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Should a drug associated with strokes and bleeding on the brain have been left in several over-the-counter medications for decades? Although since removed from common products, phenylpropanolamine, commonly known as PPA, had been an ingredient in prescription and OTC diet drugs, nasal decongestants, and cough medicines.

Background

For decades, drug manufacturers added PPA, a synthetic sympathomimetic amine, into Accutrim, Dexatrim, Robitussin, Comptrex, Triaminic, and Tavist-D. At one point, the public consumed 6 million dosages of these medications per year through syrups, tablets, solutions, and capsules.

However, ingredient labels didn’t list it as PPA. Rather, the substance went by such names as Allerx-D, Dallegy, Extendryl JR, Extendryl SR, Phenylephrine CM, Rescon ER, and Stahist.

By the 1970s, reports of PPA-associated strokes started to surface, and to follow this, a 1984 study examined the correlation, but its results were inconclusive. Over a decade later, the Consumer Health Products Association and the FDA decided to sponsor an independent study examining this relationship. After four years of research, results were published in the New England Journal of Medicine in 2000 – this time with a clear relationship established between increased stroke risks and PPA usage. Specifically, women’s risk increased 16 times and men’s three times.

After the results, the FDA’s Nonprescription Drugs Advisory Committee (NDAC) recommended PPA be removed from OTC nasal decongestants and weight loss aids. Two years later, lawsuits began at the state level.

Side Effects

PPA, however, hasn’t been eliminated from the market completely, and is still found in prescription drugs like Rinexin in the U.S. As well, the substance has been found as a component of methamphetamine – and is especially toxic when misused.

While its more severe side effects include hemorrhagic strokes and bleeding onto the brain, PPA has been associated with a range of symptoms:

  • Nausea
  • Difficult urination
  • Restlessness
  • Jitters
  • Flushing of the skin and sweating
  • Panic attacks
  • Arrhythmia and rapid heart beat
  • Pulmonary edema
  • Blood pressure spikes
  • Primary pulmonary hypertension

For the latter of these conditions, PPA has narrowed the lung’s blood vessels and increased pulmonary arterial pressure.

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