Pharmacovigilance

Roche Avastin: Investigation Launched As 12 Patients Go Blind After Receiving The Cancer Drug

Health authorities in Pakistan have initiated an investigation into two local distributors responsible for handling Swiss pharmaceutical company Roche’s Avastin cancer drug, following reports of 12 diabetic patients suffering from blindness after receiving injections of the drug. The Drug Regulatory Authority of Pakistan (DRAP) has announced that health authorities in Punjab, the country’s most populous province, are conducting this investigation into the local use of Avastin, which is licensed for use in Pakistan.

The regulator, DRAP, expressed its concerns in a statement, revealing, “Incidents of loss of vision in diabetic patients have been reported following treatment with Altered/Dispensed/Diluted Avastin injection.” The severity of these cases has led to the involvement of law enforcement, with Javed Akram, the Minister for Specialized Health in Punjab, stating that the police are questioning two individuals believed to be the distributors of the drug in the province. He further explained, “A high-level committee has been constituted to probe the issue. A case has been registered against the distributor and his aide.”

In response to these incidents, DRAP has instructed the importer to recall the suspected batches of Avastin 100mg injection, asserting that these batches were created illegally. They have temporarily halted the sale and distribution of registered Avastin injections until the quality is verified through sampling and laboratory testing to ensure the safety of public health.

Roche, the Swiss pharmaceutical company, has vehemently condemned this situation, stating that it is a criminal act of counterfeiting. They are actively cooperating with the authorities to protect patients from counterfeit drugs. Roche clarified that the vision loss issue in Pakistan was identified by authorities as a case of contamination by a third-party supplier. They also pointed out that Avastin is not approved for any use in the eye, emphasizing the health risks associated with counterfeit medicines, which may contain ineffective or harmful ingredients.

It’s important to note that Avastin is primarily recognized as a cancer drug, approved for use in over 130 countries, including the United States, to treat various types of cancer. However, in some countries, including Pakistan, it is used at lower doses and considered similar to the eye drug Lucentis for treating specific blindness-causing conditions.

The circumstances surrounding this issue also shed light on the challenges faced in the pharmaceutical industry in Pakistan, particularly in the face of a sharp devaluation of the local currency against the U.S. dollar, which has inflated drug prices. The country’s record high inflation has additionally diminished the purchasing power of its citizens, potentially driving some companies to buy drugs like Avastin and repackage them in smaller doses to make them more affordable for patients.

This investigation reflects a broader concern about patient safety and the need for regulatory oversight to ensure the authenticity and quality of pharmaceuticals in Pakistan.

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Dr. Oche Otorkpa PG Cert, MPH, PhD

Dr. Oche is a seasoned Public Health specialist who holds a post graduate certificate in Pharmacology and Therapeutics, an MPH, and a PhD both from Texila American University. He is a member of the International Society of Substance Use Professionals and a Fellow of the Royal Society for Public Health in the UK. He authored two books: "The Unseen Terrorist," published by AuthorHouse UK, and "The Night Before I Killed Addiction."
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