Patient dies one day after starting drug treatment
Novartis pharmaceutical manufacturer has informed the U.S. FDA and other regulators after the company had confirmed that the 59 year old patient had died after starting treatment of its multiple sclerosis drug Gilenya (fingolimod).
Due to this recent event the drugs safety is now in question even though this drug which had received its approval a year ago and has been well tolerated in by thousands of patients in general. To date the drug has been given to over 28,000 patients.
Novartis had stated the patient had received their first dose of the drug on November 22, one day later the patient had died. They also commented that they had successfully completed six hours of post-observation without any events. However, heart monitoring is recommended in a physicians office due to the fact this drug can slow down a patients heart rate.
The patient had endured multiple sclerosis for around ten years. Multiple sclerosis (MS) an autoimmune disease that affects the central nervous system and researchers are still looking for its cause and cure.
The drug had been approved by the FDA in September and the European Commission in March of last year. At that time the drugs safety profile was acceptable by experts noting that patients needed to be aware that drug could cause eye infections, small decrease in lung function and could lower heart rate.
Novartis has stated that at this stage the exact cause of death is still not been confirmed and the drug at this time cannot be confirmed or excluded.
Novartis has sent the case details to regulators but at this time has not informed physicians of a possible change in prescribing.
Eric Althoff, a spokesman for the Basel, Switzerland-based drug maker stated the patient who died had begun treatment on Nov. 22 and had been monitored “without incident” for six hours after taking the first dose.
Novartis also had stated they take patient safety very seriously and are gathering all available details on this case.
Tim Anderson, an analyst for Sanford C. Bernstein Ltd., wrote in a note to investors today Sudden death “smacks of being cardiovascular in nature,” he also added that due to the drug possibly slowing down the heart rate temporarily after a patient starts treatment with the drug is the reason for monitoring the patient in the doctors office after beginning treatment.
The drug has promising outlook for sales according to several analysts noting the drug could reach peak sales of over three billion dollars and seize nearly a quarter of the ten billion MS market.
Safety issues with the drug could harm the drugs outlook.
According to surveys 90% of people with MS use alternative treatments. In part the reason for this trend is the fact that over 125 medical schools which include Harvard and Stanford University School of Medicine now offer alternative therapies, this easing the minds of many persons.
Alternative medicine appeals those with MS due to the fact conventional medicine does not have a cure and alternative medicine can provide health and well being, stress management and the management of MS symptoms.
Two such therapies for the management of MS symptoms include:
Among those MS patients using chiropractic they have noted that the care received by chiropractic has helped them manage their symptoms and would recommend it to others who suffer with MS.
Montel Williams one of the most well known names advocates for chiropractic care, he also suffers with MS. He has stated that chiropractic care has decreased his pain, helped his walking ability regained strength in his leg, now both legs are level and pelvis which was once tilted is now back in place.
The goal of chiropractic care is to lessen pressure on the nerves so that body is allowed to function normally.
This form of traditional Chinese medicine has provided relief in some symptoms of MS. Not only does it decrease pain and muscle spasms but helps with bladder control. Numerous large studies have demonstrated that acupuncture treatments do provide benefits to the patients.