Pharmaceutical companies do not always follow federal reporting regulations regarding hazardous side effects of their drugs – even when there are deaths associated with the drugs.
In the United States, drug companies by law must report any serious, previously unknown side effects to the U.S. Food and Drug Administration within 15 days after they become aware of them. A recent study shows that drug manufacturers fail to do so about 10 percent of the time.
Serious Adverse Effects from Drugs
The unexpected drug side effects that must be reported to the FDA within 15 calendar days after being uncovered are broadly defined as any that are not listed on the product labeling. According to federal regulations, the serious drug “adverse effects” include:
• Birth defects
In addition to reporting their defective drugs, the pharmaceutical companies are supposed to do internal investigations and forward their findings to the FDA.
Over 40,000 Deaths from Legal Medications
A study recently published online by The Journal of American Medical Association reviewed 1.6million drug side effect reports from 2004 to 2014, and found that a little more than 160,000 of them weren’t reported within the 15-day period. Almost 40,500 of these adverse drug side effects involved the deaths of patients.
Investigators found that most of the time drug manufacturers were alerted to the unknown side effects by doctors, and suggest that doctors also must be vigilant in reporting these dangers to their patients.
Once the FDA is alerted to serious health threats from medications, the agency publishes safety alerts in an effort to protect patient safety. Any avoidable delays in getting this information to the public or withdrawing the dangerous drugs from market could be catastrophic.
You can’t count on drug companies to act responsibly. At times they may put profits before patients. Therefore, if you have suffered serious side effects while on a medication or had a family member who died from taking a drug, consult an attorney who is experienced in pharmaceutical lawsuits to review your case and seek justice on your behalf.
The choice of a lawyer is an important decision that should not be based solely on advertising.