Pennsylvania Injury Lawyer Blog

During a recent meeting between the U.S. Food and Drug Administration (FDA) and two of its advisory panels, the safety of several common drugs used to treat female bone density problems was called into question. As a result, the FDA is anticipated to revise the labeling in November for medicines classified as bisphosphonates. Specific drug products include Actonel, Boniva, and Fosamax.

Women travelled from all over the country to share experiences involving injury with the FDA panels as part of the hearings on bisphosphonate dangers. Most of the stories showed similar factors, with the majority of cases involving a critical, abnormal fracture of the femur bone that occurred unexpectedly after using one of the listed bone density drugs for several years, in many instances five or more. According to statistics, over five million women and approximately 11 percent of females 55 years of age or older use these medicines to reduce bone density loss associated with pre-osteoporosis, which can also result in breaks and fractures. The current product labeling alerts users and their doctors to monitor for symptoms of pain which may be a sign of an impending fracture.

While it was concluded that heightened and clarified product warnings were necessary, it was not yet revealed what exactly that would entail. In a 45-page statement given by the FDA, the agency cited examples from data that suggest there are no documented benefits for using the drugs more than three to five years. The report also connected the problems testified by users to long term usage, which may or may not be part of the label revision.

If you or a family member has suffered an injury in Pennsylvania from using bisphosphonates (Actonel, Boniva, Fosamax) contact the Pennsylvania dangerous drug attorneys with Anapol Schwartz at 1-866-735-2792 to discuss your case.

Pregnant women using ongoing, big doses of the pharmaceutical fluconazole (brand name Diflucan) may run an increased risk of having children with birth defects, according to a new warning issued by the U.S. Food and Drug Administration (FDA).

Fluconazole is used to treat a variety of yeast infections, pertaining to the mouth, throat, vagina, and other areas, and associated with oropharyngeal and esophageal candidiasis, vaginal candidiasis, and cryptococcal meningitis. It’s also prescribed for its anti-fungal purposes to individuals undergoing radiation therapy and chemotherapy prior to a bone marrow transplant, and to those suffering meningitis due to a particular strain of yeast infection.

The FDA mandated additional product labeling and listed harmful doses of the medicine as 400 and 800 milligrams taken daily during an expecting woman’s first trimester (the first three months of pregnancy). No advisory has been given by the FDA for using low, single doses (150 milligrams or less) to treat vaginal yeast infections.

Birth defects associated with the product, according to the FDA, may include: “abnormal facies, femoral bowing, abnormal development of the skullcap, brachycephaly, cleft lip or palate, thin ribs and long bones, congenital heart disease, and arthrogryposis.”

In addition to the increase in product labeling, with regard to the FDA’s classifications on fetal hazards due to pharmaceutical use, fluconazole’s official rating has been elevated from a category C to a category D (with the exception of low dose, short term usage). Category D claims evidence that a particular drug may be dangerous to human fetuses, while the drug’s prospective medical benefits in treating substantial or life-threatening sickness in expecting women may warrant use in some occasions, regardless of possible risks, according to the FDA.

If you’ve become pregnant while using fluconazole, have taken the drug while expecting, or have suffered ill reactions due to the drug, you may be entitled to compensation for your damages. Consult an experienced Philadelphia drug injury attorney today to learn more about your rights.

Many osteoporosis drugs will now be required to change their warning labels to reflect the risk of atypical fractures of the thigh and femur. According to a FDA alert, osteoporosis drugs, also known as bisphosphonates, have been linked to rare types of femur fractures. A "subtrochanteric" fracture is a rare fracture of the thigh that is just below the hip joint. A "diaphyseal" femur fracture is when a fracture along the long part of the thigh bone.

While it is not clear if osteoporosis drugs are a direct cause of rare femur fractures, there have been enough reports linking the drugs to these fractures to require a change on the warning labels. The drugs included in this category are Fosamax, Actonel, Boniva and Atelvia. A complete list is available on FDA’s website.

Prescription drugs are meant to improve a patient's health and quality of life. Sadly, some drugs bring about more harm than good. In certain cases, drugs simply haven’t been tested enough for doctors to understand all of the potential side effects. Dangerous prescription drugs can cause catastrophic side effects, injuries or even death. Victims of unsafe drugs would be well-advised to contact a pharmaceutical liability attorney to examine their legal rights and options.

