Articles Posted in Pharmaceutical Injuries

The United States Food and Drug Administration recently announced it was investigating whether codeine was safe for post-surgery use in children. The investigation began after the agency was notified of at least three deaths and one life-threatening adverse event in children between the ages of two and five who were allegedly given the drug following a tonsillectomy. Although each child reportedly received a medically acceptable dose of codeine prior to their reaction, doctors believe all of the children may have developed toxic drug levels due to a specific genetic trait.

According to Dr. Joseph R. Tobin, Professor and Chairman of Anesthesiology at Wake Forest University School of Medicine, codeine requires additional processing by the liver before it begins to work in the body. Codeine is reportedly transformed into morphine by liver enzymes in the patient. In about one-third of the population, codeine allegedly takes so long to metabolize it has little or no effect on pain. In others, codeine may metabolize very quickly and lead to toxic drug levels that can ultimately kill a patient. Dr. Tobin stated this is especially true in children who have anesthesia remaining in their system following surgery. When this occurs, a child may stop breathing without warning.

Most people are unaware of how quickly their bodies will metabolize codeine and there is no way to alter the metabolizing process. Still, the use of narcotics following surgery is reportedly risky in patients who are prone to respiratory depression. Dr. Peter Pronovost, a Professor at Johns Hopkins Medical Institution, stated underlying diseases such as sleep apnea and existing airway obstructions may have been a factor in the children’s deaths. He also said consumers should be aware that all pharmaceuticals can carry risks.

Many physicians reportedly believe codeine should not be used to manage post-operative pain. Safer and more effective drug alternatives reportedly include prescription drugs hydrocodone and oxycodone, as well as over-the-counter pain medications such as acetaminophen and ibuprofen. According to Dr. Alan Greene, Clinical Professor of Pediatrics at Stanford University School of Medicine, there is no demonstrated benefit to administering acetaminophen with codeine in lieu of simply administering acetaminophen to children following surgery.

Potential lawsuits are being evaluated throughout the United States for health risks that may be associated with the post-surgery use of codeine in children. If your child stopped breathing after being given codeine by a health care provider, you should contact an experienced personal injury lawyer to discuss your right to recovery.

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According to the nation’s Centers for Disease Control and Prevention (CDC), nearly 200 people in at least 13 states including Texas have contracted fungal meningitis likely as a result of receiving tainted steroid injections in their neck or spine. The rare outbreak has claimed at least 15 lives. CDC investigators have purportedly linked a preservative-free steroid called methylprednisolone created at the New England Compounding Center (NECC) to the fungal meningitis outbreak. Prior to the outbreak, methylprednisolone manufactured at NECC was reportedly shipped to at least 75 medical facilities in 23 states. All drugs created at the Massachusetts company, including three lots of the allegedly tainted steroid, were recently recalled. NECC and its sister company, Ameridose, have allegedly stopped all manufacturing operations.

According to the CDC, two different types of mold have been detected in fungal meningitis patients who were administered shots created at NECC’s compounding facility. Because both molds normally grow slowly and initial fungal meningitis symptoms may be subtle, the CDC stated more cases are likely to be diagnosed in the near future. Symptoms may include a headache, neck stiffness, fever, nausea, and an increased sensitivity to light.

Meningitis causes the membrane that surrounds a victim’s brain and spinal column to swell. Unlike other types of meningitis, the fungal form is not contagious and must be directly introduced into a patient’s central nervous system through a shot or other means. Although the incubation period can vary, fungal meningitis symptoms will generally begin to appear anywhere between one and four weeks after a patient is exposed to the fungus. Once diagnosed, a fungal meningitis patient must be treated with antifungal drugs for several weeks.

Compounding facilities are normally used to create drugs based on an individual patient’s needs. Often, the facilities will adjust the dosage or physical form of a drug before it is administered. Such facilities are also allegedly used to obtain drugs that are not commercially available or are hired to provide pharmaceutical products for medical facilities that seek to cut drug costs. Although the United States Food and Drug Administration (FDA) is tasked with regulating drug manufacturers, the agency’s role in compounding facility oversight is reportedly less clear. Still, the FDA issued a warning letter to NECC in December 2006.

At least 14,000 people across the country are believed to have received possibly tainted steroid injections. Potential fungal meningitis lawsuits are currently being evaluated throughout the nation. If you or a loved one contracted fungal meningitis after receiving a steroid injection, you should contact an experienced personal injury attorney.

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One of the country’s largest dialysis operators, German-based Fresenius Medical Care, was recently investigated by the nation’s Food and Drug Administration (FDA) in response to a number of patient deaths. Following the investigation, the FDA issued a Class I recall for the company’s Naturalyte GranuFlo Acid Concentrate and Naturalyte Liquid Acid Concentrate products. The products are used to aid in the elimination of waste during the hemodialysis procedure. According to the FDA, they may also potentially raise serum bicarbonate levels in patients undergoing dialysis. A higher serum bicarbonate level can lead to cardiac arrest and death in some patients.

