A new study suggests that taking prescription antidepressants while still highly depressed could impair driving ability.  Study author Holly J. Dannewitz says, “We already know that depression causes concentration problems.  And, now, it appears that people taking antidepressants who also have relatively higher depression scores fare significantly worse when attempting to perform a computerized simulation of driving.”  Dannewitz conducted her research while she was in graduate school at the University of North Dakota in Grand Forks.  She is currently a psychology resident there in a private practice.  Dannewitz and colleagues were scheduled to present their findings this weekend at the American Psychological Association annual meeting, in Boston.

The research team asked 60 people to “drive” a computerized version of a car in a program that mimicked real-world conditions.  About half the participants were taking at least one type of antidepressant; the other half was generally taking no medication, except for oral contraceptives in some cases.  Those on antidepressants were screened for current levels of depression and were then listed as either experiencing low or high depression at the time they underwent the test.  Participants were asked to perform common driving tasks such as braking, steering, and scanning sightlines in response to an unfolding video of car traffic, stop and speed limit signs, traffic lights, deer crossings, bicyclists, and even the appearance of helicopters. (more…)

Byetta, a drug used to treat type 2 diabetes, has been linked to hemorrhagic or necrotizing pancreatitis, prompting the Food & Drug Administration (FDA) to issue a new warning about the side effect. The FDA first notified healthcare providers about Byetta’s association with acute pancreatitis in October 2007, but since then, the agency has received six additional reports - two involving fatalities - of necrotizing or hemorrhagic pancreatitis linked to the drug.

Byetta is made by Amylin Pharmaceuticals Inc. The drug was approved by the FDA in 2005 to help type 2 diabetics better control blood sugar when other drugs were not adequate. The twice-daily injection is a synthetic form of a lizard hormone that boosts the production of insulin. Insulin is vital to controlling blood sugar levels. (more…)

Australian regulators have been investigating several cases of pancreatitis that might be linked to the cervical cancer vaccine Gardasil.  In the U.S., Gardasil has been the subject of numerous side effect reports, but both the Food & Drug Administration (FDA) and its manufacturer, Merck & Co., continue to insist that the vaccine is safe.

In Australia, three women developed pancreatitis shortly after the administration of Gardasil.  Acute pancreatitis is a sudden, debilitating attack of severe upper abdominal pain. Pancreatic enzymes irritate and burn the pancreas, and leak out into the abdominal cavity. Complications include respiratory, kidney or heart failure, all of which can be fatal. (more…)

According to court papers, Agnes Davis was prescribed phenytoin and then suffered a severe adverse reaction- Stevens-Johnson Syndrome - that allegedly led to her death.  Phenytoin is a generic version of Dilantin.  The lawsuit, filed by Willie Davis Jr. and Alice Washington—Davis’s family members—on August. 8, 2008, names 10 companies that make, label, test, market, or distribute phenytoin.  Among other issues, the defendents allege that the defendants misled and failed to adequately warn users of life-threatening side effects caused by taking phenytoin.

The complaint’s causes of action include strict product liability-failure to warn and defect in design or manufacture, fraud, breach of implied and express warranties, negligence and gross negligence.  The 10 companies named as defendants are:  Mylan Inc., Mylan Bertek Pharmaceuticals Inc., Mylan Pharmaceuticals Inc., Actavis Mid Atlantic, Morton Grove Pharmaceutical Inc., Taro Pharmaceuticals USA Inc., VistaPharm Inc., Barr Pharmaceuticals Inc., Ivax Pharmaceuticals Inc., Elkins-Sinn Inc., Hospira Inc., Hospria Worldwide Inc., and Baxter Healthcare Corporation. (more…)

Tibolone, a hormone replacement drug sold under the brand name Livial, has been linked to  a higher risk of stroke in older women.  The drug is sold in 90 countries, but was deemed “non-approvable” by the US Food & Drug Administration (FDA) in 2006.