If you believe you have been harmed by a defective drug, please call the law offices of Anapol Schwarz at 866-735-2792 to discuss your unsafe drug case. Our Fosamax injury attorneys have decades of experience and a successful track record representing victims of dangerous and defective drugs. Call us today for a free consultation and comprehensive case evaluation.

According to the U.S. Food and Drug Administration (FDA), the warnings and precautions section of labels for drugs treating osteoporosis will be changing. The change will describe the risk of subtrochanteric and diaphyseal femur fractures for patients who take bisphosphonates to treat osteoporosis. Fosamax bottles will reflect this addition, as will other medications such as Actonel, Boniva, Atelvia, and Reclast (and their respective generic products). The FDA will also require pharmacies and doctor’s offices to give patients a medication guide when they pick up their prescription for a bisphosphonate product.

Fosamax has been linked to the deterioration of other bones besides the femur in the body, such as the mouth and jaw. Millions of women have been prescribed this bisphosphonate product; and there is now evidence that shows osteoporosis patients prescribed Fosamax are likely to suffer femur fractures. A report from the American Society of Bone and Mineral Research studied 310 osteoporosis patients that suffered a rare femur fracture, such as subtrochanteric and diaphyseal fractures, and found that 94 percent of them had been taking a bisphosphonate drug, such as Fosamax. These types of femur fractures are very uncommon, accounting for less than one percent of all hip and femur fractures. While it is not clear if bisphosphonate products such as Fosamax are the cause of these rare femur fractures, patients taking bisphosphonate products are among those that predominantly report them.

The FDA recommends that healthcare professionals stop prescribing antiresorptive medications, including bisphosphonates, in patients who show risk of femur fractures.

The Fosamax lawyers at Anapol Schwartz can help those adversely affected by the dangerous drug and can help them obtain compensation for their injuries.

The Pennsylvania personal injury law firm of Anapol Schwartz represented injured clients in 39 out of 200 cases recently settled by drug maker Bayer over its dangerous drug Trasylol. The Legal Intelligencer reports that plaintiffs in these pharmaceutical liability lawsuits against Bayer alleged that the drug, which was meant to control bleeding during heart surgery, caused serious personal injuries to patients, including kidney failure and fatal heart problems.

Anapol Schwarz settled the 39 cases for $19.9 million, which amounts to an average settlement of $510,000. James Ronca, a lawyer with Anapol Schwartz, co-led the plaintiffs’ counsel for the Trasylol multi-district litigation. The settlement was reached without admission of liability from Bayer.

Trasylol was approved in 1993 by the U.S. Food and Drug Administration to help curb blood loss for patients undergoing high-risk open heart surgery. The sale of this drug generated close to $200 million annually for Bayer. Three studies released in 2006 and 2007 raised serious concerns about the incidence of kidney failure or death from the use of Trasylol. A review by the FDA yielded similar results, leading the agency to issue a warning in 2006. Bayer suspended marketing the drug in November 2007.

Drug makers, pharmacists and doctors all have a duty to make sure that the drugs they manufacture and prescribe to patients do not cause injury or harm. Most drugs have some type of side effect. However, there are some drugs, such as Trasylol, that have the potential to cause long-term damage or even death. Although the FDA plays a regulatory role in approving and monitoring drug safety, ultimately, it is the drug maker who is liable for any injuries caused by their products.

If you or a loved one has suffered major injuries from taking dangerous or defective drugs, please contact the Philadelphia product liability lawyers at Anapol Schwartz for a no-cost consultation and case evaluation. Our track record of successfully representing injured clients speaks for itself. Please call us at (866) 735-2792 to find out how we can help.

Many women have chosen the oral contraceptives, Yaz and Yasmin, as their preferred method of birth control. However, in addition to minor side effects associated with birth control pills such as bloating, weight gain and nausea/vomiting, Yaz and Yasmin have been linked to more serious side effects. These more alarming side effects include DVT (blood clots in the legs), pulmonary embolism (blood clots in the lungs), stroke and heart attack, dangerously high levels of potassium, gall bladder disease and pancreatitis, among many other serious conditions. Not all women will experience these types of side effects; however, the women that do should seek medical attention immediately.

Yaz and Yasmin are considered “fourth generation” oral contraceptives. They contain a newer synthetic progestin-like hormone called drosperinone.

