Home' Trinidad and Tobago Guardian : June 14th 2017 Contents A24 body & soul
guardian.co.tt Wednesday, June 14, 2017
Doctors and patients were excited when Actem-
ra reached the US market in 2010. Unlike compet-
ing drugs prescribed for rheumatoid arthritis, it
wasn't associated with heart attacks, heart fail-
ure, or life-threatening lung complications. Yet
in the past few years, hundreds of patients taking
Actemra have died from just such problems, and
many more have suffered harm.
The US health and science publication called STAT
analysed more than 500,000 side-effect reports on
rheumatoid arthritis drugs, and found clear evidence
that the risks of heart attacks, strokes, heart failure, and
other conditions were as high or higher for Actemra pa-
tients than for patients taking some competing drugs.
Most of those medications warn about these risks
on their labels. Actemra does not.
The US Food and Drug Administration has received
reports on 1,128 people who died after taking Actemra,
and has reviewed its safety several times since it was
approved. But the agency doesn't have sophisticated
tools to determine whether the drug was responsible
for those deaths. And the agency doesn't verify the
side-effect reports it receives.
The documents obtained by STAT often lack crucial
information, and they don't prove that Actemra was the
cause. Still, they can be telling. In one striking example,
obtained through the US Freedom of Information Act,
a doctor said no factor other than the drug could have
explained a 73-year-old man's fatal brain bleed two
days after receiving an intravenous Actemra treatment.
Another said of a 62-year-old German woman's
heart attack in 2014: "The company assessed fatal
myocardial infarction as related to (Actemra)." That
company was Roche, Actemra's manufacturer.
But neither Roche nor the FDA has moved to change
Actemra's label to alert patients and doctors of the
Experts who examined the data at STAT's request
said the FDA should immediately consider warnings
for heart failure and pancreatitis---an inflammation
of the pancreas that in its acute form can kill up to 50
per cent of patients.
The failure to warn the public, experts say, highlights
the FDA's inability to adequately scrutinise the safe-
ty of drugs after they have been approved, and to act
promptly when potential danger signs appear.
"We've done a very good job of making it easier to
approve drugs, often based on very preliminary ev-
idence. But we haven't ramped up the standards of
post-marketing surveillance to make sure that what's
been out there for several years is safe and effective,"
said Dr Vinay Prasad, an oncologist and medical ethi-
cist at the Oregon Health and Science University. "The
system is broken, and all the financial incentives are
lined up to keep it broken."
The FDA spent US$207 million since 2009 to build
a troubled big-data system called Sentinel that scours
insurance company records for serious side effects of
recently approved drugs. Among its major shortcom-
ings, critics say: It's missing most data on deaths related
to prescription drugs.
Sentinel's track record is all the more worrisome amid
the rise of an approve-first, monitor-later philosophy
Taken intravenously or by injection, Actemra has
been used by more than 760,000 patients globally and
generated sales of US$1.7 billion last year, making it
Roche's fifth highest-grossing drug. While primarily
used to treat rheumatoid arthritis---an autoimmune
disease that causes pain, swelling, and stiffness in
joints---doctors prescribe the drug "off-label" for about
60 other conditions for which it has not completed
testing for efficacy and safety.
Actemra might not be more dangerous than other
arthritis drugs, but people are misled into believing
it might be safer because problems aren't noted on
its warning label.
Rheumatoid arthritis is different from the more
common osteoarthritis, which is primarily a disease
of old age. It often starts in middle age, but it also affects
children and young adults like Alejandra Calzadillas,
a 25-year old student in Seattle. She said that after
starting Actemra, she experienced memory lapses and
mental sluggishness she called "brain fog."
"I've had moments where I've gone to start my car
... and not remembered how to turn it on," or at other
times forgotten how to put on makeup, she said. Such
cognitive side effects are not listed on the drug's label
but are a common complaint among Actemra users.
"It's terrifying with a drug when you come to the
realization that you haven't been warned by your
doctors," Calzadillas said. "It kind of ruins your life."
Source: Charles Piller, reporting for STAT---a US national
publication, produced by Boston Globe Media, which
reports stories on health, medicine and science. (https://
Hundreds died while taking arthritis drug
Is Actemra safe for everyone with
rheumatoid arthritis? Perhaps
not, finds an investigation by
STEM, a Boston-based health &
science journalism publication.
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