Drug & Device News

FDA Programs to Improve Safety

The FDA is attempting to increase the safety of medical devices by implementing a new program titled the Postmarket Transformation Initiative. The program, which will allow the FDA to identify, analyze and act on problem medical devices more quickly, is being overseen by the FDA's Center for Devices and Radiological Health's (CDRH). Those involved in this initiative intend to work toward an electronic reporting system for adverse medical device events and improved internal collaboration on post-market safety issues. The team is expected to send its recommendations to the CDRH within 4 months.

Warning on Eczema Creams

Eczema drugs Elidel Cream (pimecrolimus) and Protopic Ointment (tacrolimus) have received updated labeling about a possible risk of cancer. The new labeling also clarifies that these drugs are recommended for use as second-line treatments – meaning they should be prescribed only after other prescription topical medicines have been tried. In February 2005, the FDA's Pediatric Advisory Committee recommended that the labeling be updated with a boxed warning and a Medication Guide about the possible cancer risk for these drugs. Although a causal link has not been established, rare reports of cancer (for example, skin cancer and lymphoma) have been reported in patients who had been using these products.

Counterfeit Botox Distributors Sentenced

Two Florida doctors, Chad Livdahl and Zahra Karim, who last November pleaded guilty to selling a non-FDA-approved drug similar to the popular anti-wrinkle drug Botox, have been handed prison terms of up to 9 years and 6 years, respectively. At the Jan. 26 sentencing, U.S. District Court Judge James Cohn also ordered the doctors to pay restitution. The fake Botox sales scheme came to light after several people were poisoned with the botulinum toxin type A the convicted doctors and others were selling across the United States as a substitute for the more expensive Botox.

Heart Defibrillator Manufacturer's Woes Grow

The New York Times reports that the U.S. Attorney in Minneapolis has subpoenaed records on Guidant Corp. from the plaintiffs pursuing a Texas case against the device maker. The documents sought may indicate company executives knew their heart defibrillator devices could short-circuit but failed to warn consumers, health care providers and the government. (Meier, The New York Times, 1/28/06.) According to the Times' report, the documents show that executives met to discuss the possibility of informing health care providers of reported problems in January 2005. No such disclosure was made, however, until June 2005.

Tissue Supplier Shut Down

Biomedical Tissue Services Ltd. (BTS), of Fort Lee, NJ, a human tissue-recovery firm, along with its CEO and Executive Director of Operations, were ordered on Feb. 3 to immediately cease all manufacturing operations. The company's already-distributed tissue products were recalled at the same time because it was determined that the firm's manufacturing practices, found deficient by the FDA, could lead to the transmission of communicable diseases to tissue recipients. Among the grievances against the company were allegations that donors were inadequately screened for risk factors for, or clinical evidence of, relevant communicable diseases. In addition, the FDA found numerous instances where death certificates maintained in BTS's files contradicted death certificates obtained from the state where the death occurred on issues such as cause, place, and time of death, and the identity of the next of kin.

Drug Packaging Instructions Are Changing

The FDA is instituting a new format for the package inserts for prescription drugs. The changes, the first in 25 years, will include a new “highlights” section at the beginning of the inserts synopsizing the most important benefit and risk information, making it easier for doctors to decide what medications are right for their patients. The date of initial product approval will also be included so that physicians will know just how much of a “track record” the drug may have.

Foreign-Filled Prescriptions May Not Be What They Seem

An investigation recently conducted by the FDA has found that many foreign medications, although mar-keted under the same or similar-sounding brand names as those in the United States, contain different active ingredients than those in the U.S. “Consumers who fill U.S. prescriptions abroad, either when traveling or when shopping at foreign internet pharmacies, need to be aware of this potential health hazard,” said Dr. Murray Lumpkin, Deputy Commissioner for Inter-national and Special Programs. “The name of a drug bought from another country may be identical or similar to the name on the U.S. prescription, but the active ingredient in the medicine may be different and not provide the right treatment.”

For example, the FDA notes that, in the United States, “Flomax” is a brand name for tamsulosin, a treatment for an enlarged prostate; in Italy, the active ingredient in the product called “Flomax” is morniflumate, an anti-inflammatory drug. In the United States, “Norpramin” is the brand name for an anti-depression drug containing desipramine; in Spain, the same brand name, “Norpramin,” is used for a drug that contains omeprazole, a treatment for stomach ulcers. While some of the identical brand names have different active ingredients appropriate for the same health condition, even these products should not be substituted without the guidance of a healthcare professional because of the potential for different doses, side effects, allergies, and interactions with other drugs, says the FDA release. In addition, the FDA has found 105 U.S. brand names that have foreign counterparts that look or sound so similar that consumers who fill such prescriptions abroad may receive a drug with the wrong active ingredient. For example, in the United Kingdom, “Amyben,” a brand name for a drug product containing amiodarone, used to treat abnormal heart rhythms, could be mistaken for “Ambien,” a U.S. brand name for a sleeping pill. For more information, see the FDA's Public Health Advisory at fda.gov/oc/opacom/reports/confusingnames.html.

FDA Committee's Surprise Recommendation

The New York Times reported on Feb. 10 that an FDA advisory panel has voted to recommend that patients be warned of increased heart attack risks with the use of stimulants such as Ritalin, a commonly prescribed drug for the treatment of Attention Deficit Disorder and Hyperactivity. (Harris, The New York Times 2/10/06.) The Times noted that the recommendation was unexpected because FDA officials had asked the committee to convene only to help determine how to test for possible heart risks.

