News

June 9, 2010
Actos Manufacturer's Lawyers Agree With Plaintiff Motion For Consolidation
Thursday, October 27, 2011 - 11:43

Pre-trial Federal Actos bladder cancer lawsuits have been combined for litigation after lawyers for Takeda Pharmaceuticals, the maker of the drug, agreed with an August motion by two plaintiffs that all cases should be consolidated; however, they do not agree on where the proceedings should take place.

In late September, Tadeka lawyers filed a letter of response with the United States Judicial Panel, agreeing with the multidistrict litigation, but they also wished for the cases to be held in the Northern Distinct of Illinois, where the company’s headquarters are located. They also proposed that the cases be heard in the Western Distinct of Louisiana because there are over a dozen cases pending in that region.

According to Tadeka Pharmaceuticals, there are at least 54 cases that have been filed in various federal districts across America. New complaints continue to arise, and more cases are expected to emerge. The first lawsuit against Actos was filed on July 29 of this year.

Every lawsuit involves similar claims that the side effects of Actos caused the development of bladder cancer in those who took the drug. In addition, the plaintiffs claim that Tadeka failed to conduct thorough research on the effects of taking the drug and did not properly warn potential users against the risks involved.

Attorneys for the drug company do not agree with any of the claims launched against Tadeka by the plaintiffs, but they agree that the cases should be consolidated for multidistrict litigation. They also agree that consolidation will lessen the chances of conflicting rulings and duplicate discovery.

In July 1999, the FDA approved Actos for the treatment of Type 2 diabetes. The drug was formulated to help the body control blood sugar levels. To this day, it is a very popular medication which generated over $4 billion dollars in sales for Tadeka Pharmaceuticals last year.

In September of 2010, after a 10- year study, the FDA began looking into the risks of taking Actos. The decade long study revealed that the risk was for developing bladder cancer increased significantly with long use of the drug.

France recalled Actos in June of this year after studies showed a risk for an increase in users developing bladder cancer. The European Medicines Agency reviewed the drug’s link to bladder cancer and issued new warnings about taking the drug. In addition, they called for a six-month investigation into all patients who took Actos.

On December 1, the United States Judicial Panel will begin listening to oral arguments on the motion to consolidate the cases against the drug Actos. The proceedings will take place in Savannah, Georgia.
 

European Drug Regulator Calling For New Warnings on Actos
Monday, July 25, 2011 - 12:08

A Reuters report was released this past week claiming that the European Medicines Agency (EMA) is stressing new warnings that link Actos to bladder cancer. The diabetes drug is said to have less of a negative impact with greater focus on patient selection.

Actos, which is developed by Japanese company Takeda Pharmaceutical, will likely carry warnings issued from the European Union because of this link to bladder cancer. The results were reported to come after a safety review conducted by the European drug regulator.

The EMA had a specialized committee (The CHMP, or Committee for Medicinal Products for Human Use) who was responsible for reviewing the issues with Actos. In their findings, they stated that the benefits of the drug for some diabetics may still outweigh the potential for risk. The future warnings could include a multiple month review of the performance of each drug on individual patients. The CHMP is said to be continuing research on Actos to find specifically if the risk is affected by determining factors such as age and duration of use.

This decision comes after last month’s choice from France and Germany to suspend the use of Actos and a similar drug. French researchers found a link to an increased risk of bladder cancer in the process, resulting in a recall of the drug.

The story states that the U.S .FDA recently released a statement on Actos, saying that it would soon add information relating to the potential risk of bladder cancer after long term use. This came following the results of the FDA safety review last September; they also claimed that the drug would continue to remain on the market for now.

Actos was approved as a diabetes treatment drug in Europe in 2000 and has continued to grow ever since. Last year, Takeda Pharmacies was reported to take 27 percent of its total revenue from the selling of Actos. The report states that the diabetes drug had reached $4.8 billion in sales up to March 31.  

Actos’ major competitor is Avandia, which is developed by GlaxoSmithKline. It has already been pulled in Europe following several cases which tied use to increased heart risks. Avandia also had an extensive list of restrictions which were placed on the drug in the United States.

