Saturday, June 28, 2014

VIDEO: Multiple sclerosis death due to Tecfidera unlikely but still investigated

A news release stated a 59-year-old female hadn’t been taking Tecfidera; Biogen Idec’s new multiple sclerosis (MS) pill-form therapy, at the time of her death, but they are still investigating as she had been on the therapy for 5 ½ weeks 2 weeks prior. Side effects like nausea, diarrhea and vomiting are what had decided the cessation of the therapy and a spokeswoman for Biogen stated the patient had a “history of irritable bowel disease and recurring infections including bronchitis” Tecfidera delayed-release  capsules have surpassed Gilenya as chosen pill-form therapy in the fight against MS progression.
The company also noted the patient had died from a type of pneumonia that is a problem many with MS have. Aspiration pneumonia is something that results from one of two circumstances: the inability of clearing secretions from the nose and throat or from swallowing difficulties that results in inhalation of food particles.

Weakness of ventilator muscles occur in MS patients, causing the difficulty of breathing in or out, and it is recommended that doctors do an evaluation at the time of a patient being diagnosed with follow up every 1 to 3 years after.

The most common side effects during testing were low white-blood counts, which increase the danger of infection along with nausea, vomiting, diarrhea, indigestion, the flushing of the face or redness but, with time and continued use of therapy, the side effects can ease.

Unfortunately with the deceased patient, the side effects didn’t abate and her and her doctor had to make the decision to stop therapy.

The introduction of the drug has exceeded expectations though and, coupled with therapies like Gilenya, these pill-form medications are changing the way patients are dealing with their disease.

A month after it’s launch, Tecfidera sales had surpassed Novartis’s Gilenya, the first to the MS market pill-form therapy, but there was an admitted doctor negative comfort level when it came to the side effects.

With that being said, Gilenya’s doctor comfort level of prescribing for therapy stayed the same through out each level of analysis. There were no increases or decreases when it came to that although when it came to actually prescribing the drug, there was a very small increase in prescriptions through out.

The reason being a fair number of doctor’s feeling there was no need for prescribing a therapy with the kind of side effects Gilenya had when there was no need i.e. patient having no changes in MS progression and their MRIs.

Gilenya's numerous side effects include: low heart rate, dizziness, feeling very weak or tired; chest pain, pounding heartbeats or fluttering in your chest; severe headaches; sudden numbness or weakness, problems with speech or walking, chest tightness, trouble breathing, cough with yellow or green mucus; fever, chills, body aches, flu symptoms, nausea and vomiting, sores in your mouth and throat; swelling, warmth, redness, oozing, itchy rash or other signs of skin infection; nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice or vision issues like blurred vision, eye pain, increased sensitivity to light, or having a blind spot or shadows in the center of your vision.

Without even reading the entire list of Gilenya's side effects, it is easy to see why patients would choose Tecfidera instead.

With less side effects, Tecfidera's success at launch is more than likely also due to it being more cost effective than Gilenya.

It was not mentioned whether the patient who had died had done other MS therapies along with the Tecfidera. Although most patients do not use other MS medications along with their chosen ‘main’ therapies, it isn’t unheard of.

Story Source: The above story is based on materials provided by EXAMINER
Note: Materials may be edited for content and length