side effects

A case study reported the successful management of a multiple sclerosis (MS) patient who developed a rare condition in the brain — progressive multifocal leukoencephalopathy (PML) — due to treatment with Novartis Pharmaceutical’s Gilenya (fingolimod). The study, titled “Fingolimod-associated PML with mild IRIS in MS: A…

Part two in a series. Read part one here. In the last column, I discussed gadolinium’s role in contrasted MRI procedures and a December 2017 warning by the U.S. Food and Drug Administration that the body can retain gadolinium in its tissues and brain for years. I also shared my personal experience with…

When a doctor orders an MRI with contrast, gadolinium is usually the contrasting agent used. Gadolinium is injected into the patient’s vein after the radiologist takes the first round of MRI images. This helps the radiologist receive sharper, more readable images. In the case of multiple sclerosis (MS),…

Acute Acalculous Cholecystitis Linked to Lemtrada Use in RRMS Patients, FDA Reports The makers of Lemtrada have added the possibility of another serious side effect to the warning carried on the therapy’s label. The addition follows a Food and Drug Administration review that discovered a potentially serious…

Higher rates of adverse effects have a negative impact on a patient’s perspective about treatment with Ocrevus (ocrelizumab), according to a survey conducted by the multiple sclerosis community GeneFo. About half of the 840 patient responses surveyed so far have reported improvements from Ocrevus. Those reporting none had a higher rate…

Acute acalculous cholecystitis (AAC) is a rare but potentially life-threatening adverse effect linked to treatment with Lemtrada (alemtuzumab) in patients with relapsing-remitting multiple sclerosis (RRMS), according to a U.S. Food and Drug Administration review. The study, “Acute acalculous cholecystitis — A new safety risk for…

Six months ago, I was a reasonably svelte 14 and a half stone. I’m not sure how I managed it, but it was certainly before pitting edema wrapped itself around my shins and calves like bulbous sacks of wineskins. I managed to get on the scales a while…

Biogen and AbbVie have voluntarily withdrawn global marketing authorizations for their relapsing multiple sclerosis therapy Zinbryta (daclizumab) because of serious side effects that include brain inflammation. The Europe Medicine Agency, which oversees medications across the European Union, also released a statement recommending a “immediate suspension” of Zinbryta’s use by patients and…

Editor’s note: Tamara Sellman continues her occasional series on the “MS alphabet” with this column referencing terms starting with the letter “S.” Second in a series of five. Symptoms of MS Speech problems It’s estimated that nearly half of all people with MS struggle with speech…

Pregnant women with multiple sclerosis (MS) exposed to Tysabri (natalizumab) in the first trimester had higher rates of miscarriage and major birth defects in their babies, than women left untreated or treated with interferon beta, a study shows. Although higher, these rates were similar to those in the general…

The Food and Drug Administration (FDA) issued a safety alert about gadolinium, the dye that’s injected when our doctors order a brain MRI “with and without” contrast. The dye provides the contrast that “lights up” areas of MS inflammation in the brain. But the FDA advisory is…

The U.S. Food and Drug Administration (FDA) has updated a safety bulletin about gadolinium-based contrast agents (GBCAs), after studies raised new concerns about them. Doctors often use GBCAs to diagnose multiple sclerosis (MS), monitor disease activity and verify the effectiveness of MS therapies. Gadolinium is a metal ion, or electrically charged molecule, that…

Lemtrada (alemtuzumab) remains a “game-changer” of a treatment for relapsing multiple sclerosis (MS), with benefits continuing and no new side effects seen in a study of its use that now goes out seven years, Aaron Boster, a neuroimmunologist at Ohio Health, said in an interview at the…

Aubagio (teriflunomide) may lead to reversible nail loss, researchers at Italy's University of Bologna reported after reviewing the case of a 55-year-old woman with relapsing-remitting multiple sclerosis. They described what happened to a patient who was referred to an MS clinic after experiencing acute optic neuritis — or inflammation of the optic nerve — three months earlier. Their report, “Nail loss after teriflunomide treatment: A new potential adverse event,” was published in the journal Multiple Sclerosis and Related Disorders. Doctors had been treating the woman with intravenous methylprednisolone. Physicians had judged her slightly disabled, with an Expanded Disability Status Scale (EDSS) score of 3, but had not diagnosed her with MS. When she was diagnosed a few months later, she began receiving interferon beta-1a. It did not work, so doctors switched her to Sanofi Genzyme's Aubagio. At first, she tolerated the treatment well, having only slight nausea after taking the medication. Physicians did not detect signs of liver toxicity or high blood pressure, which are relatively common side effects of Aubagio. Roughly three months after starting the medication, however, the woman began having more trouble walking problems and had mild hair loss. Two and a half months later, she said her nails had started falling out in the past month. When doctors examined her, she had lost two nails, while others appeared to have stopped growing. They were thinner than normal and some had detached from the nail bed. In addition, her hair loss continued. She had not started using other drugs, new cosmetics, or changed her diet. A dermatologist excluded the possibility that the condition was the result of fungus, psoriasis, or other conditions that could cause nails to fall off. Because doctors suspected that Aubagio could be the cause of the nail loss, they recommended that she stopped taking it. The patient switched to Biogen's Tecfidera (dimethyl fumarate) after a couple of weeks, and her nails started to grow again. This supported doctors’ idea that Aubagio had caused the nail loss, and that it was reversible. Nail growth is similar to that of hair, researchers said. The patient’s reaction could be an unusual version of the same process that makes people lose their hair when taking Aubagio, they said. Since nail loss is not described as a side effect of Aubagio on the medication's label, researchers urged MS specialists to consider the possibility if they see patients with the problem.  