Reference:

Hirschler, Ben. (July 21, 2011). “EU agency calls for new warnings on Takeda’s Actos.” Retrieved on July 25, 2011 from Reuters

Fosamax at the center of FDA review involving cancer risk
Monday, July 25, 2011 - 10:22

According to an Associated Press story this week, the FDA has announced that it’s investigating bone-strengthening drugs due to a possible increase in throat cancer. This report comes after a number of differing research pieces on the subject has had conflicting results.

Major brands such as Fosamax and Boniva are two of the big name bone strengthening drugs which are often prescribed for postmenopausal women. The report states that FDA representatives have yet to reach a final decision on the issue and that it will require an extensive review moving forward.

The release from the FDA states that they will continue to review the risk of esophageal cancer following the use of Fosamax, Boniva, Actonel and similar drugs. Some previous research has indicated that these medications can double the risk of esophageal cancer when used, but there is certainly some conflicting data present.

The story claims that there was British research conducted in 2008 focusing on nearly 3,000 esophageal cancer patients, which found that a slightly higher rate of cancer risk than normal for those who used the drugs. The conflicting reports include a similar study conducted in the U.K. on 80,000 patients around the same time which found no link from the drugs to cancer.

The report states that bisphosphonates such as Fosamax have already been proven to cause inflammation within the esophagus. Because of this previous link, some researchers have been thought to believe that the inflammation could signal bigger effects, such as cancer.

This story comes on the heels of an upcoming separate review by the FDA on Fosamax and similar drugs based on claims that they cause jaw problems and bone fractures. An FDA advisory committee is set to meet on September 9 to discuss whether long term use is safe and to find a recommended duration of use.

For a long time now, bisphosphonates have been previously tied to increasing risk of jaw issues. Reports have previously claimed that the drugs can cause the jaw bones to rot and decay, requiring jaw surgery to correct the issues.

Fosamax has already been linked with a number of different health problems in the past. The drug has primarily been tied to claims of femur and other body fractures which are tending to occur with little trauma. With the growing number of reports, Fosamax has also been at the center of numerous lawsuits because of a perceived failure to give proper warnings about the drug’s risks.

Reference:

The Associated Press. (July 21, 2011). “FDA reviewing potential cancer risk with bone-strengthening drugs after conflicting studies.” Retrieved on July 25, 2011 from the Washington Post

FDA continuing to review vaginal mesh implants
Monday, July 18, 2011 - 15:38

According to a Los Angeles Times report this month, the U.S. Food and Drug Administration has released an updated warning focused on surgical mesh that is implanted into women to help strengthen their vaginal tissue.

The FDA was quoted as saying that they have conducted a review of literature and reports that show little evidence that the vaginal mesh implants help pelvic organ prolapse. Not only did the reviews find little advantage to using the mesh implants, but they also found numerous risks.

The report states that in September the FDA held an expert panel meeting to discuss the future of the product. Right now, it’s estimated that around 75,000 women who used vaginal mesh were treated for pelvic organ prolapse.

Warnings began to pop up concerning the vaginal mesh in 2008, mainly because of numerous reports which began to arise after 2005. According to the Times article, the FDA warned doctors to get special training in the placement of mesh. Since the 2007 FDA warning, there’s been an influx in complaints relating to prolapse repair.

According to the article, medical devices are often cleared without the requirement of clinical trial data. With these limited restrictions, a number of different products which are considered similar to other ones can be approved for selling.

The FDA is set to continue overseeing these vaginal mesh implants in all forms, to see if they may run the same level of risk. The agency has been under criticism for a few years due to the approval process for medical devices.

The report states that any future banning on the vaginal mesh products are highly unlikely, even if they required approval applications. FDA representatives have been quoted as saying that removing the products right now wouldn’t be appropriate. The agency is said to be planning on continuing spreading information to health care providers and patients concerning the possible risks associated with the products.

Mai Duc, Christine. (July 13, 2011). “FDA reevaluating vaginal mesh implants.” Retrieved on July 18, 2011 from the Los Angeles Times. 

DePuy prosthetic lawsuits continue to grow
Monday, July 18, 2011 - 09:19

A recent Wall Street Journal report chronicles the struggles of DePuy and Johnson & Johnson, who continue to face mounting lawsuits centered on their hip replacement products, specifically the ASR system. The article claims that over 1,000 lawsuits have been filed in both state and federal court, accusing Johnson & Johnson of knowing about the problems their products caused well in advance.

