According to Reuters, the U.S. Food and Drug Administration (FDA) has extended the review process for the multiple sclerosis drug Plegridy by three months as they evaluate an application for the drug’s approval.
About the Plegridy
Initially scheduled for launch in mid-2014, Plegridy is an injectable multiple sclerosis drug developed by Biogen to reduce the dosing schedule of standard interferon drugs like Avonex.
Typically, interferon drugs are dosed at least once a week. Unfortunately, the drugs can be hard to tolerate and carry flu-like symptoms, often leading to patient delaying or discontinuing treatment.
Biogen aims to increase treatment completion by limiting the number of necessary interferon injections, making the symptoms less of an occurrence.
Clinical trials for Plegridy have shown the drug to be well tolerated, meaning the drug could replace market leaders like Tysabri which has been linked to serious side effects including hypertension, hypersensitivity and death.
About Multiple Sclerosis
- Multiple sclerosis is a chronic condition that occurs when the body’s immune system mistakenly attacks and destroys the protective sheath surrounding the nerve cells in the brain, optic nerve or spinal cord.
- Over time, the damage can hinder communication between the brain, spinal cord and other areas of the body. The damage is not reversible.
- Symptoms include a loss of balance, difficulty moving arms and legs, weakness, numbness and blindness.
- While there is no cure for MS, treatment can reduce symptoms and reduce progression of the disease.
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According to Medpage Today, medical experts are pressing clinicians to observe heart failure as an important outcome in clinical trials for diabetes drugs as heart failure is one of the most common diabetes complications.
About the Diabetes Drug Trials
“We believe that heart failure should be systematically evaluated in cardiovascular outcome trials of new glucose-lower drugs, either as a component of the primary composite outcome or as a pre-specified secondary endpoint.” – John McMurray, MD, of the University of Glasgow and his colleagues as published by Medpage Today
There are currently 150,000 patients with heart disease or a high burden of cardiovascular risk enrolled in clinical trials for diabetes drugs, leading specialists in the diabetes field, like Dr. John McMurray, to encourage that medical trials consider cardiovascular outcomes when testing new glucose-lowering medication.
In the past, specialists believed that glucose-lowering medication would decrease cardiovascular risk, but recent evidence suggests that diabetes medications in fact increases cardiovascular risk.
Most trials do not look to cardiovascular burden as an endpoint; rather, they mainly view major adverse cardiovascular events (MACE) as the endpoint to avoid. MACE is a combination of cardiovascular death, heart attack, and stroke.
How Great is the Risk of Heart Failure?
- Although it is undeniably important to prevent MACE, it should be equally as important to look at the effects diabetes medication has on cardiovascular health in general.
- In fact, heart failure is significantly more common in diabetes patients than cardiovascular death, heart attacks, and strokes.
- A recent study that tested the cardiovascular outcomes for the DPP-4 inhibitor saxagliptin (Onglyza) found a signal for a higher risk of hospitalization for heart failure in diabetes patients.
- By overlooking heart failure as an important endpoint in diabetes drug trials, significant cardiovascular effects of diabetes drugs are being ignored, warned McMurray, putting diabetes patients at risk.
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Are Antidepressants linked to Autism Spectrum Disorder?
The federal U.S. Centers for Disease Control and Prevention (CDC) reports that one in every 50 American children now have some form of autism.
The CDC also reports that prescription rates for antidepressants such as Prozac, Paxil, Zoloft, Effexor, Luvox and Celexa has become equally stratospheric, with 11 percent of all Americans 12-and-over taking them, and 23 percent of women in their 40s and 50s.
According to the WND, there have been conflicts as to the use of antidepressants to treat pregnant women, but the question remains: Do antidepressants in pregnant women cause their children to be born with autism spectrum disorder?
The Research and the Controversy
Multiple studies have been conducted over the past several years addressing that very question, and research scientists have concluded that women who take modern antidepressants, also commonly called SSRIs (selective serotonin reuptake inhibitors), while pregnant are at an increased risk having a child born with autism.
Unfortunately, the answer may not be as simple as “stop medicating.”
Tim Oberlander, M.D., a professor of developmental pediatrics at the University of British Columbia in Vancouver, argues that poor maternal mental health during pregnancy is a major public health issue and that non-treatment is not always an option.
Further, Oberlander points out that while some children might be at risk from an SSRI exposure, there are many mothers and children who will benefit as well.
Lisa Croen, Ph.D., director of autism research at Kaiser Permanente Northern California shared similar concerns, adding that untreated depression during pregnancy carries its own risks, such as preterm birth and growth problems.
The problem becomes balancing the potential risks to the child with the risks of an untreated mother.
Pregnant Women Need to Consult with Physicians
In order to determine the best course of action regarding SSRIs, pregnant women taking antidepressants should consult with their healthcare providers.
By analyzing a patient’s medical history, physicians can build a treatment plan around the symptoms and severity of the patient’s depressions.
Adam Urato, M.D., assistant professor of maternal-fetal medicine at Tufts University School of Medicine in Boston explains that while some women with severe depression can become suicidal after halting treatment, the majority of women being treated with psychotropic medication are diagnosed with mild to moderate depression.
As such, there needs to be a presentation of information that is accurate, complete and correct; however, according to Urato, such information is not being made available, posing a threat to expectant mothers.
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