Selective Serotonin Reuptake Inhibitors (SSRIs) are a class of anti-depressant medications that are known to potentially cause serious and life threatening birth defects in newborns whose mothers used an SSRI during pregnancy. One of these drugs, Zoloft, has been found to more than triple the risk of serious and deadly birth defects when taken during pregnancy.

Metallosis can also cause metal ions from the implant or particles to get into the bloodstream, which may result in symptoms or illnesses elsewhere in the body, including the possibility of cancer if the metal implant contains cobalt or chromium. This is called cobaltism, and this condition may include adverse effects on the heart, nervous system and thyroid gland.

Symptoms of metallosis include:

• Pain in the groin, hip or leg (for hip implants) or around the site of the implant
• Pseudo-tumors (a mass of inflamed cells made of collected fluids that resembles a tumor)
• Rash
• Osteolysis (destruction of bone tissue)
• Systemic effects related to metal hypersensitivity

DePuy Hip Implant Recalls

The FDA announced a recall of DePuy ASR total hip system products in August 2010. This recall was based on new, unpublished data obtained from the UK joint registry, which indicated the revision rates within 5 years were approximately 13 percent. Shards of metal from the DePuy ASR total hip system have been found to grind off, causing metallosis and resulting in increased levels of the dangerous metal ions.

Contact Us

If you or someone you love was fitted with an artificial joint, only to experience failure of that device or symptoms of metallosis, contact our office. We will listen to your story and explain your legal rights and options. You may be eligible for compensation for the physical, financial and emotional losses you have suffered as a result of your defective hip implant.

Use of the diabetes drug Actos for more than one year has been shown to increase risk of bladder cancer by 40 percent.

In June 2011, the FDA required a change to be made to the Actos label reflecting a 40 percent increased risk of bladder cancer for those who take Actos for more than one year. This announcement was based on the FDA’s review of an ongoing, ten-year study. The FDA also recommended that medical professionals not prescribe Actos to patients with bladder cancer or with a prior history a bladder cancer.

At the same time, results surfaced from a study conducted in France, which also linked Actos use with an increased risk of bladder cancer. As a result, use of Actos has been suspended in France, and Germany has advised doctors not to start any more patients on Actos.

Bladder Cancer Lawsuits Filed

In August 2011, the first lawsuits were filed against Actos manufacturer Takeda Pharmaceuticals blaming the diabetes drug for instances of bladder cancer. Victims are suing for financial compensation for the cost of hospital bills and loss of income, as well as physical and emotional suffering. Legal experts predict that these are the first of many Actos lawsuits that will be filed.

Heart Risks Also a Concern

In 2007, amidst an intense debate over the safety of Type-2 diabetes drugs, the FDA asked the makers of Actos to issue a black box warning about the serious risk of adverse cardiovascular events, including heart attack, heart failure and cardiovascular-related deaths. A black box warning is the strongest FDA-requested label change that can be added to a drug.

Are You Taking Actos?

If you are taking Actos and are concerned about the risk of bladder cancer posed by this medication, it is important to speak with your healthcare provider. Remember, it is crucial to speak with a qualified physician before changing your treatment regiment or stopping Actos. Patients who choose to continue use of Actos should be made aware of the possible side effect risks and the symptoms of these complications.

Have You Been Injured by Actos?

If you or a loved one has been diagnosed with bladder cancer after taking Actos for more than one year, you may be able to seek compensation for the associated physical, financial and emotional suffering. Please contact the qualified Actos attorneys at Oshman & Mirisola to learn more about your legal rights and options. We offer a free, no-obligation consultation during which we will evaluate your case and determine the best way to help you and your family.

What is Actos?

Oral diabetes medication Actos (generic: pioglitazone) is made by Takeda Pharmaceutical Company and co-marketed in the United States by Eli Lilly Pharmaceuticals. Actos is used to control type-2 diabetes in patients whose condition is not adequately controlled by diet and exercise alone. Actos belongs to a class of drugs called Thiazolidinedione drugs, which work to lower blood glucose levels and increase the body’s sensitivity to insulin. Pioglitazone may be prescribed alone (as Actos) or in combination with other active ingredients such as metformin (sold as Actoplus Met) or glimepiride (sold as Duetact). A patient’s drug regiment may also include insulin or other medications in addition to those containing pioglitazone.

