Eighty percent of prescription drugs Americans take are now generic, but many people are asking whether these non-branded medications are safe in the wake of scandal involving the generic version of Lipitor.
Production at Ranbaxy Pharmaceuticals in India was halted recently when atorvastatin, the generic form of the cholesterol-fighting statin drug, showed glass contamination. Ranbaxy is one of six plants licensed by the FDA to provide atorvastatin, and it supplies 44 percent of the drug to the U.S. market.
“Although glass-tainted generic Lipitor is making headlines, it is not an isolated problem, but instead provides additional evidence that the nation’s drug supply is contaminated with fake or poorly manufactured drugs,” says top cardiologist Chauncey Crandall, M.D. “This is a growing problem that is putting the nation’s health at risk.
“The pressure is on from the healthcare industry to find cheaper and cheaper drugs, so the focus is on generics, which are being manufactured by developing countries using looser standards,” adds Dr. Crandall, head of preventive cardiology at the world-renowned Palm Beach Cardiovascular Clinic in Palm Beach Gardens, Fla.
The big discount chains such as Walmart, Walgreen’s, Costco, and others are under increasing pressure from the healthcare industry to find cheaper drug suppliers, said Dr. Crandall, author of the Heart Health Report. In doing so, the chains have turned increasingly to generics, which in turn puts cost pressure on drug manufacturers, he said. Drug companies have responded by going to countries with cheap labor costs.
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Although consumers are often told that brand-name drugs and generics are identical, there are critical differences, said Dr. Crandall. “We are led to believe that generic drugs are exact duplicates, but they aren’t. Factories in Third World countries may be licensed, but they are not supervised as stringently, and the drugs often aren’t even analyzed when they are brought into this country to assure that they contain what they should,” he said.
Small variations from the brand-name formulations are permitted in the manufacture of generic drugs, such as in the use of fillers and other non-active ingredients. These ingredients can cause problems in people who are sensitive to them. For instance, fillers such as starch may be wheat-based, resulting in symptoms for those who are allergic to it, and such problems may be misconstrued as side effects from the drug, Dr. Crandall said.
The pressure to drive costs downward also results in insurers switching the drugs they will cover from year to year, forcing doctors to change their prescribing habits.
“Every year, the insurance companies change their drug of choice. If you have high cholesterol, this year you may be on atorvastatin, and simvastatin (another cholesterol-fighting drug) the next. This is not because the drug will work better for you, but because the insurer can buy it cheaper,” said Dr. Crandall. “These changes can lead to drugs working less effectively in some patients, or they can experience more side effects. There can even be gaps in dosage because patients are confused.”
If you take generic Lipitor and you want to know if your prescription has been recalled, here are the steps to take:
• Call your pharmacist and ask if your prescription is for the drug that has been recalled. The recall affects 10-, 20- and 40-mg dosages in 90- and 500-pill bottles. The 80-mg dosage is not involved in the recall.
• You can also identify the bottles by the imprint RX12 on 10-mg tablets, RX828 on 20-mg tablets, and RX829 on 40-mg tablets, according to Ranbaxy.
• If you learn that you were given a drug that has been recalled, stop taking it, and consult your doctor about getting an alternative. The FDA is working with other drug manufacturers to assure there will not be a shortage.
One of the best ways to protect yourself from tainted drugs is to use care when ordering from online pharmacies:
• Use only prescriptions that have been prescribed by your doctor or other trusted healthcare professional.
• Deal with pharmacies that are licensed in the U.S.
• Avoid foreign websites selling drugs at deeply discounted prices.
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