Are Your Generic Drugs Safe and Effective?

Ten facts your doctor and pharmacist probably didn’t share you.

  1. Over ninety percent of drugs sold in America are generic.
  2. And, 80% percent of generic prescription drugs are manufactured in India & China along with the Active Pharmaceutical Ingredients (API) that are used in patented brand-name drugs.
  3. Drug manufacturing is one of India’s major industries. They have about  700 Indian drug manufacturing plants that employ tens of thousands of workers.
  4. Foreign-made generics are less regulated and sanctioned by the FDA, even when they have had substantially greater data integrity, sanitary, quality and manufacturing deficiencies.
  5. The FDA’s priority is approving new generic drugs to market faster. In 2019, over 1,200 new generic drugs were approved, while improvements in existing foreign drug manufacturing, safety and data integrity lagged behind.
  6. Neither you, nor your doctor, are likely to know where your generic medications are manufactured and if serious quality and safety deficiencies have been identified by the FDA.
  7. Pharmacies do not necessarily fill your prescription with the same generic manufacturers’ medication each time. They are commonly filled with whatever they have available, especially in mail-order and centralized pharmacy centers.
  8. The FDA approval of generic drugs is substantially less stringent than brand name drugs. And, not all generic prescription drugs are identical for the same conditions. They can differ in the potency of API and the inert ingredients that can result in substantial differences in effectiveness, side-effects and adverse reactions.
  9. The use of generic medications for certain serious medical conditions such as seizure disorders, blood thinners & bipolar disorders can have greater risks due to a narrow therapeutic range for the medication.
  10. If your generic drugs comes in an amber pharmacy vial (compared to an original manufacturer’s stock bottle), it probably doesn’t include the name of the manufacturer and the country of where the generic drug was made

The food products that you buy and eat include substanially more FDA mandated product label disclosures including the manufacturers’ address and list of ingredients than the FDA regulated generic drugs that you take daily (on blind faith) for your physical and mental health.

For more information and to learn what you can do, explore the references below.

                                             References

Bottle of Lies, 2019 by Katherine Eban

Amazon.com: Bottle of Lies: The Inside Story of the Generic Drug Boom  (9780062338785): Eban, Katherine: Books

TedMed: A Dose of Reality about Generic Drugs, 2020, Katherine Eban

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters
A Guide to Investigating Your Own Drugs, 2019 by Katherine Eban
                   The High Cost of Cheap Pills, 2019 Bloomberg News                                     (A four-part series covering a year-long investigative study of the generic drug industry)

PeoplesPharmacy.com

Kaiser Health News, 2019

The STAT, 2019

Updated post 10.27.20