PPA RECALL

October 19, 2000
Petition to the Food and Drug Administration requesting an immediate ban of all uses of PPA in over the counter products.

Public Citizen petitioned the FDA for an immediate PPA recall in over the counter products. PPA was found in many weight loss drugs and cold remedies. The consumer group found that there was an abundant amount of evidence showing the dangers of PPA, in addition to the 5-year Yale study finding “PPA increases the risk for hemorrhagic stroke.” There have been reports dating as far back as 1979 showing the adverse effects that can occur when using a product containing PPA, including hemorrhagic strokes.

Ten years ago a review of PPA found 142 cases of adverse reactions that included 24 intracranial hemorrhages, eight seizures, and eight deaths. Most of the adverse reactions were due to hemorrhagic strokes. There are also FDA reports showing that there was evidence of PPA causing hemorrhagic strokes. An FDA memo dated August 6, 1991 shows an FDA medical officer reported that there had been a total of 44 cases of strokes with 35 of them being hemorrhagic strokes. There was an updated added to the report on a September 27, 2000 memo stating an additional 16 cases of hemorrhagic strokes were associated to PPA.

To read the entire petition for the PPA recall, click here.

October 19, 2000
Testimony before the Food and Drug Administration NonPrescription Drugs Advisory Committee Meeting on Safety Issues of PPA.

Public Citizen made a testimony before the FDA regarding their petition asking for a PPA recall in over the counter products found in cold remedies and appetite suppressants. The group cited the Yale study finding “PPA increases the risk for hemorrhagic stroke”.

To read the entire publication testimony for the PPA recall, click here.

October 12, 2001
Letter urging the FDA to reject drug industry’s request for liability disclaimer in its withdrawal of products containing PPA.

The FDA had issued a notice of a “Proposal to Withdraw Approval of New Drug Applications and Abbreviated New Drug Applications” on August 14, 2001 for products containing PPA because of the safety concerns showing the link between PPA and hemorrhagic strokes. Letters from some drug companies to the FDA requested the FDA include in its final rule withdrawing approval of products containing PPA a disclaimer regarding industry liability. The disclaimer would state the withdrawal of PPA containing drugs does not mean the drugs were marketed negligently, which is the companies’ request in hopes of avoiding product liability PPA lawsuits.

To read the entire letter click here.