In 2008, the maker of Yaz and Yasmin, Bayer Pharmaceuticals, was cited by the FDA for false advertising, failing to properly research the drug, glossing over potential side effects, and failing to recall the drug when the potentially life-threatening side effects far outweighed the benefits of its use.

All oral contraceptives and other medications come with some risk of side effects. However, it is the responsibility of the manufacturer to do everything in their power to produce a drug that is as safe as possible for consumer use. If you or a loved one has suffered a serious or life-threatening injury due to the use of oral contraceptives, it would be in your best interest to contact the experienced Pennsylvania Yaz side effect attorneys at Anapol Schwartz. They can help you understand your rights and will work hard to ensure that you get the compensation you deserve. To schedule a free and confidential evaluation of your case, call 866-735-2792.

According to a recent article in Businessweek, a former FDA regulator may testify that GlaxoSmithKline, makers of the diabetes drug Avandia, withheld information indicating that Avandia increased the risks of heart trouble.

In a recent deposition, former FDA drug-safety unit manager Dr. Rosemary Johann-Liang testified that the FDA's 2001 study of Avandia found that the drug increased the risk of heart attack more than did rival medications. Glaxo also received an email from separate researchers stating that Avandia “strengthens the signals” of heart ailments, which it failed to turn over to the FDA.

Dr. Johann-Liang left the FDA in 2007 after recommending that Glaxo add additional warnings and information to Avandia's label about the risks Avandia posed to heart health. She stated that the FDA also provided Glaxo with internal information about how to improve the Avandia warnings.

An upcoming FDA advisory panel meeting in Washington will consider the risks Avandia poses of increasing heart attacks, strokes, and cardiovascular disease and whether these risks outweigh Avandia's beneficial ability to help control blood sugar. The panel may consider Dr. Johann-Liang's testimony when making its decision. The drug's manufacturer, GlaxoSmithKline, continues to maintain that no studies have proven that Avandia is dangerous.

Pharmaceutical companies have an obligation to provide consumers with the information they need to make their personal medical decisions. When information about a medication's potential harmful effects is withheld, the resulting side effects, injuries, and even deaths can affect a patient and his or her family for years to come.

If you or a loved one has been injured by a harmful or recalled drug, the experienced Avandia side effects attorneys at Anapol Schwartz stand ready to assist you. Our legal team will review the details of your case and help you hold negligent parties accountable as we fight to obtain the compensation you deserve. Please don't hesitate to call Anapol Schwartz today at 866-735-2792 for a free and confidential consultation.

The H1N1 vaccine is doing more, and less, than it’s supposed to. According to reports from both ABC News and MSNBC.com, the swine flu vaccine is not always providing the necessary safeguard against the swine flu, and is even ladling some users with unwanted side effects in the form of allergic reactions.

An ABCNews.com report has revealed that a batch of the H1N1 vaccine has been recalled in Canada. Its maker, U.K.-based GlaxoSmithKline, has recalled the vaccine because it has caused at least six known cases of severe allergic reaction in its users. So far, 170,000 doses of the vaccine have been recalled in Canada. Although reports claim that this side effect is limited to the vaccine distributed in Canada, it has yet to be seen whether or not other users in different locations are also affected by this defect. A total of 7.5 million doses of the vaccine have been distributed in Canada thus far.

MSNBC.com reports a completely different issue, this time one that has affected children. According to the article, over 800,000 doses of the H1N1 vaccine have been recalled by Sanofi Pasteur, the vaccine’s division of France-based pharmaceutical company Sanofi-Aventis Group. It has been determined that these particular doses of the vaccine are ineffective in preventing the onset of swine flu, thus putting children inoculated with the vaccine at risk of contracting the illness. The doses in question have minimal to no potency, and were distributed amongst children.

Continue reading "H1N1 Vaccine Recall Reveals Vaccine Doesn't Always Deliver as Promised" »

In what many people are referring to as “long overdue”, the FDA has recently announced its new program called “The Safe Use Initiative” to help lower wide-ranging problems associated with drug dose errors. According to a latimes.com report, the problem of drug dosage error takes a staggering toll on consumer and patient health in addition to costing about $4 billion a year. In fact, based on a study by the Institute of Medicine in 2007, approximately 1.5 million preventable “adverse drug events” take place in the United States every year. With this information in mind, it is no wonder that the Food and Drug Administration is calling on doctors, consumers, and various other healthcare professionals to help in identifying drugs and circumstances that may be particular problems.

