When the drugs hit the market, what happened to patients?
Health care providers say the number of patients in the U.S. who had adverse reactions to prescription drugs jumped by more than 60 percent between 2013 and 2016, but there’s still no clear figure on how many people actually died from the drugs.
It’s unclear how much of the spike could be explained by the surge in generic drug approvals and the emergence of the so-called “super drug.”
And a new study says that the number and type of adverse reactions may be increasing in parallel with the rise of generics.
“What we’re seeing now is a really rapid increase in the number that are potentially related to these drugs, and that’s why we’re also seeing that there is a very real threat of an increase in adverse reactions,” said Pauline Sussman, the chief executive officer of the Center for Drug Evaluation and Research at the University of Texas at Austin.
She said the number could rise as many as 50 percent by 2020, and a third of those will be related to new generics of existing medications.
“It’s not like there’s been a massive explosion in this kind of generic issue,” she said.
Sussmann, who has written several studies on the impact of generic drugs, also said the spike in adverse reaction rates might reflect the fact that many of the more commonly used drugs are less expensive.
“The more expensive the generic is, the more likely it is that it will cause an adverse reaction, because it’s not really a very good drug,” she told NBC News.
Some experts say that is a concern, but also a sign that the new generic drugs can help treat more serious diseases, like cancer and autoimmune disorders.
In her new study, Susseman and her colleagues looked at adverse reactions linked to prescription painkillers and non-steroidal anti-inflammatory drugs, or NSAIDs.
A study published in the journal Clinical Chemistry found that a whopping 50 percent of the patients with a history of a major adverse reaction to a non-pharmaceutical NSAID had a history or symptoms of at least one other major adverse response to the drug, such as kidney failure or heart disease.
The researchers said the data indicates that patients may have been misdiagnosed or overreacted to the drugs, even though many of these reactions could be easily prevented or even treated.
“We’re not talking about an epidemic of kidney failure,” Sussmans said.
“This is just a big problem.”
The new study also showed that many patients with serious medical conditions like heart failure or diabetes had more severe adverse reactions.
In general, Sussianman said the researchers found that patients with mild to moderate adverse reactions were treated more often than patients with severe or life-threatening reactions.
“There was a lot of overlap in the types of things that people with severe reactions did well versus the types that people who had mild reactions did not,” she explained.
But she cautioned that it was still unclear what role these types of reactions might play in the overall spike in patient deaths.
“I think it’s also really important to note that we don’t have data on the rate at which we’ve seen this spike in these adverse reactions, so we don:///a/AiN8qE0Bd/#.
V8Hw8k0bWZw#.VEy6z6hJ8Q” say, she said, adding that more research is needed.
“In my view, it is a problem that needs to be studied more thoroughly.”
“These types of events are extremely rare, and the vast majority of them are not life- threatening,” Sussianmans said, but added that doctors are often unaware of the risk of adverse reaction or misdiagnosis.
“So it’s really important that we’re able to identify those who are at high risk, to understand what the risks are.”