Actos has been favored for its once-a-day dose and its success with controlling blood sugar. Once competing drug Avandia was linked to serious risk of heart attack in 2006, Actos’ popularity quickly increased and sales had climbed from $2.9 billion to $4.3 billion by 2010. Sales are likely to take a hit with the revelation of the research linking long-term Actos use to bladder cancer.

Side Effects from These Drugs
Dutasteride & finasteride have been shown to cause negative side effects including:

• High-grade prostate cancer
• Low sexual desire
• Erectile dysfunction
• Problems with orgasm

FDA Warning: High-grade Prostate Cancer Risk

In June 2011, the Food and Drug Administration (FDA) issued a safety alert to doctors and 5-ARI users warning them of the increased risk of high-grade prostate cancer linked to use of finasteride and dutasteride. Use of these drugs decreases men’s chance of contracting low-risk prostate cancer, but the risk of high-grade cancer is increased for men who take a 5-ARI. High-grade cancer is aggressive and spreads more quickly than low-risk forms. The FDA states that the drugs’ benefits outweigh the risks but has requested that doctors do an individual benefit/risk analysis for each patient before prescribing Propecia, Proscar or Avodart.

The FDA reviewed the results of two large, placebo-controlled trials published in the New England Journal of Medicine: the Prostate Cancer Prevention Trial (PCPT) and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial. The results of PCPT showed that users of finasteride (Propecia or Proscar) have a 63 percent higher risk of developing high-grade prostate cancer. The risk for men taking dutasteride (Avodart and Jalyn) is double the rate of men taking a placebo, according to REDUCE.

Persistent Sexual Side Effects

Journal of Sexual Medicine
Abdulmaged M. Traish, a professor of biochemistry and urology at Boston University School of Medicine and a B.U. colleague, along with Dr. Andrew T. Guay of the Center for Sexual Function/Endocrinology at the Lahey Clinic, Northshore, in Peabody, Mass.; a reproductive medicine specialist from Muenster, Germany; and an ob-gyn from Stavanger, Norway; reviewed available scientific studies on the adverse effects of finasteride and dutasteride for an article published in the March issue of the Journal of Sexual Medicine.

Findings:

Their review found that approximately 5-23 percent of those who used the drugs experienced sexual side effects. Half of this unfortunate group had persistent issues that did not stop when discontinuing use of the drug.

If you have been suffering sexual side effects while taking Propecia, Proscar or Avodart, contact our firm for a FREE case review by calling 800-400-8182.  The call is free and there is no obligation.

George Washington University Medical School Interviews
Also in March of this year, Dr. Michael Irwig of George Washington University’s medical school released the finding of a study he conducted along with Swapna Kolukula of the Greater Baltimore Medical Center in which they interviewed 100 men, aged 21-46 who experienced sexual side-effects after using finasteride. Results for 71 of these interviews were used in the study after excluding those who had medical histories of sexual dysfunction or complex past prescription use that may influence the findings. The goals were to assess how long they took finasteride, the type and duration of sexual side effects, and the sexual frequency before and after the medication.

Findings:

• 94 percent developed low libido.
• 92 percent developed erectile dysfunction and decreased arousal.
• 69 percent developed problems with orgasm.
• Participants had used finasteride for an average of 28 months and had chronic sexual problems for an average of 40 months from the time they stopped taking the drug to the time they were interviewed for the study.
• The average number of sexual episodes per month dropped by over 2/3 after finasteride use. (from 26 to 8 times/month).

Dr. Irwig says, “This is the first series to find that symptoms persisted for at least three months despite stopping finasteride. Three months was the minimum, but some of these guys had sexual symptoms for years, some … for 5 to 10 years after. These were young guys with no medical problems, no psychiatric problems, who happened to develop these side effects.”

Medication Labeling
While the labeling on the medication in the United States currently warns about possible reversible sexual side effects, there is no reference to the effects being persistent. Other countries, including the United Kingdom and Sweden, have documented persistent risks and required medical companies to include them in labeling.

