Recently added articles from Adverse Event Reporting News:

Joint FDA-EMEA effort seen yielding extra safety data for drug approval.(Biomarkers/International)(European Medicines Agency )

Jun 17, 2008; Mashaw, Rebecca ... FDA and the European Medicines Agency (EMEA) will allow drug companies to submit a single application to each agency with the results of seven new tests that evaluate kidney damage during animal studies of new drugs. Announcing the details June 12, FDA said the tests measure the ...

Bush formally asks Congress for $275 million to enhance drug safety; Spector critical of funds timing.(Drug safety)

Jun 17, 2008 ... After some reluctance, the Bush administration June 9 formally asked Congress for an increase of $275 million above its current budget request to enhance food and drug safety programs, according to Reuters. The White House initially requested an FDA budget of $2.4 billion for ...

EU urges more collaboration after heparin scandal.(European Medicines Agency)(European Union)

Jun 17, 2008 ... Western drug agencies need to step up cooperation to head off a repeat of the recent scandal over tainted heparin and protect patients from counterfeits, the head of EMEA said June 6, according to Reuters. "Heparin is a classic example of how things can go wrong," Thomas ...

Epilepsy drugs draw industry defense.

Jun 17, 2008 ... Drug companies are scrambling to try to convince FDA not to add warnings for suicidal behavior risks to a large class of epilepsy drugs also used widely for a variety of other conditions, "The Wall Street Journal" reported June 4. On June 1, at a closed meeting of epilepsy ...

FDA reviewing arthritis drugs for childhood cancer link.(Food and Drug Administration)

Jun 17, 2008 ... FDA issued an Early Communication about an ongoing safety review to investigate a possible association between the use of Tumor Necrosis Factor (TNF) blockers and the development of lymphoma and other cancers in children and young adults. The agency is investigating ...

Anemia drugs may speed growth of cancer.

Jun 17, 2008 ... According to new studies, drugs used widely to treat anemia in cancer patients may actually speed progression of the cancer in certain individuals, "The Washington Post" reported June 2. Recent controversy over erythropoiesis-stimulating agents (ESAs) such as Procrit, Epogen and ...

Acomplia linked to deaths since approval in U.K.

Jun 17, 2008 ... Sanofi-Aventis' Acomplia weight-loss treatment, rejected last June by a panel of FDA experts, was linked to five deaths in the U.K. since the medicine went on sale two years ago, Bloomberg reported June 3. There were 720 reports of adverse drug reactions mentioned from use of ...

Drug companies drain scientific brains from FDA, leaving less confident staff.(FDA management)(United States. Food and Drug Administration)

Jun 17, 2008 ... As drug companies siphon off FDA's most experienced scientists, they leave an increasingly leaner, less confident staff that is hesitant to put new drugs on the market, analysts say in article in the June 4 "USA Today." FDA's leadership is scrambling to recruit a new generation ...

Drop in FDA warning letters points to shift in enforcement.(FDA management)(United States. Food and Drug Administration)

Jun 17, 2008 ... FDA warning letters to industry dropped by half in the last 10 years, according to a June 6 report in "The Wall Street Journal." In 2002, FDA changed its policies and required that all warning letters go through FDA's chief counsel office, a move designed to strengthen the ...

Grassley, Barton press FDA on priorities of OCI.(FDA management)(United States. Food and Drug Administration)(Office of Criminal Investigations)

Jun 17, 2008 ... FDA's Office of Criminal Investigations (OCI) is coming under scrutiny from Congress, primarily from Republicans who are concerned with its autonomy and focus, "The Wall Street Journal" reported June 10. Established after the generic drug scandals in the late 1980s, OCI has ...

FDA requests boxed warnings on older class of antipsychotic drugs.(Warnings/recalls)(Food and Drug Administration)

Jun 17, 2008 ... FDA June 16 exercised its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA) to require manufacturers of "conventional" antipsychotic drugs to make safety-related changes to prescribing information or labeling to warn about an increased risk of death ...

FDA announces labeling changes for Regranex.(Warnings/recalls)(Food and Drug Administration)

Jun 17, 2008 ... FDA announced June 6 the addition of a boxed warning to the label of Regranex Gel 0.01% (becaplermin) to address the increased risk of cancer mortality in patients who use three or more tubes of the product. Regranex is a topical cream indicated for the treatment of leg and foot ulcers ...

Single lot of morphine recalled due to double dosage.(Warnings/recalls)(Brief article)

Jun 17, 2008 ... ETHEX Corporation notified healthcare professionals of a voluntary recall of a single lot of morphine sulfate 60 mg extended release tablets (Lot No. 91762) due to a report of a tablet with twice the appropriate thickness. Oversized tablets may contain as much as two times the labeled ...

Health Canada warns about medical devices with heparin coating.(Warnings/recalls)

Jun 17, 2008 ... Health Canada issued an alert to health care practitioners about medical devices coated with contaminated heparin. The devices include but are not limited to certain cardiovascular catheters, oxygenators, pumps, filters, blood reservoirs and blood collections tubes. To minimize ...

FDA issues warning on mercury fillings.(Warnings/recalls)(Food and Drug Administration)

Jun 17, 2008 ... FDA for the first time is warning that silver dental fillings, which contain mercury, may pose a safety concern for pregnant women and young children, The Associated Press reported June 13. The agency posted the precaution on its Web site earlier this month to settle a lawsuit, ...

FDA, facing criticism, bars doctors from drug trials.(Ethics)(Food and Drug Administration)

Jun 17, 2008 ... FDA has disqualified seven doctors from conducting clinical trials of drugs and medical devices so far this year, as many as in the three previous years combined, after lawmakers complained about delays in discipline, Bloomberg News reported June 6. Among those banned this year, ...

Researchers fail to reveal full drug pay.(Ethics)

Jun 17, 2008 ... A world-renowned child psychiatrist whose work has helped fuel an explosion in the use of powerful antipsychotic medicines in children earned at least $1.6 million in consulting fees from drug makers from 2000 to 2007 but for years did not report much of this income to university ...

Grassley asks FDA to probe Glaxo's Paxil communication.(Ethics)(Brief article)

Jun 17, 2008 ... Sen. Chuck Grassley (R-IA) has asked FDA to dig in on the data that GlaxoSmithKline submitted to the agency about the antidepressant Paxil to determine if the company concealed risk of suicide for users of the drug, "The Wall Street Journal" reported June 12. Grassley pointed ...

Six dead in China after drug injection.(International)(Brief article)

Jun 17, 2008 ... Chinese authorities have suspended the sale and use of a brand of antibody drugs after six people died following injections, state media reported June 2. The unidentified victims died in east China's Jiangxi province after being given human immunoglobulins at a hospital in the ...

Democrats preparing liability legislation.(Litigation)

Jun 17, 2008 ... Democrats rankled by a recent Supreme Court decision shielding medical device companies from state liability lawsuits plan to unveil legislation to reverse the ruling, the first of many expected efforts to chop away at federal rules that restrict consumers' ability to sue, "Congress Daily" ...