FDA & Prescription Drugs | InjuryBoard Denver

Vioxx manufacturer Merck & Co. experienced a courtroom victory last week in Alabama. The jury in the product liability trial found that the Vioxx makers did not hide the serious risks associated with the drug in the case of a man who accused the company of causing his heart attack. CNNMoney.com reports on the verdict:"This plaintiff did have many pre-existing risk factors" and the heart attack...

On January 19, 2006 the FDA approved an updated label for Elidel and Protopic. Elidel and Protopic are drugs used to treat atopic dermatitis. Both drugs are calcineurin inhibitor drugs that are used topically to target cells that cause atopic dermatitis in patients. More commonly known as eczema, atopic dermatitis is a non-life-threatening skin condition that causes dry, scaly skin and severe...

Three anemia drugs were the subject of a recent study published in the New England Journal of Medicine which concluded that there was a higher chance of death, heart attack, hospitalizations for heart failure and stroke in patients with chronic kidney disease who are not on dialysis and were treated with Procrit to raise their hemoglobin levels higher than what the labeling for the product...

The American College of Obstetricians and Gynecologists (ACOG) has recently published an opinion regarding the use of selective serotonin reuptake inhibitors (SSRIs) and selective norepinephrine reuptake inhibitors for treatment of depression during pregnancy. ACOG warns that a particular SSRI known as Paxil (generic: paroxetine) should be avoided when possible by pregnant women or women who...

The FDA and CDC have updated an alert issued last year after receiving more reports of a rare neurological disorder, Guillain Barre Syndrome (GBS) following administration of a vaccine (trade name Menactra) designed to prevent meningococcal disease, a major cause of bacterial meningitis and blood stream infections.To date, a total of 15 confirmed cases of GBS have been reported among individuals...

FDA's Medwatch announced a recall today of 18 lots of Complete (R) MoisturePLUS multipurpose contact lens care solution and Active Packs which were distributed in the U.S. Certain lots were contaminated with bacteria that compromised sterility, which can carry serious health consequences, including eye infection and microbial keratitis.If you have the recalled product, you should discontinue...

The FDA has recommended that the label of Roche's popular flu drug, Tamiflu, be updated to carry warnings about possible "neuropsychiatric adverse events," particularly in pediatric patients. The recommendation follows a 10-month review of 103 cases of unsafe behavior, 67 percent of which occurred in pediatric patients. Most of the events, 95 percent, occurred in Japan, which is Tamiflu's...

The FDA and CDC have updated an alert issued last year after receiving more reports of a rare neurological disorder, Guillain Barre Syndrome (GBS) following administration of a vaccine (trade name Menactra) designed to prevent meningococcal disease, a major cause of bacterial meningitis and blood stream infections.To date, a total of 15 confirmed cases of GBS have been reported among individuals...

Two researchers have published data supporting the conclusions reached in their study last year that the heart drug Natrecor (generic name nesiritide) poses an increased risk of death. The study showed that 7.8 percent of patients taking Natrecor died within 30 days of using it; but only 3.9 percent of patients taking other drugs died within the same 30 day period. The study, which was...

The FDA is warning people not to buy prescription drugs from certain Canadian web sites that have reportedly sold counterfeit prescription drugs to U.S. consumers. The FDA recommends that people who have bought drugs from the disclosed web sites not use them because they may be unsafe. The FDA reports that lab tests have found counterfeits of the following prescription drugs: Lipitor -- for...

A study involving over 10,000 post-menopausal women over five years has concluded that, although Eli Lilly's osteoporosis treatment Evista reduces the risk of breast cancer, it also brings a 49% higher chance of a fatal stroke. Evista has been associated with an increased risk of blood clots for some time, and the drug maker's label warns of that. But the increased risk of fatal stroke was...

Nutraceutical Corp. v. Eschenbach, August 17, 2006In this case, the 10th Circuit overturned an order entered in favor of manufacturers of dietary supplements containing ephedra. The 10th Circuit held that the FDA properly carried out its statutory function by determining that there was no safe level of ephedra. What is particularly interesting is that the 10th Circuit commented that the FDA's...

On August 17, 2006, the 10th U.S. Circuit Court of Appeals in Denver ruled the U.S. Food and Drug Administration correctly followed a mandate from Congress to analyze the risks and benefits of a product; the agency determined that there is no acceptable dosage level of ephedrine-alkaloid dietary supplements. The FDA banned ephedrine-based supplements as of April 12, 2004, after finding that...

A federal jury has awarded $51 million to 62-year old Gerald Barnett, a former FBI agent who suffered a heart attack in 2002. Jurors in New Orleans found that Merck & Co. "knowingly misrepresented or failed to disclose" information about Vioxx to Barnett's doctor, who said that if Merck had disclosed the risks associated with Vioxx earlier, he would not have prescribed it for his patient. Mr....

Documents produced in a 1996 lawsuit have revealed some hitherto little known secrets about how drug companies influence doctors to prescribe their drugs. In addition to mainstream marketing and the very common free lunches provided by drug representatives, MSNBC.com draws on a recent article in the Annals of Internal Medicine to detail insidious, though apparently legal, techniques used to...