” And as skilled Jacksonville, Florida Avandia lawyers, we couldn’t agree more. It is utterly tragic when medication that is supposed to help treat a serious disease or ailment ends up making a condition worse or creating new health problems for an innocent patient to endure.

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September 24, 2009

Avandia – The News Keeps Getting Worse

Avandia is the drug many residents of Florida are discussing lately, which is used to treat Type 2 diabetes. Some users have found the cure has caused more problems than the original disease.

Heart failure can be a deadly result of taking the oral diabetes medicine, made by GlaxoSmithKline. Avandia, also known as rosiglitazone, has been found to contribute to heart attack or failure, according to a six-year study on Avandia. 6.9 percent of the patients taking the drug died or were hospitalized.

A new study from the British Medical Journal (BMJ), published in August 2009, concludes that the drug has no advantage over competitor, Actos, and is more likely to trigger heart failure and death.

The drug came under the eye of the Food and Drug Administration, which in 2007, pressured Glaxo to make a more explicit “black box” warning about the heart risks. The FDA has also required more controlled trials and testing for Avandia, but that comes too late for patients who have been taking it to control their Type 2 diabetes.

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July 28, 2009

Brunswick, Georgia Product Liability and Defective Products Attorneys

Brunswick is a city in southeastern Georgia located about 30 miles north of Florida. Home to the fourth-largest automobile port in the eastern United States, the city's economy encompasses manufacturing, agricultural processing, and bulk cargoes. In 2007, the city proper had an estimated population of 16,235 and an estimated metropolitan population of 101,792. Brunswick’s metropolitan area is the twelfth-largest in the state of Georgia and includes the counties of Glynn, Brantley, and McIntosh. With a region that encompasses such a large, varied area and a population that is on the rise, residents and visitors alike use a huge amount and wide array of products on a daily basis. When children, adults, and the elderly use products that result in personal injury or wrongful death, a Brunswick, Georgia product liability attorney can help the injured person or the decedent’s family receive compensation for financial hardships.

A lot of people don’t want to believe or admit that defective products are out there, but defective medical devices, defective auto parts, defective children’s furniture and toys, and defective electronics and household products are all an unfortunate reality and can have serious life-altering consequences. The knowledge and skills of a product liability attorney in Brunswick, Georgia is needed when taking on product designers and manufacturers who will do anything like cover up mistakes so that they aren’t held responsible for their negligent actions that put innocent people at risk for suffering life-changing injury or wrongful death.

As consumers who expect that products they purchase are safe, reliable and risk-free, it is devastating to have that trust violated. If a defective product was the cause of you or loved one’s injury, or if someone you care about has been wrongfully killed, the skilled attorneys at Farah and Farah can help. We will aggressively defend your rights and ensure that the negligent manufacturer is held responsible for the harm their dangerous product has caused. Contact the personal injury law firm of Farah and Farah today for a confidential consultation:

4216 Coral Park Drive,
Suite 107
Brunswick, GA 31520
Phone: (912) 466-8896

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July 9, 2009

Lake City Medical Malpractice and Pharmaceutical Litigation Attorneys

Lake City is located in Columbia County, Florida and is known as the “Gateway To Florida.” With a population of about 12,000 and in a county whose population is on the rise (Columbia County has close to 68,000 inhabitants as of 2006), Lake City has become a popular tourist destination as well as a stop for those on route to Southern Florida. With such an expanse of visitors and residents who encounter all sorts of medical needs due to emergencies, injuries, illnesses, or health conditions, medical malpractice in Lake City is prone to occur.

Although most of us don’t want to believe or admit that medical malpractice in Lake City poses serious life-long affects because of failure to diagnose, birth injuries, hospital negligence, and surgical injuries, this kind of negligence is a reality throughout the U.S. and Florida. The knowledge and skills of a Lake City medical malpractice attorney is needed when taking on insurance companies, big hospitals, and/or doctors who will do anything, such as cover up mistakes, so that they aren’t held responsible for their negligent actions that put innocent people at risk for suffering life-changing injury or wrongful death.