In its efforts to lower the deaths and severe health problems brought about by misuses of medication, the FDA adverse event reporting system and the organization as a whole are trying to determine the most serious threats, dangers, and risks, and find ways to prevent them from happening. The agency is supposed to hold public hearings to gather information pertaining to the following drug concerns:

• Overuse of acetaminophen (a pain reliever that can cause liver damage if too much is taken)


• Information given to patients (i.e. package inserts, labels and instructions that pharmacists distribute when giving prescriptions)


• Ways to lower dosage errors in liquid medications by including a spoon or cup to accurately regulate a dosage

Continue reading "FDA Launches "Safe Use Initiative" to Lower Drug Dosage Errors" »

Brookstone Pharmaceuticals has issued a voluntary recall of all lots of its Concentrated
Acetaminophen Drops that come in 16-ounce bulk containers. According to a consumer safety alert issued by the U.S. Food and Drug Administration, the 16-ounce container is comparable to the size normally used to package regular strength acetaminophen liquid preparations. This aspect of the product combined with the absence of an integrated dosage delivery device could possibly contribute to dosing errors or inadvertent overdosing.

Overdosing on acetaminophen can cause a variety of complications including liver toxicity, kidney damage and blood disorders. The recalled drops were manufactured by Pharmaceutical Associates Inc. Consumers and those who have this unsafe product in their possession are asked to stop using it right away.

Drug makers, pharmacists and doctors have a duty to make sure that the medications they prescribe do not cause their patients injury or harm. Some drugs have dangerous side effects that can sometimes leave patients with long-term or lifelong damage. In some cases, mislabeling of drugs can cause dosage errors, which can also result in serious personal injury or death.

Continue reading "Brookstone Recalls Acetaminophen Drops Because of Overdosing Hazards" »

In a country in which more than 22 million Americans (7.7% of the country’s population) suffer from asthma, and 10-30 percent of adults and 40 percent of children suffer from allergic rhinitis, it is no surprise that asthma and allergy medications are widely used by children and adults alike. It would seem inconceivable that these same medications we are prescribed by doctors can cause “neuropsychiatric events” to those who consume them. Ky3.com reported in a story on June 22, 2009 that this is the unfortunate conclusion of an investigation by the Food and Drug Administration. The study has prompted the agency to issue an order to the makers of Singulair and other leukotrienes, a popular asthma and allergy medication, to place warning labels on their medications which would inform consumers of potential dangerous side effects.

A mother of a boy was shocked to find out that it was her son’s asthma medication that was causing his erratic behavior. She said, “He started hitting me and kicking and screaming at me, to the point where I had to lock myself in the bathroom.” She later found out that hundreds of other parents had experienced similar occurrences. One report from another mother said, “He said, ‘I’m just going to kill myself so I don’t have to see you anymore.’ ” The boy’s condition was remarkably better after he stopped taking Singulair.

According to the FDA’s report into the mood and behavioral changes associated with Singulair, Accolate, Zyflo and Zyflo Cr, cases were reported of agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor.

Continue reading "FDA Orders Asthma and Allergy Medication Warning Labels" »

The U.S. Food and Drug Administration is warning users of Zicam pharmaceutical products about serious adverse effects caused by these unsafe drugs that have reportedly caused loss in sense of smell among hundreds of consumers. According to an ABC News report, these over-the-counter Zicam cold remedies contain zinc, an ingredient scientists say may damage nerves in the nose needed for smell. The products affected by the FDA's announcement include adult and kid-size Zicam Cold Remedy Nasal Swabs.

According to the FDA, about 130 consumers have reported a loss in sense of smell after using Matrixx Initiatives' Zicam products since 1999. Zicam cold medications never received formal approval from the FDA because they were part of a small group of medications that are not required to undergo federal review. Loss in sense of smell can not only seriously affect your quality of life, but can also be potentially life threatening. For example, people without a sense of smell may not be able to detect hazardous situations such as a fire or a gas leak.

