Group Faults Drug Inhaler in 10 Deaths

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August 10, 2001

Group Faults Drug Inhalers in 10 Deaths

By MELODY PETERSEN

At least 10 asthma patients may have died after using drug inhalers that were later recalled by the manufacturer, the Schering-Plough Corporation (news/quote), according to reports filed with federal regulators that were obtained by a consumer group.

The Food and Drug Administration said yesterday that it was investigating the reports, which were detailed in a letter from the consumer group, Public Citizen, to Tommy G. Thompson, secretary of health and human services.

Schering-Plough said there was no evidence directly tying the deaths to its recall of millions of inhalers in March 2000. The company undertook the recall out of concern that a small number of inhalers were not properly filled with albuterol, a drug that helps asthma sufferers breathe.

The company said Public Citizen's analysis of the reports was flawed. In an average year, the company noted, more than 5,000 Americans die from asthma.

"We have no evidence that a patient was ever harmed by an inhaler subject to the recalls," said William O'Donnell, a spokesman for Schering-Plough, which is based in Madison, N.J. "While there are some lawsuits claiming otherwise, we are contesting them vigorously."

The findings by Public Citizen were based on death reports typically filed by doctors, medical examiners or family members with the food and drug agency or a drug's manufacturer, which is required to pass them on to the agency.

In its letter, the group said that inhalers made by Schering-Plough were listed as the probable cause for the deaths of 17 people from September 1998 to June 2000, a period when the recalled inhalers were on pharmacy shelves or in the hands of asthma sufferers.

The reports detailing 10 of those deaths included batch numbers for the inhalers that matched products that were recalled, the group said.

According to a report on the death of a 21-year-old man, the patient "complained on several occasions that his albuterol inhaler did not seem to treat his asthma attacks as usual," the consumer group said. Another report, on the death of a 10- year-old boy, said that during an asthma attack, the child "reached for his inhaler and obtained no relief."

Mr. O'Donnell, the Schering-Plough spokesman, said the company tested some inhalers that were returned after a patient was injured or was reported to have died while using them. Every container tested held some albuterol, he said.

Dr. Sidney M. Wolfe, director of Public Citizen's health group, said that according to one report, a woman with a history of well-controlled asthma died in September 1999. The company was notified of that death on Jan. 4, 2000, he said, but did not recall most of the inhalers until March 29, almost three months later. In that time, Dr. Wolfe said, five more deaths occurred.

In July 1999, the food and drug agency warned the company in a letter that it was not properly testing some inhalers as they were made.

Schering-Plough first recalled a batch of inhalers, which were sold generically under the name Warrick Pharmaceuticals, in September 1999, after a patient found one that contained no albuterol. Hundreds of other inhalers, sold under the brand name Vanceril, were recalled in December 1999.

The recall in March 2000 covered millions of inhalers — all unexpired inhalers sold under the brand name Proventil and generic albuterol products that Schering-Plough made before Sept. 30, 1999.

Schering-Plough said yesterday that it took "extraordinary measures in 1999 and 2000 to ensure that all of its inhalers in the marketplace were safe and effective."

In the letter to Mr. Thompson, Dr. Wolfe wrote that the death reports provided "even more reason for criminally prosecuting Schering- Plough for introducing these defective products into the marketplace and failing to recall them much earlier."

A spokesman at the food and drug agency said the agency had begun to look into the case after an earlier letter from Dr. Wolfe to Mr. Thompson.

"We'll look at the new data contained in this letter very carefully," the spokesman said.

Also yesterday, a coalition of consumer groups criticized Schering- Plough on a different issue: the marketing of its allergy drug, Claritin.

The Boston-based coalition, the Prescription Access Litigation Project, filed a lawsuit in a New Jersey state court yesterday saying that Schering-Plough had deceptively advertised Claritin.

The lawsuit asserts that the company's consumer ads falsely depict the drug's benefit and fail to disclose its limited effectiveness.

Schering-Plough said it had not seen the lawsuit but noted that it complies with the federal rules on advertising.

A company spokeswoman, Denise K. Foy, said, "Claritin is a leading antihistamine because it works."

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