As patients and consumers in Lake City who often rely on the aid of pharmaceutical products to help recover from or treat an illness, we expect that the products we are prescribed or buy over-the-counter are safe and don’t pose a risk to our lives. When a manufacturing company distributes medication that causes dangerous side effects to its users, those who are injured may receive compensation; however, this is no easy task. Pharmaceutical litigation is a complex process that requires an experienced Lake City pharmaceutical litigation attorney to help evaluate your case and the evidence involved so that justice can be attained. Contact Farah and Farah today to speak with a member of our legal team or contact us at our Lake City offices:

212 N. Marion Ave Suite 208
Lake City, FL 32055
Phone: (386) 754-7534

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July 7, 2009

Orange Park Medical Malpractice and Pharmaceutical Litigation Attorneys

Orange Park is a suburb of Jacksonville located in Northeast Clay County just south of Jacksonville, Florida. Rich in history and a thriving community, Orange Park has a great deal to offer. Clay County, which Orange Park is located in, is also a bustling region of Florida. With a population in excess of 180,000 and a very high population density, hundreds of residents and visitors rely on a variety of medication to maintain healthy living or treat an illness or condition. Many people don’t want to believe or admit that pharmaceutical litigation in Orange Park occurs due to adverse drug reactions and dangerous side effects that went undetected in testing or were ignored while more products were distributed.

As patients and consumers who often rely on the aid of pharmaceutical products, we expect that the products we are prescribed or buy over-the-counter are safe and don’t pose a risk to our lives. When a manufacturing company distributes medication that causes dangerous side effects to its users, those who are injured may receive compensation; however, this is no easy task. An experienced Orange Park pharmaceutical litigation attorney can help you if you’ve suffered injury due to medication by evaluating the evidence involved so that justice can be attained.

While encountering a variety of life’s obstacles, many people require medical attention for different conditions and emergencies of all kinds. Unfortunately, cases of medical malpractice in Orange Park happen from time to time, as they do across the nation, resulting from failure to diagnose, birth injuries, hospital negligence, and surgical injuries, just to name a few. The knowledge and skills of a Orange Park medical malpractice attorney is needed when taking on insurance companies, big hospitals, and/or doctors who will do anything like cover up mistakes so that they aren’t held responsible for their negligent actions that put innocent people at risk for suffering life-changing injury or wrongful death. If you have been injured from a defective drug or have suffered medical malpractice in Orange Park, contact the personal injury law firm of Farah and Farah today for a confidential consultation:

1534 Kingsley Avenue
Orange Park, Florida 32073
Phone: (904) 264-0700

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July 2, 2009

St. Augustine Medical Malpractice and Pharmaceutical Litigation Attorneys

St. Augustine is home to the oldest port in the continental United States – in fact, St. Augustine is commonly referred to as “the nation’s oldest city.” In 2004, the population was estimated to be 12,157. Home to beautiful beaches and museums, St. Augustine continues to be a popular tourist destination in Northern Florida. Located about 40 miles south of Jacksonville and 60 miles north of Daytona Beach just 5 miles east of Interstate 95, St. Augustine is also a well traversed location.

With hundreds of residents and visitors relying on a plethora of medication to maintain healthy living or treat an illness, many people don’t want to believe or admit that pharmaceutical litigation in St. Augustine occurs. As patients and consumers who often rely on the aid of pharmaceutical products, we expect that the products we are prescribed or buy over-the-counter are safe and don’t pose a risk to our lives. When a manufacturing company distributes medication that causes dangerous side effects to its users, those who are injured may receive compensation; however, this is no easy task. Pharmaceutical litigation is a complex process that requires an experienced St. Augustine pharmaceutical litigation attorney to help evaluate your case and the evidence involved so that justice can be attained.

