30 March 2004

Is There Still Reason To Be Scared?

PPA or phenylpropanolamine, a long-time ingredient of over-the-counter cough and cold medicines, caught attention sometime in the late months of 2000. This was after a landmark study by Yale researchers who associated PPA use (women, in particular) with increased incidence of hemorrhagic stroke.

PPA, belongs to a class of medicines that stimulate the sympathetic nervous system, constrict blood vessels, and increase the force of heart contractions. It is similar to effects produced by amphetamine and cocaine intake. In people with underlying hypertension or heart problems, vascular malformations like aneurysms (which is not detected readily),taking the medicine in doses higher than prescribed, might produce detrimental results.

The Los Angeles Times (subscription needed) recently published a comprehensive special report on the PPA saga. I strongly recommend you read it here. The Times researchers reviewed thousands of pages of documents produced through discovery in PPA lawsuits and obtained from the FDA through a Freedom of Information Act request.

The LA Times special report on PPA emphasizes the following revealing facts:

- The market for PPA has been estimated at $500 million to $1 billion annually. What made PPA worth fighting for were its sales, estimated at several billion doses a year. In a deposition, Robert G. Donovan, the former head of Sandoz Consumer Health Care, said the profitability of the company's two PPA products was about 75% to 80% of revenue.

- As early as 1982, an FDA report warned that PPA had "the ability to cause cardiovascular effects, cerebral hemorrhage and cardiac arrhythmias."

- Drug manufacturers, which include some of the largest drug companies in the world like Bayer; Novartis, which absorbed Sandoz in a merger; Wyeth, which makes Dimetapp and Robitussin CF; GlaxoSmithKline, which makes Contac; opened a relentless assault on the methodology and on the integrity of the Yale University researchers who conducted the landmark 1999 study that established the PPA-hemorrhagic stroke link. They did so despite having paid for the five-year, $5-million study themselves, approving its protocol and handpicking investigators who had previously expressed skepticism about a link between PPA and stroke.

- Studies found that the degree of blood pressure elevation attributable to PPA depended on the type and quantity of product taken, whether it was taken in combination with stimulants like caffeine, whether the patient was otherwise susceptible to high blood pressure, and whether it was consumed while upright or lying down, when the impact apparently is greatest.

- As of today, more than 2,500 lawsuits have been filed by plaintiffs who say they suffered strokes shortly after taking products with PPA.

In the Philippine setting, the PPA saga is considered a closed case. Two health secretaries (Romualdez and Dayrit) in consultation with Philippine drug manufacturers have already reviewed the PPA problem and has come up with a dose ceiling of 25-26mg that must be met by all cough-and-cold remedies sold in pharmacies over the counter. Local drug makers have also highlighted that PPA dosing in local medicines are far lower than the percentage of PPA allowed in such countries as Hong Kong, United Kingdom, Japan and the United States.

In my opinion, the safest way out of the PPA problem, is not to get involved with it at all. Sure, we have the lowest dosing this side of the planet, but that does not take away the fact that PPA has been associated with hemorrhagic stroke, especially in women. Majority of those who take this cough-and-cold medicines are the younger generation, who hardly care if they have underlying chronic medical problems. They may not feel anything untoward, not until it's too late. I do not mean to scare, I just want you to be cautious on what you take.

Even if a particular cough-and-cold medicine contains "only" 25mg of PPA per tablet, you might want to limit your dose. Taking two tablets twice a day or one tablet 3-4 times a day gives you a total of 100 mg of PPA for the day, which is the maximum recommended
daily dose in Britain, and more than 60% of the allowable FDA PPA allowance in the US.

To sum up, is there still reason to be scared of PPA?

Oh yes. Be careful and be watchful.

CREDITS: Graphical clip courtesy of the Los Angeles Times.

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