What’s Next?
Merck and Co Inc. is currently fighting a number of lawsuits involving their drugs in both Canada and the United States. If you have taken dutasteride (Avodart & Jalyn) or finasteride (Proscar & Propecia) and have experienced persistent sexual dysfunction or high-grade prostate cancer you may have a legal case for damages against the drug manufacturer for the injury of erectile dysfunction and, if applicable, for a loss of consortium for your wife. To get a free claim evaluation with no obligation, contact us today. We will find answers, hold negligent companies responsible, and fight to get you the compensation you deserve.

You may also call us for FREE at 800-400-8182

Several patients have already reported these serious side effects and many people continue to be prescribed this drug combination without fully understanding the inherent risks.

The 2002 FDA warning

In 2002, the FDA first warned the public about the serious risk of rhabdomyolysis associated with taking simvastatin (Zocor) in combination with amiodarone.  Despite this initial warning, patients continued to receive this drug combination.

The 2008 FDA warning

In 2008, the FDA issued another warning about the risk of serious muscle diseases (myopathy) associated with Zocor.  The regulators explained that the new warning was necessary because more than 50 patients had developed rhabdomyolysis between 2002 and 2008.

According to the 2008 Zocor warning, the risk of developing rhabdomyolysis, myopathy, and kidney problems increases with higher doses of Zocor (simvastatin).

The 2010 FDA Zocor warning

Just last month, in March 2010, the FDA issued yet another warning over Zocor.  This time the drug agency warned about the risks of taking 80 mg doses of simvastatin in Zocor and other medications with the same active ingredient, including Vytorin and Simcor.

The FDA explains that the risk of rhabdomyolysis is greater when simvastatin is given in higher doses and in combination with amiodarone.  This risk is greater for simvastatin—Zocor—than it is for other statin drugs.

All patients who are taking Zocor should speak to their doctor about the risks of muscle disease, kidney failure, kidney disease and death associated with this drug.  Any patient who experiences any muscle or kidney related symptoms (discussed here) should consult with a doctor immediately.  If you have suffered serious injury as a result of taking Zocor, please contact our law offices today for a free and confidential evaluation of your case.

The death toll reached 15, with 13 killed instantly and two others dying later from injuries sustained in the crash. The driver and 18 passengers were injured, five of them critically. The scene of the accident was grisly, with at least one of the passengers decapitated and severed limbs among both survivors and deceased.

The bus, en route at about 5:30 a.m from the Mohegan Sun casino in Uncasville, Connecticut to Manhattan’s Chinatown neighborhood, was traveling on Interstate-95, a major highway in the Bronx. According to the bus driver, Ophadell Williams, the tour bus was in the right hand lane, and a tractor-trailer passing in the center lane clipped the bus. In an effort to evade the truck, Williams swerved causing the bus to hit the guardrail, topple over, and skid along for 300 feet. The real devastation occurred when the bus careened into a support post for a highway sign. The pole entered through the front window and, due to the bus’s velocity, sheared through the entire length of the bus, cutting through the seating area along the passenger window line and peeling the whole roof off.

The results were catastrophic. 13 people were killed immediately. Many people were hurled to the front of the bus upon impact. When the bus came to rest, passenger Chung Ninh, 59, found himself hanging upside down, held in by his seat belt. He tried to assist fellow passengers, but the first one he found was a dead woman. The driver told him to “forget this one, help another one.” Ninh and other able passengers were able to escape through a skylight. Another passenger, Jose Hernandez, said people were “screaming for help.” He tried to help people but said there was twisted metal in the way.

Rescue teams arrived quickly and found a scene of carnage. Captain James Ellson, a 20-year veteran of rescues and fires, was among the first on the scene and found “a pile of humans, either still in their seats or on the floor, wrapped in the metal, wrapped in the wreckage. They were in the full length of the bus; from the front to the rear there were bodies.”

The bus’s driver Williams said he may have been clipped by a step sticking off the read end of the tractor-trailer, but passengers have not yet corroborated his story. Passenger testimony has been difficult to attain as the passengers in the front who were most likely to have witnessed the crash are either deceased or critically wounded, and the passengers in the back are most able to give testimony but did not see the accident clearly. Authorities have received reports that the bus was exceeding the posted speed on the Interstate of 55 miles per hour. Results are pending for drug and alcohol tests of the bus driver’s blood.

