Seizure Threat Tied to Drug-swap Laws May Hurt Teva, Mylan
Sam, 17, went seven weeks without an episode while taking Zonegran, made by Tokyo-based Eisai Co. After pharmacists switched him to generic copies made by four different companies, he suffered multiple seizures daily and was hospitalized three times before doctors identified differences between the medications as the cause, said Miller, of Dayville, Connecticut. She said her sons doctor was never notified about the switches and she didnt always know what company supplied the pills.
Armed with more than 1,000 similar reports, the Epilepsy Foundation of America and other patient-advocacy groups are pressing lawmakers in at least 33 states to stop pharmacies from substituting generic drugs for the originals before patients and their doctors are alerted to the changes.
“We can lose our lives over this; we can lose our jobs,” said Ginny Miller, 45, who also has epilepsy, in a telephone interview. “If Im out there driving, with a generic medicine that Im sensitive to, I might kill you. A lot of patients dont have a choice but to use the generic. Their hands are tied.”
Products such as Zonegran and Johnson & Johnsons Topamax, also for epilepsy, may gain sales if the bans pass. Teva Pharmaceutical Industries Ltd., Mylan Inc. and other generic- drug makers might lose $29 billion over 10 years, the Pharmaceutical Care Management Association, based in Washington, said in a report in October.
Generic Sales
U.S. retail sales of generic medicine totaled $33 billion last year, IMS Health Inc., a Norwalk, Connecticut-based research company, said in a December report.
Generic drugs, copies of medicines that have lost patent protection, can cost 70 percent less than the originals. States, insurers and employers often insist that pharmacists fill patients prescriptions with a generic to save money.
Last year, 71 percent of prescriptions were filled by copies, a portion that has climbed since a 1984 U.S. law established the current system for allowing generic drugs on the market, IMS said.
While routine switching of drugs may make sense for many patients, a growing number with epilepsy, depression, heart disease and transplanted organs have suffered side effects after getting generic substitutes, say spokesmen from the Epilepsy Foundation in Landover, Maryland; the American Academy of Neurology in St. Paul, Minnesota; the American Heart Association in Dallas; and the National Kidney Foundation in New York.
Surprising Affects
The chance of adverse effects may surprise most patients who use generic drugs, said Barbara Murphy, chief of nephrology at Mount Sinai School of Medicine in New York. Individual patients, doctors and the government have to be aware of the possibility, she said.
Besides seizures, differences between original drugs and their generic forms may be linked to side effects and relapses in people with depression, rejection of transplanted organs and irregular heartbeat, according to the patient groups.
No definitive studies have compared brand-name drugs against generics using double-blind tests, which would require epileptic volunteers to take medicine that might cause a seizure relapse, said Jacqueline French, director of the Epilepsy Clinical Trials Consortium at New York University, in a telephone interview.
Chemical Differences
What is known is that generic copies of medicines can have a chemical makeup different from that of the originals, under rules issued by the U.S. Food and Drug Administration, said Eric Hargis, president of the Epilepsy Foundation.
While the FDA requires that generic versions contain the same active ingredient as the original, the amount that makes it into a patients blood can vary. To get products approved, makers of generics must show the medicines deliver to the bloodstream 80 to 125 percent of the amount of active ingredient deposited by the original drug. Colorings, binders and fillers also may differ from those of the original product.
While generics can vary that much, on average they dont, said Kathleen Jaeger, chief executive officer of the Generic Pharmaceutical Association in Arlington, Virginia. A 1997 study in the Journal of the American Medical Association found the average difference in blood levels between generics and originals was less than 4 percent, she said in a telephone interview. Thats the latest large-scale, published study to measure the difference, she said.
No Better or Worse