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stronger warnings 27 articles

European drug regulators place stronger birth defects warnings on SSRI antidepressants

Four years before she became pregnant, Anna Wilson was prescribed the antidepressant Celexa (citalopram) to treat symptoms of anxiety. Her doctor told her that it would be OK to continue to take the medication even when she starting trying to get pregnant. The safety label for Celexa did not indicate the drug would be dangerous for unborn babies. Unfortunately, Anna would learn the hard way that developing fetuses are particularly vulnerable to ill effects from the drug. Celexa is in a class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). Other drugs in this class include the brand names Paxil, ... Read More

Stress test drugs linked to heart attack, death risk

Cardiac nuclear stress test agents Lexiscan (regadenoson) and Adenoscan (adenosine) have been linked to a rare but serious risk of heart attack and death, the Food and Drug Administration (FDA) warned. The drugs are used to identify coronary artery disease in patients who cannot exercise adequately and are unable to undergo traditional exercise stress tests. The Warnings & Precautions section of Lexiscan and Adenoscan labels previously contained information about the possible risk of heart attack and death with use of these drugs. However, recent reports of serious adverse events reported to the FDA and in medical literature have prompted the FDA ... Read More

Zithromax, Zmax, Z-pak drugs linked to deadly heart rhythm abnormality

The Food and Drug Administration (FDA) is warning that a popular antibacterial drug used to treat bacterial infections such as sinusitis, pneumonia and tonsillitis has been associated with an increased risk of cardiovascular death. Azithromycin, known by the brand names Zithromax and Zmax, and are sometimes referred to as Z-Pak or Tri-Pak, may cause people to experience abnormal changes in the electrical activity of the heart that may lead to a potentially deadly abnormal heart rhythm. Those at greatest risk include people with known risk factors such as existing QT interval prolongation, low blood levels of potassium or magnesium, a ... Read More

Ortho Evra birth control patch now warns of death, permanent disability from blood clots

Stronger warnings have been placed on packages of the Ortho Evra birth control patch, informing users that studies suggest women who use the patch are at greater risk of developing potentially life-threatening blood clots than women who use some oral contraceptives. Birth control pills with the combined hormones estrogen and progestin carry a risk for blood clots. Ortho Evra is a combined hormone contraceptive, containing the progestin norelgestromin and the estrogen ethinyl estradiol. The patch is a thin, matrix-type transdermal patch that is applied to the skin and gradually releases the active ingredients to stop ovulation in order to prevent ... Read More

Senator wants stronger warnings on drugs that can harm unborn babies

Sen. Charles Schumer of New York is calling on the Food and Drug Administration (FDA) to change the safety labels on prescription medication to clearly warn women of the dangers the drugs can cause to their unborn babies. Sen. Schumer’s driving motivation was to reduce the number of babies born addicted to painkillers and other opiates, which has nearly tripled in the past 10 years. A study published recently in the Journal of the American Medical Association found that approximately 3.4 of every 1,000 babies born in 2009 was addicted to a painkiller. If the senator had his way, not ... Read More

FDA advisory panel to review safety of metal-on-metal hip implants

The safety of metal-on-metal artificial hips will be investigated by a Food and Drug Administration (FDA) expert panel this June, according to a press releases issued by the agency. The hip implants have come under scrutiny over the past few years after mounting complaints from patients and studies that show the devices are prone to premature failure and can poison patients as they wear over time. FDA expert panels are assigned to review drugs and medical devices and make recommendations on corrective steps, whether it is to order stronger warnings about a product or ban it from the market. The ... Read More

Public overwhelmingly supports stronger medical device oversight

A Consumer Reports poll shows the public overwhelmingly supports more government oversight of medical devices. The poll was released just as House and Senate Committees released draft legislation to change the way medical devices are approved by the Food and Drug Administration (FDA). Currently, the vast majority of medical devices are approved by the FDA through an accelerated program that allows devices to be approved with clinical trials to evaluate safety and efficacy if there are similar devices already on the market. This process was established several years ago to help move a backlog of devices through the system and ... Read More

Health Canada issues stronger warnings for blood thinner Pradaxa

Health regulators in Canada have issued a warning on the new blood thinner Pradaxa, sold in Canada as Pradax. The new safety label will warn that the risk of internal bleeding events may be increased among patients with kidney problems, Health Canada announced earlier this month. Pradax labels now recommend that all patients should have their renal function assessed before starting the drug, and that doctors should assess any changes in renal function for patients while on the medication, especially for patients who are 75 years of age and older. Health Canada also Pradax was not recommended for patients with ... Read More

Study investigates bleeding deaths associated with blood thinner Pradaxa

The death of Bob Smith* was a surprise to doctors. The 83-year old man was evaluated for what appeared to be a rather routine fall, and by all accounts he seemed fine. He was fully alert and oriented and could respond to verbal commands. CT scans taken when he arrived at the hospital revealed small, superficial areas of hemorrhage in his brain, but two hours later, another round of scans showed extensive progression of brain hemorrhaging. Efforts to stop the bleeding were fruitless. The elderly man fell into a deep coma and died soon after. What happened to Bob was ... Read More

First court hearing planned for Actos bladder cancer lawsuits

The first court hearing for a group of lawsuits that claim Takeda Pharmaceutical’s type 2 diabetes drug Actos causes bladder cancer has been scheduled for March 22 in federal court in Lafayette, La. Following the hearing, U.S. District Judge Rebecca Doherty says she plans to appoint lead attorneys for the consolidated cases. Doherty was assigned to preside over the lawsuits last December by the U.S. Judicial Panel on Multidistrict Litigation. Actos became a top-selling treatment for type 2 diabetes shortly after it was approved for use in 1999 by the Food and Drug Administration (FDA). Last year, the FDA issued ... Read More