Drug Safety Information for CAMPATH (Alemtuzumab)

FDA Safety-related Labeling Changes for CAMPATH (ALEMTUZUMAB) Biological Drug: Safety Information Link

Required post-approval safety study:

A prospective, registry-based observational exposure cohort study conducted in the United States, that compares the maternal, fetal, and infant outcomes of women with multiple sclerosis exposed to Lemtrada (alemtuzumab) during pregnancy to unexposed control populations (one with women with multiple sclerosis who have not been exposed to Lemtrada (alemtuzumab) in pregnancy and the other in women without multiple sclerosis). The registry will detect and record major and minor congenital malformations, spontaneous abortions, stillbirths, elective terminations, and any other adverse pregnancy outcomes. These outcomes will be assessed throughout pregnancy. Infant outcomes, including effects on postnatal growth and development, will be assessed through at least the first year of life. Due Date: 2021-04-30

Original FDA Drug Approval Date for CAMPATH: 2001-05-07

Adverse Drug Reactions for CAMPATH* (Alemtuzumab)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with CAMPATH
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Pyrexia	357
2	Cytomegalovirus infection	325
3	Death	264
4	Neutropenia	188
5	Pneumonia	185
6	Pancytopenia	163
7	Graft versus host disease	153
8	Multi-organ failure	152
9	Febrile neutropenia	151
10	Sepsis	145
11	Diarrhoea	136
12	Thrombocytopenia	133
13	Dyspnoea	133
14	Infection	131
15	Nausea	126
16	Hypotension	124
17	Respiratory failure	119
18	Vomiting	101
19	Renal failure	101
20	Adenovirus infection	96

* This side effect also appears in "Top 10 Side Effects of CAMPATH " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking CAMPATH
(associated with FDA Medwatch/FAERS Reports)

	Reason	# of FDA Reports
1	Chronic lymphocytic leukaemia	3657
2	Stem cell transplant	1202
3	Multiple sclerosis	981
4	Bone marrow conditioning regimen	699
5	Product used for unknown indication	503
6	Peripheral t-cell lymphoma unspecified	338
7	T-cell lymphoma	332
8	Immunosuppression	321
9	Renal transplant	280
10	T-cell prolymphocytic leukaemia	276

*Also a top-10 reason in AskaPatient Review Summary.

Types of Adverse Events for CAMPATH

Total Reports Filed with FDA: 16510

Number of FDA Adverse Event Reports by Patient Age for CAMPATH

Total Reports Filed with FDA: 16510*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Alemtuzumab (Campath)

Charts are based on 16510 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.