FDA Programs to Improve Safety

The FDA is attempting to increase the safety of medical devices by implementing a new program titled the Postmarket Transformation Initiative. The program, which will allow the FDA to identify, analyze and act on problem medical devices more quickly, is being overseen by the FDA's Center for Devices and Radiological Health's (CDRH). Those involved in this initiative intend to work toward an electronic reporting system for adverse medical device events and improved internal collaboration on post-market safety issues. The team is expected to send its recommendations to the CDRH within 4 months.

Warning on Eczema Creams

Eczema drugs Elidel Cream (pimecrolimus) and Protopic Ointment (tacrolimus) have received updated labeling about a possible risk of cancer. The new labeling also clarifies that these drugs are recommended for use as second-line treatments – meaning they should be prescribed only after other prescription topical medicines have been tried. In February 2005, the FDA's Pediatric Advisory Committee recommended that the labeling be updated with a boxed warning and a Medication Guide about the possible cancer risk for these drugs. Although a causal link has not been established, rare reports of cancer (for example, skin cancer and lymphoma) have been reported in patients who had been using these products.

Counterfeit Botox Distributors Sentenced

Two Florida doctors, Chad Livdahl and Zahra Karim, who last November pleaded guilty to selling a non-FDA-approved drug similar to the popular anti-wrinkle drug Botox, have been handed prison terms of up to 9 years and 6 years, respectively. At the Jan. 26 sentencing, U.S. District Court Judge James Cohn also ordered the doctors to pay restitution. The fake Botox sales scheme came to light after several people were poisoned with the botulinum toxin type A the convicted doctors and others were selling across the United States as a substitute for the more expensive Botox.

Heart Defibrillator Manufacturer's Woes Grow

The New York Times reports that the U.S. Attorney in Minneapolis has subpoenaed records on Guidant Corp. from the plaintiffs pursuing a Texas case against the device maker. The documents sought may indicate company executives knew their heart defibrillator devices could short-circuit but failed to warn consumers, health care providers and the government. (Meier, The New York Times, 1/28/06.) According to the Times' report, the documents show that executives met to discuss the possibility of informing health care providers of reported problems in January 2005. No such disclosure was made, however, until June 2005.

Tissue Supplier Shut Down

Biomedical Tissue Services Ltd. (BTS), of Fort Lee, NJ, a human tissue-recovery firm, along with its CEO and Executive Director of Operations, were ordered on Feb. 3 to immediately cease all manufacturing operations. The company's already-distributed tissue products were recalled at the same time because it was determined that the firm's manufacturing practices, found deficient by the FDA, could lead to the transmission of communicable diseases to tissue recipients. Among the grievances against the company were allegations that donors were inadequately screened for risk factors for, or clinical evidence of, relevant communicable diseases. In addition, the FDA found numerous instances where death certificates maintained in BTS's files contradicted death certificates obtained from the state where the death occurred on issues such as cause, place, and time of death, and the identity of the next of kin.

Drug Packaging Instructions Are Changing

The FDA is instituting a new format for the package inserts for prescription drugs. The changes, the first in 25 years, will include a new “highlights” section at the beginning of the inserts synopsizing the most important benefit and risk information, making it easier for doctors to decide what medications are right for their patients. The date of initial product approval will also be included so that physicians will know just how much of a “track record” the drug may have.

Foreign-Filled Prescriptions May Not Be What They Seem

An investigation recently conducted by the FDA has found that many foreign medications, although mar-keted under the same or similar-sounding brand names as those in the United States, contain different active ingredients than those in the U.S. “Consumers who fill U.S. prescriptions abroad, either when traveling or when shopping at foreign internet pharmacies, need to be aware of this potential health hazard,” said Dr. Murray Lumpkin, Deputy Commissioner for Inter-national and Special Programs. “The name of a drug bought from another country may be identical or similar to the name on the U.S. prescription, but the active ingredient in the medicine may be different and not provide the right treatment.”

For example, the FDA notes that, in the United States, “Flomax” is a brand name for tamsulosin, a treatment for an enlarged prostate; in Italy, the active ingredient in the product called “Flomax” is morniflumate, an anti-inflammatory drug. In the United States, “Norpramin” is the brand name for an anti-depression drug containing desipramine; in Spain, the same brand name, “Norpramin,” is used for a drug that contains omeprazole, a treatment for stomach ulcers. While some of the identical brand names have different active ingredients appropriate for the same health condition, even these products should not be substituted without the guidance of a healthcare professional because of the potential for different doses, side effects, allergies, and interactions with other drugs, says the FDA release. In addition, the FDA has found 105 U.S. brand names that have foreign counterparts that look or sound so similar that consumers who fill such prescriptions abroad may receive a drug with the wrong active ingredient. For example, in the United Kingdom, “Amyben,” a brand name for a drug product containing amiodarone, used to treat abnormal heart rhythms, could be mistaken for “Ambien,” a U.S. brand name for a sleeping pill. For more information, see the FDA's Public Health Advisory at fda.gov/oc/opacom/reports/confusingnames.html.

FDA Committee's Surprise Recommendation

The New York Times reported on Feb. 10 that an FDA advisory panel has voted to recommend that patients be warned of increased heart attack risks with the use of stimulants such as Ritalin, a commonly prescribed drug for the treatment of Attention Deficit Disorder and Hyperactivity. (Harris, The New York Times 2/10/06.) The Times noted that the recommendation was unexpected because FDA officials had asked the committee to convene only to help determine how to test for possible heart risks.