As I write, I’m pain-free. This is important, but not for the obvious reason. I’m pain-free and can walk — or at least stumble — about as best as I’ve been able to manage of late. It’s not much, but I can be involved in family life and get…

Editor’s note: This column is second in a series. Read the first part here. Just you wait! How many times have we heard those words or said them to someone else? I find that now it’s my turn to wait. What I’m waiting for is six months…

According to a new clinical trial, the allergy treatment cetirizine fails to alleviate a flu-like condition that interferon-beta treatment generates in people with relapsing-remitting multiple sclerosis. The results, which surprised researchers, apply to flu-like syndrome, or FLS. Cetirizine is an over-the-counter medicine sold under the brand names Zirtec, Zyrtec, Reactine, and Triz. FLS affects roughly 75 percent of patients who take interferon-beta, also known as IFN-beta. It can cause fever, chills, muscle pain, weakness, and headache. The symptoms commonly occur three to six hours after an IFN-beta injection and last up to 24 hours. Although FLS usually subsides in the first three months of IFN-beta therapy, it persists in some patients, causing them to miss doses or even discontinue the treatment. Cetirizine is an antihistamine for hay fever and allergies. The purpose of the clinical trial was to determine whether cetirizine could alleviate RRMS patients' FLS. In order to determine study results, patients did self-assessments of how much discomfort their FLS caused them. There were no significant changes in the two groups' average self-assessment scores at four and eights weeks of treatment, suggesting that cetirizine does not offer significant benefits to RRMS patients with FLS. “The addition of a [cetirizine] to the standard of care for IFNβ-induced FLS in patients with RRMS does not seem to improve symptoms significantly compared with placebo," the team wrote. "FLS continues to be inadequately treated in many RRMS patients. Further investigations are needed to elucidate the underlying mechanisms of IFNβ-induced FLS and develop adequate strategies for prevention and treatment."

The European Medicines Agency has restricted the use of Zinbryta (daclizumab) for relapsing multiple sclerosis after reports of patients experiencing severe liver damage and one dying of liver disease. The temporary order restricts Zinbryta to European Union patients with a highly active disease who have failed to respond to…

The multiple sclerosis therapy Tysabri could trigger melanoma, the Southern Network on Adverse Reactions (SONAR) has warned. Although its investigation failed to demonstrate that melanoma is more common among Tysabri-treated MS patients than in the general population, unusual features among the patients raise concerns about a possible link, the organization said. Contending that current monitoring efforts are inadequate, it suggested improvements that could generate a better understanding of the relationship between Tysabri treatment and cancer. The organization's report, published in the journal Cancer Medicine, was titled “Melanoma complicating treatment with natalizumab for multiple sclerosis: A report from the Southern Network on Adverse Reactions, also known as SONAR." SONAR is an organization that was formed in the Southern United States in 2010 to investigate adverse drug reactions that regulators might not be aware of. Its goal is to reduce the time it takes between detecting an adverse reaction and have regulators act on it. A case that a SONAR investigator came across led to the group investigating possible links between Tysabri and melanoma. A 43-year-old woman developed melanoma in her urethra, the tubing that drains urine from the bladder, after being treated with Tysabri for about two years. Melanoma is most often a skin cancer that is related to sun exposure, but the woman had no skin lesions. After extensive surgery, she relapsed and died when the cancer spread to other parts of her body. She had declined anti-cancer treatment. The case prompt SONAR to look for similar cases. Its investigators found seven studies that involved Tysabri-treated MS patients developing melanoma. In addition, they looked through the U.S. Food and Drug Administration’s Adverse Event Reporting System (FAERS) and the Tysabri Safety Surveillance Program. The surveillance program is part of the Tysabri Outcomes Unified Commitment to Health (TOUCH) database run by Tysabri's developer, Biogen, The research team found 137 cases in the FAERS database through April 1, 2014. The patients' average age was 45. Seventeen percent of the group developed tumors in locations not exposed to the sun, and nine died. The researchers said the database contained only about half the information it should have, such as tumor site, patients' family history of cancer, and earlier immunosuppressive treatment. Fifteen percent of the cases in the FAERS database were based entirely on information from the TOUCH database. Seventy-three percent were cases initially reported to FAERS but with TOUCH information added. Thirteen percent of the FAERS cases contained no additional information. Importantly, there was even less patient information in the TOUCH database than in the FAERS database. Out of eight items researchers believe a database should contain, TOUCH had information on two, on average. “The existence of the TOUCH Safety Surveillance Program, an FDA-mandated program, did not improve melanoma reporting,” the team wrote. This shortage of data stymies research into possible links between Tysabri treatment and melanoma, the researchers said. As an example, although the death rates in the databases were low, there was no information about survival in many cases, which could lead to flawed survival estimates. The investigation noted that patients received a wide range of Tysabri doses before they were diagnosed with melanoma. While some received only one or a few injections, others had been treated for a long time. These observations do not seem to support a link between Tysabri and melanoma, the team said. “A longer therapy duration would be expected if natalizumab caused melanoma via an immunologic pathway, unless existing nevi [lesions of the skin or mucus tissue] were already premalignant lesions,” the researchers wrote. But other information the team found seemed to suggest a Tysabri-melanoma link. For example, the average age of melanoma patients was much lower than that reported in the National Cancer Institute’s Surveillance, Epidemiology and End Results (SEER) database. The average age in the institute's database is 63, compared with 45 in the FAERS database and 41 in cases in academic journals. In addition, many patients developed tumors in unusual places not exposed to sunlight. Finally, the low melanoma death rate in Tysabri-treated patients differed from that seen in the general population. All these factors suggest that melanoma after Tysabri treatment could differ from other types of melanoma, the researchers argued. While the molecular workings of Tysabri might promote melanoma growth, studies so far have not found a relationship between the drug and this cancer. In fact, some studies suggest that MS patients, in general, have a lower risk of melanoma than others. The team said more information on patients could give researchers a better understanding of the potential relationship between Tysabri and melanoma. The implication was that the standard of reporting in the FAERS and TOUCH databases could improve. To minimize the risk of patients who receive Tysabri developing melanoma, the researchers offered a number of suggestions for IV centers, physicians, patients, and educational programs. For instance, they suggested that all patients should have a skin examination before the start of treatment, and regular physical and skin exams while receiving Tysabri. While noting that risk of infection and the development of tumors can occur with all immunosuppressive treatments, the team said more studies are needed to explore the risk of Tysabri-treated patients developing melanoma.

