Secret safety warnings on more than 207 medicines

Australian patients are being kept in the dark about serious adverse reactions to medicines including pancreatitis, heart failure and even death. SEE THE FULL LIST OF DRUGS

Serious adverse reactions to medicines including deaths, heart failure and pancreatitis are being hidden from Australian doctors and patients and a new study says it is “unacceptable”.

In the decade between 2007 and 2016 doctors in Canada, the US and the UK received 207 warning letters about medicine serious side effects including possible death, heart failure and pancreatitis.

However, when Sydney University researchers investigated whether Australians had been informed it found our medicines watchdog the Therapeutic Goods Administration (TGA) did not post these letters on its website.

Regulators in the UK, US and Canada do publish these letters.

Things got worse when researchers asked the TGA to provide copies of the letters to show they had been sent to doctors in Australia and they were told the agency had no central file of the letters.

The TGA told them to approach the 39 pharmaceutical companies who manufactured the medicines, says Dr Barbara Mintzes whose research is published in the journal Pharmacoepidemiol Drug Safety.

When they did so they found only four companies would provide proof they had sent out the letters in Australia.

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Only four manufacturers provided their safety letters. Picture Getty Images

Eleven companies said they did not send out the warning letters to Australian doctors.

Fifteen companies that manufactured 83 drugs with safety warnings did not provide any information at all.

Nine companies that produced 87 drugs subject to safety advisories actively refused to provide researchers with copies of the safety warning letters with some claiming the information was “commercial in confidence”.

These companies were Amgen, Astra Zeneca, Aspen, Bayer, Janssen-Cilag, Eli Lilly, Roche, LEO and Pfizer.

“We were certainly shocked to have that response from some companies,” said researcher professor Barbara Mintzes.

“The idea that a warning letter that has gone out to thousands of individual health professionals would be considered confidential is counterintuitive,” she said.

“A secret warning is no warning at all,” she said.

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In total the researchers said they received no response about whether a safety letter was issued in Australia for 170 of the 207 drugs subject to publicly available advisories in Canada, the UK or US.

Professor Mintzes says the study highlights a serious policy vacuum in which companies are free to choose whether or not to release their safety warning letters.

“Our experience highlights unacceptable company and regulatory secrecy concerning safety warnings previously sent to thousands of Australian clinicians,” the study says.

“These letters often warn of serious harm and aim to guide prescribing and medicine use.”

Even if the letters had been sent out they were not enough to protect patients, she said.

Doctors may never open them or forget the details and it was important they were included in a searchable online data base.

Dr Mintzes says we need a searchable data base of safety concerns. Picture iStock

Concerned patients in Australia had no way of finding out what was in any letters that were sent to Australian doctors because they were not published anywhere.

Information on letters sent out overseas was available on the websites of the US Food and Drug Administration and the UK’s Medicines and Healthcare products Regulatory Agency or Canada’s Health Canada but these may not relate to Australia Dr Mintzes said.

Pfizer, which refused to co-operate with researchers on providing safety advisories for 23 medicines told News Corp they had issued a safety updates to Australian doctors in 2011 and 2012.

The company had also updated its consumer medicine information pamphlet with heart disease warnings related to its anti-smoking medicine Champix, it said.

Roche said it “strongly refutes the conclusions made in the University of Sydney research paper, which inappropriately draws parallels between companies’ response to a research project and transparency of safety communication with other stakeholders”

It provided relevant safety information toconsumers through its consumer information leaflets, the company said.

Amgen said it regularly reviewed the safety profile of its products and routinely makes updates to prescribing information to communicate benefit and risk information to healthcare professionals.

“We proactively notified these updates for Prolia and Blincyto to the Therapeutic Goods Administration,” it said

“We can confirm that a letter was distributed for Blincyto and not for Prolia,” a spokeswoman for Amgen said..

A spokesperson for the TGA contested the researchers’ claims that there is a problem with secrecy relating to Dear Health Care Professional (DHCP) letters and said the information was usually provided to consumers through updated consumer information leaflets.

“The TGA appreciates that the researchers were frustrated in their inability to access these documents for their study, but because of the sheer volume of materials within scope of the request, providing the requested information was considered impractical,” the spokesperson said.

The TGA frequently published safety alerts including information for health professionals and consumers on its website and ran an adverse event database on its website, the spokesperson said.

SAMPLE OF MEDICINES SUBJECT TO SAFETY ADVISORIES OVERSEAS

Prolia (osteoporosis) can cause atypical fractures

Blincyto (cancer) can cause pancreatitis

Adempas (blood pressure) higher rate of death in some patients

Zyprexa (antipsychotic) can cause delirium

Tamiflu (influenza) linked to psychiatric problems

Xenecal (weight loss) linked to liver disorders

QUESTIONS OVER DRUG SAFETY

The table in the document below shows the medicines that were subject to safety advisories in the UK, Canada or the US. It is unknown whether the same safety advisories were issued to Australian doctors.

The first nine companies refused to provide evidence they sent letters to doctors warning them of the safety issues. The next group of companies provided no information, ignored or deflected the researchers request. The final group of companies did provide information on safety advisories.