Continue reading "Zicam Cold Remedies Linked to Loss of Smell" »

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

Due to Hydroxycut use, there has been one reported death caused by severe liver damage and 23 patients have required liver transplant surgery. It has not been revealed to the public which ingredients in Hydroxycut damage the liver. Symptoms of Hydroxycut liver damage include jaundice, weakness, brown urine, fatigue, nausea and vomiting, abdominal pain loss of appetite, and/or itching. Hydroxycut products have also been linked to a rare muscle/kidney conditions, adverse cardiovascular events and seizure.

Hydroxycut over-the-counter drugs have been purchased by over $7 million people for weight-loss, energy-enhancement, low-carb dieting, and fat-burning applications. 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?

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 track of all your symptoms and any information regarding their characteristics and onset.

You are not alone if you find yourself asking, “Do I have a Hydroxycut case?” News of the recent FDA recall has provoked concern for consumers’ rights and you may have a potential Hydroxycut lawsuit, but time to file could be limited. The experienced personal injury attorneys in Pennsylvania at Anapol Schwartz are equipped with the resources, skills, and knowledge required for your Hydroxycut lawsuit. Recover the compensation you deserve. Call our Pennsylvania Hydroxycut lawyers today at 866-735-2792 for a free and confidential consultation.

The website philly.com reported in an account on March, 25 2009 that Philadelphia community groups and city council members urged the city’s law department to sue the drugstore chain CVS for continually selling expired products and exposing the public to unsafe drugs in Pennsylvania.

Shelley Smith, city solicitor, was called upon during the City Hall Press conference to follow California and New York legal action suits taken against CVS. CVS was sued in December by New York State for the sale of expired products. Edmund Brown, California’s Attorney General, requested in June 2008 that the pharmacy remedy its problem after coming across 26 Southern California stores. Currently, California is pursuing suing CVS.

Lance Haver, Philadelphia Community Affairs Director, said, “CVS should spend the money it needs to clear the shelves of expired products that are putting our children at risk.”

Maria Quinones Sanchez, Councilwoman, said, “CVS has been caught selling expired products in our City and around the country. It is outrageous that we are here today calling on a corporate citizen to remove dangerous products from the shelves.”

Expired products found at 15 CVS stores in Philadelphia ranged from infant formula, to over-the-counter medications, and dairy products. Tablets to treat allergies were over a year old and baby’s gas relief medicine was nearly two years expired.

Bill Greenlee, Councilman, stated that legal action was required to protect the community from dangerous items sold at CVS drugstores.

Consumer class action lawsuits in Philadelphia are among the most effective tools consumers have at protecting their power over the marketplace. When a large corporation does something that adversely affects a large group of people, a class action lawsuit enables all of the affected people to act with one voice.

Anapol Schwartz represents consumers, small businesses, and injured people in class action lawsuits throughout the country, seeking money damages and other relief in the federal and state court systems.

If you or someone you know been wronged or harmed due to a company’s negligence contact Anapol Schwartz. They have helped their clients for over years and they know the law and court system to get you the compensation you deserve. Please call the experienced Philadelphia personal injury attorneys at 1-866-735-2792 for a free consultation.

Genentech, Inc. made known on April 8, 2009 the phased voluntary removal of the psoriasis drug Raptiva (efalizumab) from the United States market. Raptiva is used by adults eighteen years or older with chronic moderate-to-severe plaque psoriasis. The company’s decision was determined by the connection of Raptiva with an increased risk of progressive multifocal leukoencephalopathy (PML). This neurological disease is caused by a virus that affects the central nervous system and can be fatal.

Although Raptiva’s prescribing information was updated in October 2008 to include boxed warning on the risk of serious infections, including PML, in patients receiving Raptiva, other serious bacterial and viral infections have been known to occur. Some of the kinds of infections that can be caused by the use of Raptiva are:

• Pneumonia
• Sepsis
• Meningitis
• Encephalitis
• invasive fungal disease

Unfortunately, as we see in Raptiva, sometimes a prescription or over-the-counter drug intended to help alleviate pain and infection, or reduce pain and suffering, can sometimes cause serious injury or even death. One of the many serious aspects of the Raptiva unsafe drug recall is the fact that a patient risks increased chances of worsening his or her psoriasis condition if Raptiva use is stopped suddenly. This is why it is critical for Raptiva users to consult with their physician as soon as possible to determine an adequate alternative for treatment.

Continue reading "Raptiva Unsafe Drug Recalled" »