The WSJ report cites analysts who estimate that these hip replacements could end up costing Johnson & Johnson more than $1 billion in liability costs. Many of these cases have already been consolidated in Ohio. The article states that many are pushing for a class action suit, which would end up combining other cases into a single lawsuit. These mass litigation suits often turn out multi-million dollar deals and verdicts.

There’s an estimated 93,000 patients worldwide that have used the recalled device. Many of the claimants are saying that medical tests revealed cobalt and chromium in the bloodstream. The patients have said that the toxic metals have reached the bloodstream because the parts from the joint wear down and enter the system.

Another topic of complaint has been the fact that patients have also referenced different types of pain and inflammation as reasons for replacement. Among the many mentioned include urinary tract infections, fevers and other health issues. DePuy refuses to bridge the connection between the particles in the bloodstream and their parts, but spokespeople for the company have admitted that the devices contain chromium and cobalt.

One lawsuit that sits out right now involves a California woman who experienced a multitude of issues after using DePuy devices. The woman contends that not only did she have high amounts of chromium and cobalt in her blood, but also had fevers and urinary tract infections. This woman’s suit was recently consolidated with other similar cases.

The FDA released a warning in May, citing the fact that chromium and cobalt particles could wear off and end up within a patient’s blood. The FDA mentioned that this could lead to heavy amounts of cobalt and chromium within the blood, but didn’t specify whether the cobalt and chromium would cause symptoms.

After countless complaints and FDA interference, DePuy decided to recall some of their hip replacement devices in fall 2010. Right now, the impending cases will depend on just when DePuy was aware of the issues with its hip replacement products. If it’s found that the company knew well in advance of complications involving the device, damages are likely to be high.

References:

Rockoff, Jonathan D. and Searcey, Dionne. (July 8, 2011). “Hip Joints Set Off New Rush to Court.” Retrieved on July 18, 2011 from the Wall Street Journal

Fosamax, other osteoporosis drugs to be discussed by FDA panel
Monday, July 11, 2011 - 09:36

According to a Wall Street Journal report this week, osteoporosis drug Fosamax and similar products are going to be discussed by an FDA panel this summer. The panel will meet in September to go over the long term safety of the drugs.

The class of medications is known as bisphosphonates and has been tied to multiple thigh fractures and jaw problems when used for long periods of time. Aside from Fosamax, the report states that other drugs under review will include Actonel, Boniva, and Reclast.

The article states that bisphosphonates are currently being used by nearly 5 million Americans. In the past these drugs have been praised for their ability to build up bone mass, while cutting down the development of osteoporosis, but recent reports have tarnished the drug’s reputation. According to the WSJ report, there have been over 300 previous cases of femur fractures with patients who are taking Fosamax. In most cases, these patients have taken the drug for over five years.

The article claims that the FDA is not making a firm statement on the drug at this time. It says the FDA is claiming that it’s not clear whether the drugs were the cause of long term susceptibility, bone damage and fractures.

Although the FDA is staying mum currently, they did issue some news on Fosamax in 2010. They released warnings which mentioned the risk of fractures related to long term use of Fosamax. Since the FDA issued this original release, Fosamax and its manufacturer have been the focus of a growing number of lawsuits.

According to multiple other news reports this week, a Hawaii woman with osteoporosis sued the drug maker after breaking a thigh bone. The suit called out Fosamax distributor Merck & Co. in claiming that the drug has the opposite effects of what it’s intended to do. The woman claimed the osteoporosis drug made bones more brittle over time, rather than strengthening them.

In June, numerous Fosamax lawsuits were consolidated in the District Court of New Jersey. The decision included 37 separate cases that were pending throughout district courts all over the nation. There are also nearly a 1000 lawsuits involving Fosamax in New York alone involving jaw problems, as the source of another multi district lawsuit.

References:

Consillio, Kristen. (June 30, 2011). “Isle woman sues drugmaker after breaking thigh bone.” Retrieved on July 11, 2011 from the Honolulu Star

Corbett, Jennifer. (July 8, 2011). “FDA Panel to Discuss Safety Of Osteoporosis Drugs.” Retrieved on July 11, 2011 from the Wall Street Journal

Tylenol batch recalled over odor and gastrointestinal issues
Thursday, July 7, 2011 - 13:59

According to multiple reports including a Wall Street Journal briefing, Johnson & Johnson has recalled nearly 60,000 bottles of the pain killers. The recall centers on Tylenol extra strength and cites an odor problem as the main issue for the recall. Representatives claim there has been a string of recent complaints identifying a distinct odor smell with their Tylenol bottles and pills.

