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Napoli Bern Ripka, LLP Blog

Blog Category:

FDA and Prescription Drugs

    8/14/2008
    Paul Napoli
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    Seroquel

    Seroquel, also known as Quetiapine, is a drug that is used to treat schizophrenia and other psychotic disorders. Seroquel, manufactured by Astra-Zeneca Pharmaceuticals, was approved by the FDA in 1997. Seroquel was also used to control bipolar disorders as well as hallucinations, delusions, and hostility that were effects of having this disorder. After use of the drug, it was found that it produced some common negative side effects including nausea, vomiting, dizziness, constipation, weight gain, and fatigue.


    After some time Seroquel was linked to complications that involved muscle deterioration, distorted state of mind, and irregular blood pressure. These symptoms are linked to Neuroleptic Malignant Syndrome in which is a very serious condition that must seek medial attention. Seroquel was also linked to Tardive Dyskinesia, which is linked to a disorder found in the central nervous system that causes ticks and involuntary movements of the arms and legs. By 2003, the FDA realized what was happening with Seroquel and recommended that a warning be published since studies showed the links to the complications. In this study it showed that people who took Seroquel were more than twice as likely to develop diabetes than people who took another drug.


    People who took Seroquel that developed NMS have seen horrible side effects and complications. NMS is a fatal neurological disorder that can be formed by unfavorable reactions to antipsychotic drugs such as Seroquel. NMS can cause a decrease in attention and focus, as well as perception. Seroquel has also been marketed as a drug for ill-tempered and grouchy teenagers. However, studies have shown that those under the age of 18 who take Seroquel can cause suicidal thinking. Seroquel is known as a controlled substance, however the abuse of the drug is common. People will crush it and snort it to get high. Seroquel is also more prone for abuse because the drug is easier to get than other well-known sedatives such as vicodin or oxycotin.


    Not only where there complications that cam along with taking Seroquel, there was also problems with prescriptions. It turned out that another drug called Serzone was getting mixed up with Seroquel because of the closeness in spelling, strengths, and dosage forms. Obviously because the two drugs were made for different purposes, the effects of switching them could lead to harmful side effects.  If you or a loved one has been harmed either from the harmful side effects when taking Seroquel, or mistakenly being prescribed Seroquel, contact Napoli Bern Ripka LLP. Napoli Bern Ripka LLP has a dedicated team of lawyers ready and willing to take a look at your Seroquel case. They have the experience needed to deal with large pharmaceutical companies that intimidate others

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    Labels: FDA, napolibern.com, New York City
    6/30/2008
    Oguz Ozdemir
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    Ancure

    The Guidant Ancure system is a blood vessel graft that is used to repair an abdominal aneurism. An Aneurysm is a diseased or weakened section of the artery wall that tends to balloon or bulge due to arterial blood pressure (defined by the FDA). It is used instead of the more invasive open surgery in patients who have an abdominal aortic aneurysm and whose anatomy is not suited for the use of the single tube or bifurcated endograft device. The Ancure device, as part as the Ancure Endograft System, was suspended in 2001 by its manufacturer Guidant.  Ancure is a synthetic graft device that is used to repair abdominal aortic aneurysms. The device was suspended due to the fact that Guidant admitted to making false statements to the FDA and not submitting required reports of injuries that occurred in patients who received the Ancure device. Injuries occurring with the Ancure device include leaks, aneurysms, and ruptures which resulted in extended hospitalizations, additional surgeries, and sometimes death.


    In June 2003, Guidant and its subsidiaries agreed to pay fines of $92.4 million after pleading guilty to 10 felonies for not disclosing malfunctions of their Ancure Endograft System. Also, Guidant admitted to failing to report thousands of fatal or life-threatening malfunctions of the device or the highly invasive operations required to correct the damage when the device failed. The complaint suspected that Guidant reported only 172 malfunctions since the product was marketed to the public in 1999. The complaint also alleged that Guidant had 2,628 records of adverse event incidents, including reports that the malfunctions led to 12 deaths and 57 open heart surgeries. In April 2001, the FDA sent a letter to health care professionals who had used Ancure, warning them that “serious problems occurred” with the device. Guidant pleaded guilty to nine counts of introducing a misbranded medical device with the intent to defraud or mislead.


    If you have occurred any of these complications from using the Ancure device, please consult a doctor. In addition, it may be in your best interest to contact a personal injury lawyer at Napoli Bern Ripka who can obtain legal rights on your behalf. They have the legal expertise in dealing with large pharmaceutical companies, insurance giants, and the government. Don’t waste another moment flirting with time, for there may be limitations regarding your case

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    Labels: FDA napolibern.com New York City
    6/19/2008
    Paul Napoli
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    FDA & Prescription Drugs

    Prescription drugs that are recalled by the FDA pose a lot of questions such as: why was the drug approved in the first place, why was it taken off the market, and for how long did the FDA know about the side effects? If the FDA approves a product that is later recalled because of ill side effects with use of the product, consequences should be warranted. When buying a product that is approved by the FDA, a consumer should have peace and mind. This is not the case when the popular drug Fen-Phen was approved by the FDA then later found to cause valvular heart damage and a deadly condition known as primary pulmonary hypertension (PPH). Fen-Phen was used by many consumers as an appetite suppressant. Fen-Phen was very popular as a health kick invaded the United States in which people were trying to live a healthier lifestyle. However after using the product they did not end up any healthier, what they ended up with was severe medical problems. 


    A prescription drug is different from an over the counter drug because a prescription drug is a licensed medicine that is regulated by legislation to require a prescription before it can be obtained. The whole reason for issuing a prescription is to regulate its use due to the fact that it can cause ill side effects. When the FDA approves a product, it gives its stamp of approval. People thus entrust their lives based on this stamp, and when it fails it fails big time. Other drugs such as Ancure, Baycol, Fosamax, and Ortho Evra just to name a few are all FDA approved drugs that have been recalled. People that have been prescribed these drugs have been affected in ways that they never imagined. Whether it is a first hand account or one of a family member or friend, recalled drugs play a big impact on people’s lives. The fatalities due to the use of these drugs have caused much pain and grief for the patients, family members, and friends.


    Napoli Bern Ripka is extremely experienced in cases regarding recalled FDA approved drugs. They have successfully won their clients millions of dollars in damages due to the Fen-Phen recall. Due to pharmaceutical companies constantly pushing new products out on the market, these types of recalls are going to continue. Napoli Bern Ripka is more than willing to be the advocate for the public to stand up against large pharmaceutical conglomerates, insurance companies, and the government


     

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