Archive for the ‘dangerous drugs’ Category

On October 7, 2009, Bernstein Liebhard LLP filed a lawsuit in federal court in New York against Bayer, the manufacturer of Yasmin and YAZ birth control pills, on behalf of a California couple, Scott and Heather Crawford,Crawford v. Bayer et. al. 7:09-cv-8550 (S.D.N.Y.) The complaint lists eleven causes of action including claims for strict product liability, negligence, breach of warranty, negligent misrepresentation and/or fraud, violation of New York’s General Business Law and loss of consortium.

The Crawfords’ lawsuit alleges that, as a result of Bayer’s misleading claims regarding the effectiveness and safety of YAZ, Ms. Crawford was prescribed and began using YAZ in 2007. The lawsuit further alleges that Ms. Crawford suffered a pulmonary embolism (blood clot in the lungs) later that same year as a direct result of her use of YAZ. Click here for more information.

On August 14, 2009, the British Medical Journal Online published two studies that contain significant findings for women who use the oral contraceptives Yaz or Yasmin. One of the studies was supervised by a leading authority on oral contraceptives, Dr. F. R. Rosendaal, of Leiden University in Leiden, Netherlands, and involved 1524 women. The other study involved all of the women in Denmark, 10.4 million women years.

Yazmin and Yaz Related Studies

The two studies include: The venous thombotic risk of oral contraceptives, effects of oestrogen dose and progestogen type: results of the MEGA case-control study, van Hylckama Vlieg, Helmerhorst, Vandenbroucke, Doggen & Rosendaal, BMJ 2009;339:b2921; and Hormonal contraception and risk of venous thromboembolism: national follow-up study, Lidegaard, Lokkegaard, Svendsen, & Agger (all of Copenhagen, Denmark), BMJ 2009;339:b2890.

Findings of the British Medical Journal Online Yasmin Studies

First, the studies concluded that women taking combination oral contraceptives (OC) containing drosperinone, such as Yaz and Yasmin, are six to seven times as likely to suffer a thromboembolism (such as Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)). This risk is equal to other third generation birth control pills.

Second, the studies found that Yaz / Yasmin did not provide any increased benefit for acne or weight loss, which are benefits Bayer previously touted for the drug. The study also found that there was no proof of improved effectiveness of treatment for premenstrual dysphoric disorder (PMDD) or similar premenstrual symptoms.

Third, the study also showed that women are at the highest risk of developing having a thrombotic event in the first three months of taking the OC.

A large number of women participated in the study, which was conducted by well-credentialed clinical investigators and, therefore, Bayer really must reexamine its warnings on Yaz and Yasmin to better educate and warn women about the risks of using these products, which includes the risk of DVT, PE and gull bladder injury, among other Yasmin side effects.

Contact a Yaz Lawyer or Yasmin Attorney Today

Bernstein Liebhard LLP is vigorously investigating and pursuing claims on behalf of injured women nationwide. Contact one of our Yasmin lawyers today for a free Yasmin lawsuit or Yaz lawsuit today.

On June 17, 2009, the FDA reported the conclusions of its studies on Maxipime, an antibiotic generically known as cefepime.  Maxipime is a Bristol Meyers Squibb drug used to treat infections caused by abdominal surgery and other conditions. A recent published study suggested that patients given the drug might be more likely to suffer deadly complications compared to patients treated with other drugs.  The FDA determined that Maxipime did not increase the rate of death in its users.  The FDA reviewed the study’s data and conducted additional analyses based on additional data, including data provided by Bristol Meyers Squibb.

In a letter it sent to healthcare professionals, the FDA stated that it still approved Maxipime as an appropriate treatment for its approved indications, at least for now.  However, the FDA will continue to investigate into the safety of Maxipime.  As part of its ongoing investigation, both the FDA and Bristol Meyers Squibb are conducting separate studies on Maxipime’s potential link to increased death rates in its users.  The results of these studies will be reported in approximately a year.

Currently, the FDA has not indicated that Maxipime is a dangerous drug, but perhaps as it continues to do further investigations into the drug, it will find contrary information.  If you or loved one has been harmed by a dangerous drug, contact a dangerous drug lawyer today.

The FDA has been experimenting with new computer technology as part of a broader effort to test the safety and effectiveness of new drugs and to spot potential problems earlier on in the process.  The technology, called the Cardiovascular PhysioLab, designed by Entelos Inc. of Foster City, California, is being used with three drugs being studied for heart-related conditions.  The technology uses a mathematical model to simulate how the human body will react to certain chemical characteristics of drugs.  The goal, thus, is to use the virtual model to predict whether such drugs might cause cardiovascular problems and, if so, in what types of patients. 

While such novel efforts certainly show that the FDA is making a strong effort to research and consider the most groundbreaking technologies to ensure the safety of new drugs, it is likely that people will remain skeptic of what appears to be a computer program acting as a substitute for real patients until it has shown consistent, reliable results.  Simply punching in the characteristics of a given patient and a particular drug to obtain a computer-generated result cannot guarantee the absolute same result in a living, breathing person.  However, this could be a step forward at least in assisting the process and anticipating whether a drug could be dangerous for certain people before such adverse effects may occur.  Read more about dangerous drugs and possible side effects.

From conception to childbirth, pregnant women are challenged with managing their own health while worrying about the welfare of their unborn child. Every year, approximately 500,000 pregnant women in the U.S. battle conditions that require medical treatment, such as cancer, psychiatric illness, autoimmune disease, and influenza. Numerous warnings exist about the use of any type of medication whether prescription or over the counter. These battles leave a pregnant mother and her doctor carefully considering the proper dosage necessary to maintain health without harming the child.