In an evening news conference on March 12, Major Michael Kopy of the State police said authorities tracked down a trailer on Long Island and a tractor in Westchester County. Both have been seized and taken to a police compound in Farmingdale to determine if they may have made contact with the bus.

Video from a camera aboard the bus has been obtained, which authorities will analyze. There are also surveillance cameras on the stretch of Interstate-95 near the crash, but most are traffic cameras with no recording capability.

The tour bus is operated by World Wide Tours, a company based in Brooklyn. The statement issued by the owners of World Wide Tours expressed sympathy for the victims and their families. The company said they are cooperating with investigators.

According to the federal Motor Carrier Safety Administration, World Wide Tours was recently flagged by federal regulators for issues with fatigued drivers. Although its overall safety record was satisfactory, the company’s buses have been involved in two crashes resulting in passenger injuries in the last two years.

All the evidence is being reviewed by authorities to determine who was at fault for the disastrous crash. For now, Major Kopy said the crash is being handled as a criminal investigation.

Many, including those within the Administration, feel that the FDA should maintain a healthy antagonism toward the pharmaceutical industry, and that industry funding for FDA research offsets the balance of power between the two sides. These concerns are not unfounded. The pharmaceutical industry has undoubtedly gained leverage over the FDA through PDUFA. But given the current economic climate, there are few other practical funding options. With that in mind, Congress should aim to allocate a larger portion of the New Drug Application fee to the postmarket drug safety system, thereby ensuring that if a drug with harmful side effects does manage to slip through the review process safety net, the FDA recall will be quick and efficient. 

The FDA is in dire need of funding. According to the 1991 final report compiled by the Advisory Committee on the FDA, “Grave resource limitations impose sometimes staggering burdens on the Agency.”[1] The Institute of medicine went so far as to say that the administration was “begging for resources to do its job.”[2] This should never be the case with a program whose primary function is protecting the health of the American people.

PDUFA has undoubtedly helped reduce the funding problem. According to a study conducted by the School of Public Health and Health Services at George Washington University, “In FY 2006, PDUFA funds accounted for 42.5 percent of FDA’s total human drug program budget of $521 million (and for more than half the funds dedicated specifically to drug review).”[3] Since its inception in 1992, the act has helped increase the size of the FDA’s application review staff; as a result, the median review time for standard new drugs has decreased from 27 months in 1993, to 10.5 months in 2004.[4]  Unfortunately, when reviewing long-term drug side effects, speed and quality are not synonymous. As previously mentioned, under PDUFA the FDA is provided deadlines for its response to each NDA. Studies have shown that those drugs approved within the days and weeks closest to PDUFA deadlines are more likely to undergo labeling revisions and FDA recall.[5] One concludes then that pressure created by deadlines affects review quality.

In 2004, pharmaceutical giant Merck pulled its leading arthritis medication, Vioxx, from market. Postmarket studies found that the drug, approved as safe and effective by the FDA in May of 1999, significantly increased the risk of heart related side effects. At the time of its withdrawal, the drug had been prescribed to more than 84 million people worldwide.[6] Though perhaps the most publicized, the Vioxx incident is far from the only such instance of a faulty drug reaching the market. Another pharmaceutical powerhouse, The Warner Lambert Company, fabricated tests results so as to push three of their drugs through the NDA process. Amongst the drugs passed was Dilantin, an antiepileptic known to increase suicide risk in users. Clearly, pharmaceutical industry pressure affects the efficacy and reliability of the drug review process.

And yet, some maintain that the pharmaceutical industry’s interests are in line with those of the FDA. If drug companies push to release unsafe drugs, PDUFA advocates say, those companies will inevitably face consequences when their respective drugs face FDA recall. Pharmaceutical industry advocacy groups such as the Pharmaceutical Research and Manufacturers of America (PhRMA) argue vehemently against the repeal of PDUFA. In a 2006 press release, PhRMA stated, “fewer than three percent of approved prescription drugs have been withdrawn from the market for safety reasons over the last twenty years.”[7]—citing this statistic as proof that the industry had not abused its aforementioned leverage.