Fresenius Medical Care treats more than one-third of the approximately 400,000 dialysis patients across the United States. The company also reportedly supplies many of the dialysis machines and pharmaceutical products used at other dialysis centers nationwide. In fact, an estimated 125,000 patients are treated using GranuFlo or Naturalyte in non-company medical care centers every year.

According to an FDA official, Fresenius Medical Care is accused of failing to warn dialysis patients of the potentially fatal risks associated with use of its GranuFlo and Naturalyte products. In 2010, 941 dialysis patients who were treated with GranuFlo or Naturalyte experienced cardiac events inside of a Fresenius Medical Care clinic. Despite that the company sent an internal memorandum to warn of the heart risks associated with its products to its own dialysis center doctors, Fresenius Medical Care allegedly failed to notify other dialysis centers or the FDA.

Steven Silverman, the FDA’s Director of Compliance in the Medical Devices Division, stated it was quite troubling that Fresenius Medical Care failed to warn its entire customer base about the health risks associated with the GranuFlo and Naturalyte products. The company’s Chief Medical Officer, Dr. Franklin Maddux responded that the health risks were too preliminary to warrant publication in medical journals and Fresenius Medical Care had no other avenues through which to communicate with outside doctors who were using the product.

In March 2012, Fresenius Medical Care finally issued a warning to customers regarding the alleged increase in heart attack risk associated with use of the company’s products. In May, the FDA issued a safety alert for products such as Granuflo. The following month, a Class I recall was issued for GranuFlo and Naturalyte. A Class I recall is issued when there is a reasonable likelihood that exposure to a drug or medical product will result in a serious health complication or death.

Potential GranuFlo and Naturalyte lawsuits are being evaluated throughout the United States for health risks that may be associated with use of the products. If you or a loved one suffered a cardiac event after being treated with GranuFlo or Naturalyte, you should contact a qualified personal injury lawyer as soon as possible.

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New research published in the Journal of Sexual Medicine this month found that unwanted sexual side effects related to the anti-baldness drug Propecia may continue even after patients stop taking the drug. The study, conducted by researchers from George Washington University, asked 54 men who claimed they experienced side effects such as erectile dysfunction, shrunken genitalia, a lowered sex drive, depression, and anxiety after taking the drug for a period of at least three months about the length of time it took for their condition to improve. The author of the study, Dr. Michael Irwig, found that 96 percent of the men interviewed stated they continued to experience sexual problems more than one year after they stopped taking Propecia. According to Dr. Irwig, the results have led him to believe the drug may have inflicted permanent damage on some patients.

Propecia, or finasteride, was initially developed in 1992 by drug manufacturer Merck to treat men who experience issues related to an enlarged prostate. The drug blocks the body’s ability to create certain hormones that can contribute to hair loss in men and was approved for use in 1997. Although Merck reportedly informed the nation’s Food and Drug Administration (FDA) that some men experienced sexual side effects during clinical trials, the FDA’s website reports those side effects went away after patients stopped using the drug.

In 2011, the FDA required drug giant Merck to place a warning label on Propecia that states some men will experience sexual side effects that continue even after they stop taking the drug. The warning label was reportedly required after the FDA received over 400 reports of sexual side effects, about 60 of which failed to resolve within three months after patients stopped taking the drug. Earlier this year, the FDA required additional label warnings regarding specific sexual dysfunction disorders.

Merck has stated publicly that there is no evidence Propecia causes any sort of long-term sexual dysfunction and the drug’s label effectively warns patients regarding possible side effects related to taking it. According to Dr. Irwig, the number of patients who experience sexual side effects after taking Propecia is likely only around three percent of the overall population. Still, he stated that means thousands of men across the nation are affected because the drug is so commonly prescribed. Additionally, he said there is no way to predict who might be affected by Propecia.

Possible Propecia lawsuits are currently being evaluated throughout the United States due to a reportedly higher risk for sexual side effects such as shrunken genitalia, infertility, erectile dysfunction and neurological problems that lasted for more than three months after the drug was discontinued. If you or your loved one experienced sexual or other long-term side effects after taking Propecia or another prescription drug, you should discuss your case with a knowledgeable personal injury attorney.

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Recently released emails and other internal documents suggest the Pfizer Corporation intentionally withheld key safety information related to the company’s pain relief drug Celebrex. With annual worldwide sales in excess of $2.5 billion, the drug is one of Pfizer’s best selling products. Last year, Celebrex was prescribed to about 2.4 million people in the United States alone. Celebrex is the last of the COX-2 inhibitor pain relief drugs on the market. Other such pain drugs, including Vioxx, were removed from pharmacy shelves worldwide over reported safety issues and concerns.