Pregnancy Presents Unique Prescription Rules

Determining what is appropriate for a pregnant mother has not been easy. Shifts in the metabolism of a pregnant woman are substantial compared to a woman who is not pregnant, and, therefore, require changes in treatment. To what extent change is necessary has become difficult to determine. Conducting scientific studies on a pregnant woman to make these determinations raises both ethical and legal issues. 

Better Information About Pregnant Women About the Impact of Medications
 
The Second Wave, a movement begun this spring in Washington and composed of 30 doctors, ethicists, scientists, and government officials, aims at providing better information regarding how drugs affect pregnant women. Only in the 90’s did studies begin to include women, and, as recent as twenty years ago, members of the medical community were still using the male body as their research models and adapting those results to women. A recent 2003 law made it possible for not only women, but in some cases, children to be included in these scientific studies.

Second Wave encourages doctors and agencies to gather data on pregnant women and eases any fears by emphasizing that a lot can be done on a less dramatic level. Blood samples can be drawn and analyses conducted on pregnant women who are already taking medication out of necessity. Unfortunately, chronic illnesses that many women have do not disappear during pregnancy. It is inevitable that pregnant women will be taking medication, and studies show that two thirds of women take up to five drugs over the course of their pregnancy and labor. It is these women that can be used for the study.

While the Second Wave program looks for pregnant women willing to participate, the U.S. Food and Drug Administration is proposing to revamp its system for notifying pregnant women about adverse effects of drugs. Strikingly, only a dozen prescription drugs are approved for use by the FDA and most of these are all pregnancy related, leaving mothers with other common conditions in the dark as to effects of most medications on their unborn child.

Right now the FDA’s notification system consists of classifying drugs into one of five pregnancy-related categories, with A being the safest and X being the least necessary. Research on Category C drugs, which the FDA believes covers nearly 70% of all drugs, is much less conclusive in terms of safety for unborn children. Consequently, the FDA is moving towards eliminating these categories in favor of a system that more narrowly defines each individual drug and its effect on pregnant and nursing women. Below is a brief description of each of the five categories:

- Category A: Large number of human studies show no increased risk of birth defects when used by pregnant women. Examples include: Levothyroxine (thyroid hormone), B6, folic acid.

- Category B: Large number of animal studies show no increased risk of birth defects. No well done human studies have been conducted. Examples include: Zofran (antiemetic), amoxicillin (antibiotic).

- Category C: Animal studies suggest an increased risk and there are no large well-done human studies. Drug’s benefits may be worth the potential risk. Examples include: Zoloft, Paxil (antidepressants); Tamiflu (antiviral); Amitiza; any ACE inhibitors.

- Category D: Human studies show an increased risk of birth defects, but drug’s benefits may outweigh that risk. Examples include: tetracycline (antibiotic); Cytoxan (chemotherapy).

- Category X: Human studies show increased rates of birth defects and animal studies suggest an increased risk. The risk usually outweighs the benefits. Examples include: Accutane (acne treatment); Lipitor (cholesterol reducer).

If you or a loved one thinks you have been the victim of medical negligence because you have been wrongly prescribed medication during pregnancy or experienced adverse side effects as a result of being wrongly prescribed medication during pregnancy, you may be entitled to file a lawsuit seeking compensation for your medical expenses, pain and suffering, lost wages and more. Contact a medical malpractice lawyer today for a free and confidential case evaluation.

Advanced Medical Optics (AMO), a manufacturer of contact-lens solution, concealed complaints it received about the Complete MoisturePlus solutions causing eye infections and blindness. Government documents show AMO received complaints about the solution more than a year before it was recalled, and failed to report the complaints to the FDA as compelled by law. AMO recalled Complete MoisturePlus after the Centers for Disease Control and Prevention identified a link between the solutions and dozens of cases of serious infections called Acanthamoeba keratitis.

Acanthamoeba is a microscopic organism found in water or soil that can cause severe harm when it enters the eye. It usually enters the eye by attaching to a contact lens. Once it enters the eye, it is very difficult to kill, because it seals itself in a protective coating when faced with antibacterial drugs and protects itself from being killed for weeks or even months. If Acantheamoeba is not killed, it damages the eye and may cause blindness. In rare cases, it can even lead to a deadly infection of the brain and spinal cord. Acanthamoeba infections generally occur in, at most, two contact lens wearer per million. With 30 million contact lens user in the U.S., one would expect only 60 people to be infected. However, the figure exploded to more than 100 in 2007 alone.

Beginning in February 2006 and continuing through November of that year, AMO received a number of complaints about people diagnosed with the Acantheamoeba infections after using Complete MoisturePlus contact-lens solutions. However, these reports were not disclosed until June 2007, when the FDA went to investigate AMO’s headquarters regarding the recall. The FDA and CDC insisted that AMO recall the product after finding that contact lens wearers who had the infection were at least seven times more likely to use Complete MoisturePlus than those who did not contact the amoeba. The link between Complete MoisturePlus and Acanthamoeba keratitis is unknown, but AMO surmised it was due to improper handling and shipping of the contact-lens solutions.

Paige Reichardt was a victim of AMO’s misconduct. She became infected in 2005 and had to undergo a series of surgeries to remove her cataract lens, iris, and cornea. Ultimately, her whole eye had to be removed and replaced with a glass prosthetic. In an editorial, she described the pain as a feeling that someone had stabbed her eye with knives. Over 220 other plaintiffs had filed lawsuits against AMO, which is now part of Abbot Laboratories.

AMO’s negligence is a prime example of the devastating results that could occur when a manufacturer fails to take proper precautions in ensuring the safety of its product and properly warn people of the product’s dangers. If you are injured by a dangerous drug or defective medical device, contact a dangerous drug lawyer today.