Health alert issued for two possibly counterfeit injectable medicines

By the A.M. Costa Rica staff

The Ministry of Health announced the alert about the detection of counterfeit versions of two injectable drugs, Dolo-Neurobion and Herceptin.

According to the ministry, first, the counterfeit medication Dolo-Neurobion was detected through a complaint of a doctor, who reported that a patient bought a version of the medicine in a bottle to apply as an injection or shot.

Ministry officials confiscated the product and confirmed that it is a counterfeit.

According to the ministry, in 2016, cases of this same counterfeit drug had already been registered, in Buenos Aires in the province of Puntarenas. That year an alert was issued to prohibit the sale or purchase of this product.

Dolo-Neurobion is an anti-inflammatory medication with analgesic, antineuritic action. It is used to relieve health problems such as low back pain, cervicalgia, brachialgia, radiculitis, and peripheral neuropathies.

Also, the ministry reported another alert, for the prohibition of sale or purchase of the drug Herceptin.

This alert is due to a statement from the Federal Commission for the Protection against Health Risks of Mexico. This statement refers to the detection of a false version of the Herceptin drug in a 440mg bottle, also available as an injection or shot.

Herceptin is a biotechnological medicine for the treatment of breast cancer and advanced gastric cancer.

According to the health alert in Mexico, an investigation had been made based on the complaint filed by Laboratorios Roche S.A. from C.V., which is the pharmaceutical company that owns the original medicine.

The counterfeit product can be identified since it does not have the legend printed ¨property of the health sector prohibited sale¨, it does not have the price code printed on it, the amount of medicine is more in the counterfeit product, and when adding water to the product it does not dissolve.

The ministry calls on the general public not to buy these products because of the high risk involved in the application of counterfeit medicine.

Specialists recommend patients who use these two types of medications regularly, that they go to the doctor's appointment and request the prescription of alternative medicine.

The most recent alert, reported by A.M. Costa Rica on July 29, specialist of the National Technovigilance Center has asked plastic surgeons to suspend the use of Biocell brand breast implants.

The ministry cited an update from the U.S. Food and Drug Administration that showed an  association between these types of breast implants and a type of cancer called anaplastic large cell lymphoma.

Food and Drug asked Allergan pic company to recall all Biocell textured breast implants and tissue expanders in the United States.

Allergan, a company based in Dublin, Ireland, has decided to voluntarily and globally remove all breast implants and tissue expanders type Biocell, as a precautionary measure after the notification of the Food and Drug's Reports of Medical Devices on worldwide deaths related to these products.

"On this new information, the ministry calls on plastic surgeons to immediately suspend the use of Biocell breast implants from the manufacturer company Allergan," said the ministry in its statement. In addition, ministry specialist asked plastic surgeons to make contact to receive more information about the process to follow on this alert.

June 21, as A.M. Costa Rica reported, the Ministry made the first alert on breast implants linked to cancer. The inserts are saline-filled and silicone-filled textured breast implants.

The majority of confirmed cases of anaplastic large cell lymphoma have occurred in people with textured surface implants, although cases have been reported in patients with smooth surface implants, said the ministry in its statement.

This type of tumor is not breast cancer, but it affects the immune system and is usually found in scar tissue and fluid near the implant. In some cases, it can spread throughout the body, the ministry said.

The specialists of the National Technovigilance Center gives a couple of recommendations to women who have had this type of operation:

- It is normal that after surgery that there are swelling and pain. But, if the patient notice changes in the way the breast looks or feels after recovering from the surgery, she should contact the doctor immediately to confirm or discard the possibility of  anaplastic large cell lymphoma.

-A patient who notices any irregularities associated with implants should notify to the National Technovigilance Center. The information will be handled in a confidential manner, the center said.

"Although the number of identified cases of anaplastic large cell lymphoma is small compared to the estimated 1.5 million patients who had breast implants worldwide each year, the confirmed data and the published information that has been reviewed to date suggests that patients with breast implants have a higher risk", said Guiselle Rodríguez-Hernández, director of the center.

The Food and Drug updated alert on breast implants can be found here.*


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Have you heard about the sale of these counterfeit medicines in your community? We would like to know your thoughts on this story. Send your comments to news@amcostarica.com

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