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warnings 56 articles

New warnings added to label of potent painkiller Zohydro ER

Just months after the new potent painkiller Zohydro ER hit the market amid a slurry of controversy, a long list of new warnings including black box warnings, have been added to the opioid’s safety label. Zohydro, made by Zogenix, is the first pure hydrocodone to be approved in the United States. Hydrocodone is a potent opioid painkiller that is already marketed in combination with other painkillers such as with acetaminophen in the drug Vicodin. The FDA approved Zohydro under the premise that people with chronic pain need more treatment options. Also, the combination hydrocodone with acetaminophen puts patients at risk ... Read More

Asthma drug linked to serious cardiovascular, cerebrovascular events

The asthma drug Xolair (omalizumab) for children and adults 12 years of age and older can cause problems with the heart and blood vessels supplying the brain, the Food and Drug Administration (FDA) announced after a review of safety studies. As a result, new warnings of an elevated risk of serious cardiovascular and cerebrovascular adverse events will be added to the drug’s label. The review also investigated rates of cancer between patients using Xolar and found no difference compared to patients not being treated with Xolair. However, due to limitations in the five-year study, the agency cannot rule out the ... Read More

AL Supreme Court rules: Brand name drug makers liable for warnings on generic drug counterparts

Makers of brand-name medications can be held liable for warnings on generic drugs even if the generic was produced by another drug company, the Alabama Supreme Court ruled. A majority of the nine-member court upheld a 2013 decision, which was viewed as a defeat by business leaders in this mostly Republican state. The ruling is based on a federal lawsuit filed by Danny and Vick Weeks against five current and former drug makers alleging that long-term use of the heartburn drug metoclopramide, which was also sold under the brand name Reglan, caused a debilitating movement disorder known as tardive dyskinesia. ... Read More

New blood clot warning added to safety labels of testosterone replacement therapies

The safety labels of testosterone replacement treatments have been updated to include warnings of an increased risk of life threatening blood clots. The update comes on the heels of a Food and Drug Administration (FDA) safety alert notifying the public that during an ongoing investigation into cardiovascular risks with testosterone treatments, researchers uncovered a number of reports of thromboembolic events, or blood clots, in men using the hormone replacement products. The new warnings were added to the labels of the following testosterone therapies: Androderm transdermal system, AndroGel gel (1% and 1.62%), Aveed injection, Delatestryl injection, Fortesta gel, Striant buccal system, ... Read More

Warnings of teen suicide risk with antidepressants may have led to increase in teen suicide attempts

Researchers are concerned that recent warnings about antidepressants increasing suicide risk in teens may have contributed to a rise in teen suicide attempts. The study, published in the British Medical Journal, set out to investigate this possible power of suggestion since 2003, when the Food and Drug Administration (FDA) began publicizing suicide risks (including suicide attempts and completed suicides) with antidepressant use in young adults. The study involved data from about 2.3 million adolescents and young adults. Researchers found that the warnings led to a significant drop in antidepressant use in young people, beginning in 2003. At the same time, ... Read More

North Carolina senate supports measure to shield drug makers from personal injury claims

The North Carolina Senate has approved an amendment to a bill that would give pharmaceutical companies protection against litigation regarding adverse effects from their drugs if they have previously warned of specific side effects and followed all Food and Drug Administration (FDA) rules. If the legislation becomes law, North Carolina consumers would likely have a more difficult time suing drug companies for injuries caused by their products. Supporters say the measure will put drug companies on equal footing with consumers. Opponents disagree, saying the move could hurt people who hare harmed by side effects that emerge after a drug is ... Read More

Newer type 2 diabetes drugs carry serious side effects, pancreatic cancer risks

The newest classes of type 2 diabetes drugs may help diabetics manage their disease, but it can come at a great price. Diabetes drugs known as GLP-1, DPP-4, and SLGT2 have been associated with serious side effects including acute pancreatitis, pancreatic cancer, thyroid cancer, urinary tract infections, gastrointestinal issues, and renal and gallbladder problems, according to AdverseEvents (AE), a company that analyzes post-market side effects data. According to DrugWatch.com, Glucagon-like peptide-1 receptor (GLP-1) agonists and dipeptidyl peptidase-4 (DPP-4) inhibitors both affect levels of the incretin hormone, which helps to control blood sugar. Sodium-glucose co-transporter 2 (SGLT2) inhibitors (glucuretics) block glucose reabsorption ... Read More

North Carolina woman says prescription drug-induced psychosis led husband to kill daughters

The moment Kim Crespi of Charlotte, N.C., heard that her husband David had stabbed their 5-year-old twin daughters to death, she knew that the real culprit behind the horrific act wasn’t her spouse but a cocktail of prescription drugs, including Selective Serotonin Reuptake Inhibitors, or SSRIs – a form of antidepressants. According to Charlotte’s WBTV, David Crespi, a Charlotte-area banker, called 911 on the morning of Jan. 20, 2006 to report that he had just killed his own daughters. Mr. Crespi was arrested and ultimately took a plea bargain to avoid the death penalty. He is now serving two life ... Read More

FDA wants to reclassify transvaginal mesh as high-risk medical device

The Food and Drug Administration (FDA) proposed reclassifying transvaginal mesh devices from moderate-risk to high-risk, requiring manufacturers to submit a premarket approval application for the agency to evaluate a device’s safety and efficacy before the device can be approved for marketing. Transvaginal mesh is a type of surgical mesh that is inserted through the vagina to treat common pelvic floor disorders such as pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The mesh holds up organs that have dropped due to the stress of childbirth, obesity or age, causing symptoms such as incontinence, pain during sexual intercourse, and general discomfort. ... Read More

Young people who start antidepressants at higher doses more prone to suicidal thoughts

Children and young adults who start taking antidepressants at higher than recommended doses are twice as likely to have suicidal thoughts or attempt suicide than those who begin treatment at lower doses, according to a new study published in JAMA Internal Medicine. For the study, researchers examined data from 1998 through 2010 on about 163,000 people ages 10 to 64 who were treated for depression. Some people in the study were given the recommended dosage, while others were started at higher doses. It was not made clear why some individuals started at higher-than-typical doses. About 18 percent of 10- to ... Read More