The FDA recently released a statement exposing the risk of seizures for those with multiple sclerosis who are taking Ampyra (generic dalfampridine). Drug recall attorneys warn those taking Ampyra of this troubling development.
Responding to post-market negative side effect reports, the FDA conducted an evaluation of Ampyra and its risk of inducing seizures. Developed by Acorda Therapeutics Inc, the drug is intended to improve walking capability for MS patients. FDA evaluations found that seizure risk significantly increased in patients with moderate to severe kidney impairment. Ampyra is eliminated from the body through the kidneys, and those with any renal impairment are at a much higher risk of suffering unsafe levels of the drug in their bloodstream.
The risk of seizure was a previously known side effect of Ampyra, although the extent of which was not known until the evaluation. The FDA released a safety alert concerning its findings and updated the prescription label for both patients and physicians. Patients are now required to be monitored at least once a year while taking the drug and must cease taking the drug permanently if a seizure occurs. Federal officials are also requiring physicians to order blood tests periodically to test kidney function and calculate patient’s CrCl before prescribing Ampyra.
The drug was approved by the FDA in January of 2010 and has patent protection in the United States until 2027. Acorda’s European marketing partner, Biogen Idec Inc, is currently selling the drug under the brand name Fampyra. European officials are requesting Biogen conducts a similar evaluation to determine the drug’s long-term safety. As of August 2012 more than 55,000 MS patients were using Ampyra, and sales were exceeding $66.3 million per quarter.
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Only a few months after Ampyra’s dangers surfaced, Acorda Therapeutics suffered another setback when its low-dose version of the drug failed in a clinical study. Ampyra is currently administered in 10 mg dosages, and the FDA asked the company to carry out a study of the potentiality of a 5 mg dose. The lesser dose, however, failed to show improvement in MS patient’s walking ability and speed.
In a troubling twist, trials were conducted on the 10 mg Ampyra at the same time, and patients did not show any significant improvement in walking speed when compared with a placebo. Upon these findings, Acorda insisted that these 10 mg trials were devised differently than the trials from which the drug was originally approved. Nonetheless, these findings, particularly in light of the seizure safety alerts, do not inspire much confidence.
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As the human body ages, kidney functioning decreases and mild kidney impairment is expected after age 50. The FDA recommends that physicians should carefully consider the potential benefits of Ampyra against the risk of seizures in their more mature patients, who more than likely have mild kidney impairment. The FDA is also stating that patients should never take double or extra doses of Ampyra, even if one dose is missed. Side effects, including the risk of a severe seizure, are more frequent at higher doses.
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Reports indicate that most seizures occurred within a few days to a few weeks after initially taking Ampyra, and in patients who have no previous history of seizures. Because of this disquieting development, patients are encouraged to immediately notify their physician if they have any history of kidney problems and to never divide, crush, chew, or dissolve the medication before consumption.
Ampyra lawyers at Pintas & Mullins Law Firm warn MS patients that seizures are sometimes preceded by dizziness or lightheadedness, tightening of the chest, blurred or loss of vision, and out-of-body experiences. If you or someone you love suffered adverse health effects from Ampyra, contact an experienced drug recall attorney for a free legal consultation.