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The Federal Food & Drug Administration has asked Pfizer Inc. to pull a popular leukemia drug off the market and has suspended clinical trials on a pain medication for osteoarthritis. The agency also requested that Johnson & Johnson (McNeil Consumer Healthcare) recall several lots of Tylenol and Motrin IB.
The Leukemia drug Mylotarg, which has been used for the past decade to treat patients with Acute Myeloid Leukemia, is said to have “failed to demonstrate clinical benefit to patients enrolled in trials,” according to a Reuters News Service story.
In fact, the patients receiving the chemotherapy drug suffered higher mortality rates than patients who received no treatment at all. The trial showed a fatality rate of 5.7 percent with Mylotarg, compared to a 1.4 percent fatality rate for patients who did not receive the medicine.
Patients with AML have few treatment options and often die within months of diagnosis. AML is an acute blood cancer that begins with the change in a single cell in the bone marrow. The development of AML increases with age, but people of any age can develop it, even children.
The FDA also suspended Pfiizer’s clinical trials on an experimental pain relief medication, Tanezumab, for osteoarthritis after reports the drug caused symptoms to worsen in some patients, even to the point of needing joint replacements.
According to a Bloomberg News report the FDA ask Pfizer to “show data on potential effects in clinical studies of the drug among patients with cancer pain, interstitial cystitis, chronic lower back pain and painful diabetic peripheral neuropathy.”
Johnson & Johnson has expanded an earlier recall of some of its popular over-the-counter medications to included Tylenol and Motrin IB due to a “musty smell,” according to a MSNBC report.
Other drugs already on recall from Johnson & Johnson include: Benadryl, Children’s Tylenol, Tylenol Extra Strength, Tylenol Day & Night and Tylenol PM.
“Federal regulators said McNeil was told about the problem in early 2008 but made a limited investigation and did not tell the FDA quickly.”
