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Suit Claims Abbott Knew of Antibiotic’s Dangers

October 19, 1993

CHICAGO (AP) _ A lawsuit contends that Abbott Laboratories withheld information about the dangerous side effects of Omniflox, an antibiotic yanked off the market last year after it reportedly killed three people.

Abbott said Tuesday it had not been served with the suit and could not comment on it. The lawsuit, filed Friday in Cook County Circuit Court, seeks unspecified damages and requests certification as a class action.

Omniflox, which has a chemical name of temafloxacin, was used to treat infections of the lower respiratory system, the urinary tract and prostate gland, and skin.

Abbott withdrew it from the market in June 1992, five months after it was approved by the Food and Drug Administration. The withdrawal came after reports of severe adverse reactions, including the deaths.

Plaintiffs Jimmie Sumpter of Wheaton and Pamela Haskins of Orlando, Fla., claim they suffered breathing difficulties after taking Omniflox. Haskins also complains of a severe and persistent body rash.

The lawsuit contends that as many as 15,000 people in the United States suffered adverse reactions, most of them non-life-threatening.

It says Abbott had received reports of ill effects as early as September 1991 from Europe and other foreign markets where it had been distributing the prescription drug for at least five months before its U.S. introduction in February 1992.

″Instead of promptly relaying this information to the FDA, as it was required to under the law, and apparently placing the protection of its investment ... over the health interests of consumers in the United States, Abbott withheld this information from the FDA,″ the lawsuit says.

The company ordered the recall after the FDA received 50 reports of severe reactions, including the deaths. Reactions included low blood sugar, especially in elderly patients. Also reported were cases of hemolytic anemia, a condition in which red blood cells are destroyed, and other blood cell abnormalities. Also, there were reports of kidney and liver ailments.

About half of the patients reporting kidney problems needed to have their blood mechanically cleaned through dialysis, the FDA said.

Still other patients, the agency said, experienced allergic reactions which, in some cases, included life-threatening breathing difficulties.

Abbott spokesman Rick Moser said adverse reactions occurred in about one in 10,000 Omniflox users. He said the drug had been tested on 5,000 to 6,000 people with no ill effects before FDA approval.

″It was thought by all parties, including the FDA, to be a very promising drug,″ he said from the company’s North Chicago headquarters.

He said he did not know whether the clinical test population included overseas users.

Moser said other lawsuits are pending involving people who claim to have suffered ill effects from taking Omniflox.

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