Shortage looms for drug used to treat hyperactive children



TRENTON, N.J. (AP)—Strict federal controls on Ritalin, the popular medicine for hyperactive children, have backfired, causing a six- to eight-week delay in replenishing its supply, according to its manufacturer.

Because of annual production constraints, Ciba Geigy Corp. has stopped making the drug and doesn’t expect to resume shipments until November, spokesman Todd Fortay said Monday.

‘‘The shortages are real now and will become more acute in November,’‘ Fortay said.

The Drug Enforcement Administration, which sets the limits, blamed federal rules and foot-dragging by another agency, the Department of Justice, for the situation. Justice Department officials did not immediately return messages for comment Monday.

Ritalin and its generic substitute, methylphenidate, are classified as controlled substances. Consequently, the DEA determines the amount of the drug it believes will be needed for legitimate medical and scientific needs and sets a quota for the two companies that make it: Ciba Geigy Corp. of Summit and MD Pharmaceutical Inc. of the City of Industry, Calif.

In January, July and August, Ciba wrote the DEA, asking that the production quota be raised because of anticipated shortages during the fourth quarter of this year, Ciba spokesman Todd Fortay said.

The agency raised the quota on Oct. 7, about the time Ciba stopped making this year’s supply, the company said. It will now take Ciba six to eight weeks to gear up production again, Fortay said.

Even though MD Pharmaceutical has reported no disruption in supplying methylphenidate, some people require the trademark Ritalin version that Ciba produces, said Dr. Joseph Biederman, director of psycopharmacology at Massachusetts General Hospital in Boston.

The drug is used to treat people with attention deficit disorder, characterized by hyperactive and often aggressive behavior, said Dr. Robert D. Hunt, a Nashville, Tenn., psychiatrist.

Without it, doctors say patients can quickly relapse into impulsiveness and hyperactivity.

Last year, doctors prescribed the brand name and generic versions of the drug to a total of 900,000 patients around the country, Fortay said.

The DEA blamed most of the delay in getting the quota raised on federal regulations and foot-dragging by the Justice Department, whose approval is needed for production changes. The DEA was required to allow 30 days for public comment, and requested final clearance on May 13, agency spokeswoman Joyce McDonald said.

Clearance was granted 2^4 months later, she said. The DEA was then required to schedule two more 30-day comment periods before the change actually took effect, she said.