Asthma Inhalers Linked to Deaths

by Sandra Cassidy

Inhalers lacking albuterol, the key ingredient to relieve asthma symptoms, were shipped and used by patients resulting in deaths of some users according to investigators.

The FDA is investigating reports from Public Citizen that Schering-Plough knowingly shipped millions of what appeared to be albuterol-containing asthma devices that in fact contained no albuterol. These reports, sent from Public Citizen to Tommy G. Thompson the secretary of Health and Human Services, claim the device was shipped out after the company became aware of a seriously flawed manufacturing process.

That knowledge was imparted in a July 1999 letter sent by the FDA warning the manufacturer, Schering-Plough, that these inhalers were not being properly tested. According to the FDA five of the patients who died complained that their inhalers were not giving them the usual relief from their asthma attacks. Those who died included six people under the age of 30, three of whom were children.

In its letter Public Citizen claims that the Schering-Plough inhalers are the probable cause of at least 17 deaths from September 1998 to June 2000, a period when many of the inhalers remained on pharmacy shelves because batch numbers were limited under the recall. It is claimed that for financial reasons these inhalers were not part of the first batch number recall and that they should have been recalled in the first round. A spokesman for the FDA claims they are seriously looking into the claims made by Public Citizen. 

Schering-Plough first recalled a batch of inhalers in 1999 sold generically under the names Warrick Pharmaceuticals then later Vanceril after a patient found one that contained no albuterol. A later recall in March 2000 covered millions of inhalers sold under the brand name Proventil.

In an August 2001 letter from Public Citizen to the FDA they analyzed the adverse reactions data obtained from the FDA and claim there is a pattern of deaths in users of Schering-Plough albuterol products which occurred around the time of the two recalls starting in the fourth quarter of 1998 and ending in the second quarter of 2000. In that period 17 deaths were reported where Schering-Plough albuterol inhalers were listed as the “primary suspect” with an additional 7 deaths reported between March 30 and August 9, 2000. 

Schering-Plough claims that they had no evidence that a patient was ever harmed by an inhaler subject to the recalls.  However, at least one death was known to the company on January 4, 2000 just prior to the second March 29, 2000 recall. This death may well have precipitated an outside audit by the AAC Consulting Group in February 2000. Following the audit 59 million units of albuterol aerosol inhalers were recalled.

From the time the company learned of this death until the full recall (January 4, 2000 to March 29, 2000) five more deaths occurred in people using Schering-Plough inhalers.  

Despite a long history of problems with the manufacturing system of albuterol inhalers, Schering-Plough only initially recalled the inhalers matching the lot of the suspected inhaler.  Public Citizen claims that Schering-Plough was reckless in not ordering all of the lots subject to the first recall. Following the second recall Schering-Plough belatedly admitted “the [second] recall relates to an aerosol manufacturing problem that had been previously identified in October 1999.”  

Without treatment asthma can result in fatal airway narrowing. Asthma death rates increased steadily between 1980 and 1998, but for the most part have declined since 1999, when asthma accounted for 3.2 deaths per one million children. In 2004, the rate was 2.5 deaths per one million.

Albuterol is a bronchodilator which opens up the bronchial tubes so that more air can move through. Bronchodilators also help clear mucus from the lungs.Albuterol is a short-acting bronchodilator which is used only as needed as a “rescue” medication.

Sources
citizen.org; Request to HHS to investigate charges against Scgering-Plough        
citizen.org
 Public Citizen march 1, 2001 FDA Should Investigate Schering-Plough;
New York Times; Group faults Inhalers in 10 Deaths         
http://www.consumeraffairs.com; recalled Asthma Inhalers may be linked to Deaths

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