Anyone with a healthy amount of skepticism will see the fragility of these statistics, however. Assuming the approval of only 18 New Molecular Entities (NME) per year (this, the number of NMEs approved in 2006, was the lowest in a decade[8]), there are 360 NMEs approved every 20 years. If three percent of these NMEs are recalled, that’s nearly eleven drugs with harmful side effects that have slipped through the FDA safety net. Now, if each of those eleven recalled drugs is prescribed to just half the number of people as Merck’s Vioxx, that’s over 400 million people, or more than the population of the entire United States, consuming a potentially harmful drug. Evidently, even a three percent failure rate is too high.

Unfortunately, the economy is not as strong as it once was. Financial strains have made it nearly impossible for the government to fund FDA research without outside help. And so the FDA needs to check pharmaceutical industry pressure with one of the few tools it has left at its disposal: The postmarket safety system. The postmarket safety system is the series of reevaluations a drug faces after reaching market. Effectively, it is the FDA’s ability to recall or relabel a drug that has already been approved. In the most recent resigning of PDUFA, the act included a clause mandating the allocation of PDUFA fees to post-market safety. This is the first time the act included such a clause, and the results have been excellent. The smoking cessation drugs Chantix and Zyban, for instance, were recently relabeled to warn users against potentially harmful mood altering side effects.[9] Similarly, the FDA advisory committee recently urged for prescription painkillers such as Vicodin and Percocet, which combine opiates with acetaminophen, to be banned.[10] These postmarket alterations show not only that drugs with harmful side effects do slip through the FDA’s safety net, but also that a strong postmarket safety system is necessary and effective.

With PDUFA IV, the most recently signed version of PDUFA, an allocation of approximately $29.3 million was set aside for the enhancement of the postmarket safety system.[11] The positive effects of this allocation are clear. With the act setting a base target revenue of $392.8 million, however, the small fraction allotted to postmarket regulations is not enough. To ensure that pharmaceutical industry pressure doesn’t flood the market with unsafe drugs, a larger allocation of funds should go towards monitoring drug recall and relabeling.

Written by Nick Bakshi

[2] Committee on the Assessment of the US Drug Safety System, Institute of Medicine, The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: National Academy of Sciences, 2007. 

[3] Wood , Susan . “Reauthorizing the Prescription Drug User Fee Act: How are PDUFA, the FDA Budget, and Drug Safety Related?.” Rapid Public Health Policy Response Project (2007): Print.

[4] Wood , Susan . “Reauthorizing the Prescription Drug User Fee Act: How are PDUFA, the FDA Budget, and Drug Safety Related?.” Rapid Public Health Policy Response Project (2007): Print.

[5] Wood , Susan . “Reauthorizing the Prescription Drug User Fee Act: How are PDUFA, the FDA Budget, and Drug Safety Related?.” Rapid Public Health Policy Response Project (2007): Print.

[6] Knox, Richard. “Merck Pulls Arthritis Drug Vioxx from Market.” NPR Web.6 Jul 2009. <http://www.npr.org/templates/story/story.php?storyId=4054991>.

[7] Press release, “PhRMA Statement on the IOM Drug Safety Report.” Sept. 22, 2006.

[8] Owens, Joanna. “2006 Drug Approvals: Finding the Niche.” Nature Reviews Web.6 Jul 2009. <http://www.nature.com/nrd/journal/v6/n2/full/nrd2247.html>.

[9] “Public Health Advisory: FDA Requires New Boxed Warnings for the Smoking Cessation Drugs Chantix and Zyban.” U.S. Food and Drug Administration 07 Jan 2009 Web.6 Jul 2009. <http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm169988.htm>.

[10] “FDA Panel Urges Ban on Vicodin, Percocet.” AJC 30 June 2009 Web.6 Jul 2009. <http://www.ajc.com/health/content/shared-auto/healthnews/arth/628586.html>.

[11] Wood , Susan . “Reauthorizing the Prescription Drug User Fee Act: How are PDUFA, the FDA Budget, and Drug Safety Related?.” Rapid Public Health Policy Response Project (2007): Print.