Articles Posted in Pharmaceutical Injuries

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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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