Hormone replacement therapies (HRT)  have long been problematic medications.  In 2002, a major HRT study conducted by the National Institutes of Health (NIH) determined that Prempro and similar drugs significantly increased the risk of stroke, blood clots, heart attacks and breast cancer. The study results were so alarming that the NIH canceled the study, citing risk to the study’s participants. The authors of the study suggested that many of the women who used Prempro and other estrogen and progestin combinations HRTs should quit and talk to their doctors about alternatives. (more…)

European health regulators are taking a hard look at two cases of a potentially lethal brain infection linked to the drug Tysabri. About 31,800 people take Tysabri, which is also used to treat Multiple Sclerosis and Crohn’s disease, a digestive condition. Earlier this month, Elan and Biogen Idec, the makers of the drug, revealed that three European Tysabri patients had been diagnosed with progressive multifocal leukoencephalopathy, or PML.

PML attacks the brain and central nervous system and is usually fatal. Symptoms include vision problems, loss of coordination, and memory loss. Patients who survive the disease are often permanently disabled. In 2006, Tysabri was temporarily removed from the US market after it was learned that some patients died of PML during its clinical trials. But it was returned to the market a year later. (more…)

On July 6, 17 premature babies being treated in the Neonatal Intensive Care Unit at Christus Spohn Hospital South in Corpus Christi, Texas were overdosed with the blood thinner, Heparin.  The deaths of twin babies—Keith and Kaylynn Garcia—are believed linked to the hospital error and, now, lawyers for the Garcia family and others are preparing for today’s hearing.  Heparin is an anti-clotting drug used to flush IV—intravenous—lines.

On July 8, the hospital announced an investigation to determine the cause of the “preventable medication error.”  Also on July 8, Keith Garcia died; Kaylynn died the next day.  Hospital officials claim they have not discovered anything to indicate the Garcia twins died as a result of the Heparin overdose.  But, Keith and Kaylynn’s parents, in collaboration with parents of other affected babies, have hired attorneys to investigate if the overdose caused injuries to their babies and resulted in the twins’ deaths. (more…)

Overuse of antibiotics like Cipro and amoxicillan result in serious reactions that send  more than 140,000 people to emergency rooms every year.   Those starting statistics provide yet another reason for doctors to limit their use of the drugs.

The findings are part of a new study on antibiotic reactions in the U.S. - the first of its kind -conducted by the Centers or Disease Control (CDC).  The researchers used the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance project, a sample of 63 U.S. hospitals, between 2004 and 2006.  According to their survey, the hospitals recorded more than 6,600 emergency visits that were due to an adverse reaction to an antibiotics.  They were able to extrapolate this to the whole country and estimated that 142,000 such emergency visits are made every year. (more…)

Despite the fact that generic drug maker Ranbaxy Laboratories, Ltd. is in the  midst of a scandal and a US investigation, the Food and Drug Administration (FDA) went ahead and approved 18 of its drugs.  Ranbaxy is accused of conspiracy, falsifying statements, and healthcare fraud.  On its Website, the House Energy and Commerce Committee states that the FDA has been aware of these allegations for no less than 18 months.  “Allegations from reliable sources and supporting documents indicate a pattern of systemic fraudulent conduct, including submissions by Ranbaxy to the FDA that contain false and fabricated information,” the Justice Department wrote.

Late last month we reported that lawmakers probing allegations that Ranbaxy imported defective drugs into the US sent a letter to FDA Commissioner Andrew von Eschenbach, demanding information on each drug Ranbaxy has approval to market here.  Representatives John Dingell and Bart Stupak, both Michigan Democrats who head up the House Committee on Energy and Commerce, wrote that they were concerned that the FDA knew about problems with Ranbaxy drugs for months, but did nothing. (more…)

Vivitrol (generic: naltrexone), a drug used to treat alcohol addiction, has been causing serious injection site reactions, the Food & Drug Administration (FDA) warned today.  Among the serious problems linked to  are Vivitrol are abscesses requiring surgical drainage.

Vivitrol is manufactured by Alkermes, Inc., and is marketed by Cephalon, Inc.  Vivitrol was approved in 2006 for the  treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment.  Vivitrol is an extended release medication, and is administered via intramuscular gluteal injection once a month. (more…)