While encountering a variety of life’s obstacles, many people require medical attention for different conditions and emergencies of all kinds. Unfortunately, cases of medical malpractice in St. Augustine happen from time to time, as it does across the nation, resulting from failure to diagnose, birth injuries, hospital negligence, and surgical injuries, just to name a few. The knowledge and skills of a medical malpractice attorney is needed when taking on insurance companies, big hospitals, and/or doctors who will do anything like cover up mistakes so that they aren’t held responsible for their negligent actions that put innocent people at risk for suffering life-changing injury or wrongful death. If you have been injured from a defective drug or have suffered medical malpractice, contact the personal injury law firm of Farah and Farah today for a confidential consultation:

1301 Plantation Island Drive
Suite 206A
St. Augustine, Florida 32080
Phone: (904) 797-7977

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July 1, 2009

Zicam Warning for Consumer Safety

You may have heard the news reports about the popular cold remedy, Zicam.

The Food and Drug Administration (FDA) is ordering the maker of Zicam to cease marketing the little bottle with the big nasal spray after continuing reports that some users have lost their sense of smell.

Here are the three over-the-counter Zicam products affected:

  • Zicam Cold Remedy Nasal Gel

  • Zicam Cold Remedy Nasal Swabs

  • Zicam Cold Remedy Swabs, Kids Size (a discontinued product)


The FDA has reportedly received more than 130 reports of the loss of smell, also known as anosmia, which can be a big problem if you cannot smell spoiled food or a fire.

Perhaps most serious is that the FDA believes that Zicam maker, Matrixx, may have received more than 800 complaints directly to the company regarding product liability injury, which by a 2007 FDA regulation are supposed to be turned over to the FDA.

Matrixx Initiatives stand behind the science of its products and its belief that there is no causal link between its intranasal gel products and anosmia. The company says the FDA action is unwarranted. They plan to cooperate with the FDA to review safety data.

But for fans of Zicam, don’t worry. The cold tablets made by Zicam also deliver the homeopathic ingredient, zinc gluconate, a naturally occurring mineral. The only difference is in the delivery. Directly into the nasal passages causes the working ingredients to be absorbed immediately.

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June 4, 2009

Florida Wrongful Death of 7 Year: Foster Kids Put On Drugs At Alarming Rate

The Florida Department of Children and Families, or DCF, in the past has had a terrible reputation of covering up and denying reports of child abuse within the foster care system. The recent Florida wrongful death of a little boy in foster care has been handled much differently this time around.

Seven-year-old Gabriel Myers had been put on several psychiatric drugs for depression, and ADHD. After parents, family members and a system let him down, the little boy is assumed to have killed himself in the shower of his Broward County home.

Based on Gabriel’s death, DCF set out to find out exactly how many kids are placed on psychiatric mind-altering medications, many of which have dangerous side effects that can include suicidal thoughts. This kind risk imposed on children would require the counsel of an experienced Jacksonville pharmaceutical litigation lawyer who can help determine through an investigation who is responsible for the defective drug.

The Florida Times Union report finds that hundreds of kids in foster care have been placed on psychiatric drugs by their caregivers in Northeast Florida - 205 kids in Duval, Clay, and Nassau counties were found to be on at least one psychotropic drug. In St. Johns, Putnam, Flagler, and Volusia counties, 136 kids are medicated and 76 are on drugs in Baker, Union, Bradford, Gilchrist, Alachua and Levy counties.

What’s especially shocking is that no one gave authority for these drugs to be used on the children, and most of the drugs are not even approved for child use.

Under Florida law, parental or guardian consent must be granted in writing before children in foster care can be given psychotropic drugs to modify behavior. Oversight by a psychiatrist is required, along with court orders. DCF will now aggressively seek out those parents or guardians to get consent where it was missing in about 16 percent of the cases. According to the report, kids who stayed with family members were medicated about 4 percent of the time, while kids in group homes were medicated about 30 percent of the time.