The extra strength pills in question are those which were developed and distributed in February 2009 within the United States. According to the Wall Street Journal report, the 60,000 or so bottles of Tylenol Extra Strength carry about 225 individual caplets a piece.

Tylenol is developed under a subsidiary of Johnson & Johnson, known as McNeil. Representatives from McNeil claim that the musty and moldy odor is tied to amounts of 2, 4, 6 tribromoanisole (TBA). The chemical is said to be a byproduct of another material that is often applied to the wooden pallets that are used during the transportation and storage processes for Johnson & Johnson. According to WebMD, this compound has been known to relate to some transient gastrointestinal issues. Even though these gastrointestinal symptoms are likely to be temporary, they are not to be taken lightly.  

This marks the 24th recall within the past calendar year. The company has also had to issue recalls for other over the counter drugs, prescription medicine, hip replacements, and contacts. Among the major names involved in recalls with Johnson & Johnson are both Tylenol and Motrin.

In March, McNeil issued a recall for about 34,000 bottles of Tylenol Extended Release caplets for a similar foul odor. Then in April, the same division of Johnson & Johnson released another recall of about 57,000 bottles of Topamax, citing another musty odor as the reason. The odor has also been the source of recalls involving antipsychotic drug known as Risperdal and the HIV drug called prezista.

U.S. health administrators have promised to keep a close eye on the manufacturing plants of Johnson & Johnson ever since the odor has become a recurring issue. All together, the plants have produced nearly 300 million bottles of recalled medicines and that’s just for over the counter drugs.

Customers are advised to quit taking the Tylenol products in question and contact manufacturers. Matching product numbers are available on the side of the bottle; the recently recalled lot has a number of ABA619.  

References:

Hendrick, Bill. (June 29, 2011). “New Tylenol Recall Due to Musty Odor.” Retrieved on July 7, 2011 from WebMD

Hobson, Katherine. (June 28, 2011). “J&J Recall Watch: Extra Strength Tylenol Pulled Due to Smell.” Retrieved on July 7, 2011 from the Wall Street Journal

Zoloft, other antidepressants being linked to autism risk
Wednesday, July 6, 2011 - 15:29

According to a report from Time this month, a group of antidepressants are being linked to a greater risk of autism spectrum disorder (ASD). The report states that studies show women taking some of these antidepressants are twice as likely to give birth with an autistic child as those who don’t take them.

Time says that the research was taken on serotonin reuptake inhibitors (SSRI’s), a major class of drugs that include Prozac, Paxil and Zoloft, among others. These SSRI’s have already been the focus of continued controversy surrounding a link to many other birth defects.

The report states that it was based off a 1,800 child study which measured nearly 300 children with ASD being analyzed against 1,500 kids without the disorder. A major hurdle for the research is the fact that family depression and anxiety are generally common within those with ASD. Time reports that researchers used specific methods to separate the contributing factors.

The article states that researchers found little to no association with maternal depression when studying the treatment methods. This means that they were able to take a singular view on the risk of antidepressant treatment during pregnancy as a possible connecter to ASD in children.

Moving forward, these results seem to present a rather tough decision for pregnant women in the coming future. Time reports that around 10 percent of women are regularly treated for depression during their pregnancy and leaving it untreated could be dangerous for the child as well.

The report states that representatives at the Autism Research Program (they ran the research) are still suggesting that women keep taking their medication, regardless of the findings. Time mentioned that SSRI antidepressants are all currently classified as Category C, which means they haven’t been proven safe or unsafe for women who are pregnant.

As previously stated, this is not the first time these SSRI antidepressants have been an issue for pregnant women. Zoloft, Paxil and Prozac, along with numerous others have been linked to birth defects for some time now. They range from Persistent Pulmonary Hypertension and other heart defects, to cleft lip and palate, as well as limb defects, among others.

Given the history of SSRI’s and their connection with other birth defects, this news is critically important. These recent findings linking antidepressant use during pregnancy to autism within children will certainly continue to spark conversation and further investigation into a more detailed view of the relationship between the two.