The incriminating documents were unsealed by a federal judge in a securities fraud case against Pfizer brought by company shareholders. The documents tend to demonstrate that Pfizer officials decided to withhold important study data from the public. Company executives reportedly began analyzing ways to attack safety study results before at least one research study was completed. The company also allegedly ignored warnings from employees and outside consultants to disclose the fact that Pfizer was relying on incomplete safety data.

As prior studies tended to demonstrate Celebrex was no better at relieving pain than other common drugs such as ibuprofen, Celebrex’s chief benefit was the drug’s purported ability to relieve pain without causing stomach upset. One email from a company research director to a fellow employee expresses happiness after learning attendees at a large medical conference “swallowed” Pfizer’s story that the drug was safer on patient stomachs than other drugs on the market “hook, line, and sinker.” Pfizer, however, reportedly failed to alert the audience that the company only presented the results of a portion of the study.

Internal emails suggest the company chose to massage data and cherry pick results in an effort to make Celebrex look safer. Pfizer officials stated the company had no intent to deceive the public regarding the drug’s safety and claimed the drug’s track record of safety speaks for itself. According to Pfizer, approximately 33 million patients in the U.S. have taken the drug. Still, there is reportedly no clinical proof Celebrex is less likely to harm a patient’s stomach than other pain relief drugs. Pfizer’s decision to withhold safety data was made public in 2001 when the federal Food and Drug Administration released the entire results of the stomach safety study.

In 2004, Vioxx, manufactured by the drug company Merck, was withdrawn from the market after safety studies linked it to an increased risk of heart attacks. Some of the Vioxx safety studies also suggested using Celebrex increased a participant’s risk for heart complications. In response to such concerns, Pfizer began a now six-year-old research study designed to evaluate Celebrex’s effect on the heart. The study is not scheduled to conclude, however, until May 2014. That is the same month the drug’s patent will expire and Celebrex sales are expected to plummet.

Potential Celebrex and Vioxx lawsuits are currently being evaluated throughout the United States due to a reportedly higher risk of heart attacks and other health complications such as Stevens-Johnson Syndrome. If you or a loved one experienced heart, gastrointestinal, or other medical complications while taking a COX-2 inhibitor pain relief drug, you should contact a skilled Texas personal injury attorney as soon as possible.

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The first scheduled trial over the purported health risks to women from Bayer AG’s Yasmin family of birth control pills was delayed after a federal judge ordered the parties to mediation. On December 31, 2011, Illinois District Court Judge David Herndon postponed a trial scheduled to begin in January and referred the case to George Washington University law professor Stephen Saltzburg for mediation and possible settlement. Saltzburg has previous experience mediating drug lawsuits such as the 2010 AstraZeneca Seroquel antipsychotic litigation. No time limit was set for the mediation.

Currently, more than 10,000 lawsuits have been filed in the United States against Germany’s largest pharmaceutical company over injuries allegedly caused by the company’s Yasmin line of contraceptives. Bayer is accused of knowingly misleading women regarding health risks associated with birth control pills such as Yaz. The contraceptives, which contain the hormone drospirenone, purportedly caused blood clots in a significant percentage of the women who took them. In the litigation, Bayer is also accused of marketing its contraceptives as safer than those of the company’s competitors despite company knowledge regarding the increased blood clot risk. After numerous lawsuits were filed across the nation, the litigation was consolidated in East St. Louis, Illinois before Judge Herndon. Yaz litigation in a Pennsylvania state court was also put on hold in January over a procedural matter.

In 2011, the nation’s Food and Drug Administration (FDA) analyzed data related to approximately 835,000 women who were prescribed the Yasmin line of drospirenone-based contraceptives. The FDA warned women they were at a 74 percent higher risk of suffering from sometimes fatal blood clots while taking Yasmin than women taking other low-estrogen birth control pills. In their lawsuits, attorneys for the women pointed to FDA reports of more than 50 fatalities between 2004 and 2008 in women taking the Yasmin line of contraceptives.

In 2010, Bayer sold approximately $1.58 billion worth of contraceptives. In 2011, Yasmin reportedly had a 4.6 percent market share and was the fourth most prescribed oral contraceptive in the United States.

Potential Yaz birth control lawsuits are currently being evaluated throughout the United States due to a reportedly higher risk of blood clots in women taking the drug. If you or a loved one experienced a dangerous blood clot or other health complications while taking the Yasmin line of contraceptives, you should contact a knowledgeable personal injury attorney as soon as possible.

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