Medicines Should contain a lower dose of Phenylproparnolamine (PPA)

18 June 2008

The Department of Health has evaluated the "Health warning" email that is currently being circulated in the media about drugs containing a substance Phenylproparnolamine (PPA), and we have noted that the mail refers to a number of medicines available in the United States.

From the list of products reflected in the mail, the medicines available in South Africa are the following products, and other products listed are not available on the South African Market:

In November 2000, the Food and Drug Administration (FDA) took steps to remove Phenylpropanolamine (PPA) from all drug products. A number of drug companies voluntarily reformulated their products to exclude PPA or contain a lower dose.

The Medicine Control Council (MCC) in December 2000, reviewed the status of drugs containing this substance, based on the findings of a study done in the United States of America in which an increased risk of certain types of stroke was found in women using products containing PPA as appetite suppressants or aids to slimming.

The MCC noted that the South African situation is as follows:

PPA is also structurally related to ephedrine hydrochloride. Medicines containing ephedrine, pseudo ephedrine and d-nor-pseudo ephedrine have been rescheduled not only in South Africa as a result of widespread abuse of these components for the illicit manufacturing of drugs of abuse.

The MCC at the meeting of 13 December 2000 resolved that:

  1. All PPA-containing products available in South Africa be not allowed to contain more than 25 mg of phenylpropanolamine per dose and not more than a 100mg/day total daily dose.
  2. That all applicants of products containing more than 100 mg/day total daily dose be required to submit a Dear Doctor and Dear Pharmacist letter informing these health care professionals about the potential risks of hypertensive complications including cerebral haemorrhage associated with and guidelines on how these can be detected and avoided for review and approval by the Council. The letter should also inform these health care professionals of the steps to be taken to reformulate the product and the package insert amendments being implemented.
  3. All applicants of products containing more than 25 mg per dose are required to reformulate these products to contain a lower dose or withdraw these formulations, within 6 months of date of notification of this resolution.
  4. And that the package insert of all phenylpropanolamine-containing products be amended to include certain warnings and contra-indications for patients.

The Medicines Control Council gave a directive to the pharmaceutical and manufacturing industry to reformulate the medicines within six months. During the 6 months the manufacturers were directed to either phase out or lower the dosage of phenylpropanolamine. Applications for the amendment of the formulation were monitored for all registered products.

The inspectorate also does routine inspections and products containing this ingredient were monitored to verify whether the manufacturing of high doses had ceased. To our knowledge, applicants complied within the set time frame.

If someone should be found not to have complied with the directive, the MCC has a right to cease the product, cancel the registration of the product or declare the product undesirable. This action would then be gazetted to cease the production or sale of such a product.

Consumers can identify over-the-counter cough-cold, nasal decongestant, and weight control products containing this ingredient by looking for "phenylpropanolamine" in the list of active ingredients on the label. They can also check with their health care provider or pharmacist to see whether their prescription cough-cold or nasal decongestant product contains this ingredient.

For more information contact Charity Bhengu (012) 312 0420 or 083 679 7424

Issued by Department of Health

on behalf of Medicine Control Council (MCC) Registrar Ms Mandisa Hela