FDA & Prescription Drugs

• FDA to Study Potential Link between ADHD Drugs and Cardiovascular Problems

  Joe Saunders | September 24, 2007 1:52 AM | 0 CommentsTampa Bay, FL

  The potential link between such ADHD drugs as Adderall, Concerta, Ritalin, and Dexedrine and cardiovascular disease and strokes will be studied by the FDA. According to the September 17 FDA News item:"Case reports have described adverse cardiovascular events in adult and pediatric patients with certain underlying risk factors who receive drug treatment for ADHD, but it is unknown whether or not...

• Evista - New Breast Cancer Drug

  Brenda Fulmer | September 21, 2007 7:00 AM | 0 CommentsTampa Bay, FL

  The osteoporosis drug Evista® (raloxifene) was recently approved for use to reduce the risk of invasive breast cancers in postmenopausal women who also have osteoporosis or are at high risk for developing breast cancer http://www.fda.gov/bbs/topics/NEWS/2007/NEW01698.html. The FDA reports that Evista® is only the second drug ever approved to reduce the risk of breast cancer. Tamoxifen® was...

• First Florida Vioxx Trial Underway in Tampa

  Brenda Fulmer | September 19, 2007 1:37 PM | 0 CommentsTampa Bay, FL

  Jury selection and opening statements have now been completed in the trial of Refik Kozic v. Merck, the first Vioxx case to proceed to trial in the State of Florida. Refik Kozic, a current resident of Jacksonville and a former long-term resident of Tampa, filed his lawsuit against Merck in 2003 for injuries relating to the heart attack that he suffered after ingesting Vioxx daily for 9 weeks. ...

• NY State and Big Apple Sue Merck for Fraud

  Staff Writer | September 18, 2007 11:42 AM | 0 CommentsTampa Bay, FL

  NY Attorney General and son of former Governor Mario Cuomo, Andrew Cuomo has filed a lawsuit against Merck and Co. for fraudulently concealing safety information about the embattled drug Vioxx. NY joins ten other states who have sued the company for failing to disclose safety information about Vioxx. NY city Mayor Michael Bloomberg has also joined the lawsuit which seeks restitution for tens...

• Cephalon Criticized for Aggressive Marketing Tactics with Actiq

  Staff Writer | September 14, 2007 6:48 AM | 0 CommentsTampa Bay, FL

  Cephalon had already been criticized for its inappropriate and aggressive marketing techniques when it sent a "Dear Doctor" letter to physicians warning them about the possible side effects in Fentora. These side effects include 4 deaths, one a suicide. Actiq and Fentora were approved for cancer patients only. Yet, as we've seen before, the drugs are marketed more broadly than their intended...

• NuvaRing Birth Control-Another Risky Birth Control Method

  Staff Writer | September 13, 2007 5:50 AM | 0 CommentsTampa Bay, FL

  NuvaRing has been associated with venous thromboembolic (VTE) events such as pulmonary embolism (PE) and deep vein thrombosis (DVT) as well as ischemic stroke (CVA) and myocardial infarction (MI), or heart attack.Like OrthoEvra, NuvaRing has shown to cause serious adverse health risks for consumers of the product. This vaginal ring contains a relatively high dose of etonogestrel.

• Wyeth Facing 3 More HRT-Induced Breast Cancer Survivors

  Brenda Fulmer | September 10, 2007 9:54 AM | 0 CommentsTampa Bay, FL

  Jury selection will begin on September 10, 2007, in the latest round in the HRT litigation involving Wyeth. Pfizer was also a defendant in the case, but, according to Bloomberg, settled with the plaintiffs in late August. This trial involves the claims of three Nevada women, one of whom is terminal, who developed breast cancer after taking the combination hormone replacement therapy drugs...

• Off-Label Drug Promotion - New Litigation Frontier?

  Brenda Fulmer | September 10, 2007 8:41 AM | 0 CommentsTampa Bay, FL

  Schering-Plough is now facing eight lawsuits in coordinated federal MDL proceedings in Newark. These lawsuits follow a plea agreement in which the company agreed to pay $435 million to settle criminal and civil charges stemming from its improper, off-label marketing programs and payment of "kickbacks" to prescribing physicians. The pending lawsuits involve several popular Schering-Plough drugs:...

• Questions Surrounding Drug-Coated Stents Persist

  Brenda Fulmer | September 10, 2007 7:51 AM | 0 CommentsTampa Bay, FL

  Patients who received drug-coated stents after a heart attack are nearly five times more likely to die within 6 to 24 months afterwards when compared to patients who received older "bare metal" stents according to a recent study presented at the European Society of Cardiology meeting in Vienna last week. This study analyzed 2,300 patients in 14 countries who are included in the GRACE Registry...

• Vioxx Class Action Rejected

  Brenda Fulmer | September 10, 2007 6:32 AM | 0 CommentsTampa Bay, FL

  The New Jersey Supreme Court rejected a request by a union health plan to certify a national class action lawsuit against Merck on September 6, 2007. The claims were brought under New Jersey's consumer fraud statutes by a union health plan on behalf of health insurers who paid for Vioxx prescriptions. The class had been previously certified by Judge Higbee, the New Jersey state court judge who...