Previously unpublished results of clinical trials of Lemtrada (alemtuzumab) appears to contain key information as to why many multiple sclerosis patients who use it develop other autoimmune diseases. Researchers looked at the immune cell mix after Lemtrada depleted many of those cells. They discovered that certain B-cells repopulate the body earlier…

The latest drug media storm to erupt in Britain is “Spice,” which causes users to become living statues. Exactly a year ago, I became a living statue for six weeks, and not one reporter hassled me. That would have broken the monotony! We all have our own version…

A multiple sclerosis (MS) patient treated in Germany with Ocrevus (ocrelizumab) has developed the dreaded brain infection progressive multifocal leukoencephalopathy (PML). But it is not clear whether the recently approved Genentech/Roche-developed treatment is the cause. The patient took the last dose of a three-year course of Tysabri (natalizumab) in February. Tysabri is…

A large-scale study revealed potential adverse reactions to beta-interferon (IFN-β) therapy, one of the most common treatments used for relapsing-remitting multiple sclerosis (RRMS). According to the study published in the journal Neurology, patients have an increased risk of stroke, migraine, depression, and of developing abnormalities in the blood. In…

It’s been less than a month since Ocrevus was approved by the FDA, and the buzz hasn’t died down. Though there is some trepidation, the MS community is incredibly excited about what the new “game-changing” medication can do for patients all across the country. Here are just a few…

I was a teenager during the 1980s and cannot say the word “holiday” without Madonna’s song playing briefly in my head. For most holidays the perky music seems okay, but for discussion of a “drug holiday” it feels a bit off. Sort of like, “Yay! You have a chronic…

The past few days have been remarkable in the multiple sclerosis (MS) community, with the U.S. Food and Drug Administration (FDA) approving Ocrevus to treat relapsing MS (RRMS) and primary progressive MS (PPMS) in the United States. Ocrevus — adminstered intravenously every six months — is the first drug…

With the recent approval of Ocrevus (ocrelizumab) for both primary progressive and relapsing multiple sclerosis (MS), interest in the medication is peaking. To help readers of Multiple Sclerosis News Today better understand this new medication and how it works, as well issues dealing with access, use, and potential side effects, here is a summary…

Treatment with a compound called BIIB074 shows promise in reducing pain caused by trigeminal neuralgia — a  condition that occasionally affects multiple sclerosis (MS) patients — with few side effects, a new clinical trial finds. The Swiss study, “Safety and efficacy of a Nav1.7 selective sodium channel blocker in Titrigeminal neuralgia:…

Interferons (Beta and Alpha) are the oldest of the disease-modifying treatments, or DMTs, for people with MS. Interferons include Avonex, Betaseron, Rebif, and Plegridy. This column won’t get into the pros and cons of each of these treatments. Instead, I’d like to focus on one of the more…

Tecfidera (dimethyl fumarate or DMF) use by multiple sclerosis (MS) patients can result in liver injury and, in rare cases, even severe injury, a study found, leading its researchers to recommend that patients’ on this treatment be carefully monitored for signs of injury. The study, “…