At Farah and Farah, our skilled Jacksonville personal injury and wrongful death attorneys have been defending the rights of those injured or killed by the negligence of pharmaceutical companies and other large parties. Call us today for a free consultation at 800-533-3555.

May 13, 2009

Weight Loss Drug Hydroxycut Recall

After 25 reports of liver damage and severe liver injury, the Food and Drug Administration has taken the popular weight loss supplement Hydroxycut off the market to protect consumers. What does this recall mean for the millions of people who have bought Hydroxycut products? To start with, if you haven’t already stopped taking Hydroxycut products, it is advised that you do so immediately.

Hydroxycut over-the-counter drugs were purchased by over $7 million people for weight-loss, energy-enhancement, low-carb dieting, and fat-burning applications. It has not been revealed to the public which ingredients in Hydroxycut damage the liver. Due to Hydroxycut use, there has been one reported death caused by severe liver damage and 23 patients have required liver transplant surgery. Considering the prominent use of Hydroxycut nationwide, these numbers pose questions of how many cases of liver damage and liver injury have gone unreported and what will the future hold for any new cases?

Symptoms of Hydroxycut liver damage include jaundice, brown urine, fatigue, abdominal pain, weakness, nausea and vomiting, loss of appetite, and/or itching. Hydroxycut products have also been linked to a rare muscle/kidney conditions, adverse cardiovascular events and seizure.

Liver damage can be irreversible, which is why it is crucial to seek medical attention for your injuries if you have experienced any symptoms of liver failure or liver damage after using Hydroxycut products. You may also want to keep a log of all symptoms and any information regarding their characteristics and onset.

The next question you may be asking yourself is: Do I have a Hydroxycut case? News of the May 1 FDA recall has prompted concern for consumers’ rights and you may have a potential Hydroxycut lawsuit, but you must act soon. The experienced personal injury attorneys in Florida at Farah & Farah have the knowledge and skills to help you pursue justice in your Hydroxcut case. Contact us at 800-533-3555 for more information and a free case consultation.

April 9, 2009

Raptiva Drug Recall

It was reported in an article yesterday, April 8, 2009 that Raptiva (efalizumab), used to treat patients with chronic plaque psoriasis, has been taken off the U.S. market by manufacturers Genetech, Inc.

The company has withdrawn the defective product because of a potential risk of patients developing progressive multifocal leukoencephalopathy (PML), a rare and seriously fatal neurologic disease caused by a virus that affects the central nervous system. Genetech estimates that 46,000 patients worldwide have been treated with Raptiva since its FDA approval in 2003.

Approximately 2,000 patients in the U.S. may be receiving Raptiva for chronic plaque psoriasis. Anyone who is currently taking Raptiva should see their physician immediately to discuss alternative treatment. There is potential for severe psoriasis worsening if a patient abruptly discontinues using Raptiva, which is why patients must talk with their doctor before stopping treatment.

PML is not the only side effect from use of the dangerous drug Raptiva. Since the drug is an agent which suppresses the immune system, many serious viral and bacterial infections have been known to occur.

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March 31, 2009

Defective Drug Byetta Connected to Pancreatitis

More and more cases are occurring of the prescription drug Byetta causing severe conditions of pancreatitis. About forty cases of patients developing some kind of pancreatitis have been reported to the Food & Drug Administration (FDA) to date.

Forty is indeed a high number of innocent victims suffering from a paramedical drug that was meant to help lower their blood sugar levels as type-2 diabetes patients. The initial dose of Byetta, generic name Exenatide, is injected under the skin subcutaneously, either in the thigh, abdomen, or upper arm.

Severe cases of hemorrhagic pancreatitis in which the pancreas becomes inflamed and bleeds, as well as necrotizing pancreatitis where the inflamed pancreas destroys itself, are the most common issues being reported in association with the use of dangerous drug Byetta.

In 2008, the first serious side effects of the Byetta defective drug were seen when four patients needed to be hospitalized and two patients died as a result of taking the medication.

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