References:

Park, Alice. (July 5, 2011). “Antidepressant Use During Pregnancy Linked to Higher Risk of Autism.” Retrieved on July 6, 2011 from Time

Chantix: Further research ties drug to heart problems
Wednesday, July 6, 2011 - 09:27

According to a CNN report, new research from a Canadian Journal concludes that Chantix, a smoking cessation drug, could raise the risk of heart problems. Just last month the U.S. Food and Drug Administration cited research showing a similar link between Chantix and heart problems.

The black box warning that the drug carries from the FDA is one of the most severe and restrictive labels that can be assigned, often issued to drugs with numerous side effects. According to the report, Chantix has been the subject of a long list of concerns that continue to grow with mounting lawsuits, warnings and research studies.

The controversy surrounding Chantix has often centered on numerous psychological issues that may occur while taking the drug. It has previously been linked to mood swings, depression, suicidal tendencies and hostility.

According to the report, the recent study was conducted in the Canadian Medical Association Journal and included around 8,200 people who took either a Chantix or a placebo. There was a noticeable difference in the risk of heart problems between the two groups. The CNN report mentions that a statistical evaluation which combines previous studies calculates around a 72 percent risk of increased heart problems.

Just last month the FDA issued a warning to the drug which stated that it may be connected to a small risk of cardiovascular events, especially in those who have cardiovascular disease. Some doctors are already having doubts about prescribing the medicine. In the CNN report, Dr. Sonal Singh (one of the authors of the most recent Chantix study) has said that he is already hesitant to prescribe the drug. This is primarily because smokers tend to have cardiovascular issues to begin with and that Chantix seems to amplify that.

Chantix manufacturer, Pfizer stands firmly that there is no statistical evidence that the drug has been the direct cause of psychological issues. This evidence is hard enough to prove because smokers often have some mental health problems, as depression and some other issues are higher in those who smoke.

According to CNN, Pfizer is currently facing nearly 2,000 pending cases that blame Chantix for psychological issues. The article mentioned that nearly a third of these cases focused on suicidal tendencies or attempts, while 10 percent center on blackouts or seizures. The report also stated that half of the cases involve issues like psychiatric injury, chemical imbalance and depression.

References:

Park, Madison. (July 5, 2011). “Heart risks added to Chantix health concerns.” Retrieved on July 6, 2011 from CNN Health

Depakote use during pregnancy could harm kids’ intellectual abilities
Tuesday, July 5, 2011 - 16:01

According to a US News report last week, epilepsy drug Depakote has been tied to more risk of birth defects recently. The U.S. Food and Drug Administration released a statement to doctors warning women that fetal exposure to some seizure, epilepsy and migraine drugs can have negative effects on intellectual ability in their children.

The report states that the FDA claims that women who take certain medications during their pregnancy could have an increased risk of lower cognitive abilities than children why may be exposed to some other medicines during pregnancy. The medications in question include Depakote, Stavzor and some of their generic counterparts.

The research is said to be based on epidemiological studies that compared fetal exposure and IQ scores and other cognitive tests, according to US News. Depakote and its generic counterparts are approved for use to combat migraines, epilepsy and bipolar disorder. The report states that the FDA said the drugs are often used for off label purposes as well.

Already tied to other birth defects like neural tube issues and pulmonary hypertension, Depakote was also the subject of a late 2010 study in Sweden which spotlighted underperforming teenagers who were born after use of the drug during pregnancy.

The FDA is suggesting that any women who have epilepsy begin planning their pregnancies. This would allow doctors to come up with strategic treatment plans and prevent some of the dangerous exposure during the pregnancy.

Depakote has been under fire for a while now, as the FDA issued a black box warning in 2006 which linked a potential risk of birth defects to use of the epilepsy drug. Some of the common birth defects that have been tied to the drug include cleft palate, abnormal development, limb defects, and spina bifida.

The drug has also been proven to cause some problems when being used as early as the first trimester. This meant that women could have trouble preventing birth defects even if using Depakote before they even knew they were pregnant.

References:

HelathDay News. (June 30, 2011). “Fetal Exposure to Common Epilepsy Drugs May Harm Kids’ IQ: FDA” Retrieved on July 5, 2011 from U.S. News and Report