Reports of adverse reactions to prescription drugs rose 9.4 percent in 2011, according to a nonprofit that monitors safe medication practices. The Quarterwatch reportfound 179,855 drug reactions classified as serious or fatal, an increase of over 15,000 from 2010.
- Manufacturers must report adverse effects that they learn about to the FDA
- Only one to 10 percent of adverse effects are reported
- Drug companies liable if they do not properly warn of potential side effects
Heart attacks, kidney failure, stroke and death – it’s dangerous out there in the world of prescription medicine. Every year millions of people face side effects from the cutting-edge pills and therapies they take to address various health problems.
By law, drug manufacturers must report to the FDA any adverse reactions to their drugs that come to their attention, be it from a patient complaint, a lawsuit or even just a mention on Twitter. Consumers and doctors may also report adverse effects to the FDA. Using those numbers, Quaterwatch compiled its report on all the reports of serious negative side effects that made it to the FDA in 2011, finding that reports have risen nearly 10 percent in the past year.
The top ten drugs with adverse effects were Pradaxa, Coumadin, Levaquin, Carboplatin, Zestril, Cisplatin, Zocor, Cymbalta, Cipro and Bactrim. If you’re taking any of the above and experiencing serious side effects, rest assured that you aren’t alone. In fact, drug experts contend that only one to 10 percent of adverse effects are ever reported to the FDA, meaning negative side effects are much more widespread than the Quaterwatch report would indicate. “We’re missing anywhere from 99 percent to 90 percent” of the adverse effects, saysThomas Lamb, an attorney in North Carolina who maintains a blog on prescription drug news.
Seven Year Rule
Unfortunately, side effects are an inevitable tradeoff, the price you pay for taking advantage of the benefits offered by modern pharmaceuticals. However, there are ways that consumers can protect themselves and try to shield themselves from the worst consequences. The advocacy group Public Citizen suggests only using drugs that have been on the market for more than seven years, unless there is no alternative.
“Unless the new drug is a groundbreaking or novel therapy, stay with tried drugs, on the market for seven years, the reason being that clinical trials prior to FDA approval may detect certain side effects but not all of them,” Lamb says. “The common-sense advice is to stay away from new drugs while you figure out what other safety issues may emerge.”
Another way patients can protect themselves is to use drug interaction checkers commonly found online to make sure that their various prescriptions aren’t in conflict with one another or causing problems that a single drug wouldn’t create on its own. When consumers use multiple doctors and specialists and might use a mail order pharmacy or acquire drugs from a number of locations, contraindicated combinations of medication might slip through without a medical professional catching the problem.
“In the past, people said if there’s an issue the doctor would pick up on it, or the pharmacy might let me know,” says Lamb. “Now there’s often not just one source where people are getting medications from. It’s prudent for them to take safety measures into their own hands.”
Call the Lawyers
So if you’re injured by a prescription drug, can you sue? Not necessarily. For one thing, generic drugs are protected from lawsuits. And name-brand drugs are protected to some extent as long as they provide adequate warning of their potential side effects. Drug companies are required to warn of injury their drug might cause on the label and supplementary packaging, as well as inform the FDA of any side effects that come to light after the drug is already approved and shipped out to the market.
On the other hand, scores of drugs are facing lawsuits for not disclosing or under reporting potentially disastrous side effects. If you are facing serious side effects from a drug that you weren’t properly warned about, it’s time to consult a lawyer. “The allegation is that the drug company didn’t include sufficient warnings in their prescribing information or label about a serious side effect risk they had knowledge about,” Lamb explains. “It may be buried in the label as opposed to put in warnings in the precautions section, or put most prominently in black box warning.” A simple Google search can reveal if other people are having similar problems, and are finding success seeking restitution in court