Makers of Opioids Told by FDA to Reduce Abuse

More than a dozen drug companies who make morphine, oxycodone, methadone, and other potent painkillers called opioids must develop plans to reduce the hundreds of deaths caused by the drugs each year, the U.S. Food and Drug Administration said.

The FDA has notified Johnson & Johnson, King Pharmaceuticals, Purdue Pharma, and other large generic drug companies about the new requirements. The companies and others produce the popular drugs, which are designed for patients battling severe pain, such as that due to cancer. However, while the drugs have proven effective at relieve extreme pain in some patients, they are prone to addiction and abuse.

Numerous FDA warnings about the potential for abuse of the drugs issued in recent years have failed to curb widespread misuse of the drugs, prompting the stronger FDA response, officials said. It is further evidence that powerful narcotics such as opioids, while legal and regulated by the government, are just as dangerous — and perhaps more so — than illegal drugs.

Rates of Opioid Use and Abuse Rise

The rates of abuse and accidental overdoses of opioids have risen in the past 10 years, with about 21 million opioid prescriptions written in 2007, according to the FDA.

In March 2009, the FDA plans to meet with 16 drug companies to discuss plans for reducing abuse of the drugs. Possible scenarios include stronger warning label language, cautionary letters sent to physicians, and greater restrictions on who can be given the drugs, the FDA said.

The companies invited to the meeting make drug products which contain generally very high doses of the painkillers and are therefore more prone to abuse and addiction.

Doctors and Patients Are To Blame

Much of the abuse can be blamed on physicians who wrongly prescribe opioids to patients who are not good candidates for the drugs. In many cases, prescriptions are written to patients who say they are suffering from migraine headaches, which is not an FDA-approved use of the powerful drugs. Some patients have overdosed on the drugs by chewing extended-release pills, which are supposed to be swallowed whole.

Opioids Must Be Handled Carefully

Tens of millions of Americans currently are prescribed morphine, oxycodone, and other powerful opioids, but the real number of people taking the drugs is unknown. Drug addicts are drawn to the drugs, which provide potent doses of painkiller and can be highly addictive. Break-ins at pharmacies frequently target these types of drugs, which is evidence of their popularity on the streets.

The fact that doctors improperly prescribing opioids for migraine headaches and other conditions for which the drugs are not appropriate is troublesome. The use of the drugs should only be used for patients coping with extreme pain which cannot be controlled with strong does. Handing opioids out like candy to patients who are not good candidates for the drugs only increases the chances that patients will become addicted or otherwise abuse them, leading to accidental overdoses or intentional suicides.

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